RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.

{ "type": "p", "children": [], "text": "RALDESY\n \n TMis indicated for the treatment of major depressive disorder (MDD) in adults.\n\n " }

The initial dosage of RALDESY for the treatment of MDD in adults is 150 mg daily, taken orally, in divided doses. The dosage should be initiated at a low-dose and increased gradually, depending on clinical response and an tolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage [see Dosage and Administration (2.5)]

The dose may be increased by 50 mg daily every 3 to 4 days. The maximum recommended dosage for outpatients usually should not exceed 400 mg daily in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to, but not in excess, of 600 mg daily in divided doses.

Administer RALDESY orally after a meal or light snack [see Clinical Pharmacology (12.3)].

Prior to initiating treatment with RALDESY or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7)].

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

Coadministration with Strong CYP3A4 Inhibitors Consider reducing RALDESY dose based on tolerability when RALDESY is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1)].

Coadministration with Strong CYP3A4 Inducers Consider increasing RALDESY dose based on therapeutic response when RALDESY is coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1)].

Adverse reactions may occur upon discontinuation of RALDESY  [see Warnings and Precautions (5.8)]. Gradually reduce the dosage rather than stopping RALDESY abruptly whenever possible.

RALDESY (10 mg/mL) Oral Solution: Clear, colorless solution

{ "type": "p", "children": [], "text": "RALDESY (10 mg/mL) Oral Solution: Clear, colorless solution" }

RALDESY is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome  [see Warnings and Precautions (5.2), Drug Interactions (7.1)].

{ "type": "p", "children": [], "text": "RALDESY is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome \n \n [see\n \n Warnings and Precautions (5.2),\n \n Drug Interactions (7.1)].\n \n \n" }

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 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 1.

Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of                                                                                    Antidepressants in Pediatric and Adult Patients

<div class="scrollingtable"><table cellspacing="0" width="60%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Age Range (years)</span> </p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Increases Compared to Placebo</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> <p class="First">&lt;18</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">14 additional patients</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> <p class="First">18-24</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5 additional patients</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Decreases Compared to Placebo</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> <p class="First">25-64</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1 fewer patient</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule"> <p class="First">≥65</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6 fewer patients</p> </td> </tr> </tbody> </table></div>

It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients 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 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 RALDESY, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

SSRIs, including RALDESY, 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, tryptophan, buspirone, 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 signs and 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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of RALDESY with MAOIs is contraindicated. In addition, do not initiate RALDESY 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). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking RALDESY, discontinue RALDESY before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7.1)].

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

Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease. Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes. Postmarketing reports, including torsade de pointes have been reported at doses of 100 mg or less with the immediate-release trazodone hydrochloride tablets. RALDESY should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. RALDESY is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering RALDESY to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including RALDESY) may cause cardiac arrhythmias [see Adverse Reactions (6.2)] .

Trazodone hydrochloride prolongs the QT/QT cinterval. The use of RALDESY Should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia [see Drug Interactions (7.1)].

Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.

Drugs that interfere with serotonin reuptake inhibition, including RALDESY, 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. Bleeding events related to drugs that interfere with serotonin reuptake 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 RALDESY and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing RALDESY.

Cases of priapism (painful erections greater than 6 hours in duration) have been reported in males receiving trazodone hydrochloride tablets. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Males who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention [see Adverse Reactions (6.2), Overdosage (10)].

RALDESY should be used with caution in males who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease).

In patients with bipolar disorder, treating a depressive episode with RALDESY or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with RALDESY, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration (2.3)] .

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 (2.6)].

RALDESY TM may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

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

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including RALDESY. 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 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, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue RALDESY 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 and SNRIs [see Use in Specific Populations (8.5)] .

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 of RALDESY for the treatment of MDD in adults is based on studies of trazodone hydrochloride tablets. Below is a display of adverse reactions of trazodone hydrochloride tablets from those studies.

Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone hydrochloride Tablets -treated Patients and Greater than                                                     the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies

<div class="scrollingtable"><table cellspacing="0" width="60%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First">Inpatients</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First">Outpatients</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Trazodone hydrochloride</span> </p> <p>N=142</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">Placebo <br/> N=95 </p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Trazodone hydrochloride</span> </p> <p>N=157</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">Placebo <br/> N=158 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Allergic</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Skin Condition/Edema</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Autonomic</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Blurred Vision</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">15%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Constipation</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Dry Mouth</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">15%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">34%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">20%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Cardiovascular</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Hypertension</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">20%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">*</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Hypotension</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Syncope</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">CNS</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Confusion</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Decreased Concentration</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Disorientation</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">*</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Dizziness/Light-Headedness</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">20%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">28%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">15%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Drowsiness</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">24%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">41%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">20%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Fatigue</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">11%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Headache</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">10%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">20%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">16%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Nervousness</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">15%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">11%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Gastrointestinal</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Abdominal/Gastric Disorder</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Diarrhea</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Nausea/Vomiting</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">10%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">13%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">10%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Musculoskeletal</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Aches/Pains</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Neurological</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Incoordination</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">*</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Tremors</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">4%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Other</span> </p> </td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td><td class="Botrule Lrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Eyes Red/Tired/Itching</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Head Full-Heavy</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Malaise</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Nasal/Sinus Congestion</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First">Weight Gain</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">0</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">5%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">2%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule"> <p class="First">Weight Loss</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">*</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">3%</p> </td> </tr> </tbody> </table></div>

Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.

