Paroxetine is indicated in adults for the treatment of:

{ "type": "p", "children": [], "text": "Paroxetine is indicated in adults for the treatment of:" }

{ "type": "ul", "children": [ "Major depressive disorder (MDD)", "Obsessive compulsive disorder (OCD)", "Panic disorder (PD)", "Social anxiety disorder (SAD)", "Generalized anxiety disorder (GAD)", "Posttraumatic stress disorder (PTSD)" ], "text": "" }

Administer paroxetine oral suspension as a single daily dose in the morning, with or without food.

Shake the oral suspension well before administration.

The recommended starting dosages and maximum dosages of paroxetine oral suspension in patients with MDD, OCD, PD, and PTSD are presented in Table 1.

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

Table 1: Recommended Daily Dosage of Paroxetine Oral Suspension in Patients with MDD, OCD, PD, and PTSD

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="564.053"> <colgroup> <col width="21.4218344730016%"/> <col width="37.2907333176138%"/> <col width="41.2874322093846%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Indication</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Starting Dose</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Maximum Dose</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">MDD<br/> </td><td align="center" class="Rrule" valign="middle">20 mg<br/> </td><td align="center" class="Rrule" valign="middle">50 mg<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">OCD<br/> </td><td align="center" class="Rrule" valign="middle">20 mg<br/> </td><td align="center" class="Rrule" valign="middle">60 mg<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">PD<br/> </td><td align="center" class="Rrule" valign="middle">10 mg<br/> </td><td align="center" class="Rrule" valign="middle">60 mg<br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">PTSD<br/> </td><td align="center" class="Rrule" valign="middle">20 mg<br/> </td><td align="center" class="Rrule" valign="middle">50 mg<br/> </td> </tr> </tbody> </table></div>

SAD

The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of paroxetine oral suspension was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of paroxetine oral suspension has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily [see Clinical Studies (14.4)].

GAD

The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of paroxetine oral suspension in GAD was demonstrated in patients dosed in a range of 20 mg to 50 mg daily. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg daily [see Clinical Studies (14.5)].

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

Prior to initiating treatment with paroxetine oral suspension or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6)].

The recommended initial dosage is 10 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day.

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI and initiation of paroxetine oral suspension. In addition, at least 14 days must elapse after stopping paroxetine oral suspension before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

Adverse reactions may occur upon discontinuation of paroxetine oral suspension[see Warnings and Precautions (5.7)]. Gradually reduce the dosage rather than stopping paroxetine oral suspension abruptly whenever possible.

Paroxetine Oral Suspension is available as:

{ "type": "p", "children": [], "text": "Paroxetine Oral Suspension is available as:" }

{ "type": "ul", "children": [ "10 mg/5 mL orange colored, orange flavored suspension in bottles containing 250 mL." ], "text": "" }

Paroxetine oral suspension is contraindicated in patients:

{ "type": "p", "children": [], "text": "Paroxetine oral suspension is contraindicated in patients:" }

{ "type": "ul", "children": [ "Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].\n", "Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7)].\n", "Taking pimozide because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7)].\n", "With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine oral suspension [see Adverse Reactions (6.1), (6.2)]." ], "text": "" }

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 2.

Table 2: Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="550"> <colgroup> <col width="22.7256208358571%"/> <col width="77.2743791641429%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Age Range</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Drug-Placebo Difference in Number of Patients with Suicidal Thoughts and Behaviors per 1,000 Patients Treated</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold">Increases </span><span class="Bold">Compared </span><span class="Bold">to </span><span class="Bold">Placebo</span><span class="Bold"></span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">&lt;18 years old <br/> </td><td align="center" class="Rrule" valign="middle">14 additional cases<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">18-24 years old <br/> <br/> </td><td align="center" class="Rrule" valign="middle">5 additional cases<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> Decreases </span><span class="Bold">Compared </span><span class="Bold">to</span><span class="Bold"></span><span class="Bold"> Placebo</span><span class="Bold"></span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">25-64 years old <br/> <br/> </td><td align="center" class="Rrule" valign="middle">1 fewer case<br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">≥65 years old <br/> <br/> </td><td align="center" class="Rrule" valign="middle">6 fewer cases<br/> </td> </tr> </tbody> </table></div>

Paroxetine oral suspension is not approved for use in pediatric patients.

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing paroxetine oral suspension , in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

SSRIs, including paroxetine, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7.1)]. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of paroxetine oral suspension with MAOIs is contraindicated. In addition, do not initiate paroxetine oral suspension in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking paroxetine oral suspension , discontinue paroxetine oral suspension before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7)].

Monitor all patients taking paroxetine oral suspension for the emergence of serotonin syndrome. Discontinue treatment with paroxetine oral suspension and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of paroxetine oral suspension with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

The CYP2D6 inhibitory properties of paroxetine can elevate plasma levels of thioridazine and pimozide. Since thioridazine and pimozide given alone produce prolongation of the QTc interval and increase the risk of serious ventricular arrhythmias, the use of paroxetine is contraindicated in combination with thioridazine and pimozide [see Contraindications (4), Drug Interactions (7), Clinical Pharmacology (12.3)].

Based on meta-analyses of epidemiological studies, exposure to paroxetine in the first trimester of pregnancy is associated with a less than 2-fold increase in the rate of cardiovascular malformations among infants. For women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine oral suspension should be initiated only after consideration of the other available treatment options [see Use in Specific Populations (8.1)].

Drugs that interfere with serotonin reuptake inhibition, including paroxetine, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations (8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients about the increased risk of bleeding associated with the concomitant use of paroxetine oral suspension and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

In patients with bipolar disorder, treating a depressive episode with paroxetine oral suspension or another antidepressant may precipitate a mixed/manic episode. During controlled clinical trials of paroxetine oral suspension, hypomania or mania occurred in approximately 1% of paroxetine oral suspension-treated unipolar patients compared to 1.1% of active-control and 0.3% of placebo-treated unipolar patients. Prior to initiating treatment with paroxetine oral suspension, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Dosage and Administration (2.7)].

During clinical trials of GAD and PTSD, gradual decreases in the daily dose by 10 mg/day at weekly intervals followed by 1 week at 20 mg/day was used before treatment was discontinued. The following adverse reactions were reported at an incidence of 2% or greater for paroxetine and were at least twice that reported for placebo: Abnormal dreams, paresthesia, and dizziness. Adverse reactions have been reported upon discontinuation of treatment with paroxetine in pediatric patients. The safety and effectiveness of paroxetine in pediatric patients have not been established [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.4)].

Paroxetine oral suspension has not been systematically evaluated in patients with seizure disorders. Patients with history of seizures were excluded from clinical studies. During clinical studies, seizures occurred in 0.1% of patients treated with paroxetine. Paroxetine should be prescribed with caution in patients with a seizure disorder. Discontinue paroxetine oral suspension in any patient who develops seizures.

The pupillary dilation that occurs following use of many antidepressant drugs including paroxetine may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Cases of angle-closure glaucoma associated with use of paroxetine have been reported. Avoid use of antidepressants, including paroxetine oral suspension in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SSRIs, including paroxetine. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue paroxetine oral suspension and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs [see Use in Specific Populations (8.5)].

Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced with concomitant use of paroxetine oral suspension as a result of paroxetine’s irreversible inhibition of CYP2D6 and lower blood levels of tamoxifen [see Drug Interactions (7)]. One study suggests that the risk may increase with longer duration of coadministration. However, other studies have failed to demonstrate such a risk. When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition.

Epidemiological studies on bone fracture risk during exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment.

Use of SSRIs, including paroxetine, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm. It is important for prescribers to inquire about sexual function prior to initiation of paroxetine oral suspension and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data for paroxetine are from:

Adverse Reactions Leading to Discontinuation

Twenty percent (1,199/6,145) of patients treated with paroxetine in clinical trials in MDD and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with paroxetine in clinical trials in SAD, OCD, PD, GAD, and PTSD, respectively, discontinued treatment due to an adverse reaction. The most common adverse reactions (>1%) associated with discontinuation (i.e., those adverse reactions associated with dropout at a rate approximately twice or greater for paroxetine compared to placebo) are presented in Table 3:

Table 3: Adverse Reactions Reported as Leading to Discontinuation (≥1% of Paroxetine -Treated Patients and Greater than Placebo) in MDD, OCD, PD, SAD, GAD, and PTSD Trials

Where numbers are not provided the incidence of the adverse reactions in patients treated with paroxetine was not >1% or was not greater than or equal to 2 times the incidence of placebo.

a. Incidence corrected for gender.

Most Common Adverse Reactions

The most commonly observed adverse reactions associated with the use of paroxetine (incidence of 5% or greater and at least twice that for placebo) were:

MDD: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

OCD: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

PD: Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

SAD: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.

GAD: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

PTSD: Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Adverse Reactions in Patients with MDD

Table 4 presents the adverse reactions that occurred at an incidence of 1% or more and greater than placebo in clinical trials of paroxetine-treated patients with MDD.

Table 4: Adverse Reactions (≥1% of Paroxetine-Treated Patients and Greater than Placebo) in 6-Week Clinical Trials for MDD a. Includes mostly “lump in throat” and “tightness in throat.” b. Percentage corrected for gender. c. Mostly “ejaculatory delay.” d. Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction,” and “impotence.” e. Includes mostly “difficulty with micturition” and “urinary hesitancy.” f. Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.” Adverse Reactions in Patients with OCD, PD, and SAD Table 5 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with OCD, PD, and SAD Table 5. Adverse Reactions (≥2% of Paroxetine-Treated Patients and Greater than Placebo) in 10 to 12-Week Clinical Trials for OCD, PD, and SAD  

a. Percentage corrected for gender. Adverse Reactions in Patients with GAD and PTSD Table 6 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with GAD and PTSD. Table 6.Adverse Reactions (≥2% of Paroxetine-Treated Patients and Greater than Placebo) in 8- to 12-Week Clinical Trials for GAD and PTSDa

 a.       Percentage corrected for gender.

Dose Dependent Adverse Reactions

MDD 

A comparison of adverse reaction rates in a fixed-dose study comparing paroxetine 10 mg, 20 mg, 30 mg, and 40 mg once daily with placebo in the treatment of MDD revealed dose dependent adverse reactions, as shown in Table 7: 

Table 7. Adverse Reactions (≥5% of Paroxetine-Treated Patients and ≥ Twice the Rate of Placebo) in a Dose-Comparison Trial in the Treatment of MDD OCD

In a fixed-dose study comparing placebo and paroxetine 20 mg, 40 mg, and 60 mg in the treatment of OCD, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned.

PD

In a fixed-dose study comparing placebo and paroxetine 10 mg, 20 mg, and 40 mg in the treatment of PD, the following adverse reactions were shown to be dose-dependent: asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation.

SAD

In a fixed-dose study comparing placebo and paroxetine 20 mg, 40 mg and 60 mg in the treatment of SAD, for most of the adverse reactions, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned.

GAD

In a fixed-dose study comparing placebo and paroxetine 20 mg and 40 mg in the treatment of GAD, the following adverse reactions were shown to be dose-dependent: asthenia, constipation, and abnormal ejaculation.

PTSD

In a fixed-dose study comparing placebo and paroxetine 20 mg and 40 mg in the treatment of PTSD, the following adverse reactions were shown to be dose-dependent: impotence and abnormal ejaculation.

Male and Female Sexual Dysfunction

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

The percentage of patients reporting symptoms of sexual dysfunction in males and females with MDD, OCD, PD, SAD, GAD, and PTSD are displayed in Table 8.

Table 8. Adverse Reactions Related to Sexual Dysfunction in Patients Treated with Paroxetine in Clinical Trials of MDD, OCD, PD, SAD, GAD, and PTSD

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="550"> <colgroup> <col width="41.6212286441294%"/> <col width="31.5642796558827%"/> <col width="26.8144916999879%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold"> Paroxetine</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold">Placebo</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> <br/> <span class="Bold">n (males)</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold">1446 </span><span class="Bold">%</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold">1042 </span><span class="Bold">%</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> <br/> Decreased Libido<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 6 to 15<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 0 to 5<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> <br/> Ejaculatory Disturbance<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 13 to 28<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 0 to 2<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> <br/> Impotence<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 2 to 9<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 0 to 3<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"> <br/> <span class="Bold">n (females)</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold">1822 </span><span class="Bold">%</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> <span class="Bold">1340 </span><span class="Bold">%</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> <br/> Decreased Libido<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 0 to 9<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 0 to 2<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle"> <br/> Orgasmic Disturbance<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 2 to 9<br/> </td><td align="center" class="Rrule" valign="middle"> <br/> 0 to 1<br/> </td> </tr> </tbody> </table></div>

Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

Hallucinations

In pooled clinical trials of paroxetine, hallucinations were observed in 0.2% of paroxetine-treated patients compared to 0.1% of patients receiving placebo. 

Less Common Adverse Reactions 

The following adverse reactions occurred during the clinical studies of paroxetine and are not included elsewhere in the labeling. 

Adverse reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 patients. 

Body as a Whole 

Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer. 

Cardiovascular System Frequent: Hypertension, tachycardia; infrequent: Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor,phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles. 

Digestive System Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, abnormal liver function tests, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries. Endocrine System Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis. Hemic and Lymphatic Systems 

Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia. Metabolic and Nutritional Frequent: Weight gain; infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased. Musculoskeletal System Frequent: Arthralgia; infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany. Nervous System Frequent: Emotional lability, vertigo; infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressivereaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome. Respiratory System Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration. Skin and Appendages Frequent: Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash. Special Senses 

Frequent: Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect. Urogenital System Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.

The following reactions have been identified during post approval use of paroxetine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), syndrome of inappropriate ADH secretion, prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, oculogyric crisis which has been associated with concomitant use of pimozide; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anosmia, hyposmia, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women. There has been a case report of severe hypotension when paroxetine was added to chronic metoprolol treatment.

Table 9 presents clinically significant drug interactions with paroxetine.

{ "type": "p", "children": [], "text": "Table 9 presents clinically significant drug interactions with paroxetine." }

Table 9: Clinically Significant Drug Interactions with Paroxetine

{ "type": "p", "children": [], "text": "\nTable 9: Clinically Significant Drug Interactions with Paroxetine\n" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="624"> <colgroup> <col width="22.7340743907653%"/> <col width="77.2659256092347%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Monoamine Oxidase Inhibitors (MAOIs)</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td class="Rrule" valign="top">The concomitant use of SSRIs, including paroxetine, and MAOIs increases the risk of serotonin syndrome.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Paroxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[see Dosage and Administration (2.5), Contraindications (4), Warnings and Precautions </span><span class="Italics">(5.2)]</span>.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td class="Rrule" valign="top">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Pimozide and Thioridazine</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td class="Rrule" valign="top">Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Paroxetine is contraindicated in patients taking pimozide or thioridazine <span class="Italics">[see Contraindications (4)].</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Other Serotonergic Drugs</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td class="Rrule" valign="top">The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of paroxetine and/or concomitant serotonergic drugs <span class="Italics">[see Warnings and Precautions (5.2)]</span>.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td class="Rrule" valign="top">other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span><span class="Italics"></span> <br/> </td><td class="Rrule" valign="top">Theconcurrentuse of anantiplateletagentoranticoagulant with paroxetine maypotentiate the risk ofbleeding.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics"> Intervention</span><span class="Italics"></span> <br/> </td><td class="Rrule" valign="top">Informpatientsofthe increasedrisk of bleedingassociated with the concomitantuse ofparoxetine andantiplateletagentsand anticoagulants. For patients takingwarfarin,carefullymonitor the international normalizedratio<span class="Italics"> [see</span><span class="Italics">Warningsand Precautions(5.5)]</span>.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Examples</span><span class="Italics"></span> <br/> </td><td class="Rrule" valign="top">aspirin, clopidogrel, heparin,warfarin<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Drugs </span><span class="Bold">Highly</span><span class="Bold">Bound toPlasmaProtein</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics"> Clinical Impact</span> <br/> </td><td class="Rrule" valign="top">Paroxetine is highlybound to plasma protein. The concomitant useof paroxetine with another drugthat ishighlyboundto plasma protein may increasefreeconcentrationsofparoxetine or othertightly-bound drugs in plasma<span class="Italics">.</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Monitor foradversereactionsandreducedosageof paroxetine orother protein-bound drugs as warranted.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td class="Rrule" valign="top">warfarin<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Drugs</span><span class="Bold"></span><span class="Bold"> Metabolized </span><span class="Bold">by </span><span class="Bold">CYP2D6</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td class="Rrule" valign="top">Paroxetine is a CYP2D6inhibitor <span class="Italics">[see Clinical Pharmacology(12.3)].</span>The concomitant use of paroxetine with a CYP2D6substrate may increasetheexposure of the CYP2D6substrate.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Decreasethe dosage of a CYP2D6substrate if neededwith concomitantparoxetine use.Conversely,anincreaseindosageof a CYP2D6substratemay be needed if paroxetine is discontinued.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Examples</span><span class="Italics"></span> <br/> </td><td class="Rrule" valign="top">propafenone,flecainide,atomoxetine, desipramine, dextromethorphan,metoprolol,nebivolol,perphenazine,tolterodine,venlafaxine, risperidone. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">Tamoxifen</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics"> Clinical Impact</span><span class="Bold"></span> <br/> </td><td class="Rrule" valign="top">Concomitant use oftamoxifen with paroxetine maylead to reduced plasmaconcentrations ofthe active metabolite (endoxifen)andreducedefficacyoftamoxifen.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Consideruse ofanalternativeantidepressantwithlittle or noCYP2D6 inhibition <span class="Italics">[seeWarningsand Precautions(5.11)].</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="top"><span class="Bold"> Fosamprenavir/Ritonavir</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span><span class="Bold"></span> <br/> </td><td class="Rrule" valign="top">Co-administration of fosamprenavir/ritonavir withparoxetine significantly decreased plasmalevels of paroxetine.<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td class="Rrule" valign="top">Anydose adjustment should be guidedbyclinicaleffect (tolerabilityandefficacy).<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"624\">\n<colgroup>\n<col width=\"22.7340743907653%\"/>\n<col width=\"77.2659256092347%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Monoamine Oxidase Inhibitors (MAOIs)</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">The concomitant use of SSRIs, including paroxetine, and MAOIs increases the risk of serotonin syndrome.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Paroxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class=\"Italics\">[see Dosage and Administration (2.5), Contraindications (4), Warnings and Precautions </span><span class=\"Italics\">(5.2)]</span>.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Pimozide and Thioridazine</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Paroxetine is contraindicated in patients taking pimozide or thioridazine <span class=\"Italics\">[see Contraindications (4)].</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Other Serotonergic Drugs</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of paroxetine and/or concomitant serotonergic drugs <span class=\"Italics\">[see Warnings and Precautions (5.2)]</span>.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span><span class=\"Italics\"></span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Theconcurrentuse of anantiplateletagentoranticoagulant with paroxetine maypotentiate the risk ofbleeding.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\"> Intervention</span><span class=\"Italics\"></span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Informpatientsofthe increasedrisk of bleedingassociated with the concomitantuse ofparoxetine andantiplateletagentsand anticoagulants. For patients takingwarfarin,carefullymonitor the international normalizedratio<span class=\"Italics\"> [see</span><span class=\"Italics\">Warningsand Precautions(5.5)]</span>.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span><span class=\"Italics\"></span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">aspirin, clopidogrel, heparin,warfarin<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Drugs </span><span class=\"Bold\">Highly</span><span class=\"Bold\">Bound toPlasmaProtein</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\"> Clinical Impact</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Paroxetine is highlybound to plasma protein. The concomitant useof paroxetine with another drugthat ishighlyboundto plasma protein may increasefreeconcentrationsofparoxetine or othertightly-bound drugs in plasma<span class=\"Italics\">.</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Monitor foradversereactionsandreducedosageof paroxetine orother protein-bound drugs as warranted.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">warfarin<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Drugs</span><span class=\"Bold\"></span><span class=\"Bold\"> Metabolized </span><span class=\"Bold\">by </span><span class=\"Bold\">CYP2D6</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Paroxetine is a CYP2D6inhibitor <span class=\"Italics\">[see Clinical Pharmacology(12.3)].</span>The concomitant use of paroxetine with a CYP2D6substrate may increasetheexposure of the CYP2D6substrate.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Decreasethe dosage of a CYP2D6substrate if neededwith concomitantparoxetine use.Conversely,anincreaseindosageof a CYP2D6substratemay be needed if paroxetine is discontinued.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span><span class=\"Italics\"></span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">propafenone,flecainide,atomoxetine, desipramine, dextromethorphan,metoprolol,nebivolol,perphenazine,tolterodine,venlafaxine, risperidone. <br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Tamoxifen</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\"> Clinical Impact</span><span class=\"Bold\"></span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Concomitant use oftamoxifen with paroxetine maylead to reduced plasmaconcentrations ofthe active metabolite (endoxifen)andreducedefficacyoftamoxifen.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Consideruse ofanalternativeantidepressantwithlittle or noCYP2D6 inhibition <span class=\"Italics\">[seeWarningsand Precautions(5.11)].</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\"> Fosamprenavir/Ritonavir</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span><span class=\"Bold\"></span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Co-administration of fosamprenavir/ritonavir withparoxetine significantly decreased plasmalevels of paroxetine.<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td class=\"Rrule\" valign=\"top\">Anydose adjustment should be guidedbyclinicaleffect (tolerabilityandefficacy).<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including paroxetine, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866- 961-2388 or visiting online at https://womensmentalhealth.org/ clinical-and-research-programs/pregnancyregistry/antidepressants/.

Risk Summary

Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.5) and Clinical Considerations].

Paroxetine is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. While individual epidemiological studies on the association between paroxetine use and cardiac malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see Data). There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including paroxetine during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations). For women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options.

No evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits. These doses are approximately 8 (rat) and less than 2 (rabbit) times the maximum recommended human dose (MRHD – 60 mg) on an mg/m2 basis. When paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. This effect occurred at a dose of 1 mg/kg/day which is less than the MRHD on an mg/m2 basis (See Data).

The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryofetal risk

Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and the postpartum.

Maternal Adverse Reactions

Use of paroxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.5)].

Fetal/Neonatal adverse reactions

Neonates exposed to paroxetine and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs or possibly a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2)].

Data

Human Data

Published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformations have reported inconsistent results; however, meta-analyses of population-based cohort studies published between 1996 – 2017 indicate a less than 2-fold increased risk for overall cardiovascular malformations. Specific cardiac malformations identified in two meta-analyses include an approximately 2 to 2.5-fold increased risk for right ventricular outflow tract defects. One meta-analysis also identified an increased risk (less than 2-fold) for bulbus cordis anomalies and anomalies of cardiac septal closure, and an increased risk for atrial septal defect (pooled OR 2.38, 95% CI 1.14-4.97). Important limitations of the studies included in these meta-analyses include potential confounding by indication, depression severity, and potential exposure misclassification.

Exposure to SSRIs, particularly later in pregnancy, may have an increased risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality.

Animal Data

Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 8 (rat) and less than 2 (rabbit) times the maximum recommended human dose (MRHD – 60 mg) on an mg/m2 basis. These studies have revealed no evidence of developmental effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. This effect occurred at a dose of 1 mg/kg/day which is less than the MRHD on an mg/m2 basis. The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known.

Risk Summary 

Data from the published literature report the presence of paroxetine in human milk (see Data). There are reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to paroxetine through breast milk (see Clinical Considerations). There are no data on the effect of paroxetine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for paroxetine and any potential adverse effects on the breastfed child from paroxetine or from underlying maternal condition.

Clinical Considerations

Infants exposed to paroxetine should be monitored for agitation, irritability, poor feeding and poor weight gain.

Data

Published literature suggests the presence of paroxetine in human milk with relative infant doses ranging between 0.4% to 2.2%, and a milk/plasma ratio of <1. No significant amounts were detected in the plasma of infants after breastfeeding.

Infertility

Male

Based on findings from clinical studies, paroxetine may affect sperm quality which may impair fertility; it is not known if this effect is reversible [see Nonclinical Toxicology (13.1)].

The safety and effectiveness of paroxetine oral suspension in pediatric patients have not been established [see Box Warning]. Effectiveness was not demonstrated in three placebo-controlled trials in 752 paroxetine-treated pediatric patients with MDD.

Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1)]. Decreased appetite and weight loss have been observed in association with the use of SSRIs.

In placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with paroxetine and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.

Adverse reactions upon discontinuation of treatment with paroxetine in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain.

In premarketing clinical trials with paroxetine, 17% of patients treated with paroxetine (approximately 700) were 65 years of age or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

SSRIs including paroxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.7)].

Increased plasma concentrations of paroxetine oral suspension occur in patients with renal and hepatic impairment. The initial dosage of paroxetine oral suspension should be reduced in patients with severe renal impairment and in patients with severe hepatic impairment [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

The following have been reported with paroxetine overdosage:

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{ "type": "ul", "children": [ "Seizures, which may be delayed, and altered mental status including coma. ", "Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. ", "Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). " ], "text": "" }

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose.

{ "type": "p", "children": [], "text": "Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose." }

Consider contacting a poison center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

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Paroxetine Oral Suspension contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'­methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3•HCl•1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:

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Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water.

{ "type": "p", "children": [], "text": "Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water." }

Paroxetine Oral Suspension

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Paroxetine Oral Suspension is for oral administration. Each 5 mL contains 10 mg of paroxetine equivalent to 11.1 mg of paroxetine hydrochloride.

{ "type": "p", "children": [], "text": "Paroxetine Oral Suspension is for oral administration. Each 5 mL contains 10 mg of paroxetine equivalent to 11.1 mg of paroxetine hydrochloride." }

Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&C Yellow No. 6, simethicone emulsion and purified water.

{ "type": "p", "children": [], "text": "Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&C Yellow No. 6, simethicone emulsion and purified water." }

The mechanism of action of paroxetine in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).

Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake (SSRI) and has only very weak effects on norepinephrine and dopamine neuronal reuptake.

Nonlinearity in pharmacokinetics is observed with increasing doses of paroxetine.

In a meta-analysis of paroxetine from 4 studies done in healthy volunteers following multiple dosing of 20 mg/day to 40 mg/day, males did not exhibit a significantly lower Cmax or AUC than females.

Absorption

Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. In a study in which normal male subjects (n = 15) received 30 mg tablets daily for 30 days, steady-state paroxetine concentrations were achieved by approximately 10 days for most subjects, although it may take substantially longer in an occasional patient. At steady state, mean values of Cmax, Tmax, Cmin, and T½ were 61.7 ng/mL (CV 45%), 5.2 hr. (CV 10%), 30.7 ng/mL (CV 67%), and 21 hours (CV 32%), respectively. The steady-state Cmax and Cmin values were about 6 and 14 times what would be predicted from single-dose studies. Steady-state drug exposure based on AUC0-24 was about 8 times greater than would have been predicted from single-dose data in these subjects. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable.

Paroxetine is equally bioavailable from the oral suspension and tablet.

Effect of Food

The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food. AUC was only slightly increased (6%) when drug was administered with food but the Cmax was 29% greater, while the time to reach peak plasma concentration decreased from 6.4 hours post-dosing to 4.9 hours.

Distribution

Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma.

Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng/mL and 400 ng/mL, respectively. Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/mL. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin.

Elimination

Metabolism

The mean elimination half-life is approximately 21 hours (CV 32%) after oral dosing of 30 mg tablets daily for 30 days of paroxetine.

In steady-state dose proportionality studies involving elderly and nonelderly patients, at doses of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway. In comparison to Cmin values after 20 mg daily, values after 40 mg daily were only about 2 to 3 times greater than doubled.

Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by CYP2D6. Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment. The role of this enzyme in paroxetine metabolism also suggests potential drug-drug interactions [see Drug Interactions (7)]. Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 (poor metabolizers).

Excretion

Approximately 64% of a 30-mg oral solution dose of paroxetine was excreted in the urine with 2% as the parent compound and 62% as metabolites over a 10-day post-dosing period. About 36% was excreted in the feces (probably via the bile), mostly as metabolites and less than 1% as the parent compound over the 10-day post-dosing period.

Drug Interaction Studies

There are clinically significant, known drug interactions between paroxetine and other drugs [see Drug Interactions (7)].

Figure 1. Impact of Paroxetine on the Pharmacokinetics of Co-Administered Drugs (log scale) Figure 2. Impact of Co-Administered Drugs on the Pharmacokinetics of Paroxetine Theophylline: Reports of elevated theophylline levels associated with paroxetine treatment have been reported. While this interaction has not been formally studied, it is recommended that theophylline levels be monitored when these drugs are concurrently administered. Drugs Metabolized by Cytochrome CYP3A4 An in vivo interaction study involving the coadministration under steady-state conditions of paroxetine and terfenadine, a substrate for CYP3A4, revealed no effect of paroxetine on terfenadine pharmacokinetics. In addition, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least 100 times more potent than paroxetine as an inhibitor of the metabolism of several substrates for this enzyme, including terfenadine, triazolam, and cyclosporine. Paroxetine’s extent of inhibition of CYP3A4 activity is not expected to be of clinical significance. Specific Populations The impact of specific populations on the pharmacokinetics of paroxetine are shown in Figure 3.The recommended starting dosage and maximum dosage of paroxetine is reduced in elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment [see Dosage and Administration (2.4)]. Figure 3. Impact of Specific Population on the Pharmacokinetics of Paroxetine (log scale)

Carcinogenesis

Two-year carcinogenicity studies were conducted in rodents given paroxetine in the diet at 1, 5, and 25 mg/kg/day (mice) and 1, 5, and 20 mg/kg/day (rats). These doses are up to 2 (mouse) and 3 (rat) times the MRHD of 60 mg on a mg/m2 basis. There was a significantly greater number of male rats in the high-dose group with reticulum cell sarcomas (1/100, 0/50, 0/50, and 4/50 for control, low-, middle-, and high-dose groups, respectively) and a significantly increased linear trend across dose groups for the occurrence of lymphoreticular tumors in male rats. Female rats were not affected. Although there was a dose-related increase in the number of tumors in mice, there was no drug-related increase in the number of mice with tumors. The relevance of these findings to humans is unknown.

Mutagenesis

Paroxetine produced no genotoxic effects in a battery of 5 in vitro and 2 in vivo assays that included the following: Bacterial mutation assay, mouse lymphoma mutation assay, unscheduled DNA synthesis assay, and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes and in a dominant lethal test in rats.

Impairment of Fertility

A reduced pregnancy rate was found in reproduction studies in rats at a dose of paroxetine of 15 mg/kg/day, which is 2 times the MRHD of 60 mg on a mg/m2 basis. Irreversible lesions occurred in the reproductive tract of male rats after dosing in toxicity studies for 2 to 52 weeks. These lesions consisted of vacuolation of epididymal tubular epithelium at 50 mg/kg/day and atrophic changes in the seminiferous tubules of the testes with arrested spermatogenesis at 25 mg/kg/day (8 and 4 times the MRHD of 60 mg on a mg/m2 basis).

The efficacy of paroxetine as a treatment for major depressive disorder (MDD) has been established in 6 placebo-controlled studies of patients with MDD (aged 18 to 73). In these studies, paroxetine was shown to be statistically significantly more effective than placebo in treating MDD by at least 2 of the following measures: Hamilton Depression Rating Scale (HDRS), the Hamilton depressed mood item, and the Clinical Global Impression (CGI)-Severity of Illness. Paroxetine was statistically significantly better than placebo in improvement of the HDRS sub-factor scores, including the depressed mood item, sleep disturbance factor, and anxiety factor.

Long-term efficacy of paroxetine for treatment of MDD in outpatients was demonstrated in a randomized withdrawal study. Patients who responded to paroxetine (HDRS total score <8) during an initial 8-week open-label treatment phase were then randomized to continue paroxetine or placebo, for up to 1 year. Patients treated with paroxetine demonstrated a statistically significant lower relapse rate during the withdrawal phase (15%) compared to those on placebo (39%). Effectiveness was similar for male and female patients.

The effectiveness of paroxetine in the treatment of obsessive compulsive disorder (OCD) was demonstrated in two 12-week multicenter placebo-controlled studies of adult outpatients (Studies 1 and 2). Patients had moderate to severe OCD (DSM-IIIR) with mean baseline ratings on the Yale Brown Obsessive Compulsive Scale (YBOCS) total score ranging from 23 to 26. In study 1, a dose-range finding study, patients received fixed daily doses of paroxetine 20 mg, 40 mg, or 60 mg. Study 1 demonstrated that daily doses of paroxetine 40 mg and 60 mg are effective in the treatment of OCD. Patients receiving doses of paroxetine 40 mg and 60 mg experienced a mean reduction of approximately 6 and 7 points, respectively, on the YBOCS total score which was statistically significantly greater than the approximate 4-point reduction at 20 mg and a 3-point reduction in the placebo-treated patients. Study 2 was a flexible-dose study comparing paroxetine 20 mg to 60 mg daily with clomipramine 25 mg to 250 mg daily or placebo). In this study, patients receiving paroxetine experienced a mean reduction of approximately 7 points on the YBOCS total score, which was statistically significantly greater than the mean reduction of approximately 4 points in placebo-treated patients.

The following table provides the outcome classification by treatment group on Global Improvement items of the Clinical Global Impression (CGI) scale for Study 1.

Table 10: Outcome Classification (%) on CGI-Global Improvement Item for Completers in Study 1 in Patients with OCD

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="624"> <colgroup> <col width="26.1538461538462%"/> <col width="18.4615384615385%"/> <col width="18.4615384615385%"/> <col width="18.4615384615385%"/> <col width="18.4615384615385%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Outcome Classification</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Placebo</span> <br/> <span class="Bold">(n = 74)</span> <br/> <span class="Bold">%</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Paroxetine</span> <br/> <span class="Bold">20 mg</span> <br/> <span class="Bold">(n = 75)</span> <br/> <span class="Bold">%</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Paroxetine</span> <br/> <span class="Bold">40 mg</span> <br/> <span class="Bold">(n = 66)</span> <br/> <span class="Bold">%</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Paroxetine</span> <br/> <span class="Bold">60 mg</span> <br/> <span class="Bold">(n = 66)</span> <br/> <span class="Bold">%</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Worse<br/> </td><td align="center" class="Rrule" valign="middle">14<br/> </td><td align="center" class="Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">3<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">No Change<br/> </td><td align="center" class="Rrule" valign="middle">44<br/> </td><td align="center" class="Rrule" valign="middle">35<br/> </td><td align="center" class="Rrule" valign="middle">22<br/> </td><td align="center" class="Rrule" valign="middle">19<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Minimally Improved<br/> </td><td align="center" class="Rrule" valign="middle">24<br/> </td><td align="center" class="Rrule" valign="middle">33<br/> </td><td align="center" class="Rrule" valign="middle">29<br/> </td><td align="center" class="Rrule" valign="middle">34<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">Much Improved<br/> </td><td align="center" class="Rrule" valign="middle">11<br/> </td><td align="center" class="Rrule" valign="middle">18<br/> </td><td align="center" class="Rrule" valign="middle">22<br/> </td><td align="center" class="Rrule" valign="middle">24<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top">Very Much Improved<br/> </td><td align="center" class="Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">20<br/> </td><td align="center" class="Rrule" valign="middle">20<br/> </td> </tr> </tbody> </table></div>

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender.

The long-term efficacy of paroxetine for the treatment of OCD was established in a long-term extension to Study 1. Patients who responded to paroxetine during the 3-month double-blind phase and a 6-month extension on open-label paroxetine 20 mg to 60 mg daily were randomized to either paroxetine or placebo in a 6-month double-blind relapse prevention phase. Patients randomized to paroxetine were statistically significantly less likely to relapse than placebo-treated patients.

The effectiveness of paroxetine in the treatment of panic disorder (PD) was demonstrated in three 10- to 12-week multicenter, placebo-controlled studies of adult outpatients (Studies 1, 2, and 3). Patients had PD (DSM-IIIR), with or without agoraphobia. In these studies, paroxetine was shown to be statistically significantly more effective than placebo in treating PD by at least 2 out of 3 measures of panic attack frequency and on the Clinical Global Impression Severity of Illness score.

Study 1 was a 10-week dose-range finding study; patients received fixed doses of paroxetine 10 mg, 20 mg, or 40 mg daily or placebo. A statistically significant difference from placebo was observed only for the paroxetine 40 mg daily group. At endpoint, 76% of patients receiving paroxetine 40 mg daily were free of panic attacks, compared to 44% of placebo-treated patients.

Study 2 was a 12-week flexible-dose study comparing paroxetine 10 mg to 60 mg daily and placebo. At endpoint, 51% of paroxetine-treated patients were free of panic attacks compared to 32% of placebo-treated patients.

Study 3 was a 12-week flexible-dose study comparing paroxetine 10 mg to 60 mg daily to placebo in patients concurrently receiving standardized cognitive behavioral therapy. At endpoint, 33% of the paroxetine-treated patients showed a reduction to 0 or 1 panic attacks compared to 14% of placebo-treated patients.

In Studies 2 and 3, the mean paroxetine dose for completers at endpoint was approximately 40 mg daily.

Long-term efficacy of paroxetine in PD was demonstrated in an extension to Study 1. Patients who responded to paroxetine during the 10-week double-blind phase and during a 3-month double-blind extension phase were randomized to either paroxetine 10 mg, 20 mg, or 40 mg daily or placebo in a 3-month double-blind relapse prevention phase. Patients randomized to paroxetine were statistically significantly less likely to relapse than placebo-treated patients.

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender.

The effectiveness of paroxetine in the treatment of social anxiety disorder (SAD) was demonstrated in three 12-week, multicenter, placebo-controlled studies (Studies 1, 2, and 3) of adult outpatients with SAD (DSM-IV). In these studies, the effectiveness of paroxetine compared to placebo was evaluated on the basis of (1) the proportion of responders, as defined by a Clinical Global Impression (CGI) Improvement score of 1 (very much improved) or 2 (much improved), and (2) change from baseline in the Liebowitz Social Anxiety Scale (LSAS).

Studies 1 and 2 were flexible-dose studies comparing paroxetine 20 mg to 50 mg daily and placebo. Paroxetine demonstrated statistically significant superiority over placebo on both the CGI Improvement responder criterion and the Liebowitz Social Anxiety Scale (LSAS). In Study 1, for patients who completed to week 12, 69% of paroxetine-treated patients compared to 29% of placebo-treated patients were CGI Improvement responders. In Study 2, CGI Improvement responders were 77% and 42% for the paroxetine- and placebo-treated patients, respectively.

Study 3 was a 12-week study comparing fixed doses of paroxetine 20 mg, 40 mg, or 60 mg daily with placebo. Paroxetine 20 mg was statistically significantly superior to placebo on both the LSAS Total Score and the CGI Improvement responder criterion; there were trends for superiority over placebo for the paroxetine 40 mg and 60 mg daily dose groups. There was no indication in this study of any additional benefit for doses higher than 20 mg daily.

Subgroup analyses generally did not indicate differences in treatment outcomes as a function of age, race, or gender.

The effectiveness of paroxetine in the treatment of generalized anxiety disorder (GAD) was demonstrated in two 8-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients with GAD (DSM-IV).

Study 1 was an 8-week study comparing fixed doses of paroxetine 20 mg or 40 mg daily with placebo. Doses of paroxetine 20 mg or 40 mg were both demonstrated to be statistically significantly superior to placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score. There was not sufficient evidence in this study to suggest a greater benefit for the paroxetine 40 mg daily dose compared to the 20 mg daily dose.

Study 2 was a flexible-dose study comparing paroxetine 20 mg to 50 mg daily and placebo. Paroxetine demonstrated statistically significant superiority over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score.

A third study, a flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo, did not demonstrate statistically significant superiority of paroxetine over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score, the primary outcome.

Subgroup analyses did not indicate differences in treatment outcomes as a function of race or gender. There were insufficient elderly patients to conduct subgroup analyses on the basis of age.

In a long-term trial, 566 patients meeting DSM-IV criteria for GAD, who had responded during a single-blind, 8-week acute treatment phase with paroxetine 20 mg to 50 mg daily, were randomized to continuation of paroxetine at their same dose, or to placebo, for up to 24 weeks of observation for relapse. Response during the single-blind phase was defined by having a decrease of >2 points compared to baseline on the CGI-Severity of Illness scale, to a score of <3. Relapse during the double-blind phase was defined as an increase of >2 points compared to baseline on the CGI-Severity of Illness scale to a score of >4, or withdrawal due to lack of efficacy. Patients continuing to receive paroxetine experienced a statistically significantly lower relapse rate over the subsequent 24 weeks compared to those receiving placebo.

The effectiveness of paroxetine in the treatment of Posttraumatic Stress Disorder (PTSD) was demonstrated in two 12-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients who met DSM-IV criteria for PTSD. The mean duration of PTSD symptoms for the 2 studies combined was 13 years (ranging from 0.1 year to 57 years). The percentage of patients with secondary MDD or non-PTSD anxiety disorders in the combined 2 studies was 41% (356 out of 858 patients) and 40% (345 out of 858 patients), respectively. Study outcome was assessed by (1) the Clinician-Administered PTSD Scale Part 2 (CAPS-2) score and (2) the Clinical Global Impression-Global Improvement Scale (CGI-I). The CAPS-2 is a multi-item instrument that measures 3 aspects of PTSD with the following symptom clusters: Reexperiencing/intrusion, avoidance/numbing and hyperarousal. The 2 primary outcomes for each trial were (1) change from baseline to endpoint on the CAPS-2 total score (17 items), and (2) proportion of responders on the CGI-I, where responders were defined as patients having a score of 1 (very much improved) or 2 (much improved).

Study 1 was a 12-week study comparing fixed doses of paroxetine 20 mg or 40 mg daily to placebo. Doses of paroxetine 20 mg and 40 mg were demonstrated to be statistically significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I. There was not sufficient evidence in this study to suggest a greater benefit for the 40 mg daily dose compared to the 20 mg daily dose.

Study 2 was a 12-week flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo. Paroxetine was demonstrated to be significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I.

A third study, a flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo, demonstrated paroxetine to be statistically significantly superior to placebo on change from baseline for CAPS-2 total score, but not on proportion of responders on the CGI-I.

The majority of patients in these trials were women (68% women: 377 out of 551 subjects in Study 1 and 66% women: 202 out of 303 subjects in Study 2). Subgroup analyses did not indicate differences in treatment outcomes as a function of gender. There were an insufficient number of patients who were 65 years and older or were non-Caucasian to conduct subgroup analyses on the basis of age or race, respectively.

Paroxetine Oral Suspension is supplied as:

{ "type": "p", "children": [], "text": "Paroxetine Oral Suspension is supplied as:" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="623"> <colgroup> <col width="16.6720136883756%"/> <col width="22.7462303496952%"/> <col width="33.3440273767511%"/> <col width="27.2377285851781%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Strength</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Color/Flavor</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Package Configuration</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">NDC Number</span> <br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">10 mg/5 mL<br/> </td><td align="center" class="Rrule" valign="middle">Orange/orange<br/> </td><td align="center" class="Rrule" valign="middle">Bottles containing 250 mL<br/> </td><td align="center" class="Rrule" valign="middle">70954-319-10<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"623\">\n<colgroup>\n<col width=\"16.6720136883756%\"/>\n<col width=\"22.7462303496952%\"/>\n<col width=\"33.3440273767511%\"/>\n<col width=\"27.2377285851781%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">Strength</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\"><span class=\"Bold\">Color/Flavor</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\"><span class=\"Bold\">Package Configuration</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\"><span class=\"Bold\">NDC Number</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">10 mg/5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">Orange/orange<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">Bottles containing 250 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">70954-319-10<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]." }

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Medication Guide)." }

Suicidal Thoughts and Behaviors

{ "type": "p", "children": [], "text": "\nSuicidal Thoughts and Behaviors\n" }

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)]." }

Serotonin Syndrome

{ "type": "p", "children": [], "text": "\nSerotonin Syndrome\n" }

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of paroxetine oral suspension with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].

{ "type": "p", "children": [], "text": "Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of paroxetine oral suspension with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)]." }

Concomitant Medications

{ "type": "p", "children": [], "text": "\nConcomitant Medications\n" }

Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for drug-drug interactions [see Warning and Precautions (5.3), Drug Interactions (7)].

{ "type": "p", "children": [], "text": "Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for drug-drug interactions [see Warning and Precautions (5.3), Drug Interactions (7)]." }

Increased Risk of Bleeding

{ "type": "p", "children": [], "text": "\nIncreased Risk of Bleeding\n" }

Inform patients about the concomitant use of paroxetine oral suspension with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Inform patients about the concomitant use of paroxetine oral suspension with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5)].\n" }

Activation of Mania/Hypomania

{ "type": "p", "children": [], "text": "\nActivation of Mania/Hypomania\n" }

Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.6)]." }

Discontinuation Syndrome

{ "type": "p", "children": [], "text": "\nDiscontinuation Syndrome\n" }

Advise patients not to abruptly discontinue paroxetine oral suspension and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when paroxetine oral suspension is discontinued [See Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Advise patients not to abruptly discontinue paroxetine oral suspension and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when paroxetine oral suspension is discontinued [See Warnings and Precautions (5.7)].\n" }

Sexual Dysfunction

{ "type": "p", "children": [], "text": "Sexual Dysfunction" }

Advise patients that use of paroxetine may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.13)].

{ "type": "p", "children": [], "text": "Advise patients that use of paroxetine may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.13)]." }

Administration Information for Oral Suspension

{ "type": "p", "children": [], "text": "Administration Information for Oral Suspension" }

Instruct patients to shake the oral suspension well before administration [see Dosage and Administration (2.1)].

{ "type": "p", "children": [], "text": "Instruct patients to shake the oral suspension well before administration [see Dosage and Administration (2.1)].\n" }

Allergic Reactions

{ "type": "p", "children": [], "text": "\nAllergic Reactions\n" }

Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.1, 6.2)].

{ "type": "p", "children": [], "text": "Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.1, 6.2)]." }

EmbryoFetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryoFetal Toxicity\n" }

Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paroxetine. Advise women of risks associated with first trimester use of paroxetine and that use later in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to paroxetine during pregnancy [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paroxetine. Advise women of risks associated with first trimester use of paroxetine and that use later in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to paroxetine during pregnancy [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].\n" }

Lactation

{ "type": "p", "children": [], "text": "\nLactation\n" }

Advise breastfeeding women using paroxetine to monitor infants for agitation, irritability, poor feeding, and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

{ "type": "p", "children": [], "text": "Advise breastfeeding women using paroxetine to monitor infants for agitation, irritability, poor feeding, and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)]." }

Females and Males of Reproductive Potential

{ "type": "p", "children": [], "text": "\nFemales and Males of Reproductive Potential\n" }

Advise men that paroxetine may affect sperm quality, which may impair fertility; it is not known if this effect is reversible [see Use in Specific Populations (8.3)].

{ "type": "p", "children": [], "text": "Advise men that paroxetine may affect sperm quality, which may impair fertility; it is not known if this effect is reversible [see Use in Specific Populations (8.3)].\n" }

All trademarks are the property of their respective owners.

{ "type": "p", "children": [], "text": "All trademarks are the property of their respective owners." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Novitium Pharma LLC

{ "type": "p", "children": [], "text": "\nNovitium Pharma LLC\n" }

70 Lake Drive, East Windsor

{ "type": "p", "children": [], "text": "70 Lake Drive, East Windsor" }

New Jersey 08520

{ "type": "p", "children": [], "text": "New Jersey 08520" }

Issued: 03/2025

{ "type": "p", "children": [], "text": "\nIssued: 03/2025" }

 LB4256-06

{ "type": "p", "children": [], "text": " LB4256-06" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="599.564"> <colgroup> <col width="100%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="top"> <span class="Bold">MEDICATION GUIDE</span> <br/> <span class="Bold">Paroxetine <span class="Bold">(pa rox’ e teen)</span></span> <br/> <span class="Bold">Oral Suspension</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">What is the most important information I should know about <span class="Bold">paroxetine oral suspension</span>?</span> <br/> <span class="Bold">Paroxetine oral suspension can cause serious side effects, including:</span> <br/> <ul class="Disc"> <li> <span class="Bold">Increased risk of suicidal thoughts or actions. </span>Paroxetine oral suspension and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the <span class="Bold">first few months of treatment or when the dose is changed</span>. <span class="Bold">Paroxetine oral suspension is not for use in children.</span> </li> </ul> <ul class="Disc"> <li> <span class="Bold">Depression or other mental illnesses are the most important causes of suicidal thoughts and actions.</span> </li> </ul> <span class="Bold">How can I watch for and try to prevent suicidal thoughts and actions?</span> <br/> <ul class="Disc"> <li>Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.</li> <li>Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.</li> <li>Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.<br/> <br/> </li> </ul> <span class="Bold">Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span> <br/> <img alt="med-guide-1" src="/dailymed/image.cfm?name=med-guide-1.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a"/>  </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">What is paroxetine oral suspension?</span> <br/> Paroxetine oral suspension is a prescription medicine used in adults to treat:<br/> <ul class="Disc"> <li>A certain type of depression called Major Depressive Disorder (MDD)</li> <li>Obsessive Compulsive Disorder (OCD)</li> <li>Panic Disorder (PD)</li> <li>Social Anxiety Disorder (SAD)</li> <li>Generalized Anxiety Disorder (GAD)</li> <li>Posttraumatic Stress Disorder (PTSD)</li> </ul> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">Do not take paroxetine oral suspension if you:</span> <br/> <ul class="Disc"> <li> <span class="Bold"> </span>take a monoamine oxidase inhibitor (MAOI)</li> <li>have stopped taking an MAOI in the last 14 days</li> <li>are being treated with the antibiotic linezolid or the intravenous methylene blue</li> <li>are taking pimozide</li> <li>are taking thioridazine</li> <li>are allergic to paroxetine or any of the ingredients in paroxetine oral suspension. See the end of this Medication Guide for a complete list of ingredients in paroxetine oral suspension.</li> </ul> <br/> Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.<br/>  <br/> <span class="Bold">Do not start taking an MAOI for at least 14 days after you stop treatment with </span><span class="Bold">paroxetine oral suspension.</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">Before taking paroxetine oral suspension, tell your healthcare provider about all your medical conditions, including if you:</span> <br/> <ul class="Disc"> <li>have heart problemshave or had bleeding problems<br/> </li> <li>have, or have a family history of, bipolar disorder, mania or hypomania</li> <li>have or had seizures or convulsions</li> <li>have glaucoma (high pressure in the eye)</li> <li>have low sodium levels in your blood</li> <li>have bone problems</li> <li>have kidney or liver problems</li> <li> are pregnant or plan to become pregnant. Paroxetine may harm your unborn baby.</li> </ul> <ul class="Disc"> <li>Taking paroxetine oral suspension during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth.</li> <li>Taking paroxetine oral suspension during your third trimester of pregnancy may cause your baby to have breathing, temperature, and feeding problems, low muscle tone, and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth. Talk to your healthcare provider about the risk to your unborn baby if you take paroxetine during pregnancy.</li> <li>Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine oral suspension.</li> <li>There is a pregnancy registry for females who are exposed to paroxetine during pregnancy. The purpose of the registry is to collect information about the health of females exposed to paroxetine and their baby. If you become pregnant during treatment with paroxetine oral suspension, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry /antidepressants/.</li> </ul> <ul class="Disc"> <li>are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine oral suspension.</li> </ul> <span class="Bold">Tell your healthcare provider about all the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/> <br/> Paroxetine oral suspension and some other medicines may affect each other causing possible serious side effects. Paroxetine oral suspension may affect the way other medicines work and other medicines may affect the way paroxetine oral suspension works.<br/> <br/> <span class="Bold">Especially tell your healthcare provider if you take:</span> <br/> <ul class="Disc"> <li>medicines used to treat migraine headaches called triptans<br/> </li> <li>tricyclic antidepressants<br/> </li> <li>lithium<br/> </li> <li>tramadol, fentanyl, meperidine, methadone, or other opioids</li> <li>tryptophan</li> <li>buspirone</li> <li>amphetamines</li> <li>St. John’s Wort<br/> </li> <li>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin<br/> </li> <li>diuretics<br/> </li> <li>tamoxifen<br/> </li> <li>medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serontonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)<br/> </li> </ul> Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take paroxetine oral suspension with your other medicines.<br/>  <br/> Do not start or stop any other medicines during treatment with paroxetine oral suspension without talking to your healthcare provider first. Stopping paroxetine oral suspension suddenly may cause you to have serious side effects. See, <span class="Bold">“What are the possible side effects of </span><span class="Bold">paroxetine oral suspension?”.</span> <br/>  <br/> Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">How should I take </span><span class="Bold">paroxetine oral suspension?</span> <br/> <ul class="Disc"> <li>Take paroxetine oral suspension exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine oral suspension until it is the right dose for you.</li> <li>Take paroxetine oral suspension 1 time each day in the morning.</li> <li>Paroxetine oral suspension may be taken with or without food.</li> <li>If you are taking paroxetine oral suspension, shake the suspension well before taking.</li> <li>If you take too much paroxetine oral suspension, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.</li> </ul> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">What are possible side effects of </span><span class="Bold">paroxetine oral suspension?</span> <br/> <span class="Bold">Paroxetine oral suspension can cause serious side effects, including:</span> <br/> <ul class="Disc"> <li>See, <span class="Bold">“What is the most important information I should know about </span><span class="Bold">paroxetine oral suspension?”</span> <br/> </li> <li> <span class="Bold">Serotonin syndrome.</span> A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine oral suspension with certain other medicines. See, “Who should not take paroxetine oral suspension?” <span class="Bold">Call your healthcare provider or go to the nearest hospital emergency room right away</span> if you have any of the following signs and symptoms of serotonin syndrome:</li> </ul> <img alt="med-guide-2" src="/dailymed/image.cfm?name=med-guide-2.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a"/><ul class="Disc"> <li> <span class="Bold">Eye problems (angle-closure glaucoma)</span>. Paroxetine oral suspension may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.<br/> </li> </ul> <ul class="Disc"> <li> <span class="Bold">Medicine interactions.</span> Taking paroxetine oral suspension with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.</li> <li> <span class="Bold">Seizures (convulsions).</span> </li> <li> <span class="Bold">Manic episodes. </span>Manic episodes may happen in people with bipolar disorder who take paroxetine oral suspension. Symptoms may include:<br/> </li> </ul> <img alt="med-guide-3" src="/dailymed/image.cfm?name=med-guide-3.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a"/>  <ul class="Disc"> <li> <span class="Bold">Discontinuation syndrome.</span> Suddenly stopping paroxetine oral suspension may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:<br/> </li> </ul> <img alt="med-guide-4" src="/dailymed/image.cfm?name=med-guide-4.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a"/><br/> <ul class="Disc"> <li> <span class="Bold">Low sodium levels in your blood (hyponatremia).</span> Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine oral suspension. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:<br/> </li> </ul> <ul class="Disc"> <li>headache</li> <li>difficulty concentrating</li> <li>memory changes</li> <li>confusion</li> <li>weakness and unsteadiness on your feet which can lead to falls</li> </ul> <span class="Bold">In more severe or more sudden cases, signs and symptoms include:</span> <br/> <ul class="Disc"> <li>seeing or hearing things that are not real (hallucinations)</li> <li>fainting</li> <li>seizures</li> <li>coma</li> <li>stopping breathing (respiratory arrest)</li> </ul> <ul class="Disc"> <li> <span class="Bold">Abnormal bleeding. </span>Taking paroxetine oral suspension with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising.</li> <li> <span class="Bold">Bone</span><span class="Bold">fractures.</span> </li> <li> <span class="Bold">Sexual problems (dysfunction). </span>Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine oral suspension, may cause sexual problems.<br/> </li> </ul>Symptoms in males may include:<br/> <ul class="Disc"> <li>Delayed ejaculation or inability to have an ejaculation</li> <li>Decreased sex drive</li> <li>Problems getting or keeping an erection</li> </ul> <br/>Symptoms in females may include:<ul class="Disc"> <li>Decreased sex drive</li> <li>Delayed orgasm or inability to have an orgasm</li> </ul>Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine. There may be treatments your healthcare provider can suggest.<br/> <br/> <span class="Bold">The most common side effects of paroxetine oral suspension include:</span> <br/> <img alt="med-guide-5" src="/dailymed/image.cfm?name=med-guide-5.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a"/><br/>These are not all the possible side effects of paroxetine oral suspension.<br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">How should I store </span><span class="Bold">paroxetine oral suspension?</span> <br/> <ul class="Disc"> <li>Store paroxetine oral suspension at 68° to 77ºF (20° to 25ºC).</li> </ul> <span class="Bold">Keep p</span><span class="Bold">aroxetine and all medicines out of the reach of children.</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"> <span class="Bold">General information about the safe and effective use of </span><span class="Bold">paroxetine oral suspension.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine oral suspension for a condition for which it was not prescribed. Do not give paroxetine oral suspension to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine oral suspension that is written for healthcare professionals.<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top"> <span class="Bold">What are the ingredients in </span><span class="Bold">paroxetine oral suspension?</span> <br/>  <br/> <span class="Bold">Active ingredient:</span> Paroxetine hydrochloride<br/>  <br/> <span class="Bold">Inactive ingredients:</span> <br/>  <br/> <span class="Bold">Oral suspension:</span> polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&amp;C Yellow No. 6, simethicone emulsion and purified water.<br/>  <br/> All trademarks are the property of their respective owners.<br/>  <br/> Manufactured by:<br/> <span class="Bold">Novitium Pharma LLC</span> <br/> 70 Lake Drive, East Windsor<br/> New Jersey 08520 <br/> <br/>For more information about paroxetine oral suspension, call 1-855-204-1431.<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"599.564\">\n<colgroup>\n<col width=\"100%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">MEDICATION GUIDE</span>\n<br/> <span class=\"Bold\">Paroxetine <span class=\"Bold\">(pa rox’ e teen)</span></span>\n<br/> <span class=\"Bold\">Oral Suspension</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">What is the most important information I should know about <span class=\"Bold\">paroxetine oral suspension</span>?</span>\n<br/> <span class=\"Bold\">Paroxetine oral suspension can cause serious side effects, including:</span>\n<br/> <ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Increased risk of suicidal thoughts or actions. </span>Paroxetine oral suspension and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the <span class=\"Bold\">first few months of treatment or when the dose is changed</span>. <span class=\"Bold\">Paroxetine oral suspension is not for use in children.</span>\n</li>\n</ul> <ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Depression or other mental illnesses are the most important causes of suicidal thoughts and actions.</span>\n</li>\n</ul> <span class=\"Bold\">How can I watch for and try to prevent suicidal thoughts and actions?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.</li>\n<li>Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.</li>\n<li>Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.<br/>\n<br/> </li>\n</ul>\n<span class=\"Bold\">Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span>\n<br/>\n<img alt=\"med-guide-1\" src=\"/dailymed/image.cfm?name=med-guide-1.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a\"/>  </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">What is paroxetine oral suspension?</span>\n<br/> Paroxetine oral suspension is a prescription medicine used in adults to treat:<br/>\n<ul class=\"Disc\">\n<li>A certain type of depression called Major Depressive Disorder (MDD)</li>\n<li>Obsessive Compulsive Disorder (OCD)</li>\n<li>Panic Disorder (PD)</li>\n<li>Social Anxiety Disorder (SAD)</li>\n<li>Generalized Anxiety Disorder (GAD)</li>\n<li>Posttraumatic Stress Disorder (PTSD)</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">Do not take paroxetine oral suspension if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\"> </span>take a monoamine oxidase inhibitor (MAOI)</li>\n<li>have stopped taking an MAOI in the last 14 days</li>\n<li>are being treated with the antibiotic linezolid or the intravenous methylene blue</li>\n<li>are taking pimozide</li>\n<li>are taking thioridazine</li>\n<li>are allergic to paroxetine or any of the ingredients in paroxetine oral suspension. See the end of this Medication Guide for a complete list of ingredients in paroxetine oral suspension.</li>\n</ul> <br/> Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.<br/>  <br/> <span class=\"Bold\">Do not start taking an MAOI for at least 14 days after you stop treatment with </span><span class=\"Bold\">paroxetine oral suspension.</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">Before taking paroxetine oral suspension, tell your healthcare provider about all your medical conditions, including if you:</span>\n<br/> <ul class=\"Disc\">\n<li>have heart problemshave or had bleeding problems<br/>\n</li>\n<li>have, or have a family history of, bipolar disorder, mania or hypomania</li>\n<li>have or had seizures or convulsions</li>\n<li>have glaucoma (high pressure in the eye)</li>\n<li>have low sodium levels in your blood</li>\n<li>have bone problems</li>\n<li>have kidney or liver problems</li>\n<li> are pregnant or plan to become pregnant. Paroxetine may harm your unborn baby.</li>\n</ul>\n<ul class=\"Disc\">\n<li>Taking paroxetine oral suspension during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth.</li>\n<li>Taking paroxetine oral suspension during your third trimester of pregnancy may cause your baby to have breathing, temperature, and feeding problems, low muscle tone, and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth. Talk to your healthcare provider about the risk to your unborn baby if you take paroxetine during pregnancy.</li>\n<li>Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine oral suspension.</li>\n<li>There is a pregnancy registry for females who are exposed to paroxetine during pregnancy. The purpose of the registry is to collect information about the health of females exposed to paroxetine and their baby. If you become pregnant during treatment with paroxetine oral suspension, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry /antidepressants/.</li>\n</ul>\n<ul class=\"Disc\">\n<li>are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine oral suspension.</li>\n</ul> <span class=\"Bold\">Tell your healthcare provider about all the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/> <br/> Paroxetine oral suspension and some other medicines may affect each other causing possible serious side effects. Paroxetine oral suspension may affect the way other medicines work and other medicines may affect the way paroxetine oral suspension works.<br/> <br/> <span class=\"Bold\">Especially tell your healthcare provider if you take:</span>\n<br/>\n<ul class=\"Disc\">\n<li>medicines used to treat migraine headaches called triptans<br/>\n</li>\n<li>tricyclic antidepressants<br/>\n</li>\n<li>lithium<br/>\n</li>\n<li>tramadol, fentanyl, meperidine, methadone, or other opioids</li>\n<li>tryptophan</li>\n<li>buspirone</li>\n<li>amphetamines</li>\n<li>St. John’s Wort<br/>\n</li>\n<li>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin<br/>\n</li>\n<li>diuretics<br/>\n</li>\n<li>tamoxifen<br/>\n</li>\n<li>medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serontonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)<br/>\n</li>\n</ul> Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take paroxetine oral suspension with your other medicines.<br/>  <br/> Do not start or stop any other medicines during treatment with paroxetine oral suspension without talking to your healthcare provider first. Stopping paroxetine oral suspension suddenly may cause you to have serious side effects. See, <span class=\"Bold\">“What are the possible side effects of </span><span class=\"Bold\">paroxetine oral suspension?”.</span>\n<br/>  <br/> Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">How should I take </span><span class=\"Bold\">paroxetine oral suspension?</span>\n<br/> <ul class=\"Disc\">\n<li>Take paroxetine oral suspension exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine oral suspension until it is the right dose for you.</li>\n<li>Take paroxetine oral suspension 1 time each day in the morning.</li>\n<li>Paroxetine oral suspension may be taken with or without food.</li>\n<li>If you are taking paroxetine oral suspension, shake the suspension well before taking.</li>\n<li>If you take too much paroxetine oral suspension, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.</li>\n</ul> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">What are possible side effects of </span><span class=\"Bold\">paroxetine oral suspension?</span>\n<br/> <span class=\"Bold\">Paroxetine oral suspension can cause serious side effects, including:</span>\n<br/> <ul class=\"Disc\">\n<li>See, <span class=\"Bold\">“What is the most important information I should know about </span><span class=\"Bold\">paroxetine oral suspension?”</span> <br/>\n</li>\n<li>\n<span class=\"Bold\">Serotonin syndrome.</span> A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine oral suspension with certain other medicines. See, “Who should not take paroxetine oral suspension?” <span class=\"Bold\">Call your healthcare provider or go to the nearest hospital emergency room right away</span> if you have any of the following signs and symptoms of serotonin syndrome:</li>\n</ul>\n<img alt=\"med-guide-2\" src=\"/dailymed/image.cfm?name=med-guide-2.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a\"/><ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Eye problems (angle-closure glaucoma)</span>. Paroxetine oral suspension may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.<br/>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Medicine interactions.</span> Taking paroxetine oral suspension with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.</li>\n<li> <span class=\"Bold\">Seizures (convulsions).</span>\n</li>\n<li>\n<span class=\"Bold\">Manic episodes. </span>Manic episodes may happen in people with bipolar disorder who take paroxetine oral suspension. Symptoms may include:<br/>\n</li>\n</ul>\n<img alt=\"med-guide-3\" src=\"/dailymed/image.cfm?name=med-guide-3.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a\"/>  <ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Discontinuation syndrome.</span> Suddenly stopping paroxetine oral suspension may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:<br/>\n</li>\n</ul>\n<img alt=\"med-guide-4\" src=\"/dailymed/image.cfm?name=med-guide-4.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a\"/><br/>\n<ul class=\"Disc\">\n<li> <span class=\"Bold\">Low sodium levels in your blood (hyponatremia).</span> Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine oral suspension. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:<br/>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>headache</li>\n<li>difficulty concentrating</li>\n<li>memory changes</li>\n<li>confusion</li>\n<li>weakness and unsteadiness on your feet which can lead to falls</li>\n</ul>\n<span class=\"Bold\">In more severe or more sudden cases, signs and symptoms include:</span>\n<br/>\n<ul class=\"Disc\">\n<li>seeing or hearing things that are not real (hallucinations)</li>\n<li>fainting</li>\n<li>seizures</li>\n<li>coma</li>\n<li>stopping breathing (respiratory arrest)</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Abnormal bleeding. </span>Taking paroxetine oral suspension with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising.</li>\n<li> <span class=\"Bold\">Bone</span><span class=\"Bold\">fractures.</span>\n</li>\n<li>\n<span class=\"Bold\">Sexual problems (dysfunction). </span>Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine oral suspension, may cause sexual problems.<br/>\n</li>\n</ul>Symptoms in males may include:<br/>\n<ul class=\"Disc\">\n<li>Delayed ejaculation or inability to have an ejaculation</li>\n<li>Decreased sex drive</li>\n<li>Problems getting or keeping an erection</li>\n</ul>\n<br/>Symptoms in females may include:<ul class=\"Disc\">\n<li>Decreased sex drive</li>\n<li>Delayed orgasm or inability to have an orgasm</li>\n</ul>Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine. There may be treatments your healthcare provider can suggest.<br/> <br/> <span class=\"Bold\">The most common side effects of paroxetine oral suspension include:</span>\n<br/>\n<img alt=\"med-guide-5\" src=\"/dailymed/image.cfm?name=med-guide-5.jpg&amp;setid=134e76f0-45cf-47eb-b6e1-cdb3bb522a0a\"/><br/>These are not all the possible side effects of paroxetine oral suspension.<br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">How should I store </span><span class=\"Bold\">paroxetine oral suspension?</span>\n<br/> <ul class=\"Disc\">\n<li>Store paroxetine oral suspension at 68° to 77ºF (20° to 25ºC).</li>\n</ul> <span class=\"Bold\">Keep p</span><span class=\"Bold\">aroxetine and all medicines out of the reach of children.</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">General information about the safe and effective use of </span><span class=\"Bold\">paroxetine oral suspension.</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine oral suspension for a condition for which it was not prescribed. Do not give paroxetine oral suspension to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine oral suspension that is written for healthcare professionals.<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">What are the ingredients in </span><span class=\"Bold\">paroxetine oral suspension?</span>\n<br/>  <br/> <span class=\"Bold\">Active ingredient:</span> Paroxetine hydrochloride<br/>  <br/> <span class=\"Bold\">Inactive ingredients:</span>\n<br/>  <br/> <span class=\"Bold\">Oral suspension:</span> polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&amp;C Yellow No. 6, simethicone emulsion and purified water.<br/>  <br/> All trademarks are the property of their respective owners.<br/>  <br/> Manufactured by:<br/> <span class=\"Bold\">Novitium Pharma LLC</span>\n<br/> 70 Lake Drive, East Windsor<br/> New Jersey 08520 <br/> <br/>For more information about paroxetine oral suspension, call 1-855-204-1431.<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

This Medication Guide has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration." }

Issued: 03/2025

{ "type": "p", "children": [], "text": "\nIssued: 03/2025" }

LB4256-06

{ "type": "p", "children": [], "text": "LB4256-06" }

BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

{ "type": "p", "children": [], "text": "BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause." }

Limitations of Use:

{ "type": "p", "children": [], "text": "\nLimitations of Use:\n" }

BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE has a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower BRISDELLE dosage has not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing product that is indicated for such use.

{ "type": "p", "children": [], "text": "BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE has a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower BRISDELLE dosage has not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing product that is indicated for such use.\n" }

The recommended oral dosage of BRISDELLE for the treatment of moderate to severe VMS associated with menopause is 7.5 mg once daily, at bedtime, with or without food [see Clinical Pharmacology (12.3)].

Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with BRISDELLE. Conversely, allow at least 14 days after stopping BRISDELLE before starting an MAOI [see Contraindications (4.1), Warnings and Precautions (5.2) and Drug Interactions (7.3)].

BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg” on the capsule. Each capsule contains 9.69 mg of paroxetine mesylate equivalent to 7.5 mg paroxetine base.

{ "type": "p", "children": [], "text": "BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg” on the capsule. Each capsule contains 9.69 mg of paroxetine mesylate equivalent to 7.5 mg paroxetine base." }

BRISDELLE is contraindicated in patients:

{ "type": "p", "children": [], "text": "BRISDELLE is contraindicated in patients:" }

{ "type": "ul", "children": [ "Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interaction (7)].", "Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interaction (7)].", "Taking pimozide because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interaction (7)].", "With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in BRISDELLE [see Adverse Reactions (6.2)]\n", "Who are or become pregnant because menopausal VMS does not occur during pregnancy and BRISDELLE may cause fetal harm [see Use in Specific Populations (8.1)]." ], "text": "" }

SSRIs increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term trials for the treatment of major depressive disorder (MDD) and other psychiatric disorders - BRISDELLE is not approved for use in any psychiatric condition or in pediatric and young adult patients [see Indications and Usage (1) and Use in Specific Populations (8.4)]. There is limited information regarding suicidal thoughts and behaviors in females who use BRISDELLE for treatment of moderate to severe VMS associated with menopause. The BRISDELLE trials excluded females with a presence or history of previous psychiatric disorders.

Monitor all BRISDELLE-treated patients for any emergence of suicidal thoughts and behaviors, especially during the initial few months of BRISDELLE therapy. Counsel family members to monitor for changes in behavior and to alert the health care provider if such changes occur. Consider discontinuing BRISDELLE in patients who experience emergent suicidal thoughts or behaviors or symptoms that might be precursors to suicidal thoughts or behaviors, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

BRISDELLE can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., monoamine oxidase inhibitors (MAOIs) [see Contraindications (4), Drug Interactions (7.3)]. Serotonin syndrome can also occur when BRISDELLE is used alone.

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of BRISDELLE with MAOIs is contraindicated. Do not start BRISDELLE in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dosage range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral or local tissue injection) or at lower dosages. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking BRISDELLE, The patient should be taken off BRISDELLE before initiating treatment with the MAOI [see Contraindications (4.1)]. If concomitant use of BRISDELLE with other serotonergic drugs (besides MAOIs) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during BRISDELLE initiation [see Contraindications (4.1) Drug Interactions (7.3)].

Monitor all patients taking BRISDELLE for the emergence of serotonin syndrome. Discontinue BRISDELLE and any concomitant serotonergic agents immediately if the above events occur and initiate supportive symptomatic treatment.

Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when concomitantly administered with paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6 and lower tamoxifen blood levels [see Drug Interactions (7.1)]. However, other studies have failed to demonstrate such a risk.

When tamoxifen is used for the treatment or prevention of breast cancer, weigh the likely benefit of BRISDELLE for treating moderate to severe VMS associated with menopause vs. the risk of possible decreased tamoxifen effectiveness, and consider avoiding the concomitant use of BRISDELLE.

SSRIs, including BRISDELLE, increased the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk [see Drug Interactions (7.3)]. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients about the risk of bleeding associated with the concomitant use of BRISDELLE and antiplatelet agents or anticoagulants [see Drug Interactions (7.1)]. For patients taking warfarin, carefully monitor the international normalized ratio.

The pupillary dilation that occurs following use of SSRIs, including BRISDELLE, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Cases of angle-closure glaucoma associated with use of paroxetine have been reported. Avoid use of SSRIs, including BRISDELLE, in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SSRIs, including BRISDELLE. Cases with serum sodium lower than 110 mmol/L have been reported in patients using SSRIs. Geriatric patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs [see Use in Specific Populations (8.5)]. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, the hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue BRISDELLE and institute appropriate medical intervention.

Epidemiological studies on bone fracture risk following exposure to SSRIs have reported an association between SSRI treatment and fractures. It is unknown to what extent fracture risk is directly attributable to SSRI treatment. If a BRISDELLE-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising, consider the possibility of a fragility fracture.

BRISDELLE is only indicated for the treatment of moderate to severe VMS and is not approved for use in treating either depression or bipolar depression. However, prior to initiating treatment with BRISDELLE, all patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It is generally believed (though not established in controlled trials) that use of an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.

In clinical studies of another paroxetine product, seizures occurred in 0.1% of paroxetine-treated patients.

Use BRISDELLE cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Discontinue BRISDELLE in any patient who develops seizures.

Use of SSRIs, including BRISDELLE, may cause symptoms of sexual dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

It is important for prescribers to inquire about sexual function prior to initiation of BRISDELLE and to inquire specifically about changes in sexual function during treatment because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes. Discuss potential management strategies to support patients in making informed decisions about treatment.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot directly be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to BRISDELLE in the following randomized, placebo-controlled trials for the treatment of moderate to severe VMS associated with menopause [see Clinical Studies (14)]: (1) one 8-week Phase 2 trial, (2) one 12-week Phase 3 trial and (3) one 24-week Phase 3 trial. In these trials, a total of 635 postmenopausal females received BRISDELLE 7.5 mg administered orally once daily and 641 postmenopausal females received placebo. In these trials, 68% were White, 30% were Black or African American (30%), and 2% were other races, with a mean age of 55 years (range 40 to 73 years). Postmenopausal females with a history of suicidal ideation or suicidal behavior were excluded from these trials.

Serious Adverse Reactions:

In the pooled Phase 2 and Phase 3 trials, three BRISDELLE-treated patients reported a serious adverse reaction of suicidal ideation and one BRISDELLE-treated patient reported a serious adverse reaction of suicide attempt. There were no serious adverse reactions of suicidal ideation or suicide attempt reported among the placebo-treated patients.

Adverse Reactions Leading to Study Discontinuation:

A total of 4.7% of females taking BRISDELLE discontinued from the clinical trials due to an adverse reaction, compared to 3.7% of females on placebo; the most frequent adverse reactions leading to discontinuation among paroxetine-treated females were: abdominal pain (0.3%), attention disturbances (0.3%), headache (0.3%), and suicidal ideation (0.3%).

Common Adverse Reactions:

Overall, based on investigators’ determinations about what events were likely to be drug-related, about 20% of postmenopausal females treated with BRISDELLE reported at least 1 adverse reaction in the three controlled trials. The most common adverse reactions (≥ 2% and at a higher incidence in BRISDELLE-treated females compared to placebo-treated females) reported in these trials were headache, fatigue/malaise/lethargy, and nausea/vomiting. Of these commonly reported adverse reactions, nausea occurred primarily within the first 4 weeks of BRISDELLE treatment and fatigue occurred primarily within the first week of BRISDELLE treatment, and decreased in frequency with continued therapy.

The adverse reactions that occurred in ≥ 2% of BRISDELLE-treated patients and at a higher incidence in BRISDELLE-treated females compared to placebo-treated females are shown in Table 1 for the pooled Phase 2 and Phase 3 trials.

Table 1: Incidence of Common Adverse Reactions in the Phase 2 and Phase 3 Trials of Postmenopausal Females with Moderate to Severe VMS1

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0" width="75%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Incidence n (%)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">BRISDELLE (n = 635)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">BRISDELLE (n = 641)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Headache</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">40 (6.3)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">31 (4.8)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Fatigue, malaise, lethargy</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">31 (4.9)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">18 (2.8)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Nausea, vomiting</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">27 (4.3)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15 (2.3)</p> </td> </tr> </tbody> </table></div>

1 ≥ 2% BRISDELLE-treated patients and at a higher incidence in BRISDELLE-treated females compared to placebo-treated females.

Adverse Reactions After Discontinuing BRISDELLE

Certain symptoms were seen more frequently in postmenopausal females at the time of discontinuation of BRISDELLE compared to discontinuation of placebo and have also been reported upon discontinuation of other paroxetine products, particularly after abrupt discontinuation. Adverse reactions reported after discontinuation of BRISDELLE included increased dreaming/nightmares, muscle cramps/spasms/twitching, headache, nervousness/anxiety, fatigue/tiredness, restless feeling in legs, and trouble sleeping/insomnia. While these adverse reactions were generally self-limiting, there have been reports of serious discontinuation symptoms with other paroxetine products.

The following adverse reactions have been identified during post-approval use of this and other paroxetine products. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura, Events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, agranulocytosis).

Cardiac Disorders: Atrial fibrillation, Pulmonary edema, Ventricular fibrillation, Ventricular tachycardia (including torsades de pointes).

Gastrointestinal Disorders: Pancreatitis, Pancreatitis hemorrhagic, Vomiting.

General Disorders and Administration Site Conditions: Death, Drug withdrawal syndrome, Malaise.

Hepatobiliary Disorders: Drug-induced liver injury, Hepatic failure, Jaundice.

Immune System Disorders: Anaphylaxis, Angioedema, Toxic epidermal necrolysis.

Investigations: Elevated liver tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction).

Metabolism and Nutrition Disorders: Diabetes mellitus inadequate control, Type 2 diabetes mellitus.

Nervous System Disorders: Neuroleptic malignant syndrome, Paresthesia, Somnolence, Tremor, Anosmia, Hyposmia

Psychiatric Disorders: Aggression, Agitation, Anxiety, Confusional state, Depression, Disorientation, Homicidal ideation, Insomnia, Restlessness.

Respiratory, Thoracic and Mediastinal Disorders: Pulmonary hypertension.

Skin and Subcutaneous Tissue Disorders: Hyperhidrosis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS).

Paroxetine is a strong CYP2D6 inhibitor. Clinical drug interaction studies have been performed with substrates of CYP2D6 and show that paroxetine can inhibit the metabolism of drugs metabolized by CYP2D6 [see Clinical Pharmacology (12.3)]. Table 2 contains examples of drugs with a metabolism that may be affected by concomitant use with BRISDELLE.

Table 2 Effects of Paroxetine on Other Drugs

<div class="scrollingtable"><table width="75%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule" valign="top"><span class="Bold">Concomitant Drug Name</span></td><td class="Botrule Lrule Rrule" valign="top"><span class="Bold">Effect of Paroxetine on Other Drugs</span></td><td class="Botrule Lrule Rrule" valign="top"><span class="Bold">Clinical Recommendations</span></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Thioridazine</td><td class="Botrule Lrule Rrule" valign="top">Increased plasma concentrations of thioridazine<br/>Potential QTc prolongation</td><td class="Botrule Lrule Rrule" valign="top">Concomitant use of thioridazine and BRISDELLE is contraindicated.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Pimozide<br/> <br/> </td><td class="Botrule Lrule Rrule" valign="top">Increased plasma concentrations of pimozide.<br/>Potential QTc prolongation</td><td class="Botrule Lrule Rrule" valign="top">Concomitant use of pimozide and BRISDELLE is contraindicated.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Tamoxifen<br/> </td><td class="Botrule Lrule Rrule" valign="top">Reduced plasma concentrations of active tamoxifen metabolite</td><td class="Botrule Lrule Rrule" valign="top">Consider avoiding concomitant use of tamoxifen and BRISDELLE.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Tricyclic Antidepressants (TCA) (e.g., Desipramine)</td><td class="Botrule Lrule Rrule" valign="top">Increased plasma concentrations and elimination half-life</td><td class="Botrule Lrule Rrule" valign="top">Plasma TCA concentrations may need to be monitored and the TCA dosage may need to be reduced if a TCA is used concomitantly with BRISDELLE. Monitor tolerability.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Risperidone<br/> <br/> </td><td class="Botrule Lrule Rrule" valign="top">Increased plasma concentrations of risperidone</td><td class="Botrule Lrule Rrule" valign="top">A lower risperidone dosage may be necessary (see the risperidone Prescribing Information for). Monitor tolerability.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Atomoxetine<br/> <br/> </td><td class="Botrule Lrule Rrule" valign="top">Increased exposure of atomoxetine</td><td class="Botrule Lrule Rrule" valign="top">A lower atomoxetine dosage of may be necessary (see atomoxetine Prescribing Information for). Monitor tolerability.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Drugs Highly Bound to Plasma Protein (e.g., Warfarin)</td><td class="Botrule Lrule Rrule" valign="top">Increased free plasma concentrations</td><td class="Botrule Lrule Rrule" valign="top">The warfarin dosage may need to be reduced. Monitor tolerability and the International Normalized Ratio.</td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Digoxin<br/> </td><td class="Botrule Lrule Rrule" valign="top">Decreased plasma concentrations<br/>of digoxin</td><td class="Botrule Lrule Rrule" valign="top">The digoxin dosage of may need to be increased. Monitor digoxin concentrations and clinical effect.</td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top">Theophylline<br/> <br/> </td><td class="Botrule Lrule Rrule" valign="top">Increased plasma concentrations<br/>of theophylline</td><td class="Botrule Lrule Rrule" valign="top">The theophylline dosage of may need to be decreased. Monitor theophylline concentrations and tolerability.</td> </tr> </tbody> </table></div>

Use caution with concomitant use of BRISDELLE with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide).

The metabolism and pharmacokinetics of paroxetine may be affected by the induction and inhibition of drug metabolizing enzymes such as CYP2D6. Table 3 contains a list of drugs that may affect the pharmacokinetics of BRISDELLE when administered concomitantly [see Clinical Pharmacology (12.3)].

Table 3 Effects of Other Drugs on Paroxetine

<div class="scrollingtable"><table width="75%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Concomitant<br/>Drug Name</span></td><td align="center" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Effect of Concomitant Drug on Paroxetine</span></td><td align="center" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Clinical Recommendations</span></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Phenobarbital</td><td class="Botrule Lrule Rrule" valign="top">Decreased paroxetine exposure</td><td class="Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Phenytoin</td><td class="Botrule Lrule Rrule" valign="top">Decreased paroxetine exposure</td><td class="Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top">Fosamprenavir/Ritonavir</td><td class="Botrule Lrule Rrule" valign="top">Decreased plasma concentration<br/>of paroxetine</td><td class="Lrule Rrule" valign="top">Monitor clinical effect of BRISDELLE.<br/> <br/>No BRISDELLE dosage adjustment is needed.</td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top">Cimetidine</td><td class="Botrule Lrule Rrule" valign="top">Increased plasma concentration<br/>of paroxetine</td><td class="Botrule Lrule Rrule"></td> </tr> </tbody> </table></div>

Use caution if BRISDELLE is used concomitantly with other drugs that inhibit CYP2D6 (e.g., quinidine).

Monoamine Oxidase Inhibitors

Serious adverse reactions such as serotonin syndrome have been reported in patients treated with a SSRI and a concomitant monoamine oxidase inhibitor (MAOI), in patients started on an SSRI who recently received an MAOI and in patients started on an MAOI who recently received an SSRI. Therefore, concomitant use of MAOIs with BRISDELLE or use of BRISDELLE and an MAOI within 14 days of each other is contraindicated [see Dosage and Administration (2.2), Contraindications (4.1) and Warnings and Precautions (5.2)].

Serotonergic Drugs

If concomitant use of BRISDELLE with other serotonergic drugs (e.g., other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation [see Warnings and Precautions (5.2)].

An interaction between paroxetine and tryptophan may occur when they are co-administered. Adverse reactions, consisting primarily of headache, nausea, sweating, and dizziness, have been reported when tryptophan was administered to patients taking paroxetine. Consequently, concomitant use of BRISDELLE with tryptophan is not recommended.

Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)

Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs are concomitantly administered with NSAIDs, aspirin, warfarin. or other drugs that affect coagulation. There may be a pharmacodynamic interaction between paroxetine and warfarin that causes an increased bleeding diathesis despite unaltered prothrombin time. Carefully monitor patients receiving warfarin therapy when BRISDELLE is initiated or discontinued [see Warnings and Precautions (5.4)].

Risk Summary

BRISDELLE is contraindicated in pregnant females and not indicated for use in pre-menopausal females. Based on epidemiologic and animal studies, paroxetine can cause fetal harm. Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.4)].

Paroxetine is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant female during the first trimester. While individual epidemiological studies on the association between paroxetine use and cardiovascular malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see Data). There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including BRISDELLE, during pregnancy.

No evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits. These doses are approximately 64 times (rat) and less than 16 times (rabbit) the maximum recommended human dose (MRHD) of BRISDELLE (7.5 mg) on an mg/m2 basis. When paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. This effect occurred at a dose of 1 mg/kg/day which is 1.3 times the MRHD on an mg/m2 basis (see Data).

Data

Human Data: Published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformations have reported inconsistent results; however, meta-analyses of population-based cohort studies published between 1996-2017 indicate a less than 2-fold increased risk for overall cardiovascular malformations. Specific cardiac malformations identified in two meta-analyses include approximately 2 to 2.5-fold increased risk for right ventricular outflow tract defects. One meta-analysis also identified an increased risk (less than 2-fold) for bulbus cordis anomalies and anomalies of cardiac septal closure, and an increased risk for atrial septal defects (pooled OR 2.38, 95% CI 1.14-4.97). Important limitations of the studies included in these meta-analyses include potential confounding by indication, depression severity, and potential exposure misclassification.

Exposure to SSRIs, particularly later in pregnancy, may have an increased risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality.

Animal Data: Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 64 times (rat) and less than 16 times (rabbit) MRHD of BRISDELLE (7.5 mg) on an mg/m2 basis. These studies have revealed no evidence of malformations. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. This effect occurred at a dose of 1 mg/kg/day which is 1.3 times the MRHD on an mg/m2 basis. The no effect dose for rat pup mortality was not determined. The cause of these deaths is not known.

Safety and effectiveness of BRISDELLE in pediatric patients have not been established; BRISDELLE is not indicated in the pediatric population.

Clinical trials of BRISDELLE did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients. Patients 65 years of age and older may have elevated paroxetine plasma concentrations compared to younger adult patients. However, the recommended BRISDELLE dosage in patients 65 years of age and older is that same as that as younger patients [see Clinical Pharmacology (12.3)].

SSRIs have been associated with cases of clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.6)].

The recommended BRISDELLE dosage in patients with renal impairment is the same as those with normal renal function [see Clinical Pharmacology (12.3)].

The recommended BRISDELLE dosage in patients with hepatic impairment is the same as those with normal hepatic function [see Clinical Pharmacology (12.3)].

The following have been reported with paroxetine tablets overdose:

{ "type": "p", "children": [], "text": "The following have been reported with paroxetine tablets overdose:" }

{ "type": "ul", "children": [ "Seizures, which may be delayed, and altered mental status including coma.", "Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.", "Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk)." ], "text": "" }

Consider contacting the Poison Help Line (1-800-221-2222) or a medical toxicologist for overdose management recommendations.

{ "type": "p", "children": [], "text": "Consider contacting the Poison Help Line (1-800-221-2222) or a medical toxicologist for overdose management recommendations." }

BRISDELLE (paroxetine) is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of moderate to severe VMS associated with menopause. It is identified chemically as (-)-trans-4R- (4’-fluorophenyl) - 3S - [(3’, 4’-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C19H20FNO3•CH3SO3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:

{ "type": "p", "children": [], "text": "BRISDELLE (paroxetine) is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of moderate to severe VMS associated with menopause. It is identified chemically as (-)-trans-4R- (4’-fluorophenyl) - 3S - [(3’, 4’-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C19H20FNO3•CH3SO3H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:" }

The mesylate salt of paroxetine is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/mL in water.

{ "type": "p", "children": [], "text": "The mesylate salt of paroxetine is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/mL in water." }

Each pink capsule contains 9.69 mg of paroxetine mesylate equivalent to 7.5 mg paroxetine base.

{ "type": "p", "children": [], "text": "Each pink capsule contains 9.69 mg of paroxetine mesylate equivalent to 7.5 mg paroxetine base." }

Inactive ingredients consist of: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&C Yellow #6, FD&C Red #3, FD&C Red #40, shellac, and black iron oxide.

{ "type": "p", "children": [], "text": "Inactive ingredients consist of: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&C Yellow #6, FD&C Red #3, FD&C Red #40, shellac, and black iron oxide." }

Nonclinical studies have shown that paroxetine is an SSRI; BRISDELLE is not an estrogen. The mechanism of action of BRISDELLE for the treatment of moderate to severe VMS associated with menopause is unknown.

Studies at clinically relevant BRISDELLE doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. Paroxetine is a neuronal serotonin reuptake inhibitor with weak effects on norepinephrine and dopamine neuronal reuptake in vitro. Paroxetine also has low affinity for muscarinic alpha1-, alpha2-, beta-adrenergic, dopamine (D2)-, 5-HT1-, 5-HT2-, and histamine (H1)-receptors.

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of paroxetine for the treatment of moderate to severe VMS associated with menopause have not been fully characterized.

Absorption

Paroxetine is completely absorbed after oral dosing.

In a study in which healthy postmenopausal females (n=24) received BRISDELLE 7.5 mg once daily for 14 days, steady-state paroxetine concentrations were achieved by approximately 12 days of dosing for most subjects, although it may take substantially longer in an occasional patient. Peak concentrations were reached at a median of 6 hours (3 to 8 hours range). Steady-state mean values of Cmax, Cmin, and AUC0-last were 13.10 ng/mL (CV 91%), 7.17 ng/mL (CV 99%), and 237 hr*ng/mL (CV 94%), respectively.

Steady-state AUC0-24 values were about 3 times those of AUC0-inf following a single BRISDELLE dose, indicating non-linear pharmacokinetics. Steady-state Cmax values were approximately 5 times greater than those attained after a single BRISDELLE dose and steady-state exposure based on AUC0-24 was about 10 times greater than AUC0-24 after a single dose.

The nonlinear kinetics and excess accumulation are due to the fact that CYP2D6, an enzyme that is in part responsible for paroxetine metabolism, is readily saturable.

Effect of Food: The effects of food on the bioavailability of paroxetine were studied after administration of another paroxetine product with a dosage higher than BRISDELLE. AUC was slightly increased (6%) when paroxetine was administered with food and the Cmax was 29% greater, while the time to reach peak plasma concentration decreased from 6.4 hours post-dosing to 4.9 hours. These changes are not clinically significant [see Dosage and Administration (2.1)].

Distribution

Paroxetine distributes throughout the body, including the central nervous system, with only 1% remaining in the plasma.

Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng/mL and 400 ng/mL, respectively. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin.

Elimination

Metabolism: Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by cytochrome CYP2D6. The role of this enzyme in paroxetine metabolism also suggests potential drug interactions [see Drug Interactions (7)]. At steady state, when the CYP2D6 pathway is essentially saturated, paroxetine clearance is governed by alternative P450 isozymes, which, unlike CYP2D6, show no evidence of saturation.

Excretion: Approximately 64% of a 30 mg oral solution of another paroxetine product (four times the recommended BRISDELLE dosage) was excreted in the urine with 2% as the parent compound and 62% as metabolites over a 10-day post-dosing period. About 36% of the dose was excreted in the feces (probably via the bile), mostly as metabolites and less than 1% as the parent compound over the 10-day post-dosing period.

Specific Populations

Patients with Renal and Hepatic Impairment: Increased plasma concentrations of paroxetine occur in subjects with renal and hepatic impairment. The mean plasma concentration in patients with creatinine clearance below 30 mL/min was approximately 4 times greater than seen in normal volunteers. Patients with creatinine clearance of 30 to 60 mL/min and patients with hepatic impairment had about a 2-fold increase in plasma concentrations (AUC, Cmax) [see Use in Specific Populations (8.6, 8.7)].

Geriatric Patients: In a multiple-dose study in geriatric patients with another paroxetine product at doses of 20, 30, and 40 mg (1.7, 4, and 5.3, times the maximum recommended BRISDELLE dosage, respectively), Cmin concentrations were about 70% to 80% greater than the respective Cmin concentrations in younger adult subjects [see Use in Specific Populations (8.5)].

Drug Interaction Studies

Potential Effect of BRISDELLE on Other Drugs

Potential Effect of Other Drugs on BRISDELLE

Concomitant use of paroxetine with other drugs that alter CYP enzymes activities including CYP2D6 may affect the plasma concentrations of paroxetine. Specific studies investigating the effect of other drugs on paroxetine are listed below:

Carcinogenesis

Two-year carcinogenicity studies were conducted in rodents given paroxetine in the diet at 1, 5, and 25 mg/kg/day (mice) and 1, 5, and 20 mg/kg/day (rats). The doses used in these carcinogenicity studies were approximately 16 (mouse) and 26 (rat) times the MHRD for BRISDELLE for the treatment of moderate to severe VMS associated with menopause. There was a significantly greater number of male rats in the high-dose group with reticulum cell sarcomas (1/100, 0/50, 0/50, and 4/50 for control, low-, middle-, and high-dose groups, respectively) and a significantly increased linear trend across groups for the occurrence of lymphoreticular tumors in male rats. Female rats were not affected. Although there was a dose-related increase in the number of tumors in mice, there was no paroxetine -related increase in the number of mice with tumors. The relevance of these findings to humans is unknown.

Mutagenesis

Paroxetine produced no genotoxic effect in a battery of 5 in vitro and 2 in vivo assays that included the following: bacterial mutation assay, mouse lymphoma mutation assay, unscheduled DNA synthesis assay, and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes and in a dominant lethal test in rats.

The effectiveness of BRISDELLE as a treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause was established in two Phase 3 randomized, double-blind, placebo-controlled clinical trials in 1,174 postmenopausal females. In these trials, patients must have had a minimum of 7-8 moderate to severe VMS per day at baseline (≥ 50 per week) for 30 days prior to receiving study drug. Patients were randomized to BRISDELLE 7.5 mg orally once daily or daily placebo:

{ "type": "p", "children": [], "text": "The effectiveness of BRISDELLE as a treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause was established in two Phase 3 randomized, double-blind, placebo-controlled clinical trials in 1,174 postmenopausal females. In these trials, patients must have had a minimum of 7-8 moderate to severe VMS per day at baseline (≥ 50 per week) for 30 days prior to receiving study drug. Patients were randomized to BRISDELLE 7.5 mg orally once daily or daily placebo:" }

{ "type": "ul", "children": [ "Trial 1 was a 12-week trial with a total of 606 postmenopausal females (average age 55 years; 65% White, 33% Black or African American, and 2% other races; 10.6% were Hispanic/Latina and 89.4% were not Hispanic/Latina; 18% surgically menopausal and 82% naturally menopausal).", "Trial 2 was a 24-week trial with a total of 568 postmenopausal females (average age 54 years; 76% White, 22% Black or African American, and 2% other races; 6.5% were Hispanic/Latina and 93.5% were not Hispanic/Latina; 20% surgically menopausal and 81% naturally menopausal)." ], "text": "" }

The co-primary efficacy endpoints for both trials were the reduction from baseline in VMS frequency and VMS severity at Weeks 4 and 12.

{ "type": "p", "children": [], "text": "The co-primary efficacy endpoints for both trials were the reduction from baseline in VMS frequency and VMS severity at Weeks 4 and 12." }

{ "type": "ul", "children": [ "Data from Trial 1 showed a statistically significant reduction from baseline in the frequency of moderate to severe VMS at Week 4 and Week 12 and a statistically significant reduction in the severity of moderate to severe VMS at Week 4 in the BRISDELLE group compared to the placebo group (Table 4).", "Data from Trial 2 showed a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS at Week 4 and Week 12 in the BRISDELLE group compared to placebo group (Table 5)." ], "text": "" }

Table 4: Trial 1: Changes in the Daily Frequency and Daily Severity of VMS at Weeks 4 and 12 in Postmenopausal Females with Moderate to Severe VMS (MITT Population)

{ "type": "p", "children": [], "text": "\nTable 4: Trial 1: Changes in the Daily Frequency and Daily Severity of VMS at Weeks 4 and 12 in Postmenopausal Females with Moderate to Severe VMS (MITT Population)\n" }

<div class="scrollingtable"><table width="75%"> <tbody class="Headless"> <tr class="First"> <td></td><td align="center" class="Botrule" colspan="2" valign="top"><span class="Bold">Frequency</span></td><td align="center" class="Botrule" colspan="2" valign="top"><span class="Bold">Severity</span></td> </tr> <tr> <td class="Botrule"></td><td align="center" class="Botrule" valign="top"><span class="Bold">BRISDELLE</span></td><td align="center" class="Botrule" valign="top"><span class="Bold">Placebo</span></td><td align="center" class="Botrule" valign="top"><span class="Bold">BRISDELLE</span></td><td align="center" class="Botrule" valign="top"><span class="Bold">Placebo</span></td> </tr> <tr> <td><span class="Bold">Baseline</span></td><td></td><td></td><td></td><td></td> </tr> <tr> <td>    n</td><td align="center">301</td><td align="center">305</td><td align="center">301</td><td align="center">305</td> </tr> <tr> <td>    Median</td><td align="center">10.4</td><td align="center">10.4</td><td align="center">2.5</td><td align="center">2.5</td> </tr> <tr> <td><span class="Bold"><span class="Italics">Change from baseline at Week 4 </span></span></td><td></td><td></td><td></td><td></td> </tr> <tr> <td>     n</td><td align="center">289</td><td align="center">293</td><td align="center">281</td><td align="center">289</td> </tr> <tr> <td>     Median</td><td align="center">-4.3</td><td align="center">-3.1</td><td align="center">-0.05</td><td align="center">0.00</td> </tr> <tr> <td>     Treatment Difference*</td><td align="center">-1.2</td><td align="center"></td><td align="center">-0.05</td><td align="center"></td> </tr> <tr> <td><span class="Italics">     P</span>-value<span class="Sup">#</span></td><td align="center">&lt;0.01</td><td align="center"></td><td align="center">&lt;0.01</td><td align="center"></td> </tr> <tr> <td><span class="Bold"><span class="Italics">Change from baseline at Week 12</span></span></td><td></td><td></td><td></td><td></td> </tr> <tr> <td>     n</td><td align="center">264</td><td align="center">274</td><td align="center">236</td><td align="center">253</td> </tr> <tr> <td>     Median</td><td align="center">-5.9</td><td align="center">-5.0</td><td align="center">-0.06</td><td align="center">-0.02</td> </tr> <tr> <td>     Treatment Difference<span class="Sup">*</span></td><td align="center">-0.9</td><td align="center"></td><td align="center">-0.04</td><td align="center"></td> </tr> <tr class="Last"> <td valign="top"><span class="Italics">     P</span>-value<span class="Sup">#</span></td><td align="center" valign="top">&lt;0.01</td><td align="center" valign="top"></td><td align="center" valign="top">0.17</td><td align="center" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td></td><td align=\"center\" class=\"Botrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Frequency</span></td><td align=\"center\" class=\"Botrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Severity</span></td>\n</tr>\n<tr>\n<td class=\"Botrule\"></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">BRISDELLE</span></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">Placebo</span></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">BRISDELLE</span></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">Placebo</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Baseline</span></td><td></td><td></td><td></td><td></td>\n</tr>\n<tr>\n<td>    n</td><td align=\"center\">301</td><td align=\"center\">305</td><td align=\"center\">301</td><td align=\"center\">305</td>\n</tr>\n<tr>\n<td>    Median</td><td align=\"center\">10.4</td><td align=\"center\">10.4</td><td align=\"center\">2.5</td><td align=\"center\">2.5</td>\n</tr>\n<tr>\n<td><span class=\"Bold\"><span class=\"Italics\">Change from baseline at Week 4 </span></span></td><td></td><td></td><td></td><td></td>\n</tr>\n<tr>\n<td>     n</td><td align=\"center\">289</td><td align=\"center\">293</td><td align=\"center\">281</td><td align=\"center\">289</td>\n</tr>\n<tr>\n<td>     Median</td><td align=\"center\">-4.3</td><td align=\"center\">-3.1</td><td align=\"center\">-0.05</td><td align=\"center\">0.00</td>\n</tr>\n<tr>\n<td>     Treatment Difference*</td><td align=\"center\">-1.2</td><td align=\"center\"></td><td align=\"center\">-0.05</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td><span class=\"Italics\">     P</span>-value<span class=\"Sup\">#</span></td><td align=\"center\">&lt;0.01</td><td align=\"center\"></td><td align=\"center\">&lt;0.01</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td><span class=\"Bold\"><span class=\"Italics\">Change from baseline at Week 12</span></span></td><td></td><td></td><td></td><td></td>\n</tr>\n<tr>\n<td>     n</td><td align=\"center\">264</td><td align=\"center\">274</td><td align=\"center\">236</td><td align=\"center\">253</td>\n</tr>\n<tr>\n<td>     Median</td><td align=\"center\">-5.9</td><td align=\"center\">-5.0</td><td align=\"center\">-0.06</td><td align=\"center\">-0.02</td>\n</tr>\n<tr>\n<td>     Treatment Difference<span class=\"Sup\">*</span></td><td align=\"center\">-0.9</td><td align=\"center\"></td><td align=\"center\">-0.04</td><td align=\"center\"></td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\"><span class=\"Italics\">     P</span>-value<span class=\"Sup\">#</span></td><td align=\"center\" valign=\"top\">&lt;0.01</td><td align=\"center\" valign=\"top\"></td><td align=\"center\" valign=\"top\">0.17</td><td align=\"center\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

MITT population: all consented and randomized patients with valid baseline daily hot flash diary data who had taken at least 1 dose of study drug and had at least 1 day of on-treatment daily hot flash diary data. * Treatment Difference: the difference between the median changes from baseline. # P-value was obtained from rank-ANCOVA model.

{ "type": "p", "children": [], "text": "MITT population: all consented and randomized patients with valid baseline daily hot flash diary data who had taken at least 1 dose of study drug and had at least 1 day of on-treatment daily hot flash diary data.\n\t\t\t\t * Treatment Difference: the difference between the median changes from baseline.\n\t\t\t\t # P-value was obtained from rank-ANCOVA model." }

Table 5: Trial 2: Changes in the Daily Frequency and Daily Severity of VMS at Weeks 4 and 12 in Postmenopausal Females with Moderate to Severe VMS (MITT Population)

{ "type": "p", "children": [], "text": "\nTable 5: Trial 2: Changes in the Daily Frequency and Daily Severity of VMS at Weeks 4 and 12 in Postmenopausal Females with Moderate to Severe VMS (MITT Population)\n" }

<div class="scrollingtable"><table width="75%"> <tbody class="Headless"> <tr class="First"> <td></td><td align="center" class="Botrule" colspan="2" valign="top"><span class="Bold">Frequency</span></td><td align="center" class="Botrule" colspan="2" valign="top"><span class="Bold">Severity</span></td> </tr> <tr> <td class="Botrule"></td><td align="center" class="Botrule" valign="top"><span class="Bold">BRISDELLE</span></td><td align="center" class="Botrule" valign="top"><span class="Bold">Placebo</span></td><td align="center" class="Botrule" valign="top"><span class="Bold">BRISDELLE</span></td><td align="center" class="Botrule" valign="top"><span class="Bold">Placebo</span></td> </tr> <tr> <td><span class="Bold">Baseline</span></td><td></td><td></td><td></td><td></td> </tr> <tr> <td>         n</td><td align="center">284</td><td align="center">284</td><td align="center">284</td><td align="center">284</td> </tr> <tr> <td>         Median</td><td align="center">9.9</td><td align="center">9.6</td><td align="center">2.5</td><td align="center">2.5</td> </tr> <tr> <td><span class="Bold"><span class="Italics">Change from baseline at Week 4 </span></span></td><td></td><td></td><td></td><td></td> </tr> <tr> <td>         n</td><td align="center">276</td><td align="center">274</td><td align="center">268</td><td align="center">271</td> </tr> <tr> <td>         Median</td><td align="center">-3.8</td><td align="center">-2.5</td><td align="center">-0.04</td><td align="center">-0.01</td> </tr> <tr> <td>         Treatment Difference*</td><td align="center">-1.3</td><td align="center"></td><td align="center">-0.03</td><td align="center"></td> </tr> <tr> <td><span class="Italics">         P</span>-value<span class="Sup">#</span></td><td align="center">&lt;0.01</td><td align="center"></td><td align="center">0.04</td><td align="center"></td> </tr> <tr> <td><span class="Bold"><span class="Italics">Change from baseline at Week 12</span></span></td><td></td><td></td><td></td><td></td> </tr> <tr> <td>         n</td><td align="center">257</td><td align="center">244</td><td align="center">245</td><td align="center">236</td> </tr> <tr> <td>         Median</td><td align="center">-5.6</td><td align="center">-3.9</td><td align="center">-0.05</td><td align="center">0.00</td> </tr> <tr> <td>         Treatment Difference*</td><td align="center">-1.7</td><td align="center"></td><td align="center">-0.05</td><td align="center"></td> </tr> <tr class="Last"> <td valign="top"><span class="Italics">         P</span>-value<span class="Sup">#</span></td><td align="center" valign="top">&lt;0.01</td><td align="center" valign="top"></td><td align="center" valign="top">&lt;0.01</td><td align="center" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td></td><td align=\"center\" class=\"Botrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Frequency</span></td><td align=\"center\" class=\"Botrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Severity</span></td>\n</tr>\n<tr>\n<td class=\"Botrule\"></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">BRISDELLE</span></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">Placebo</span></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">BRISDELLE</span></td><td align=\"center\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">Placebo</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Baseline</span></td><td></td><td></td><td></td><td></td>\n</tr>\n<tr>\n<td>         n</td><td align=\"center\">284</td><td align=\"center\">284</td><td align=\"center\">284</td><td align=\"center\">284</td>\n</tr>\n<tr>\n<td>         Median</td><td align=\"center\">9.9</td><td align=\"center\">9.6</td><td align=\"center\">2.5</td><td align=\"center\">2.5</td>\n</tr>\n<tr>\n<td><span class=\"Bold\"><span class=\"Italics\">Change from baseline at Week 4 </span></span></td><td></td><td></td><td></td><td></td>\n</tr>\n<tr>\n<td>         n</td><td align=\"center\">276</td><td align=\"center\">274</td><td align=\"center\">268</td><td align=\"center\">271</td>\n</tr>\n<tr>\n<td>         Median</td><td align=\"center\">-3.8</td><td align=\"center\">-2.5</td><td align=\"center\">-0.04</td><td align=\"center\">-0.01</td>\n</tr>\n<tr>\n<td>         Treatment Difference*</td><td align=\"center\">-1.3</td><td align=\"center\"></td><td align=\"center\">-0.03</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td><span class=\"Italics\">         P</span>-value<span class=\"Sup\">#</span></td><td align=\"center\">&lt;0.01</td><td align=\"center\"></td><td align=\"center\">0.04</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td><span class=\"Bold\"><span class=\"Italics\">Change from baseline at Week 12</span></span></td><td></td><td></td><td></td><td></td>\n</tr>\n<tr>\n<td>         n</td><td align=\"center\">257</td><td align=\"center\">244</td><td align=\"center\">245</td><td align=\"center\">236</td>\n</tr>\n<tr>\n<td>         Median</td><td align=\"center\">-5.6</td><td align=\"center\">-3.9</td><td align=\"center\">-0.05</td><td align=\"center\">0.00</td>\n</tr>\n<tr>\n<td>         Treatment Difference*</td><td align=\"center\">-1.7</td><td align=\"center\"></td><td align=\"center\">-0.05</td><td align=\"center\"></td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\"><span class=\"Italics\">         P</span>-value<span class=\"Sup\">#</span></td><td align=\"center\" valign=\"top\">&lt;0.01</td><td align=\"center\" valign=\"top\"></td><td align=\"center\" valign=\"top\">&lt;0.01</td><td align=\"center\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

MITT population: all consented and randomized patients with valid baseline daily hot flash diary data who had taken at least 1 dose of study drug and had at least 1 day of on-treatment daily hot flash diary data. * Treatment Difference: the difference between the median changes from baseline. # P-value is obtained from rank-ANCOVA model.

{ "type": "p", "children": [], "text": "MITT population: all consented and randomized patients with valid baseline daily hot flash diary data who had taken at least 1 dose of study drug and had at least 1 day of on-treatment daily hot flash diary data.\n\t\t\t\t \n* Treatment Difference: the difference between the median changes from baseline.\n\t\t\t\t \n# P-value is obtained from rank-ANCOVA model." }

Persistence of benefit at 24 weeks in Trial 2 was evaluated with a responder analysis where responders were defined as those patients who achieved ≥ 50% reduction from baseline in the frequency of moderate to severe VMS at Week 24. The proportion of patients who achieved a ≥ 50% reduction in the frequency of moderate to severe VMS from baseline to Week 24 was 48% in the BRISDELLE group and 36% in the placebo group at Week 24.

{ "type": "p", "children": [], "text": "Persistence of benefit at 24 weeks in Trial 2 was evaluated with a responder analysis where responders were defined as those patients who achieved ≥ 50% reduction from baseline in the frequency of moderate to severe VMS at Week 24. The proportion of patients who achieved a ≥ 50% reduction in the frequency of moderate to severe VMS from baseline to Week 24 was 48% in the BRISDELLE group and 36% in the placebo group at Week 24." }

BRISDELLE (paroxetine) capsules is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg”.

{ "type": "p", "children": [], "text": "BRISDELLE (paroxetine) capsules is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg”." }

NDC 83107-027-30 blister packs of 30

{ "type": "p", "children": [], "text": "NDC 83107-027-30 blister packs of 30" }

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and humidity.

{ "type": "p", "children": [], "text": "Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and humidity." }

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Medication Guide)." }

Instruct patients to read the Medication Guide before starting therapy with BRISDELLE and to reread it each time the prescription is renewed.

{ "type": "p", "children": [], "text": "Instruct patients to read the Medication Guide before starting therapy with BRISDELLE and to reread it each time the prescription is renewed." }

Suicidal Thoughts and Behaviors

{ "type": "p", "children": [], "text": "\nSuicidal Thoughts and Behaviors\n" }

Advise patients, their families, and their caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and to alert the health care provider if such changes occur [see Boxed Warning and Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients, their families, and their caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and to alert the health care provider if such changes occur [see Boxed Warning and Warnings and Precautions (5.1)]." }

Serotonin Syndrome

{ "type": "p", "children": [], "text": "\nSerotonin Syndrome\n" }

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of BRISDELLE with triptans, tricyclic antidepressants, opioids, linezolid, tramadol, amphetamines, St. John’s Wort, lithium, tryptophan supplements, other serotonergic agents, or antipsychotic drugs. Instruct patients to contact their health care provider, or report to the emergency room, should they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7.3)].

{ "type": "p", "children": [], "text": "Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of BRISDELLE with triptans, tricyclic antidepressants, opioids, linezolid, tramadol, amphetamines, St. John’s Wort, lithium, tryptophan supplements, other serotonergic agents, or antipsychotic drugs. Instruct patients to contact their health care provider, or report to the emergency room, should they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7.3)]." }

Potential Impact on Tamoxifen Efficacy

{ "type": "p", "children": [], "text": "\nPotential Impact on Tamoxifen Efficacy\n" }

Caution patients that efficacy of tamoxifen may be reduced when administered concomitantly and counsel them about the likely benefit of paroxetine for treating VMS vs. the risk of possible decreased tamoxifen effectiveness [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Caution patients that efficacy of tamoxifen may be reduced when administered concomitantly and counsel them about the likely benefit of paroxetine for treating VMS vs. the risk of possible decreased tamoxifen effectiveness [see Warnings and Precautions (5.3)]." }

Increased Risk of Bleeding

{ "type": "p", "children": [], "text": "\nIncreased Risk of Bleeding\n" }

Caution patients about the concomitant use of BRISDELLE and NSAIDs, aspirin, warfarin, and other anticoagulants because combined use of drugs that interfere with serotonin reuptake has been associated with an increased risk of bleeding [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Caution patients about the concomitant use of BRISDELLE and NSAIDs, aspirin, warfarin, and other anticoagulants because combined use of drugs that interfere with serotonin reuptake has been associated with an increased risk of bleeding [see Warnings and Precautions (5.4)]." }

Angle-Closure Claucoma

{ "type": "p", "children": [], "text": "\nAngle-Closure Claucoma\n" }

Advise patients that taking BRISDELLE can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma -existing [See Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Advise patients that taking BRISDELLE can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma -existing [See Warnings and Precautions (5.5)]." }

Hyponatremia

{ "type": "p", "children": [], "text": "\nHyponatremia\n" }

Caution patients about the risk of hyponatremia, particularly elderly patients and those who are taking diuretics or are volume-depleted [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Caution patients about the risk of hyponatremia, particularly elderly patients and those who are taking diuretics or are volume-depleted [see Warnings and Precautions (5.6)]." }

Bone Fracture

{ "type": "p", "children": [], "text": "\nBone Fracture\n" }

Inform patients that there is the possibility for an increased risk of fracture [see Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Inform patients that there is the possibility for an increased risk of fracture [see Warnings and Precautions (5.7)]." }

Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania

{ "type": "p", "children": [], "text": "\nScreening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania\n" }

Advise patients, their families, and their caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions (5.8)].

{ "type": "p", "children": [], "text": "Advise patients, their families, and their caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions (5.8)]." }

Pregnancy

{ "type": "p", "children": [], "text": "\nPregnancy\n" }

Advise patients to notify their physician if they become pregnant during therapy [see Contraindications (4.5) and Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Advise patients to notify their physician if they become pregnant during therapy [see Contraindications (4.5) and Use in Specific Populations (8.1)]." }

Drug Interactions

{ "type": "p", "children": [], "text": "\nDrug Interactions\n" }

Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal supplements, because there is a potential for interaction with paroxetine [see Drug Interactions (7)].

{ "type": "p", "children": [], "text": "Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal supplements, because there is a potential for interaction with paroxetine [see Drug Interactions (7)]." }

Sexual Dysfunction

{ "type": "p", "children": [], "text": "\nSexual Dysfunction\n" }

Advise patients that use of BRISDELLE may cause symptoms of sexual dysfunction in female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.10)].

{ "type": "p", "children": [], "text": "Advise patients that use of BRISDELLE may cause symptoms of sexual dysfunction in female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.10)]." }

Allergic Reactions

{ "type": "p", "children": [], "text": "\nAllergic Reactions\n" }

Advise patients to seek medical attention if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.2)].

{ "type": "p", "children": [], "text": "Advise patients to seek medical attention if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.2)]." }

BRISDELLE is a registered trademark of Legacy Pharma Inc.

{ "type": "p", "children": [], "text": "BRISDELLE is a registered trademark of Legacy Pharma Inc." }

©2025 Legacy Pharma Inc. All rights reserved.

{ "type": "p", "children": [], "text": "\n©2025 Legacy Pharma Inc. All rights reserved." }

Manufactured for: Legacy Pharma Inc. George Town, Grand Cayman KY1-9012

{ "type": "p", "children": [], "text": "Manufactured for:\n Legacy Pharma Inc.\n George Town, Grand Cayman\n KY1-9012" }

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0" width="90%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">MEDICATION GUIDE</span> </p> <p>BRISDELLE<span class="Sup">®</span> (bris-del)</p> <p>(paroxetine)</p> <p>capsules</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Read this Medication Guide that comes with BRISDELLE before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.</p> <br/> <p></p> <p> <span class="Bold">What is the most important information I should know about BRISDELLE?</span> </p> <p>BRISDELLE may cause serious side effects, including:</p> <ul class="Disc"> <li> <span class="Bold">Increased risk of suicidal thoughts or actions</span>. BRISDELLE and related antidepressant medicines may increase suicidal thoughts or actions within the first few months of treatment.<ul class="Circle"> <li>Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.</li> <li>Watch for these changes and call your healthcare provider right away if you notice:<ul> <li>New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.</li> <li>Pay close attention to any changes when BRISDELLE is started.</li> </ul> </li> <li>Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.</li> </ul> </li> </ul> <p></p> <p> <span class="Bold">Call your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you:</span> </p> <ul class="Circle"> <li>attempts to commit suicide</li> <li>acting on dangerous impulses</li> <li>acting aggressive or violent</li> <li>thoughts about suicide or dying</li> <li>new or worse depression</li> <li>new or worse anxiety or panic attacks</li> <li>feeling agitated, restless, angry or irritable</li> <li>trouble sleeping</li> <li>an increase in activity or talking more than what is normal for you</li> <li>other unusual changes in behavior or mood</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What is BRISDELLE?</span> </p> <ul> <li>BRISDELLE is a prescription medicine used to treat moderate to severe hot flashes associated with menopause.</li> <li>BRISDELLE is not any for psychiatric problems such as depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder.</li> <li>BRISDELLE is not for use in children.</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Who should not take BRISDELLE?</span> </p> <p> <span class="Bold">Do not take BRISDELLE if you:</span> </p> <ul> <li> <span class="Bold">take a Monoamine Oxidase Inhibitor (MAOI). </span>Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or the intravenous methylene blue. <ul class="Circle"> <li>Do not take an MAOI within 14 days of stopping BRISDELLE unless directed to do so by your healthcare provider.</li> <li>Do not start BRISDELLE if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.</li> <li> <span class="Bold">People who take BRISDELLE close in time to an MAOI may have a serious or life-threatening side effect called serotonin syndrome. Get medical help right away if you have any of these symptoms:</span> <ul> <li>high fever</li> <li>uncontrolled muscle spasms</li> <li>stiff muscles</li> <li>rapid changes in heart rate or blood pressure</li> <li>confusion</li> <li>loss of consciousness (pass out)</li> <li>nausea, vomiting, or diarrhea</li> </ul> </li> </ul> </li> </ul> <ul> <li> <span class="Bold">take thioridazine</span>. Do not take thioridazine together with BRISDELLE because this can cause serious heart rhythm problems or sudden death.</li> <li> <span class="Bold">take the antipsychotic medicine pimozide</span>. Do not take pimozide together with BRISDELLE because this can cause serious heart problems.</li> <li> <span class="Bold">are allergic to paroxetine or any of the ingredients in BRISDELLE. See the end of this Medication Guide for a complete list of ingredients in BRISDELLE</span>.</li> <li> <span class="Bold">are pregnant or become pregnant</span>. BRISDELLE can harm your unborn baby. Call your healthcare provider if you become pregnant while taking BRISDELLE.</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What should I tell my healthcare provider before taking BRISDELLE?</span> </p> <br/> <p> <span class="Bold">Before taking BRISDELLE, tell your healthcare provider about all of your medical conditions, including if you:</span> </p> <ul> <li>have liver problems</li> <li>have kidney problems</li> <li>have or had seizures or convulsions</li> <li>have or have a family history of bipolar disorder, mania or hypomania</li> <li>have low sodium levels in your blood</li> <li>have or had bleeding problems</li> <li>have glaucoma (high pressure in the eye)</li> <li>have bone problems</li> </ul> <p> <span class="Bold">Tell your healthcare provider about all the medicines that you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRISDELLE and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.</p> <br/> <p>If you take BRISDELLE, you should not take any other medicines that contain paroxetine, including Paxil, Paxil CR and Pexeva.</p> <br/> <p> <span class="Bold">Especially tell your healthcare provider if you take</span>:</p> <ul> <li>triptans used to treat migraine headache</li> <li>medicines used to treat mood, anxiety, psychotic or thought disorders, including MAOIs, SSRIs, tricyclics, lithium, buspirone, or antipsychotics</li> <li>tramadol, fentanyl, meperidine, methadone, or other opioids</li> <li>over-the-counter supplements such as tryptophan or St. John’s Wort</li> <li>amphetamines</li> <li>thioridazine</li> <li>pimozide</li> <li>tamoxifen</li> <li>atomoxetine</li> <li>cimetidine</li> <li>digoxin</li> <li>theophylline</li> <li>medicines to treat irregular heart rate (like propafenone, flecainide, and encainide)</li> <li>medicines used to treat schizophrenia</li> <li>certain medicines used to treat HIV infection</li> <li>the blood thinner warfarin</li> <li>nonsteroidal anti-inflammatory drugs (NSAIDs) (like ibuprofen, naproxen, or aspirin)</li> <li>certain medicines used to treat seizures (like phenobarbital and phenytoin)</li> <li>other drugs containing paroxetine, the medicine in BRISDELLE</li> </ul> <p>Ask your healthcare provider if you are not sure if you are taking any of these medications.</p> <br/> <p>Your healthcare provider or pharmacist can tell you if it is safe to take BRISDELLE with your other medicines. Do not start or stop any medicine while taking BRISDELLE without talking to your healthcare provider first.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">How should I take BRISDELLE?</span> </p> <ul> <li>Take BRISDELLE exactly as your healthcare provider tells you to take it.</li> <li>Take BRISDELLE 1 time each day at bedtime.</li> <li>BRISDELLE may be taken with or without food.</li> <li>If you take too much BRISDELLE, call your healthcare provider or Poison Help line right away, or go to the nearest emergency room right away.</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of BRISDELLE?</span> </p> <p> <span class="Bold">BRISDELLE may cause serious side effects, including:</span> </p> <ul> <li>See “What is the most important information I should know about BRISDELLE?”</li> <li> <span class="Bold">Serotonin syndrome. This condition can be life-threatening and can happen when you take BRISDELLE with certain other medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of serotonin syndrome:</span> <ul> <li>agitation (nervousness), hallucinations, coma or other changes in mental status</li> <li>coordination problems or muscle twitching (small movements of the muscles that you cannot control)</li> <li>racing heartbeat, high or low blood pressure</li> <li>sweating or fever</li> <li>nausea, vomiting, or diarrhea</li> <li>muscle rigidity</li> <li>dizziness</li> <li>flushing</li> <li>tremors</li> <li>seizures</li> </ul> </li> </ul> <ul class="Disc"> <li> <span class="Bold">Reduced effectiveness of tamoxifen</span>. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take BRISDELLE. If you are taking tamoxifen, tell your healthcare provider before starting BRISDELLE.</li> <li> <span class="Bold">Abnormal bleeding</span>. BRISDELLE may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or aspirin.</li> <li> <span class="Bold">Visual problems (angle-closure glaucoma).</span> BRISDELLE may cause a visual problem called angle-closure glaucoma. Symptoms may include:<ul> <li>eye pain</li> <li>changes in vision</li> <li>swelling or redness in or around the eye</li> </ul> </li> </ul> <p>Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.</p> <ul> <li> <span class="Bold">Low salt (sodium) levels in the blood</span>. Elderly people and those taking diuretics or are dehydrated are at greater risk of experiencing low salt levels in their blood. Symptoms may include:<ul> <li>headache</li> <li>weakness or feeling unsteady</li> <li>confusion, problems concentrating or thinking or memory problems</li> <li>seeing or hearing things that are not there (hallucinations)</li> <li>fainting (syncope)</li> <li>seizures</li> <li>stopping breathing (respiratory arrest)</li> </ul> </li> </ul> <ul class="Disc"> <li> <span class="Bold">Bone fractures. </span>Women who take BRISDELLE may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone. </li> <li> <span class="Bold">Manic episodes. Manic episodes may happen in people with bipolar disorder who take BRISDELLE. Symptoms may include</span>: <ul> <li>greatly increased energy</li> <li>severe trouble sleeping</li> <li>racing thoughts</li> <li>reckless behavior</li> <li>unusually grand ideas</li> <li>excessive happiness or irritability</li> <li>talking more or faster than usual</li> </ul> </li> </ul> <ul class="Disc"> <li> <span class="Bold">Seizures</span> </li> <li> <span class="Bold">Sexual problems (dysfunction).</span> Taking selective serotonin reuptake inhibitors (SSRIs), including BRISDELLE, may cause symptoms of sexual problems. Symptoms in females may include: <ul> <li>decreased sexual drive</li> <li>delayed or inability to have an orgasm</li> </ul> </li> </ul> <p>The most common side effects of BRISDELLE include:</p> <ul> <li>headache</li> <li>tiredness</li> <li>nausea and vomiting</li> </ul> <p>Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of BRISDELLE. For more information, ask your healthcare provider or pharmacist.</p> <p></p> <p> <span class="Bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">How should I store BRISDELLE?</span> </p> <ul> <li>Store BRISDELLE at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>Keep BRISDELLE out of the light.</li> <li>Keep BRISDELLE dry.</li> </ul> <p> <span class="Bold">Keep BRISDELLE and all medicines out of the reach of children</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of BRISDELLE.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRISDELLE for a condition for which it was not prescribed. Do not give BRISDELLE to other people, even if they have the same condition. It may harm them. You may ask your healthcare provider or pharmacist for information about BRISDELLE that is written for healthcare professionals.<span class="Bold"></span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in BRISDELLE?</span> </p> <p> <span class="Bold">Active ingredient</span>: paroxetine</p> <p> <span class="Bold">Inactive ingredients</span>: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&amp;C Yellow #6, FD&amp;C Red #3, FD&amp;C Red #40, shellac and black iron oxide.</p> <br/> <p>Manufactured for:</p> <p>Legacy Pharma Inc., George Town, Grand Cayman</p> <br/> <p>BRISDELLE is a registered trademark of Legacy Pharma Inc.</p> <p> <span class="Sup">©</span>2025 Legacy Pharma Inc. All rights reserved.</p> <p>For more information about BRISDELLE go to www.BRISDELLE.com</p> <p>MDG90757001</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"90%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">MEDICATION GUIDE</span>\n</p>\n<p>BRISDELLE<span class=\"Sup\">®</span> (bris-del)</p>\n<p>(paroxetine)</p>\n<p>capsules</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Read this Medication Guide that comes with BRISDELLE before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.</p>\n<br/>\n<p></p>\n<p>\n<span class=\"Bold\">What is the most important information I should know about BRISDELLE?</span>\n</p>\n<p>BRISDELLE may cause serious side effects, including:</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Increased risk of suicidal thoughts or actions</span>. BRISDELLE and related antidepressant medicines may increase suicidal thoughts or actions within the first few months of treatment.<ul class=\"Circle\">\n<li>Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.</li>\n<li>Watch for these changes and call your healthcare provider right away if you notice:<ul>\n<li>New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.</li>\n<li>Pay close attention to any changes when BRISDELLE is started.</li>\n</ul>\n</li>\n<li>Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.</li>\n</ul>\n</li>\n</ul>\n<p></p>\n<p>\n<span class=\"Bold\">Call your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you:</span>\n</p>\n<ul class=\"Circle\">\n<li>attempts to commit suicide</li>\n<li>acting on dangerous impulses</li>\n<li>acting aggressive or violent</li>\n<li>thoughts about suicide or dying</li>\n<li>new or worse depression</li>\n<li>new or worse anxiety or panic attacks</li>\n<li>feeling agitated, restless, angry or irritable</li>\n<li>trouble sleeping</li>\n<li>an increase in activity or talking more than what is normal for you</li>\n<li>other unusual changes in behavior or mood</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is BRISDELLE?</span>\n</p>\n<ul>\n<li>BRISDELLE is a prescription medicine used to treat moderate to severe hot flashes associated with menopause.</li>\n<li>BRISDELLE is not any for psychiatric problems such as depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder.</li>\n<li>BRISDELLE is not for use in children.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Who should not take BRISDELLE?</span>\n</p>\n<p>\n<span class=\"Bold\">Do not take BRISDELLE if you:</span>\n</p>\n<ul>\n<li>\n<span class=\"Bold\">take a Monoamine Oxidase Inhibitor (MAOI). </span>Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or the intravenous methylene blue.\n\t\t\t\t\t\t\t\t\t<ul class=\"Circle\">\n<li>Do not take an MAOI within 14 days of stopping BRISDELLE unless directed to do so by your healthcare provider.</li>\n<li>Do not start BRISDELLE if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.</li>\n<li>\n<span class=\"Bold\">People who take BRISDELLE close in time to an MAOI may have a serious or life-threatening side effect called serotonin syndrome. Get medical help right away if you have any of these symptoms:</span>\n<ul>\n<li>high fever</li>\n<li>uncontrolled muscle spasms</li>\n<li>stiff muscles</li>\n<li>rapid changes in heart rate or blood pressure</li>\n<li>confusion</li>\n<li>loss of consciousness (pass out)</li>\n<li>nausea, vomiting, or diarrhea</li>\n</ul>\n</li>\n</ul>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">take thioridazine</span>. Do not take thioridazine together with BRISDELLE because this can cause serious heart rhythm problems or sudden death.</li>\n<li>\n<span class=\"Bold\">take the antipsychotic medicine pimozide</span>. Do not take pimozide together with BRISDELLE because this can cause serious heart problems.</li>\n<li>\n<span class=\"Bold\">are allergic to paroxetine or any of the ingredients in BRISDELLE. See the end of this Medication Guide for a complete list of ingredients in BRISDELLE</span>.</li>\n<li>\n<span class=\"Bold\">are pregnant or become pregnant</span>. BRISDELLE can harm your unborn baby. Call your healthcare provider if you become pregnant while taking BRISDELLE.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I tell my healthcare provider before taking BRISDELLE?</span>\n</p>\n<br/>\n<p>\n<span class=\"Bold\">Before taking BRISDELLE, tell your healthcare provider about all of your medical conditions, including if you:</span>\n</p>\n<ul>\n<li>have liver problems</li>\n<li>have kidney problems</li>\n<li>have or had seizures or convulsions</li>\n<li>have or have a family history of bipolar disorder, mania or hypomania</li>\n<li>have low sodium levels in your blood</li>\n<li>have or had bleeding problems</li>\n<li>have glaucoma (high pressure in the eye)</li>\n<li>have bone problems</li>\n</ul>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines that you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRISDELLE and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.</p>\n<br/>\n<p>If you take BRISDELLE, you should not take any other medicines that contain paroxetine, including Paxil, Paxil CR and Pexeva.</p>\n<br/>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider if you take</span>:</p>\n<ul>\n<li>triptans used to treat migraine headache</li>\n<li>medicines used to treat mood, anxiety, psychotic or thought disorders, including MAOIs, SSRIs, tricyclics, lithium, buspirone, or antipsychotics</li>\n<li>tramadol, fentanyl, meperidine, methadone, or other opioids</li>\n<li>over-the-counter supplements such as tryptophan or St. John’s Wort</li>\n<li>amphetamines</li>\n<li>thioridazine</li>\n<li>pimozide</li>\n<li>tamoxifen</li>\n<li>atomoxetine</li>\n<li>cimetidine</li>\n<li>digoxin</li>\n<li>theophylline</li>\n<li>medicines to treat irregular heart rate (like propafenone, flecainide, and encainide)</li>\n<li>medicines used to treat schizophrenia</li>\n<li>certain medicines used to treat HIV infection</li>\n<li>the blood thinner warfarin</li>\n<li>nonsteroidal anti-inflammatory drugs (NSAIDs) (like ibuprofen, naproxen, or aspirin)</li>\n<li>certain medicines used to treat seizures (like phenobarbital and phenytoin)</li>\n<li>other drugs containing paroxetine, the medicine in BRISDELLE</li>\n</ul>\n<p>Ask your healthcare provider if you are not sure if you are taking any of these medications.</p>\n<br/>\n<p>Your healthcare provider or pharmacist can tell you if it is safe to take BRISDELLE with your other medicines. Do not start or stop any medicine while taking BRISDELLE without talking to your healthcare provider first.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take BRISDELLE?</span>\n</p>\n<ul>\n<li>Take BRISDELLE exactly as your healthcare provider tells you to take it.</li>\n<li>Take BRISDELLE 1 time each day at bedtime.</li>\n<li>BRISDELLE may be taken with or without food.</li>\n<li>If you take too much BRISDELLE, call your healthcare provider or Poison Help line right away, or go to the nearest emergency room right away.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of BRISDELLE?</span>\n</p>\n<p>\n<span class=\"Bold\">BRISDELLE may cause serious side effects, including:</span>\n</p>\n<ul>\n<li>See “What is the most important information I should know about BRISDELLE?”</li>\n<li>\n<span class=\"Bold\">Serotonin syndrome. This condition can be life-threatening and can happen when you take BRISDELLE with certain other medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of serotonin syndrome:</span>\n<ul>\n<li>agitation (nervousness), hallucinations, coma or other changes in mental status</li>\n<li>coordination problems or muscle twitching (small movements of the muscles that you cannot control)</li>\n<li>racing heartbeat, high or low blood pressure</li>\n<li>sweating or fever</li>\n<li>nausea, vomiting, or diarrhea</li>\n<li>muscle rigidity</li>\n<li>dizziness</li>\n<li>flushing</li>\n<li>tremors</li>\n<li>seizures</li>\n</ul>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Reduced effectiveness of tamoxifen</span>. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take BRISDELLE. If you are taking tamoxifen, tell your healthcare provider before starting BRISDELLE.</li>\n<li>\n<span class=\"Bold\">Abnormal bleeding</span>. BRISDELLE may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or aspirin.</li>\n<li>\n<span class=\"Bold\">Visual problems (angle-closure glaucoma).</span> BRISDELLE may cause a visual problem called angle-closure glaucoma. Symptoms may include:<ul>\n<li>eye pain</li>\n<li>changes in vision</li>\n<li>swelling or redness in or around the eye</li>\n</ul>\n</li>\n</ul>\n<p>Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.</p>\n<ul>\n<li>\n<span class=\"Bold\">Low salt (sodium) levels in the blood</span>. Elderly people and those taking diuretics or are dehydrated are at greater risk of experiencing low salt levels in their blood. Symptoms may include:<ul>\n<li>headache</li>\n<li>weakness or feeling unsteady</li>\n<li>confusion, problems concentrating or thinking or memory problems</li>\n<li>seeing or hearing things that are not there (hallucinations)</li>\n<li>fainting (syncope)</li>\n<li>seizures</li>\n<li>stopping breathing (respiratory arrest)</li>\n</ul>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Bone fractures. </span>Women who take BRISDELLE may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone.\n </li>\n<li>\n<span class=\"Bold\">Manic episodes. Manic episodes may happen in people with bipolar disorder who take BRISDELLE. Symptoms may include</span>:\n\t\t\t\t\t\t\t\t\t\t <ul>\n<li>greatly increased energy</li>\n<li>severe trouble sleeping</li>\n<li>racing thoughts</li>\n<li>reckless behavior</li>\n<li>unusually grand ideas</li>\n<li>excessive happiness or irritability</li>\n<li>talking more or faster than usual</li>\n</ul>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Seizures</span>\n</li>\n<li>\n<span class=\"Bold\">Sexual problems (dysfunction).</span> Taking selective serotonin reuptake inhibitors (SSRIs), including BRISDELLE, may cause symptoms of sexual problems. Symptoms in females may include:\n <ul>\n<li>decreased sexual drive</li>\n<li>delayed or inability to have an orgasm</li>\n</ul>\n</li>\n</ul>\n<p>The most common side effects of BRISDELLE include:</p>\n<ul>\n<li>headache</li>\n<li>tiredness</li>\n<li>nausea and vomiting</li>\n</ul>\n<p>Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of BRISDELLE. For more information, ask your healthcare provider or pharmacist.</p>\n<p></p>\n<p>\n<span class=\"Bold\">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store BRISDELLE?</span>\n</p>\n<ul>\n<li>Store BRISDELLE at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>Keep BRISDELLE out of the light.</li>\n<li>Keep BRISDELLE dry.</li>\n</ul>\n<p>\n<span class=\"Bold\">Keep BRISDELLE and all medicines out of the reach of children</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of BRISDELLE.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRISDELLE for a condition for which it was not prescribed. Do not give BRISDELLE to other people, even if they have the same condition. It may harm them. You may ask your healthcare provider or pharmacist for information about BRISDELLE that is written for healthcare professionals.<span class=\"Bold\"></span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in BRISDELLE?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient</span>: paroxetine</p>\n<p>\n<span class=\"Bold\">Inactive ingredients</span>: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&amp;C Yellow #6, FD&amp;C Red #3, FD&amp;C Red #40, shellac and black iron oxide.</p>\n<br/>\n<p>Manufactured for:</p>\n<p>Legacy Pharma Inc., George Town, Grand Cayman</p>\n<br/>\n<p>BRISDELLE is a registered trademark of Legacy Pharma Inc.</p>\n<p>\n<span class=\"Sup\">©</span>2025 Legacy Pharma Inc. All rights reserved.</p>\n<p>For more information about BRISDELLE go to www.BRISDELLE.com</p>\n<p>MDG90757001</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Medication Guide has been approved by the U.S. Food and Drug Administration                                                                                                         Revised: 02/2025

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration                                                                                                         Revised: 02/2025" }

BRISDELLE (paroxetine) Capsules is available as 7.5 mg - NDC 83107-027-30 - 30 Caps Blister Label

{ "type": "p", "children": [], "text": "\nBRISDELLE (paroxetine) Capsules is available as 7.5 mg - NDC 83107-027-30 - 30 Caps Blister Label\n" }

BRISDELLE (paroxetine) Capsules is available as 7.5 mg - NDC 83107-027-30 - 30 Caps Blister Carton

{ "type": "p", "children": [], "text": "\nBRISDELLE (paroxetine) Capsules is available as 7.5 mg - NDC 83107-027-30 - 30 Caps Blister Carton\n" }

Paroxetine tablets are indicated in adults for the treatment of:

{ "type": "p", "children": [], "text": "\nParoxetine tablets are indicated in adults for the treatment of:" }

{ "type": "ul", "children": [ "Major depressive disorder (MDD)", "Obsessive compulsive disorder (OCD)", "Panic disorder (PD)", "Social anxiety disorder (SAD)", "Generalized anxiety disorder (GAD)", "Posttraumatic stress disorder (PTSD)" ], "text": "" }

Administer paroxetine tablets as a single daily dose in the morning, with or without food.

The recommended starting dosages and maximum dosages of paroxetine tablets in patients with MDD, OCD, PD, and PTSD are presented in Table 1.

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

<div class="scrollingtable"><table class="Noautorules" width="584"> <caption> <span>Table 1 Recommended Daily Dosage of Paroxetine Tablets in Patients with MDD, OCD, PD, and PTSD</span> </caption> <col width="158"/> <col width="213"/> <col width="213"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Indication</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Starting Dose</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Maximum Dose</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">MDD <br/> </td><td align="center" class="Botrule Rrule" valign="top">20 mg <br/> </td><td align="center" class="Botrule Rrule" valign="top">50 mg <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">OCD <br/> </td><td align="center" class="Botrule Rrule" valign="top">20 mg <br/> </td><td align="center" class="Botrule Rrule" valign="top">60 mg <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">PD <br/> </td><td align="center" class="Botrule Rrule" valign="top">10 mg <br/> </td><td align="center" class="Botrule Rrule" valign="top">60 mg <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">PTSD <br/> </td><td align="center" class="Botrule Rrule" valign="top">20 mg <br/> </td><td align="center" class="Botrule Rrule" valign="top">50 mg <br/> </td> </tr> </tbody> </table></div>

SAD

The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 mg to 60 mg daily.

While the safety of paroxetine tablets has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily [see Clinical Studies ( 14.4)].

GAD

The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of paroxetine tablets in GAD was demonstrated in patients dosed in a range of 20 mg to 50 mg daily. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg daily [see Clinical Studies ( 14.5)].

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

Prior to initiating treatment with paroxetine tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6)].

The recommended initial dosage is 10 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day.

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI and initiation of paroxetine tablets. In addition, at least 14 days must elapse after stopping paroxetine before starting an MAOI antidepressant [see Contraindications ( 4), Warnings and Precautions ( 5.2)].

Adverse reactions may occur upon discontinuation of paroxetine tablets [see Warnings and Precautions ( 5.7)]. Gradually reduce the dosage rather than stopping paroxetine abruptly whenever possible.

Paroxetine tablets, USP are available as:

{ "type": "p", "children": [], "text": "Paroxetine tablets, USP are available as:" }

{ "type": "ul", "children": [ "20 mg: White to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC, 16 and bisect' on one side and plain on other side" ], "text": "" }

Paroxetine tablets are contraindicated in patients:

{ "type": "p", "children": [], "text": "\nParoxetine tablets are contraindicated in patients:" }

{ "type": "ul", "children": [ "Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome\n \n [see Warnings and Precautions (\n \n 5.2), Drug Interactions (\n \n 7)].\n \n \n", "Taking thioridazine because of risk of QT prolongation\n \n [see Warnings and Precautions (\n \n 5.3, Drug Interactions (\n \n 7)]\n \n \n", "Taking pimozide because of risk of QT prolongation\n \n [see Warnings and Precautions (\n \n 5.3), Drug Interactions (\n \n 7)].\n \n \n", "With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [\n \n see Adverse Reactions (\n \n 6.1), (\n \n 6.2)].\n \n \n" ], "text": "" }

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 2.

<div class="scrollingtable"><table class="Noautorules" width="423"> <caption> <span>Table 2 Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients</span> </caption> <col width="146"/> <col width="277"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Age Range</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Drug-Placebo Difference in Number of Patients with Suicidal Thoughts and Behaviors per 1,000 Patients Treated</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Increases Compared to Placebo</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">&lt; 18 years old <br/> </td><td align="center" class="Botrule Rrule" valign="top">14 additional cases <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">18 years to 24 years old <br/> </td><td align="center" class="Botrule Rrule" valign="top">5 additional cases <br/> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Decreases Compared to Placebo</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">25 years to 64 years old <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 fewer case <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">≥ 65 years old <br/> </td><td align="center" class="Botrule Rrule" valign="top">6 fewer cases <br/> </td> </tr> </tbody> </table></div>

Paroxetine is not approved for use in pediatric patients.

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing paroxetine, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

SSRIs, including paroxetine, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines and St. John's Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications ( 4), Drug Interactions ( 7.1)].   Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of paroxetine with MAOIs is contraindicated.  In addition, do not initiate paroxetine in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking paroxetine discontinue paroxetine before initiating treatment with the MAOI [see Contraindications ( 4), Drug Interactions ( 7)].

Monitor all patients taking paroxetine for the emergence of serotonin syndrome. Discontinue treatment with paroxetine and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of paroxetine with other serotonergic drugs is clinically warranted, inform patients of the increased risk for  serotonin syndrome and monitor for symptoms.

The CYP2D6 inhibitory properties of paroxetine can elevate plasma levels of thioridazine and pimozide. Since thioridazine and pimozide given alone produce prolongation of the QTc interval and increase the risk of serious ventricular arrhythmias, the use of paroxetine is contraindicated in combination with thioridazine and pimozide [see Contraindications ( 4), Drug Interactions ( 7), Clinical Pharmacology ( 12.3)].

Based on meta-analyses of epidemiological studies, exposure to paroxetine in the first trimester of pregnancy is associated with a less than 2-fold increase in the rate of cardiovascular malformations among infants. For women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine, should be initiated only after consideration of the other available treatment options [see Use in Specific Populations ( 8.1)].

Drugs that interfere with serotonin reuptake inhibition, including paroxetine, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations ( 8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients about the increased risk of bleeding associated with the concomitant use of paroxetine and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

In patients with bipolar disorder, treating a depressive episode with paroxetine or another antidepressant may precipitate a mixed/manic episode. During controlled clinical trials of paroxetine, hypomania or mania occurred in approximately 1% of paroxetine-treated unipolar patients compared to 1.1% of active-control and 0.3% of placebo-treated unipolar patients. Prior to initiating treatment with paroxetine, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Dosage and Administration ( 2.7)].

During clinical trials of GAD and PTSD, gradual decreases in the daily dose by 10 mg/day at weekly intervals followed by 1 week at 20 mg/day was used before treatment was discontinued. The following adverse reactions were reported at an incidence of 2% or greater for paroxetine and were at least twice that reported for placebo: Abnormal dreams, paresthesia, and dizziness adverse reactions have been reported upon discontinuation of treatment with paroxetine in pediatric patients. The safety and effectiveness of paroxetine in pediatric patients have not been established [see Boxed Warning, Warnings and Precautions ( 5.1), Use in Specific Populations ( 8.4)].

Paroxetine tablets have not been systematically evaluated in patients with seizure disorders. Patients with history of seizures were excluded from clinical studies. During clinical studies, seizures occurred in 0.1% of patients treated with paroxetine. Paroxetine should be prescribed with caution in patients with a seizure disorder. Discontinue paroxetine in any patient who develops seizures.

The pupillary dilation that occurs following use of many antidepressant drugs including paroxetine may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Cases of angle-closure glaucoma associated with use of paroxetine have been reported. Avoid use of antidepressants, including paroxetine in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SSRIs, including paroxetine. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.  In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue paroxetine and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs [see Use in Specific Populations ( 8.5)].

Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced with concomitant use of paroxetine as a result of paroxetine's irreversible inhibition of CYP2D6 and lower blood levels of tamoxifen [see Drug Interactions ( 7)]. One study suggests that the risk may increase with longer duration of co-administration. However, other studies have failed to demonstrate such a risk. When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition.

Epidemiological studies on bone fracture risk during exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment.

Use of SSRIs, including paroxetine, may cause symptoms of sexual dysfunction [see Adverse Reactions ( 6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm. It is important for prescribers to inquire about sexual function prior to initiation of paroxetine and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data for paroxetine are from:

Adverse Reactions Leading to Discontinuation

Twenty percent (1,199/6,145) of patients treated with paroxetine in clinical trials in MDD and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with paroxetine in clinical trials in SAD, OCD, PD, GAD, and PTSD, respectively, discontinued treatment due to an adverse reaction. The most common adverse reactions (≥ 1%) associated with discontinuation (i.e., those adverse reactions associated with dropout at a rate approximately twice or greater for paroxetine compared to placebo) are presented in Table 3.

<div class="scrollingtable"><table class="Noautorules" width="0"> <caption> <span>Table 3 Adverse Reactions Reported as Leading to Discontinuation (≥ 1% of Paroxetine-Treated Patients and Greater than Placebo) in MDD, OCD, PD, SAD, GAD, and PTSD Trials</span> </caption> <col width="110"/> <col width="73"/> <col width="53"/> <col width="73"/> <col width="53"/> <col width="73"/> <col width="53"/> <col width="73"/> <col width="53"/> <col width="73"/> <col width="53"/> <col width="73"/> <col width="53"/> <tfoot> <tr> <td align="left" colspan="13"> <p class="First Footnote">Where numbers are not provided the incidence of the adverse reactions in patients treated with paroxetine was not &gt; 1% or was not greater than or equal to 2 times the incidence of placebo.</p> </td> </tr> <tr> <td align="left" colspan="13"> <p class="First Footnote"> <span class="Sup">a.</span>Incidence corrected for gender. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td class="Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">MDD</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">OCD</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">PD</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">SAD</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">GAD</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">PTSD</span> <br/> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">CNS</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Somnolence <br/> </td><td align="center" class="Rrule" valign="top">2.3 <br/> </td><td align="center" class="Rrule" valign="top">0.7 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1.9 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">3.4 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">0.2 <br/> </td><td align="center" class="Rrule" valign="top">2.8 <br/> </td><td align="center" class="Rrule" valign="top">0.6 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Insomnia <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">1.7 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">1.3 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">3.1 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Agitation <br/> </td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">0.5 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Tremor <br/> </td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1.7 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">0.2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Anxiety <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Dizziness <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">1.5 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">1.9 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0.2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Gastrointestinal</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Constipation <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Nausea <br/> </td><td align="center" class="Rrule" valign="top">3.2 <br/> </td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">1.9 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">3.2 <br/> </td><td align="center" class="Rrule" valign="top">1.2 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">0.2 <br/> </td><td align="center" class="Rrule" valign="top">2.2 <br/> </td><td align="center" class="Rrule" valign="top">0.6 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Diarrhea <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Dry Mouth <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Vomiting <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Flatulence <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0.3 <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Other</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule">Asthenia <br/> </td><td align="center" class="Rrule" valign="top">1.6 <br/> </td><td align="center" class="Rrule" valign="top">0.4 <br/> </td><td align="center" class="Rrule" valign="top">1.9 <br/> </td><td align="center" class="Rrule" valign="top">0.4 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">2.5 <br/> </td><td align="center" class="Rrule" valign="top">0.6 <br/> </td><td align="center" class="Rrule" valign="top">1.8 <br/> </td><td align="center" class="Rrule" valign="top">0.2 <br/> </td><td align="center" class="Rrule" valign="top">1.6 <br/> </td><td align="center" class="Rrule" valign="top">0.2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Abnormal <br/>   Ejaculation <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">1.6 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">2.1 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">4.9 <br/> </td><td align="center" class="Rrule" valign="top">0.6 <br/> </td><td align="center" class="Rrule" valign="top">2.5 <br/> </td><td align="center" class="Rrule" valign="top">0.5 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Sweating <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">0.3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">1.1 <br/> </td><td align="center" class="Rrule" valign="top">0.2 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Impotence <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">1.5 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Libido <br/>    Decreased <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> </tbody> </table></div>

Most Common Adverse Reactions

The most commonly observed adverse reactions associated with the use of paroxetine (incidence of 5% or greater and at least twice that for placebo) were:

MDD:Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

OCD:Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

PD:Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

SAD:Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.

GAD:Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

PTSD:Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Adverse Reactions in Patients with MDD

Table 4 presents the adverse reactions that occurred at an incidence of 1% or more and greater than placebo in clinical trials of paroxetine-treated patients with MDD.

<div class="scrollingtable"><table class="Noautorules" width="639"> <caption> <span>Table 4 Adverse Reactions (≥ l% of Paroxetine-Treated Patients and Greater than Placebo) in 6-Week Clinical Trials for MDD</span> </caption> <col width="213"/> <col width="213"/> <col width="213"/> <tfoot> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">a</span>Includes mostly "lump in throat" and "tightness in throat." </p> </td> </tr> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">b</span>Percentage corrected for gender. </p> </td> </tr> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">c</span>Mostly "ejaculatory delay." </p> </td> </tr> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">d</span>Includes "anorgasmia," "erectile difficulties," "delayed ejaculation/orgasm," and "sexual dysfunction," and "impotence." </p> </td> </tr> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">e</span>Includes mostly "difficulty with micturition" and "urinary hesitancy." </p> </td> </tr> <tr> <td align="left" colspan="3"> <p class="First Footnote"> <span class="Sup">f</span>Includes mostly "anorgasmia" and "difficulty reaching climax/orgasm." </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="center" class="Lrule Rrule Toprule" valign="top"><span class="Bold">Body System/</span> <br/> <span class="Bold">Adverse Reaction</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Paroxetine</span> <br/> <span class="Bold">(n = 421)</span> <br/> <span class="Bold">%</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Placebo</span> <br/> <span class="Bold">(n = 421)</span> <br/> <span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule Toprule" valign="top"><span class="Bold">Body as a Whole</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"> <br/> </td><td align="center" class="Rrule Toprule" valign="top"> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Headache <br/> </td><td align="center" class="Rrule" valign="top">18 <br/> </td><td align="center" class="Rrule" valign="top">17 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Asthenia <br/> </td><td align="center" class="Botrule Rrule" valign="top">15 <br/> </td><td align="center" class="Botrule Rrule" valign="top">6 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Cardiovascular</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Palpitation <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vasodilation <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Dermatologic</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Sweating <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Rash <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Gastrointestinal</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Nausea <br/> </td><td align="center" class="Rrule" valign="top">26 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dry Mouth <br/> </td><td align="center" class="Rrule" valign="top">18 <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Constipation <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Diarrhea <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Decreased Appetite <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Flatulence <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Oropharynx Disorder <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dyspepsia <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Musculoskeletal</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Myopathy <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Myalgia <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Myasthenia <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Nervous System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Somnolence <br/> </td><td align="center" class="Rrule" valign="top">23 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dizziness <br/> </td><td align="center" class="Rrule" valign="top">13 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Insomnia <br/> </td><td align="center" class="Rrule" valign="top">13 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Tremor <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Nervousness <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Anxiety <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Paresthesia <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Libido Decreased <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Drugged Feeling <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Confusion <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Respiration</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Yawn <br/> </td><td align="center" class="Botrule Rrule" valign="top">4 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Special Senses</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Blurred Vision <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Taste Perversion <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Urogenital System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Ejaculatory Disturbance <span class="Sup">b,c</span> <br/> </td><td align="center" class="Rrule" valign="top">13 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Other Male Genital  Disorders <span class="Sup">b,d</span> <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Urinary Frequency <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Urination Disorder <span class="Sup">e</span> <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Female Genital Disorders <span class="Sup">b,f</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> </tbody> </table></div>

Adverse Reactions in Patients with OCD, PD, and SAD

Table 5 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with OCD, PD, and SAD.

<div class="scrollingtable"><table class="Noautorules" width="0"> <caption> <span>Table 5 Adverse Reactions (≥ 2% of Paroxetine-Treated Patients and Greater than Placebo) in 10 to 12-Week Clinical Trials for OCD, PD, and SAD</span> </caption> <col width="155"/> <col width="88"/> <col width="78"/> <col width="88"/> <col width="75"/> <col width="88"/> <col width="82"/> <tfoot> <tr> <td align="left" colspan="7"> <p class="First Footnote"> <span class="Sup">a</span>. Percentage corrected for gender. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left" class="Lrule Rrule Toprule" rowspan="3" valign="top"><span class="Bold">Body</span> <br/> <span class="Bold">System/Preferred</span> <br/> <span class="Bold">Term</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Obsessive Compulsive</span> <br/> <span class="Bold">Disorder</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Panic Disorder</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Social Anxiety</span> <br/> <span class="Bold">Disorder</span> <br/> </td> </tr> <tr> <td align="center" class="Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td> </tr> <tr> <td align="center" class="Rrule" valign="top"><span class="Bold">(n = 542)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 265)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 469)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 324)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 425)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 339)</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Body as a Whole</span> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Asthenia <br/> </td><td align="center" class="Rrule" valign="top">22 <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">22 <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Abdominal Pain <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Chest Pain <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Back Pain <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Chills <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Trauma <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Cardiovascular</span> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="top"> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Vasodilation <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Palpitation <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Dermatologic</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Sweating <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Rash <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Gastrointestinal</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Nausea <br/> </td><td align="center" class="Rrule" valign="top">23 <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">23 <br/> </td><td align="center" class="Rrule" valign="top">17 <br/> </td><td align="center" class="Rrule" valign="top">25 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dry Mouth <br/> </td><td align="center" class="Rrule" valign="top">18 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">18 <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Constipation <br/> </td><td align="center" class="Rrule" valign="top">16 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Diarrhea <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Decreased Appetite <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dyspepsia <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Flatulence <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Increased Appetite <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vomiting <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Musculoskeletal</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Myalgia <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">4 <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Nervous System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Insomnia <br/> </td><td align="center" class="Rrule" valign="top">24 <br/> </td><td align="center" class="Rrule" valign="top">13 <br/> </td><td align="center" class="Rrule" valign="top">18 <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">21 <br/> </td><td align="center" class="Rrule" valign="top">16 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Somnolence <br/> </td><td align="center" class="Rrule" valign="top">24 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td><td align="center" class="Rrule" valign="top">19 <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">22 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dizziness <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Tremor <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Nervousness <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Libido Decreased <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Agitation <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Anxiety <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Abnormal Dreams <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Concentration Impaired <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Depersonalization <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Myoclonus <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Amnesia <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Respiratory System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Rhinitis <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Pharyngitis <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Yawn <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">5 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Special Senses</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Abnormal Vision <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Taste Perversion <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Urogenital System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Abnormal Ejaculation <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">23 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">21 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">28 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dysmenorrhea <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Female Genital Disorders <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Impotence <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Urinary Frequency <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Urination Impaired <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Urinary Tract Infection <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td> </tr> </tbody> </table></div>

Adverse Reactions in Patients with GAD and PTSD

Table 6 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with GAD and PTSD.

<div class="scrollingtable"><table class="Noautorules" width="472"> <caption> <span>Table 6 Adverse Reactions (≥ 2% of Paroxetine-Treated Patients and Greater than Placebo) in 8- to 12-Week Clinical Trials for GAD and PTSD <span class="Sup">a</span></span> </caption> <col width="135"/> <col width="92"/> <col width="76"/> <col width="93"/> <col width="76"/> <tfoot> <tr> <td align="left" colspan="5"> <p class="First Footnote"> <span class="Sup">a.</span>Percentage corrected for gender. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="4" valign="top"><span class="Bold">Body</span> <br/> <span class="Bold">System/Preferred Term</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Generalized Anxiety</span> <br/> <span class="Bold">Disorder</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Posttraumatic Stress</span> <br/> <span class="Bold">Disorder</span> <br/> </td> </tr> <tr> <td align="center" class="Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">Placebo</span> <br/> </td> </tr> <tr> <td align="center" class="Rrule" valign="top"><span class="Bold">(n = 735)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 529)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 676)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 504)</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Body as a</span> <br/> <span class="Bold">Whole</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Asthenia <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Headache <br/> </td><td align="center" class="Rrule" valign="top">17 <br/> </td><td align="center" class="Rrule" valign="top">14 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Infection <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Abdominal Pain <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Trauma <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">6 <br/> </td><td align="center" class="Botrule Rrule" valign="top">5 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Cardiovascular</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vasodilation <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Dermatologic</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Sweating <br/> </td><td align="center" class="Botrule Rrule" valign="top">6 <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">5 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Gastrointestinal</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Nausea <br/> </td><td align="center" class="Rrule" valign="top">20 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">19 <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dry Mouth <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Constipation <br/> </td><td align="center" class="Rrule" valign="top">10 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Diarrhea <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Decreased <br/> Appetite <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Vomiting <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dyspepsia <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">5 <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Nervous System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Insomnia <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td><td align="center" class="Rrule" valign="top">8 <br/> </td><td align="center" class="Rrule" valign="top">12 <br/> </td><td align="center" class="Rrule" valign="top">11 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Somnolence <br/> </td><td align="center" class="Rrule" valign="top">15 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">16 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Dizziness <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">6 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Tremor <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Nervousness <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Libido Decreased <br/> </td><td align="center" class="Rrule" valign="top">9 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Abnormal Dreams <br/> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Respiratory</span> <br/> <span class="Bold">System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Respiratory <br/> Disorder <br/> </td><td align="center" class="Rrule" valign="top">7 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Sinusitis <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td><td align="center" class="Rrule" valign="top">- <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Yawn <br/> </td><td align="center" class="Botrule Rrule" valign="top">4 <br/> </td><td align="center" class="Botrule Rrule" valign="top">- <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">&lt; 1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Special Senses</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Abnormal Vision <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Urogenital</span> <br/> <span class="Bold">System</span> <br/> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Abnormal <br/> Ejaculation <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">25 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">13 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Female Genital <br/> Disorder <span class="Sup">a</span> <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td><td align="center" class="Rrule" valign="top">5 <br/> </td><td align="center" class="Rrule" valign="top">1 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Impotence <span class="Sup">a</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top">4 <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td><td align="center" class="Botrule Rrule" valign="top">9 <br/> </td><td align="center" class="Botrule Rrule" valign="top">1 <br/> </td> </tr> </tbody> </table></div>

Dose Dependent Adverse Reactions

MDD

A comparison of adverse reaction rates in a fixed-dose study comparing paroxetine 10 mg, 20 mg, 30 mg, and 40 mg once daily with placebo in the treatment of MDD revealed dose dependent adverse reactions, as shown in Table 7.

<div class="scrollingtable"><table class="Noautorules" width="0"> <caption> <span>Table 7 Adverse Reactions (≥ 5% of Paroxetine-Treated Patients and ≥ Twice the Rate of Placebo) (in a Dose-Comparison Trial in the Treatment of MDD)</span> </caption> <col width="211"/> <col width="84"/> <col width="72"/> <col width="72"/> <col width="84"/> <col width="73"/> <tbody class="Headless"> <tr> <td align="left" class="Lrule Rrule Toprule" rowspan="2" valign="top"><span class="Bold">Body System/Preferred Term</span> <br/> </td><td align="center" class="Rrule Toprule"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="4"><span class="Bold">Paroxetine</span> <br/> </td> </tr> <tr> <td align="center" class="Rrule" valign="top"> <br/> <span class="Bold">n=51</span> <br/> </td><td align="center" class="Rrule"><span class="Bold">10 mg</span> <br/> <span class="Bold">n=102</span> <br/> </td><td align="center" class="Rrule Toprule"><span class="Bold">20 mg</span> <br/> <span class="Bold">n=104</span> <br/> </td><td align="center" class="Rrule Toprule"><span class="Bold">30 mg</span> <br/> <span class="Bold">n=101</span> <br/> </td><td align="center" class="Rrule Toprule"><span class="Bold">40 mg</span> <br/> <span class="Bold">n=102</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Body as a Whole</span> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Asthenia <br/> </td><td align="center" class="Botrule Rrule">0 <br/> </td><td align="center" class="Botrule Rrule">2.9 <br/> </td><td align="center" class="Botrule Rrule">10.6 <br/> </td><td align="center" class="Botrule Rrule">13.9 <br/> </td><td align="center" class="Botrule Rrule">12.7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Dermatology</span> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Sweating <br/> </td><td align="center" class="Botrule Rrule">2 <br/> </td><td align="center" class="Botrule Rrule">1 <br/> </td><td align="center" class="Botrule Rrule">6.7 <br/> </td><td align="center" class="Botrule Rrule">8.9 <br/> </td><td align="center" class="Botrule Rrule">11.8 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Gastrointestinal</span> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Constipation <br/> </td><td align="center" class="Rrule">5.9 <br/> </td><td align="center" class="Rrule">4.9 <br/> </td><td align="center" class="Rrule">7.7 <br/> </td><td align="center" class="Rrule">9.9 <br/> </td><td align="center" class="Rrule">12.7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Decreased Appetite <br/> </td><td align="center" class="Rrule">2 <br/> </td><td align="center" class="Rrule">2 <br/> </td><td align="center" class="Rrule">5.8 <br/> </td><td align="center" class="Rrule">4 <br/> </td><td align="center" class="Rrule">4.9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Diarrhea <br/> </td><td align="center" class="Rrule">7.8 <br/> </td><td align="center" class="Rrule">9.8 <br/> </td><td align="center" class="Rrule">19.2 <br/> </td><td align="center" class="Rrule">7.9 <br/> </td><td align="center" class="Rrule">14.7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Dry Mouth <br/> </td><td align="center" class="Rrule">2 <br/> </td><td align="center" class="Rrule">10.8 <br/> </td><td align="center" class="Rrule">18.3 <br/> </td><td align="center" class="Rrule">15.8 <br/> </td><td align="center" class="Rrule">20.6 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Nausea <br/> </td><td align="center" class="Botrule Rrule">13.7 <br/> </td><td align="center" class="Botrule Rrule">14.7 <br/> </td><td align="center" class="Botrule Rrule">26.9 <br/> </td><td align="center" class="Botrule Rrule">34.7 <br/> </td><td align="center" class="Botrule Rrule">36.3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Nervous System</span> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Anxiety <br/> </td><td align="center" class="Rrule">0 <br/> </td><td align="center" class="Rrule">2 <br/> </td><td align="center" class="Rrule">5.8 <br/> </td><td align="center" class="Rrule">5.9 <br/> </td><td align="center" class="Rrule">5.9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Dizziness <br/> </td><td align="center" class="Rrule">3.9 <br/> </td><td align="center" class="Rrule">6.9 <br/> </td><td align="center" class="Rrule">6.7 <br/> </td><td align="center" class="Rrule">8.9 <br/> </td><td align="center" class="Rrule">12.7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Nervousness <br/> </td><td align="center" class="Rrule">0 <br/> </td><td align="center" class="Rrule">5.9 <br/> </td><td align="center" class="Rrule">5.8 <br/> </td><td align="center" class="Rrule">4 <br/> </td><td align="center" class="Rrule">2.9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Paresthesia <br/> </td><td align="center" class="Rrule">0 <br/> </td><td align="center" class="Rrule">2.9 <br/> </td><td align="center" class="Rrule">1 <br/> </td><td align="center" class="Rrule">5 <br/> </td><td align="center" class="Rrule">5.9 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Somnolence <br/> </td><td align="center" class="Rrule">7.8 <br/> </td><td align="center" class="Rrule">12.7 <br/> </td><td align="center" class="Rrule">18.3 <br/> </td><td align="center" class="Rrule">20.8 <br/> </td><td align="center" class="Rrule">21.6 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Tremor <br/> </td><td align="center" class="Botrule Rrule">0 <br/> </td><td align="center" class="Botrule Rrule">0 <br/> </td><td align="center" class="Botrule Rrule">7.7 <br/> </td><td align="center" class="Botrule Rrule">7.9 <br/> </td><td align="center" class="Botrule Rrule">14.7 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Special Senses</span> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Blurred Vision <br/> </td><td align="center" class="Botrule Rrule">2 <br/> </td><td align="center" class="Botrule Rrule">2.9 <br/> </td><td align="center" class="Botrule Rrule">2.9 <br/> </td><td align="center" class="Botrule Rrule">2 <br/> </td><td align="center" class="Botrule Rrule">7.8 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule"><span class="Bold">Urogenital System</span> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td><td align="center" class="Rrule"> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Abnormal Ejaculation <br/> </td><td align="center" class="Rrule">0 <br/> </td><td align="center" class="Rrule">5.8 <br/> </td><td align="center" class="Rrule">6.5 <br/> </td><td align="center" class="Rrule">10.6 <br/> </td><td align="center" class="Rrule">13 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule">Impotence <br/> </td><td align="center" class="Rrule">0 <br/> </td><td align="center" class="Rrule">1.9 <br/> </td><td align="center" class="Rrule">4.3 <br/> </td><td align="center" class="Rrule">6.4 <br/> </td><td align="center" class="Rrule">1.9 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">Male Genital Disorders <br/> </td><td align="center" class="Botrule Rrule">0 <br/> </td><td align="center" class="Botrule Rrule">3.8 <br/> </td><td align="center" class="Botrule Rrule">8.7 <br/> </td><td align="center" class="Botrule Rrule">6.4 <br/> </td><td align="center" class="Botrule Rrule">3.7 <br/> </td> </tr> </tbody> </table></div>

OCD

In a fixed-dose study comparing placebo and paroxetine 20 mg, 40 mg, and 60 mg in the treatment of OCD, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned.

PD

In a fixed-dose study comparing placebo and paroxetine 10 mg, 20 mg, and 40 mg in the treatment of PD, the following adverse reactions were shown to be dose-dependent: asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation.

SAD

In a fixed-dose study comparing placebo and paroxetine 20 mg, 40 mg and 60 mg in the treatment of SAD, for most of the adverse reactions, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned.

GAD

In a fixed-dose study comparing placebo and paroxetine 20 mg and 40 mg in the treatment of GAD, the following adverse reactions were shown to be dose-dependent: asthenia, constipation, and abnormal ejaculation.

PTSD

In a fixed-dose study comparing placebo and paroxetine 20 mg and 40 mg in the treatment of PTSD, the following adverse reactions were shown to be dose-dependent: impotence and abnormal ejaculation.

Male and Female Sexual Dysfunction

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

The percentage of patients reporting symptoms of sexual dysfunction in males and females with MDD, OCD, PD, SAD, GAD, and PTSD are displayed in Table 8.

<div class="scrollingtable"><table class="Noautorules" width="571"> <caption> <span>Table 8 Adverse Reactions Related to Sexual Dysfunction in Patients Treated with Paroxetine in Clinical Trials of MDD, OCD, PD, SAD, GAD, and PTSD</span> </caption> <col width="294"/> <col width="138"/> <col width="139"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Paroxetine</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Placebo</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">n (males)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">1,446</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">1,042</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Decreased Libido <br/> </td><td align="center" class="Botrule Rrule" valign="top">6 to15 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 to 5 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Ejaculatory Disturbance <br/> </td><td align="center" class="Botrule Rrule" valign="top">13 to 28 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 to 2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Impotence <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 to 9 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 to 3 <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">n (females)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">1,822</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">1,340</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Decreased Libido <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 to 9 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 to 2 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Orgasmic Disturbance <br/> </td><td align="center" class="Botrule Rrule" valign="top">2 to 9 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 to 1 <br/> </td> </tr> </tbody> </table></div>

Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

Hallucinations

In pooled clinical trials of paroxetine, hallucinations were observed in 0.2% of paroxetine-treated patients compared to 0.1% of patients receiving placebo.

Less Common Adverse Reactions

The following adverse reactions occurred during the clinical studies of paroxetine and are not included elsewhere in the labeling.

Adverse reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 patients.

Body as a Whole

Infrequent:Allergic reaction, chills, face edema, malaise, neck pain; rare:Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.

Cardiovascular System

Frequent:Hypertension, tachycardia; infrequent:Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare:Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.

Digestive System

Infrequent:Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, abnormal liver function tests, rectal hemorrhage, ulcerative stomatitis; rare:Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.

Endocrine System

Rare:Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.

Hemic and Lymphatic Systems

Infrequent:Anemia, leukopenia, lymphadenopathy, purpura; rare:Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional

Frequent:Weight gain; infrequent:Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare:Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.

Musculoskeletal System

Frequent:Arthralgia; infrequent:Arthritis, arthrosis; rare:Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.

Nervous System

Frequent:Emotional lability, vertigo; infrequent:Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare:Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.

Respiratory System

Infrequent:Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare:Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.

Skin and Appendages

Frequent:Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare:Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.

Special Senses

Frequent:Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare:Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.

Urogenital System

Infrequent:Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare:Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.

The following reactions have been identified during post approval use of paroxetine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barr¡SR syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), syndrome of inappropriate ADH secretion, prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, oculogyric crisis which has been associated with concomitant use of pimozide; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anosmia, hyposmia, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women. There has been a case report of severe hypotension when paroxetine was added to chronic metoprolol treatment.

Table 9 presents clinically significant drug interactions with paroxetine.

{ "type": "p", "children": [], "text": "\nTable 9 presents clinically significant drug interactions with paroxetine.\n" }

<div class="scrollingtable"><table class="Noautorules" width="590"> <caption> <span>Table 9 Clinically Significant Drug Interactions with Paroxetine</span> </caption> <col width="121"/> <col width="469"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Monoamine Oxidase Inhibitors (MAOIs)</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of SSRIs, including paroxetine, and MAOIs increases the risk of serotonin syndrome. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Paroxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[see Dosage and Administration ( <a href="#ID599">2.5</a>), Contraindications ( <a href="#ID614">4</a>), Warnings and Precautions ( <a href="#ID624">5.2</a>)] </span>. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Pimozide and Thioridazine</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Paroxetine is contraindicated in patients taking pimozide or thioridazine <span class="Italics">[see Contraindications ( <a href="#ID614">4</a>)] </span>. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Other Serotonergic Drugs</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of paroxetine and/or concomitant serotonergic drugs <span class="Italics">[see Warnings and Precautions ( <a href="#ID624">5.2</a>)] </span>. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines and St. John's Wort. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concurrent use of an antiplatelet agent or anticoagulant with paroxetine may potentiate the risk of bleeding. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Inform patients of the increased risk of bleeding associated with the concomitant use of paroxetine and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio <span class="Italics">[see Warnings and Precautions ( <a href="#ID630">5.5</a>)] </span>. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">aspirin, clopidogrel, heparin, warfarin <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Drugs Highly Bound to Plasma Protein</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Paroxetine is highly bound to plasma protein. The concomitant use of paroxetine with another drug that is highly bound to plasma protein may increase free concentrations of paroxetine or other tightly-bound drugs in plasma. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Monitor for adverse reactions and reduce dosage of paroxetine or other protein-bound drugs as warranted. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">warfarin <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Drugs Metabolized by CYP2D6</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Paroxetine is a CYP2D6 inhibitor <span class="Italics">[see Clinical Pharmacology ( <a href="#ID702">12.3</a>)] </span>. The concomitant use of paroxetine with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Decrease the dosage of a CYP2D6 substrate if needed with concomitant paroxetine use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if paroxetine is discontinued. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Examples</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Tamoxifen</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Concomitant use of tamoxifen with paroxetine may lead to reduced plasma concentrations of the active metabolite (endoxifen) and reduced efficacy of tamoxifen <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Consider use of an alternative antidepressant with little or no <br/> CYP2D6 inhibition <span class="Italics">[see Warnings and Precautions ( <a href="#ID642">5.11</a>)] </span>. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Fosamprenavir/Ritonavir</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Co-administration of fosamprenavir/ritonavir with paroxetine significantly decreased plasma levels of paroxetine. <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention</span> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Any dose adjustment should be guided by clinical effect (tolerability and efficacy). <br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"590\">\n<caption>\n<span>Table 9 Clinically Significant Drug Interactions with Paroxetine</span>\n</caption>\n<col width=\"121\"/>\n<col width=\"469\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Monoamine Oxidase Inhibitors (MAOIs)</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">The concomitant use of SSRIs, including paroxetine, and MAOIs increases the risk of serotonin syndrome. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Paroxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue\n \n <span class=\"Italics\">[see Dosage and Administration (\n \n <a href=\"#ID599\">2.5</a>), Contraindications (\n \n <a href=\"#ID614\">4</a>), Warnings and Precautions (\n \n <a href=\"#ID624\">5.2</a>)]\n \n </span>. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Pimozide and Thioridazine</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Paroxetine is contraindicated in patients taking pimozide or thioridazine\n \n <span class=\"Italics\">[see Contraindications (\n \n <a href=\"#ID614\">4</a>)]\n \n </span>. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Other Serotonergic Drugs</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of paroxetine and/or concomitant serotonergic drugs\n \n <span class=\"Italics\">[see Warnings and Precautions (\n \n <a href=\"#ID624\">5.2</a>)]\n \n </span>. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines and St. John's Wort. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">The concurrent use of an antiplatelet agent or anticoagulant with paroxetine may potentiate the risk of bleeding. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Inform patients of the increased risk of bleeding associated with the concomitant use of paroxetine and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio\n \n <span class=\"Italics\">[see Warnings and Precautions (\n \n <a href=\"#ID630\">5.5</a>)]\n \n </span>. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">aspirin, clopidogrel, heparin, warfarin \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Drugs Highly Bound to Plasma Protein</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Paroxetine is highly bound to plasma protein. The concomitant use of paroxetine with another drug that is highly bound to plasma protein may increase free concentrations of paroxetine or other tightly-bound drugs in plasma. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Monitor for adverse reactions and reduce dosage of paroxetine or other protein-bound drugs as warranted. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">warfarin \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Drugs Metabolized by CYP2D6</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Paroxetine is a CYP2D6 inhibitor\n \n <span class=\"Italics\">[see Clinical Pharmacology (\n \n <a href=\"#ID702\">12.3</a>)]\n \n </span>. The concomitant use of paroxetine with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Decrease the dosage of a CYP2D6 substrate if needed with concomitant paroxetine use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if paroxetine is discontinued. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Examples</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Tamoxifen</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Concomitant use of tamoxifen with paroxetine may lead to reduced plasma concentrations of the active metabolite (endoxifen) and reduced efficacy of tamoxifen \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Consider use of an alternative antidepressant with little or no \n <br/> CYP2D6 inhibition\n \n <span class=\"Italics\">[see Warnings and Precautions (\n \n <a href=\"#ID642\">5.11</a>)]\n \n </span>. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Fosamprenavir/Ritonavir</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Clinical Impact</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Co-administration of fosamprenavir/ritonavir with paroxetine significantly decreased plasma levels of paroxetine. \n <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Italics\">Intervention</span>\n<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Any dose adjustment should be guided by clinical effect (tolerability and efficacy). \n <br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5) and Clinical Considerations].

Paroxetine is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. While individual epidemiological studies on the association between paroxetine use and cardiac malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see Data).There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data)and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including paroxetine during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations).For women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options.

No evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits. These doses are approximately 8 (rat) and less than 2 (rabbit) times the maximum recommended human dose (MRHD – 60 mg) on an mg/m2 basis. When paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. This effect occurred at a dose of 1 mg/kg/day which is less than the MRHD on an mg/m2 basis ( See Data).

The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryofetal risk

Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and the postpartum.

Maternal Adverse Reactions

Use of paroxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5)].

Fetal/Neonatal adverse reactions

Neonates exposed to paroxetine and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability and constant crying. These findings are consistent with either a direct toxic effect of SSRIs or possibly a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.2)].

Data

Human Data

Published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformations have reported inconsistent results; however, meta-analyses of population-based cohort studies published between 1996 – 2017 indicate a less than 2-fold increased risk for overall cardiovascular malformations. Specific cardiac malformations identified in two meta-analyses include an approximately 2 to 2.5-fold increased risk for right ventricular outflow tract defects. One meta-analysis also identified an increased risk (less than 2-fold) for bulbus cordis anomalies and anomalies of cardiac septal closure, and an increased risk for atrial septal defect (pooled OR 2.38, 95% CI 1.14-4.97). Important limitations of the studies included in these meta-analyses include potential confounding by indication, depression severity and potential exposure misclassification.

Exposure to SSRIs, particularly later in pregnancy, may have an increased risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality.

Animal Data

Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 8 (rat) and less than 2 (rabbit) times the maximum recommended human dose (MRHD 60 mg) on an mg/m2 basis. These studies have revealed no evidence of developmental effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. This effect occurred at a dose of 1 mg/kg/day which is less than the MRHD on an mg/m2 basis. The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known.

Risk Summary

Data from the published literature report the presence of paroxetine in human milk (see Data).There are reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to paroxetine through breast milk (see Clinical Considerations). There are no data on the effect of paroxetine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Paxil and any potential adverse effects on the breastfed child from paroxetine or from underlying maternal condition.

Clinical Considerations

Infants exposed to paroxetine should be monitored for agitation, irritability, poor feeding and poor weight gain.

Data

Published literature suggests the presence of paroxetine in human milk with relative infant doses ranging between 0.4% to 2.2%, and a milk/plasma ratio of <1. No significant amounts were detected in the plasma of infants after breastfeeding.

Infertility

Male

Based on findings from clinical studies, paroxetine may affect sperm quality which may impair fertility; it is not known if this effect is reversible [see Nonclinical Toxicology ( 13.1)].

The safety and effectiveness of paroxetine in pediatric patients have not been established [see Box Warning].Effectiveness was not demonstrated in three placebo-controlled trials in 752 paroxetine-treated pediatric patients with MDD.

Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions ( 5.1)]. Decreased appetite and weight loss have been observed in association with the use of SSRIs.

In placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with paroxetine and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self- harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.

Adverse reactions upon discontinuation of treatment with paroxetine in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain.

In premarketing clinical trials with paroxetine, 17% of patients treated with paroxetine (approximately 700) were 65 years of age or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see Dosage and Administration ( 2.4), Clinical Pharmacology ( 12.3)].

SSRIs including paroxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.7)].

Increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. The initial dosage of paroxetine should be reduced in patients with severe renal impairment and in patients with severe hepatic impairment [see Dosage and Administration ( 2.4), Clinical  Pharmacology ( 12.3)].

The following have been reported with paroxetine tablet overdosage:

{ "type": "p", "children": [], "text": "\nThe following have been reported with paroxetine tablet overdosage:" }

{ "type": "ul", "children": [ "Seizures, which may be delayed, and altered mental status including coma.", "Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.", "Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk)." ], "text": "" }

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose.

{ "type": "p", "children": [], "text": "\nGastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose." }

Consider contacting a Poison Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

{ "type": "p", "children": [], "text": "Consider contacting a Poison Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations." }

Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C 19H 20FNO 3•HCl•1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:

{ "type": "p", "children": [], "text": "\nParoxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-\n \n trans-4\n \n R-(4'-fluorophenyl)-3\n \n S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C\n \n 19H\n \n 20FNO\n \n 3•HCl•1/2H\n \n 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:\n\n " }

Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water.

{ "type": "p", "children": [], "text": "\nParoxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water." }

Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.

{ "type": "p", "children": [], "text": "Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide." }

The mechanism of action of paroxetine in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).

Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitrostudies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake (SSRI) and has only very weak effects on norepinephrine and dopamine neuronal reuptake.

Nonlinearity in pharmacokinetics is observed with increasing doses of paroxetine.

In a meta-analysis of paroxetine from 4 studies done in healthy volunteers following multiple dosing of 20 mg/day to 40 mg/day, males did not exhibit a significantly lower C maxor AUC than females.

Absorption

Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. In a study in which normal male subjects (n = 15) received 30 mg tablets daily for 30 days, steady-state paroxetine concentrations were achieved by approximately 10 days for most subjects, although it may take substantially longer in an occasional patient. At steady state, mean  values  of  C max,  T max,  C min,  and  T ½  were 61.7 ng/mL  (CV 45%),  5.2 hr.  (CV 10%), 30.7 ng/mL (CV 67%), and 21 hours (CV 32%), respectively. The steady-state C max  and C minvalues were about 6 and 14 times what would be predicted from single-dose studies. Steady-state drug exposure based on AUC 0-24was about 8 times greater than would have been predicted from single-dose data in these subjects. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable.

Paroxetine is equally bioavailable from the oral suspension and tablet.

Effect of Food

The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food. AUC was only slightly increased (6%) when drug was administered with food but the C maxwas 29% greater, while the time to reach peak plasma concentration decreased from 6.4 hours post-dosing to 4.9 hours.

Distribution

Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma.

Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng/mL and 400 ng/mL, respectively. Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/mL. Paroxetine does not alter the in vitroprotein binding of phenytoin or warfarin.

Elimination

Metabolism

The mean elimination half-life is approximately 21 hours (CV 32%) after oral dosing of 30 mg tablets daily for 30 days of paroxetine.

In steady-state dose proportionality studies involving elderly and nonelderly patients, at doses of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway. In comparison to C minvalues after 20 mg daily, values after 40 mg daily were only about 2 to 3 times greater than doubled.

Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by CYP2D6. Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment. The role of this enzyme in paroxetine metabolism also suggests potential drug-drug interactions [see Drug Interactions ( 7)]. Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 (poor metabolizers).

Excretion

Approximately 64% of a 30-mg oral solution dose of paroxetine was excreted in the urine with 2% as the parent compound and 62% as metabolites over a 10-day post-dosing period. About 36% was excreted in the feces (probably via the bile), mostly as metabolites and less than 1% as the parent compound over the 10-day post-dosing period.

Drug Interaction Studies

There are clinically significant, known drug interactions between paroxetine and other drugs [see Drug Interactions ( 7)].

Figure 1

Impact of Paroxetine on the Pharmacokinetics of Co-Administered Drugs (log scale)

Figure 2

Impact of Co-Administered Drugs on the Pharmacokinetics of Paroxetine

Theophylline:Reports of elevated theophylline levels associated with paroxetine treatment have been reported. While this interaction has not been formally studied, it is recommended that theophylline levels be monitored when these drugs are concurrently  administered.

Drugs Metabolized by Cytochrome CYP3A4

An in vivointeraction study involving the co-administration under steady-state conditions of paroxetine and terfenadine, a substrate for CYP3A4, revealed no effect of paroxetine on terfenadine pharmacokinetics. In addition, in vitrostudies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least 100 times more potent than paroxetine as an inhibitor of the metabolism of several substrates for this enzyme, including terfenadine, triazolam and cyclosporine. Paroxetine's extent of inhibition of CYP3A4 activity is  not expected to be of clinical significance.

Specific Populations

The impact of specific populations on the pharmacokinetics of paroxetine are shown in Figure 3.

The recommended starting dosage and maximum dosage of paroxetine is reduced in elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment [see Dosage and Administration ( 2.4)].

Figure 3

Impact of Specific Population on the Pharmacokinetics of Paroxetine (log scale)

Carcinogenesis

Two-year carcinogenicity studies were conducted in rodents given paroxetine in the diet at 1 mg/kg/day, 5 mg/kg/day, and 25 mg/kg/day (mice) and 1 mg/kg/day, 5 mg/kg/day, and 20 mg/kg/day (rats). These doses are up to 2 (mouse) and 3 (rat) times the MRHD of 60 mg on a mg/m 2basis. There was a significantly greater number of male rats in the high-dose group with reticulum cell sarcomas (1/100, 0/50, 0/50, and 4/50 for control, low-, middle-, and high-dose groups, respectively) and a significantly increased linear trend across dose groups for the occurrence of lymphoreticular tumors in male rats.

Female rats were not affected. Although there was a dose-related increase in the number of tumors in mice, there was no drug-related increase in the number of mice with tumors. The relevance of these findings to humans is unknown.

Mutagenesis

Paroxetine produced no genotoxic effects in a battery of 5 in vitroand 2 in vivoassays that included the following: Bacterial mutation assay, mouse lymphoma mutation assay, unscheduled DNA synthesis assay, and tests for cytogenetic aberrations in vivoin mouse bone marrow and in vitroin human lymphocytes and in a dominant lethal test in rats.

Impairment of Fertility

A reduced pregnancy rate was found in reproduction studies in rats at a dose of paroxetine of 15 mg/kg/day, which is 2 times the MRHD of 60 mg on a mg/m 2  basis. Irreversible lesions occurred in the reproductive tract of male rats after dosing in toxicity studies for 2 weeks to 52 weeks. These lesions consisted of vacuolation of epididymal tubular epithelium at 50 mg/kg/day and atrophic changes in the seminiferous tubules of the testes with arrested spermatogenesis at 25 mg/kg/day (8 and 4 times the MRHD of 60 mg on a mg/m 2basis).

The efficacy of paroxetine as a treatment for major depressive disorder (MDD) has been established in 6 placebo-controlled studies of patients with MDD (aged 18 to 73). In these studies, paroxetine was shown to be statistically significantly more effective than placebo in treating MDD by at least 2 of the following measures: Hamilton Depression Rating Scale (HDRS), the Hamilton depressed mood item, and the Clinical Global Impression (CGI)-Severity of Illness. Paroxetine was statistically significantly better than placebo in improvement of the HDRS sub-factor scores, including the depressed mood item, sleep disturbance factor, and anxiety factor.

Long-term efficacy of paroxetine for treatment of MDD in outpatients was demonstrated in a randomized withdrawal study. Patients who responded to paroxetine (HDRS total score < 8) during an initial 8-week open-label  treatment phase were then randomized to continue paroxetine or placebo, for up to 1 year. Patients treated with paroxetine demonstrated a statistically significant lower relapse rate during the withdrawal phase (15%) compared to those on placebo (39%). Effectiveness was similar for male and female patients.

The effectiveness of paroxetine in the treatment of obsessive compulsive disorder (OCD) was demonstrated in two 12-week multicenter placebo-controlled studies of adult outpatients (Studies 1 and 2). Patients had moderate to severe OCD (DSM-IIIR) with mean baseline ratings on the Yale Brown Obsessive Compulsive Scale (YBOCS) total score ranging from 23 to 26. In study 1, a dose-range finding study, patients received fixed daily doses of paroxetine 20 mg, 40 mg, or 60 mg. Study 1  demonstrated that daily doses of paroxetine 40 mg and 60 mg are effective in the treatment of OCD. Patients receiving doses of paroxetine 40 mg and 60 mg experienced a mean reduction of approximately 6 and 7 points, respectively, on the YBOCS total score which was statistically significantly greater than the approximate 4-point reduction at 20 mg and a 3-point reduction in the placebo-treated patients. Study 2 was a flexible-dose study comparing paroxetine 20 mg to 60 mg daily with clomipramine 25 mg to 250 mg daily or placebo). In this study, patients receiving paroxetine experienced a mean reduction of approximately 7 points on the YBOCS total score, which was statistically significantly greater than the mean reduction of approximately 4 points in placebo-treated patients.

The following table provides the outcome classification by treatment group on Global

Improvement items of the Clinical Global Impression (CGI) scale for Study 1.

<div class="scrollingtable"><table class="Noautorules" width="591"> <caption> <span>Table 10 Outcome Classification (%) on CGI-Global Improvement Item for Completers in Study 1 in Patients with OCD</span> </caption> <col width="175"/> <col width="108"/> <col width="102"/> <col width="97"/> <col width="109"/> <tbody class="Headless"> <tr> <td align="left" class="Lrule Rrule Toprule" valign="top"><span class="Bold">Outcome</span> <br/> <span class="Bold">Classification</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Placebo</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Paroxetine 20 mg</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Paroxetine 40 mg</span> <br/> </td><td align="center" class="Rrule Toprule" valign="top"><span class="Bold">Paroxetine  60 mg</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 74)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 75)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 66)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(n = 66)</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">%</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Worse <br/> </td><td align="center" class="Botrule Rrule" valign="top">14 <br/> </td><td align="center" class="Botrule Rrule" valign="top">7 <br/> </td><td align="center" class="Botrule Rrule" valign="top">7 <br/> </td><td align="center" class="Botrule Rrule" valign="top">3 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">No Change <br/> </td><td align="center" class="Botrule Rrule" valign="top">44 <br/> </td><td align="center" class="Botrule Rrule" valign="top">35 <br/> </td><td align="center" class="Botrule Rrule" valign="top">22 <br/> </td><td align="center" class="Botrule Rrule" valign="top">19 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Minimally Improved <br/> </td><td align="center" class="Botrule Rrule" valign="top">24 <br/> </td><td align="center" class="Botrule Rrule" valign="top">33 <br/> </td><td align="center" class="Botrule Rrule" valign="top">29 <br/> </td><td align="center" class="Botrule Rrule" valign="top">34 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Much Improved <br/> </td><td align="center" class="Botrule Rrule" valign="top">11 <br/> </td><td align="center" class="Botrule Rrule" valign="top">18 <br/> </td><td align="center" class="Botrule Rrule" valign="top">22 <br/> </td><td align="center" class="Botrule Rrule" valign="top">24 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Very Much Improved <br/> </td><td align="center" class="Botrule Rrule" valign="top">7 <br/> </td><td align="center" class="Botrule Rrule" valign="top">7 <br/> </td><td align="center" class="Botrule Rrule" valign="top">20 <br/> </td><td align="center" class="Botrule Rrule" valign="top">20 <br/> </td> </tr> </tbody> </table></div>

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender.

The long-term efficacy of paroxetine for the treatment of  OCD was established in a long-term extension to Study 1. Patients who responded to paroxetine during the 3-month double-blind phase and a 6-month extension on open-label paroxetine 20 mg to 60 mg daily were randomized to either paroxetine or placebo in a 6-month double-blind relapse prevention phase. Patients randomized to paroxetine were statistically significantly less likely to relapse than placebo-treated patients.

The effectiveness of paroxetine in the treatment of panic disorder (PD) was demonstrated in three 10- to 12-week multicenter, placebo-controlled studies of adult outpatients (Studies 1, 2, and 3). Patients had PD (DSM-IIIR), with or without agoraphobia. In these studies, paroxetine was shown to be statistically significantly more effective than placebo in treating PD by at least 2 out of 3 measures of panic attack frequency and on the Clinical Global Impression Severity of Illness score.

Study 1 was a 10-week dose-range finding study; patients received fixed doses of paroxetine 10 mg, 20 mg, or 40 mg daily or placebo. A statistically significant difference from placebo was observed only for the paroxetine 40 mg daily group. At endpoint, 76% of patients receiving paroxetine 40 mg daily were free of panic attacks, compared to 44% of placebo-treated patients.

Study 2 was a 12-week flexible-dose study comparing paroxetine 10 mg to 60 mg daily and placebo. At endpoint, 51% of paroxetine-treated patients were free of panic attacks compared to 32% of placebo-treated patients.

Study 3 was a 12-week flexible-dose study comparing paroxetine 10 mg to 60 mg daily to placebo in patients concurrently receiving standardized cognitive behavioral therapy. At endpoint, 33% of the paroxetine-treated patients showed a reduction to 0 or 1 panic attacks compared to 14% of placebo-treated patients.

In Studies 2 and 3, the mean paroxetine dose for completers at endpoint was approximately 40 mg daily.

Long-term efficacy of paroxetine in PD was demonstrated in an extension to Study 1. Patients who responded to paroxetine during the 10-week double-blind phase and during a 3-month double-blind extension phase were randomized to either paroxetine 10 mg, 20 mg, or 40 mg daily or placebo in a 3-month double-blind relapse prevention phase. Patients randomized to paroxetine were statistically significantly less likely to relapse than placebo-treated patients.

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender.

The effectiveness of paroxetine in the treatment of social anxiety disorder (SAD) was demonstrated in three 12-week, multicenter, placebo-controlled studies (Studies 1, 2, and 3) of adult outpatients with SAD (DSM-IV). In these studies, the effectiveness of paroxetine compared to placebo was evaluated on the basis of (1) the proportion of responders, as defined by a Clinical Global Impression (CGI) Improvement score of 1 (very much improved) or 2 (much improved), and (2) change from baseline in the Liebowitz Social Anxiety Scale (LSAS).

Studies 1 and 2 were flexible-dose studies comparing paroxetine 20 mg to 50 mg daily and placebo. Paroxetine demonstrated statistically significant superiority over placebo on both the CGI Improvement responder criterion and the Liebowitz Social Anxiety Scale (LSAS). In Study 1, for patients  who  completed  to  week 12,  69%  of  paroxetine-treated  patients  compared  to  29%  of placebo-treated patients were CGI Improvement responders. In Study 2, CGI Improvement responders were 77% and 42% for the paroxetine- and placebo-treated patients, respectively.

Study 3 was a 12-week study comparing fixed doses of paroxetine 20 mg, 40 mg, or 60 mg daily with placebo. Paroxetine 20 mg was statistically significantly superior to placebo on both the LSAS Total Score and the CGI Improvement responder criterion; there were trends for superiority over placebo for the paroxetine 40 mg and 60 mg daily dose groups. There was no indication in this study of any additional benefit for doses higher than 20 mg daily.

Subgroup analyses generally did not indicate differences in treatment outcomes as a function of age, race, or gender.

The effectiveness of paroxetine in the treatment of generalized anxiety disorder (GAD) was demonstrated in two 8-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients with GAD (DSM-IV).

Study 1 was an 8-week study comparing fixed doses of paroxetine 20 mg or 40 mg daily with placebo. Doses of paroxetine 20 mg or 40 mg  were both demonstrated to be statistically significantly superior to placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score.

There was not sufficient evidence in this study to suggest a greater benefit for the paroxetine 40 mg daily dose compared to the 20 mg daily dose.

Study 2 was a flexible-dose study comparing paroxetine 20 mg to 50 mg daily and placebo. Paroxetine demonstrated statistically significant superiority over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score.

A third study, a flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo, did not demonstrate statistically significant superiority of paroxetine over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score, the primary outcome.

Subgroup analyses did not indicate differences in treatment outcomes as a function of race or gender. There were insufficient elderly patients to conduct subgroup analyses on the basis of age.

In a long-term trial, 566 patients meeting DSM-IV criteria for GAD, who had responded during a single-blind, 8-week acute treatment phase with paroxetine 20 mg to 50 mg daily, were randomized to continuation of paroxetine at their same dose, or to placebo, for up to 24 weeks of observation for relapse. Response during the single-blind phase was defined by having a decrease of ≥ 2 points compared to baseline on the CGI-Severity of Illness scale, to a score of ≤ 3. Relapse during the double-blind phase was defined as an increase of ≥ 2 points compared to baseline on the CGI-Severity of Illness scale to a score of ≥ 4, or withdrawal due to lack of efficacy. Patients continuing to receive paroxetine experienced a statistically significantly lower relapse rate over the subsequent 24 weeks compared to those receiving placebo.

The effectiveness of paroxetine in the treatment of Posttraumatic Stress Disorder (PTSD) was demonstrated in two 12-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients who met DSM-IV criteria for PTSD. The mean duration of PTSD symptoms for the 2 studies combined was 13 years (ranging from 0.1 year to 57 years). The percentage of patients with secondary MDD or non-PTSD anxiety disorders in the combined 2 studies was 41% (356 out of 858 patients) and 40% (345 out of 858 patients), respectively. Study outcome was assessed by (1) the Clinician-Administered PTSD Scale Part 2 (CAPS-2) score and (2) the Clinical Global Impression-Global Improvement Scale (CGI-I). The CAPS-2 is a multi-item instrument that measures 3 aspects of PTSD with the following symptom clusters: Reexperiencing/intrusion, avoidance/numbing and hyperarousal. The 2 primary outcomes for each trial were (1) change from baseline to endpoint on the CAPS-2 total score (17 items), and (2) proportion of responders on the CGI-I, where responders were defined as patients having a score of 1 (very much improved) or 2 (much improved).

Study 1 was a 12-week study comparing fixed doses of paroxetine 20 mg or 40 mg daily to placebo. Doses of paroxetine 20 mg and 40 mg were demonstrated to be statistically significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I. There was not sufficient evidence in this study to suggest a greater benefit for the 40 mg daily dose compared to the 20 mg daily dose.

Study 2 was a 12-week flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo. Paroxetine was demonstrated to be significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I.

A third study, a flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo, demonstrated paroxetine to be statistically significantly superior to placebo on change from baseline for CAPS-2 total score, but not on proportion of responders on the CGI-I.

The majority of patients in these trials were women (68% women: 377 out of 551 subjects in Study 1 and 66% women: 202 out of 303 subjects in Study 2). Subgroup analyses did not indicate differences in treatment outcomes as a function of gender. There were an insufficient number of patients who were 65 years and older or were non-Caucasian to conduct subgroup analyses on the basis of age or race, respectively.

Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of 'ZC, 16 and bisect' on one side and plain on other side, and are supplied as follows:

{ "type": "p", "children": [], "text": "Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of 'ZC, 16 and bisect' on one side and plain on other side, and are supplied as follows:" }

NDC: 70518-3518-00

{ "type": "p", "children": [], "text": "NDC: 70518-3518-00" }

NDC: 70518-3518-01

{ "type": "p", "children": [], "text": "NDC: 70518-3518-01" }

NDC: 70518-3518-02

{ "type": "p", "children": [], "text": "NDC: 70518-3518-02" }

NDC: 70518-3518-03

{ "type": "p", "children": [], "text": "NDC: 70518-3518-03" }

NDC: 70518-3518-04

{ "type": "p", "children": [], "text": "NDC: 70518-3518-04" }

PACKAGING: 100 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 100 in 1 BOTTLE PLASTIC" }

PACKAGING: 30 in 1 BLISTER PACK

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BLISTER PACK" }

PACKAGING: 100 in 1 BOX

{ "type": "p", "children": [], "text": "PACKAGING: 100 in 1 BOX" }

PACKAGING: 1 in 1 POUCH

{ "type": "p", "children": [], "text": "PACKAGING: 1 in 1 POUCH" }

PACKAGING: 30 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BOTTLE PLASTIC " }

Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature]." }

Repackaged and Distributed By:

{ "type": "p", "children": [], "text": "Repackaged and Distributed By:" }

Remedy Repack, Inc.

{ "type": "p", "children": [], "text": "Remedy Repack, Inc." }

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

{ "type": "p", "children": [], "text": "625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762" }

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

{ "type": "p", "children": [], "text": "\nAdvise the patient to read the FDA-approved patient labeling (Medication Guide)." }

Suicidal Thoughts and Behaviors

{ "type": "p", "children": [], "text": "\nSuicidal Thoughts and Behaviors\n" }

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1)].

{ "type": "p", "children": [], "text": "Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider\n \n [see Boxed Warning and Warnings and Precautions (\n \n 5.1)].\n \n \n" }

Serotonin Syndrome

{ "type": "p", "children": [], "text": "\nSerotonin Syndrome\n" }

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of paroxetine with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.2), Drug Interactions ( 7)].

{ "type": "p", "children": [], "text": "Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of paroxetine with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome\n \n [see Warnings and Precautions (\n \n 5.2), Drug Interactions (\n \n 7)].\n \n \n" }

Concomitant Medications

{ "type": "p", "children": [], "text": "\nConcomitant Medications\n" }

Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for drug-drug interactions [see Warning and Precautions ( 5.3), Drug Interactions ( 7)].

{ "type": "p", "children": [], "text": "Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for drug-drug interactions\n \n [see Warning and Precautions (\n \n 5.3), Drug Interactions (\n \n 7)].\n \n \n" }

Increased Risk of Bleeding

{ "type": "p", "children": [], "text": "\nIncreased Risk of Bleeding\n" }

Inform patients about the concomitant use of paroxetine with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.5)].

{ "type": "p", "children": [], "text": "Inform patients about the concomitant use of paroxetine with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding\n \n [see Warnings and Precautions (\n \n 5.5)].\n \n \n" }

Activation of Mania/Hypomania

{ "type": "p", "children": [], "text": "\nActivation of Mania/Hypomania\n" }

Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.6)].

{ "type": "p", "children": [], "text": "Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider\n \n [see Warnings and Precautions (\n \n 5.6)].\n \n \n" }

Discontinuation Syndrome

{ "type": "p", "children": [], "text": "\nDiscontinuation Syndrome\n" }

Advise patients not to abruptly discontinue paroxetine and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when paroxetine is discontinued [see Warnings and Precautions ( 5.7)].

{ "type": "p", "children": [], "text": "Advise patients not to abruptly discontinue paroxetine and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when paroxetine is discontinued\n \n [see Warnings and Precautions (\n \n 5.7)].\n \n \n" }

Sexual Dysfunction

{ "type": "p", "children": [], "text": "\nSexual Dysfunction\n" }

Advise patients that use of paroxetine may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( 5.13)].

{ "type": "p", "children": [], "text": "Advise patients that use of paroxetine may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider\n \n [see Warnings and Precautions (\n \n 5.13)].\n \n \n" }

Allergic Reactions

{ "type": "p", "children": [], "text": "\nAllergic Reactions\n" }

Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions ( 6.1, 6.2)].

{ "type": "p", "children": [], "text": "Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing\n \n [see Adverse Reactions (\n \n 6.1,\n \n 6.2)].\n \n \n" }

Embryo-Fetal Toxicity

{ "type": "p", "children": [], "text": "\nEmbryo-Fetal Toxicity\n" }

Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paroxetine. Advise women of risks associated with first trimester use of paroxetine and that use later in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding and/or persistent pulmonary hypertension of the newborn (PPHN) [see Warnings and Precautions ( 5.4), Use in Specific Populations ( 8.1)]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to paroxetine during pregnancy [see Warnings and Precautions ( 5.4), Use in Specific Populations ( 8.1)].

{ "type": "p", "children": [], "text": "Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paroxetine. Advise women of risks associated with first trimester use of paroxetine and that use later in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding and/or persistent pulmonary hypertension of the newborn (PPHN)\n \n [see Warnings and Precautions (\n \n 5.4), Use in Specific Populations (\n \n 8.1)].\n \n Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to paroxetine during pregnancy\n \n [see Warnings and Precautions (\n \n 5.4), Use in Specific Populations (\n \n 8.1)].\n \n \n" }

Lactation

{ "type": "p", "children": [], "text": "\nLactation\n" }

Advise breastfeeding women using paroxetine to monitor infants for agitation, irritability, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2)].

{ "type": "p", "children": [], "text": "Advise breastfeeding women using paroxetine to monitor infants for agitation, irritability, poor feeding and poor weight gain and to seek medical care if they notice these signs\n \n [see Use in Specific Populations (\n \n 8.2)].\n \n \n" }

Females and Males of Reproductive Potential

{ "type": "p", "children": [], "text": "\nFemales and Males of Reproductive Potential\n" }

Advise men that paroxetine may affect sperm quality, which may impair fertility; it is not known if this effect is reversible [see Use in Specific Populations ( 8.3)].

{ "type": "p", "children": [], "text": "Advise men that paroxetine may affect sperm quality, which may impair fertility; it is not known if this effect is reversible\n \n [see Use in Specific Populations (\n \n 8.3)].\n \n \n" }

Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

{ "type": "p", "children": [], "text": "Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779." }

Repackaged By / Distributed By: RemedyRepack Inc.

{ "type": "p", "children": [], "text": "Repackaged By / Distributed By: RemedyRepack Inc." }

625 Kolter Drive, Indiana, PA 15701

{ "type": "p", "children": [], "text": "625 Kolter Drive, Indiana, PA 15701" }

(724) 465-8762

{ "type": "p", "children": [], "text": "(724) 465-8762" }

Repackaged and Distributed By:

{ "type": "p", "children": [], "text": "\nRepackaged and Distributed By:\n" }

Remedy Repack, Inc.

{ "type": "p", "children": [], "text": "\nRemedy Repack, Inc.\n" }

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

{ "type": "p", "children": [], "text": "\n625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762\n" }

<div class="scrollingtable"><table class="Noautorules" width="638"> <colgroup> <col width="213"/> <col width="106"/> <col width="18"/> <col width="88"/> <col width="213"/> </colgroup> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="5" valign="top"><span class="Bold">Medication Guide</span> <br/> <span class="Bold">Paroxetine (pa rox' e teen) Tablets, USP</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="5" valign="top"><span class="Bold">What is the most important information I should know about paroxetine tablets?</span> <br/> <span class="Bold">Paroxetine tablets can cause serious side effects, including:</span> <br/> <span class="Bold">● Increased risk of suicidal thoughts or actions.</span>Paroxetine tablets and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the <span class="Bold">first few months of treatment or when the dose is changed. Paroxetine tablets are not for use in children.</span> <br/> <span class="Bold"> ○ Depression or other mental illnesses are the most important causes of suicidal thoughts and actions.</span> <br/> <br/> <span class="Bold">How can I watch for and try to prevent suicidal thoughts and actions?</span> <br/> <span class="Bold">○ </span>Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the does is changed. <br/> <span class="Bold">○ </span>Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. <br/> <span class="Bold">○ </span>Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. <br/> <span class="Bold">Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span></td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top"><span class="Bold">○ </span>attempts to commit suicide </td><td align="left" class="Rrule" colspan="3" valign="top"><span class="Bold">○ </span>acting on dangerous impulses </td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top"><span class="Bold">○ </span>acting aggressive or violent </td><td align="left" class="Rrule" colspan="3" valign="top"><span class="Bold">○ </span>thoughts about suicide or dying </td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top"><span class="Bold">○ </span>new or worse depression </td><td align="left" class="Rrule" colspan="3" valign="top"><span class="Bold">○ </span>new or worse anxiety or panic attacks </td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top"><span class="Bold">○ </span>feeling agitated, restless, angry, or irritable </td><td align="left" class="Rrule" colspan="3" valign="top"><span class="Bold">○ </span>trouble sleeping </td> </tr> <tr> <td align="left" class="Botrule Lrule" colspan="2" valign="top"><span class="Bold">○ </span>an increase in activity and talking more than what is normal for you </td><td align="left" class="Botrule Rrule" colspan="3" valign="top"><span class="Bold">○ </span>other unusual changes in behavior or mood </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">What are paroxetine tablets?</span> <br/> Paroxetine tablets are prescription medicine used in adults to treat: <br/> ● A certain type of depression called Major Depressive Disorder (MDD) <br/> ● Obsessive Compulsive Disorder (OCD) <br/> ● Panic Disorder (PD) <br/> ● Social Anxiety Disorder (SAD) <br/> ● Generalized Anxiety Disorder (GAD) <br/> ● Posttraumatic Stress Disorder (PTSD) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">Do not take paroxetine tablets if you:</span> <br/> ● take a monoamine oxidase inhibitor (MAOI) <br/> ● have stopped taking an MAOI in the last 14 days <br/> ● are being treated with the antibiotic linezolid or the intravenous methylene blue <br/> ● are taking pimozide <br/> ● are taking thioridazine <br/> ● are allergic to paroxetine or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets. <br/> Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. <br/> <br/> <span class="Bold">Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine tablets.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">Before taking paroxetine tablets, tell your healthcare provider about all your medical conditions, including if you:</span> <br/> ● have heart problems <br/> ● have or had bleeding problems <br/> ● have, or have a family history of, bipolar disorder, mania or hypomania <br/> ● have or had seizures or convulsions <br/> ● have glaucoma (high pressure in the eye) <br/> ● have low sodium levels in your blood <br/> ● have bone problems <br/> ● have kidney or liver problems <br/> ● are pregnant or plan to become pregnant. Paroxetine tablets may harm your unborn baby. <br/> o Taking paroxetine during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth. <br/> o Taking paroxetine during your third trimester of pregnancy may cause your baby to have breathing, temperature and feeding problems, low muscle tone and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth. Talk to your healthcare provider about the risk to your unborn baby if you take paroxetine during pregnancy. <br/> o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine. <br/> o There is a pregnancy registry for females who are exposed to paroxetine during pregnancy. The purpose of the registry is to collect information about the health of females exposed to paroxetine and their baby. If you become pregnant during treatment with paroxetine talk to your healthcare provider. <br/> ● are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine tablets. <br/> <br/> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> Paroxetine tablets and some other medicines may affect each other causing possible serious side effects. Paroxetine tablets may affect the way other medicines work and other medicines may affect the way paroxetine tablet works. <br/> <span class="Bold">Especially tell your healthcare provider if you take:</span> <ul class="Disc"> <li>medicines used to treat migraine headaches called triptans</li> <li>tricyclic antidepressants</li> <li>lithium</li> <li>Tramadol, fentanyl, meperidine, methadone, or other opioids</li> <li>tryptophan</li> <li> buspirone</li> <li>amphetamines</li> <li>St. John's Wort</li> <li>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin</li> <li>diuretics</li> <li>tamoxifen</li> <li>medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)</li> </ul> Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take paroxetine tablets with your other medicines. <br/> Do not start or stop any other medicines during treatment with paroxetine tablets without talking to your healthcare provider first. Stopping paroxetine tablets suddenly may cause you to have serious side effects <span class="Bold">.</span>See, <span class="Bold">"What are the possible side effects of paroxetine tablets?"</span> <br/> <br/> Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">How should I take paroxetine tablets?</span> <br/> ● Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you. <br/> ● Take paroxetine tablet 1 time each day in the morning. <br/> ● Paroxetine tablets may be taken with or without food. <br/> ● If you take too much paroxetine tablets, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="5" valign="top"><span class="Bold">What are possible side effects of paroxetine tablets?</span> <br/> <span class="Bold">Paroxetine tablets can cause serious side effects, including:</span> <br/> ● See, <span class="Bold">"What is the most important information I should know about paroxetine tablets?"</span> <br/> ● <span class="Bold">Serotonin syndrome.</span>A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine tablets with certain other medicines. See, "Who should not take paroxetine tablets?" <span class="Bold">Call your healthcare provider or go to the nearest hospital emergency room right away</span>if you have any of the following signs and symptoms of serotonin syndrome: </td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ agitation</td><td align="left" class="Rrule" colspan="3" valign="top">○ sweating</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ seeing or hearing things that are not real (hallucinations)</td><td align="left" class="Rrule" colspan="3" valign="top">○ flushing</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ confusion</td><td align="left" class="Rrule" colspan="3" valign="top">○ high body temperature (hyperthermia)</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ coma</td><td align="left" class="Rrule" colspan="3" valign="top">○ shaking (tremors), stiff muscles, or muscle twitching</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ fast heart beat</td><td align="left" class="Rrule" colspan="3" valign="top">○ loss of coordination</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ changes in blood pressure</td><td align="left" class="Rrule" colspan="3" valign="top">○ seizures</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ dizziness</td><td align="left" class="Rrule" colspan="3" valign="top">○ nausea, vomiting, diarrhea</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="5" valign="top">● <span class="Bold">Eye problems (angle-closure glaucoma).</span>Paroxetine tablets may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. <br/> ● <span class="Bold">Medicine interactions.</span>Taking paroxetine tablets with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation. <br/> ● <span class="Bold">Seizures (convulsions).</span> <br/> ● <span class="Bold">Manic episodes.</span>Manic episodes may happen in people with bipolar disorder who take paroxetine tablets. Symptoms may include: </td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ greatly increased energy</td><td align="left" class="Rrule" colspan="3" valign="top">○ severe problems sleeping</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ racing thoughts</td><td align="left" class="Rrule" colspan="3" valign="top">○ reckless behavior</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ unusually grand ideas</td><td align="left" class="Rrule" colspan="3" valign="top">○ excessive happiness or irritability</td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top">○ talking more or faster than usual</td><td class="Rrule" colspan="3" valign="top"></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="5" valign="top"><span class="Bold"> ● Discontinuation syndrome.</span>Suddenly stopping paroxetine tablets may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include: </td> </tr> <tr> <td align="left" class="Lrule" valign="top">○ nausea</td><td align="left" colspan="3" valign="top">○ electric shock feeling (paresthesia)</td><td align="left" class="Rrule" valign="top">○ tiredness</td> </tr> <tr> <td align="left" class="Lrule" valign="top">○ sweating</td><td align="left" colspan="3" valign="top">○ tremor</td><td align="left" class="Rrule" valign="top">○ problems sleeping</td> </tr> <tr> <td align="left" class="Lrule" valign="top">○ changes in your mood</td><td align="left" colspan="3" valign="top">○ anxiety</td><td align="left" class="Rrule" valign="top">○ hypomania</td> </tr> <tr> <td align="left" class="Lrule" valign="top">irritability and agitation</td><td align="left" colspan="3" valign="top">○ confusion</td><td align="left" class="Rrule" valign="top">○ ringing in your ears (tinnitus)</td> </tr> <tr> <td align="left" class="Lrule" valign="top">○ dizziness</td><td align="left" colspan="3" valign="top">○ headache</td><td align="left" class="Rrule" valign="top">○ seizures</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="5" valign="top"><span class="Bold">● Low sodium levels in your blood (hyponatremia).</span>Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine tablets. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include: <br/> ○ headache <br/> ○ difficulty concentrating <br/> ○ memory changes <br/> ○ confusion <br/> ○ weakness and unsteadiness on your feet which can lead to falls <br/> <span class="Bold"> In more severe or more sudden cases, signs and symptoms include:</span> <br/> ○ seeing or hearing things that are not real (hallucinations) <br/> ○ fainting <br/> ○ seizures <br/> ○ coma <br/> ○ stopping breathing (respiratory arrest) <br/> <span class="Bold">● Abnormal bleeding.</span>Taking paroxetine tablets with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising. <br/> <span class="Bold">● Bone fractures.</span> <br/> <span class="Bold">● </span><span class="Bold">Sexual problems (dysfunction).</span>Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine, may cause sexual problems. <br/> <br/> Symptoms in males may include: <br/> o Delayed ejaculation or inability to have an ejaculation <br/> o Decreased sex drive <br/> o Problems getting or keeping an erection <br/> Symptoms in females may include: <br/> o Decreased sex drive <br/> o Delayed orgasm or inability to have an orgasm <br/> Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine. There may be treatments your healthcare provider can suggest. <br/> <br/> <span class="Bold">The most common side effects of paroxetine tablets include:</span> <br/> </td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ male and female sexual function problems</td><td align="left" class="Rrule" colspan="2" valign="top">○ weakness (asthenia)</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ constipation</td><td align="left" class="Rrule" colspan="2" valign="top">○ decreased appetite</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ diarrhea</td><td align="left" class="Rrule" colspan="2" valign="top">○ dizziness</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ dry mouth</td><td align="left" class="Rrule" colspan="2" valign="top">○ infection</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ problems sleeping</td><td align="left" class="Rrule" colspan="2" valign="top">○ nausea</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ nervousness</td><td align="left" class="Rrule" colspan="2" valign="top">○ sleepiness</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ sweating</td><td align="left" class="Rrule" colspan="2" valign="top">○ shaking (tremor)</td> </tr> <tr> <td align="left" class="Lrule" colspan="3" valign="top">○ yawning</td><td class="Rrule" colspan="2" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top">These are not all the possible side effects of paroxetine tablets. <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">How should I store paroxetine tablets?</span> <ul class="Disc"> <li>Store paroxetine tablets between 68°F to 77°F (20°C to 25°C).</li> <li>Paroxetine tablets come in child-resistant bottle pack of 30's and 90's.</li> </ul> <span class="Bold">Keep paroxetine tablets and all medicines out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">General information about the safe and effective use of paroxetine tablets.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine tablets for a condition for which it was not prescribed. Do not give paroxetine tablets to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine tablets that is written for healthcare professionals. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="5" valign="top"><span class="Bold">What are the ingredients in paroxetine tablets?</span> <br/> <span class="Bold">Active ingredient:</span>paroxetine hydrochloride, USP <br/> <span class="Bold">Inactive ingredients:</span>dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide. <br/> Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">Repackaged and Distributed By:</span> </p> <p> <span class="Bold">Remedy Repack, Inc.</span> </p> <p> <span class="Bold">625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" colspan="5" valign="top">Rev.: 01/25</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"638\">\n<colgroup>\n<col width=\"213\"/>\n<col width=\"106\"/>\n<col width=\"18\"/>\n<col width=\"88\"/>\n<col width=\"213\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">Medication Guide</span>\n<br/>\n<span class=\"Bold\">Paroxetine (pa rox' e teen) Tablets, USP</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">What is the most important information I should know about paroxetine tablets?</span>\n<br/>\n<span class=\"Bold\">Paroxetine tablets can cause serious side effects, including:</span>\n<br/>\n<span class=\"Bold\">● Increased risk of suicidal thoughts or actions.</span>Paroxetine tablets and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the \n <span class=\"Bold\">first few months of treatment or when the dose is changed. Paroxetine tablets are not for use in children.</span>\n<br/>\n<span class=\"Bold\"> ○ Depression or other mental illnesses are the most important causes of suicidal thoughts and actions.</span>\n<br/>\n<br/>\n<span class=\"Bold\">How can I watch for and try to prevent suicidal thoughts and actions?</span>\n<br/>\n<span class=\"Bold\">○ </span>Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the does is changed.\n <br/>\n<span class=\"Bold\">○ </span>Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.\n <br/>\n<span class=\"Bold\">○ </span>Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.\n <br/>\n<span class=\"Bold\">Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">○ </span>attempts to commit suicide\n </td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">○ </span>acting on dangerous impulses\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">○ </span>acting aggressive or violent\n </td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">○ </span>thoughts about suicide or dying\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">○ </span>new or worse depression\n </td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">○ </span>new or worse anxiety or panic attacks\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">○ </span>feeling agitated, restless, angry, or irritable\n </td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">○ </span>trouble sleeping\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">○ </span>an increase in activity and talking more than what is normal for you\n </td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">○ </span>other unusual changes in behavior or mood\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">What are paroxetine tablets?</span>\n<br/>\n\t\t\tParoxetine tablets are prescription medicine used in adults to treat:\n <br/>\n\t\t\t● A certain type of depression called Major Depressive Disorder (MDD)\n <br/>\n\t\t\t● Obsessive Compulsive Disorder (OCD)\n <br/>\n\t\t\t● Panic Disorder (PD)\n <br/>\n\t\t\t● Social Anxiety Disorder (SAD)\n <br/>\n\t\t\t● Generalized Anxiety Disorder (GAD)\n <br/>\n\t\t\t● Posttraumatic Stress Disorder (PTSD)\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">Do not take paroxetine tablets if you:</span>\n<br/>\n\t\t\t● take a monoamine oxidase inhibitor (MAOI)\n <br/>\n\t\t\t● have stopped taking an MAOI in the last 14 days\n <br/>\n\t\t\t● are being treated with the antibiotic linezolid or the intravenous methylene blue\n <br/>\n\t\t\t● are taking pimozide\n <br/>\n\t\t\t● are taking thioridazine\n <br/>\n\t\t\t● are allergic to paroxetine or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.\n <br/>\n\t\t\tAsk your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.\n <br/>\n<br/>\n<span class=\"Bold\">Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine tablets.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">Before taking paroxetine tablets, tell your healthcare provider about all your medical conditions, including if you:</span>\n<br/>\n\t\t\t● have heart problems\n <br/>\n\t\t\t● have or had bleeding problems\n <br/>\n\t\t\t● have, or have a family history of, bipolar disorder, mania or hypomania\n <br/>\n\t\t\t● have or had seizures or convulsions\n <br/>\n\t\t\t● have glaucoma (high pressure in the eye)\n <br/>\n\t\t\t● have low sodium levels in your blood\n <br/>\n\t\t\t● have bone problems\n <br/>\n\t\t\t● have kidney or liver problems\n <br/>\n\t\t\t● are pregnant or plan to become pregnant. Paroxetine tablets may harm your unborn baby.\n <br/>\n\t\t\to Taking paroxetine during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth.\n <br/>\n\t\t\to Taking paroxetine during your third trimester of pregnancy may cause your baby to have breathing, temperature and feeding problems, low muscle tone and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth. Talk to your healthcare provider about the risk to your unborn baby if you take paroxetine during pregnancy.\n <br/>\n\t\t\to Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine.\n <br/>\n\t\t\to There is a pregnancy registry for females who are exposed to paroxetine during pregnancy. The purpose of the registry is to collect information about the health of females exposed to paroxetine and their baby. If you become pregnant during treatment with paroxetine talk to your healthcare provider.\n <br/>\n\t\t\t● are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine tablets.\n <br/>\n<br/>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements.\n <br/>\n\t\t\tParoxetine tablets and some other medicines may affect each other causing possible serious side effects. Paroxetine tablets may affect the way other medicines work and other medicines may affect the way paroxetine tablet works.\n <br/>\n<span class=\"Bold\">Especially tell your healthcare provider if you take:</span>\n<ul class=\"Disc\">\n<li>medicines used to treat migraine headaches called triptans</li>\n<li>tricyclic antidepressants</li>\n<li>lithium</li>\n<li>Tramadol, fentanyl, meperidine, methadone, or other opioids</li>\n<li>tryptophan</li>\n<li> buspirone</li>\n<li>amphetamines</li>\n<li>St. John's Wort</li>\n<li>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin</li>\n<li>diuretics</li>\n<li>tamoxifen</li>\n<li>medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)</li>\n</ul>\n\t\t\tAsk your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take paroxetine tablets with your other medicines.\n <br/>\n\t\t\tDo not start or stop any other medicines during treatment with paroxetine tablets without talking to your healthcare provider first. Stopping paroxetine tablets suddenly may cause you to have serious side effects \n <span class=\"Bold\">.</span>See, \n <span class=\"Bold\">\"What are the possible side effects of paroxetine tablets?\"</span>\n<br/>\n<br/>\n\t\t\tKnow the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">How should I take paroxetine tablets?</span>\n<br/>\n\t\t\t● Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you.\n <br/>\n\t\t\t● Take paroxetine tablet 1 time each day in the morning.\n <br/>\n\t\t\t● Paroxetine tablets may be taken with or without food.\n <br/>\n\t\t\t● If you take too much paroxetine tablets, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">What are possible side effects of paroxetine tablets?</span>\n<br/>\n<span class=\"Bold\">Paroxetine tablets can cause serious side effects, including:</span>\n<br/>\n\t\t\t● See, \n <span class=\"Bold\">\"What is the most important information I should know about paroxetine tablets?\"</span>\n<br/>\n\t\t\t● \n <span class=\"Bold\">Serotonin syndrome.</span>A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine tablets with certain other medicines. See, \"Who should not take paroxetine tablets?\" \n <span class=\"Bold\">Call your healthcare provider or go to the nearest hospital emergency room right away</span>if you have any of the following signs and symptoms of serotonin syndrome:\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ agitation</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ sweating</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ seeing or hearing things that are not real (hallucinations)</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ flushing</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ confusion</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ high body temperature (hyperthermia)</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ coma</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ shaking (tremors), stiff muscles, or muscle twitching</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ fast heart beat</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ loss of coordination</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ changes in blood pressure</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ seizures</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ dizziness</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ nausea, vomiting, diarrhea</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">● \n <span class=\"Bold\">Eye problems (angle-closure glaucoma).</span>Paroxetine tablets may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.\n <br/>\n\t\t\t● \n <span class=\"Bold\">Medicine interactions.</span>Taking paroxetine tablets with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.\n <br/>\n\t\t\t● \n <span class=\"Bold\">Seizures (convulsions).</span>\n<br/>\n\t\t\t● \n <span class=\"Bold\">Manic episodes.</span>Manic episodes may happen in people with bipolar disorder who take paroxetine tablets. Symptoms may include:\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ greatly increased energy</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ severe problems sleeping</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ racing thoughts</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ reckless behavior</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ unusually grand ideas</td><td align=\"left\" class=\"Rrule\" colspan=\"3\" valign=\"top\">○ excessive happiness or irritability</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">○ talking more or faster than usual</td><td class=\"Rrule\" colspan=\"3\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\"> ● Discontinuation syndrome.</span>Suddenly stopping paroxetine tablets may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">○ nausea</td><td align=\"left\" colspan=\"3\" valign=\"top\">○ electric shock feeling (paresthesia)</td><td align=\"left\" class=\"Rrule\" valign=\"top\">○ tiredness</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">○ sweating</td><td align=\"left\" colspan=\"3\" valign=\"top\">○ tremor</td><td align=\"left\" class=\"Rrule\" valign=\"top\">○ problems sleeping</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">○ changes in your mood</td><td align=\"left\" colspan=\"3\" valign=\"top\">○ anxiety</td><td align=\"left\" class=\"Rrule\" valign=\"top\">○ hypomania</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">irritability and agitation</td><td align=\"left\" colspan=\"3\" valign=\"top\">○ confusion</td><td align=\"left\" class=\"Rrule\" valign=\"top\">○ ringing in your ears (tinnitus)</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">○ dizziness</td><td align=\"left\" colspan=\"3\" valign=\"top\">○ headache</td><td align=\"left\" class=\"Rrule\" valign=\"top\">○ seizures</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">● Low sodium levels in your blood (hyponatremia).</span>Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine tablets. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:\n <br/>\n\t\t\t○ headache\n <br/>\n\t\t\t○ difficulty concentrating\n <br/>\n\t\t\t○ memory changes\n <br/>\n\t\t\t○ confusion\n <br/>\n\t\t\t○ weakness and unsteadiness on your feet which can lead to falls\n <br/>\n<span class=\"Bold\"> In more severe or more sudden cases, signs and symptoms include:</span>\n<br/>\n\t\t\t○ seeing or hearing things that are not real (hallucinations)\n <br/>\n\t\t\t○ fainting\n <br/>\n\t\t\t○ seizures\n <br/>\n\t\t\t○ coma\n <br/>\n\t\t\t○ stopping breathing (respiratory arrest)\n <br/>\n<span class=\"Bold\">● Abnormal bleeding.</span>Taking paroxetine tablets with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising.\n <br/>\n<span class=\"Bold\">● Bone fractures.</span>\n<br/>\n<span class=\"Bold\">● </span><span class=\"Bold\">Sexual problems (dysfunction).</span>Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine, may cause sexual problems.\n <br/>\n<br/>\n\t\t\tSymptoms in males may include:\n <br/>\n\t\t\to Delayed ejaculation or inability to have an ejaculation\n <br/>\n\t\t\to Decreased sex drive\n <br/>\n\t\t\to Problems getting or keeping an erection\n <br/>\n\t\t\tSymptoms in females may include:\n <br/>\n\t\t\to Decreased sex drive\n <br/>\n\t\t\to Delayed orgasm or inability to have an orgasm\n <br/>\n\t\t\tTalk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine. There may be treatments your healthcare provider can suggest.\n <br/>\n<br/>\n<span class=\"Bold\">The most common side effects of paroxetine tablets include:</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ male and female sexual function problems</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ weakness (asthenia)</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ constipation</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ decreased appetite</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ diarrhea</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ dizziness</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ dry mouth</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ infection</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ problems sleeping</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ nausea</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ nervousness</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ sleepiness</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ sweating</td><td align=\"left\" class=\"Rrule\" colspan=\"2\" valign=\"top\">○ shaking (tremor)</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\" valign=\"top\">○ yawning</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">These are not all the possible side effects of paroxetine tablets.\n <br/>\n\t\t\tCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">How should I store paroxetine tablets?</span>\n<ul class=\"Disc\">\n<li>Store paroxetine tablets between 68°F to 77°F (20°C to 25°C).</li>\n<li>Paroxetine tablets come in child-resistant bottle pack of 30's and 90's.</li>\n</ul>\n<span class=\"Bold\">Keep paroxetine tablets and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">General information about the safe and effective use of paroxetine tablets.</span>\n<br/>\n\t\t\tMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine tablets for a condition for which it was not prescribed. Do not give paroxetine tablets to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine tablets that is written for healthcare professionals.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\"><span class=\"Bold\">What are the ingredients in paroxetine tablets?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span>paroxetine hydrochloride, USP\n <br/>\n<span class=\"Bold\">Inactive ingredients:</span>dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.\n <br/>\n\t\t\tMedication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.\n </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Repackaged and Distributed By:</span>\n</p>\n<p>\n<span class=\"Bold\">Remedy Repack, Inc.</span>\n</p>\n<p>\n<span class=\"Bold\">625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">Rev.: 01/25</td>\n</tr>\n</tbody>\n</table></div>" }

This Medication Guide has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration." }

Repackaged By / Distributed By: RemedyRepack Inc.

{ "type": "p", "children": [], "text": "Repackaged By / Distributed By: RemedyRepack Inc." }

625 Kolter Drive, Indiana, PA 15701

{ "type": "p", "children": [], "text": "625 Kolter Drive, Indiana, PA 15701" }

(724) 465-8762

{ "type": "p", "children": [], "text": "(724) 465-8762" }

DRUG: Paroxetine

{ "type": "p", "children": [], "text": "DRUG: Paroxetine" }

GENERIC: Paroxetine

{ "type": "p", "children": [], "text": "GENERIC: Paroxetine" }

DOSAGE: TABLET, FILM COATED

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ADMINSTRATION: ORAL

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NDC: 70518-3518-00

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NDC: 70518-3518-01

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NDC: 70518-3518-02

{ "type": "p", "children": [], "text": "NDC: 70518-3518-02" }

NDC: 70518-3518-03

{ "type": "p", "children": [], "text": "NDC: 70518-3518-03" }

NDC: 70518-3518-04

{ "type": "p", "children": [], "text": "NDC: 70518-3518-04" }

COLOR: white

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SHAPE: ROUND

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SCORE: Two even pieces

{ "type": "p", "children": [], "text": "SCORE: Two even pieces" }

SIZE: 8 mm

{ "type": "p", "children": [], "text": "SIZE: 8 mm" }

IMPRINT: ZC;16

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PACKAGING: 100 in 1 BOTTLE, PLASTIC

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PACKAGING: 30 in 1 BLISTER PACK

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PACKAGING: 100 in 1 BOX

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PACKAGING: 1 in 1 POUCH

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PACKAGING: 30 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BOTTLE PLASTIC " }

ACTIVE INGREDIENT(S):

{ "type": "p", "children": [], "text": "ACTIVE INGREDIENT(S):" }

{ "type": "ul", "children": [ "PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20mg in 1" ], "text": "" }

INACTIVE INGREDIENT(S):

{ "type": "p", "children": [], "text": "INACTIVE INGREDIENT(S):" }

{ "type": "ul", "children": [ "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "ANHYDROUS LACTOSE", "HYPROMELLOSES", "MAGNESIUM STEARATE", "POLYETHYLENE GLYCOL 6000", "SODIUM STARCH GLYCOLATE TYPE A POTATO", "POVIDONE", "TALC", "TITANIUM DIOXIDE" ], "text": "" }