The following adverse reactions have been identified during post-approval use of trazodone hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:

Blood and lymphatic system disorders:hemolytic anemia, leukocytosis

Cardiac disorders:cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3)].

Endocrine disorders:inappropriate ADH syndrome

Eye disorders:diplopia

Gastrointestinal disorders:increased salivation, nausea/vomiting

General disorders and administration site conditions:chills, edema, unexplained death, weakness

Hepatobiliary disorders:cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations

Investigations:increased amylase

Metabolism and nutrition disorders:methemoglobinemia

Nervous system disorders:aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo

Psychiatric disorders:abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor

Renal and urinary disorders:urinary incontinence, urinary retention

Reproductive system and breast disorders:breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6)]

Respiratory, thoracic and mediastinal disorders:apnea

Skin and subcutaneous tissue disorders:alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria

Vascular disorders:vasodilation

Table 3 displays clinically significant drug Interactions with RALDESY.

Table 3: Clinically Significant Drug Interactions with RALDESY

<div class="scrollingtable"><table cellspacing="0" width="80%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Monoamine Oxidase Inhibitors (MAOIs)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">The concomitant use of MAOIs and serotonergic drugs including RALDESY increases the risk of serotonin syndrome.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">RALDESY is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[see <a href="#MGS4">Contraindications (4)</a>, Dosage and Administration ( <a href="#MGS23">2.3</a>, <a href="#MGS24">2.4)</a>, and <a href="#MGS52">Warnings and Precautions (5.2)</a>]. </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Other Serotonergic Drugs</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">The concomitant use of serotonergic drugs, including RALDESY and other serotonergic drugs increases the risk of serotonin syndrome.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Monitor patients for signs and symptoms of serotonin syndrome, particularly during RALDESY initiation. If serotonin syndrome occurs, consider discontinuation of RALDESY and/or concomitant serotonergic drugs <span class="Italics">[see <a href="#MGS52">Warnings and Precautions (5.2)</a>]. </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Antiplatelet Agents and Anticoagulants</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with RALDESY may potentiate the risk of bleeding.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Inform patients of the increased risk of bleeding with the concomitant use of RALDESY and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing RALDESY <span class="Italics">[see <a href="#MGS55">Warnings and Precautions (5.5)</a>]. </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Strong CYP3A4 Inhibitors</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">The concomitant use of RALDESY and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of RALDESY alone.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">If RALDESY is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of RALDESY should be considered <span class="Italics">[see <a href="#MGS25">Dosage and Administration (2.5)</a>, <a href="#MGS53">Warnings and Precautions (5.3)</a>]. </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Strong CYP3A4 Inducers</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">The concomitant use of RALDESY and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of RALDESY alone.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Patients should be closely monitored to see if there is a need for an increased dose of RALDESY when taking CYP3A4 inducers <span class="Italics">[see <a href="#MGS25">Dosage and Administration (2.5)</a>]. </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Digoxin and Phenytoin</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of RALDESY can increase digoxin or phenytoin concentrations.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Measure serum digoxin or phenytoin concentrations before initiating concomitant use of RALDESY. Continue monitoring and reduce digoxin or phenytoin dose as necessary.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Central Nervous System (CNS) Depressants</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">RALDESY may enhance the response CNS depressants.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Patients should be counseled that RALDESY may enhance the response to alcohol, barbiturates, and other CNS depressants.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> QT Interval Prolongation</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> Clinical Impact:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Concomitant use of drugs that prolong the QT interval may add to the QT effects of RALDESY and increase the risk of cardiac arrhythmia.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule"> <p class="First"> Intervention:</p> </td><td class="Botrule Lrule Rrule"> <p class="First">Avoid the use of RALDESY in combination with other drugs known to prolong QTc <span class="Italics">[see <a href="#MGS53">Warnings and Precautions (5.3)</a>] </span>. </p> </td> </tr> </tbody> </table></div>

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data). There are risks associated with untreated depression in pregnancy (see Clinical Considerations) . Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m 2basis (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. 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 postpartum.

Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All available studies have methodological limitations, including small sample size and inconsistent comparator groups.

Animal Data No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2basis. Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 to 22 times the MRHD on a mg/m 2basis were observed. No further details on these studies are available.

Risk Summary Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified an association of adverse effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RALDESY and any potential adverse effects on the breastfed child from RALDESY or from the underlying maternal condition.

Safety and effectiveness of RALDESY in the pediatric patients have not been established.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1)].

Reported clinical literature and experience with trazodone has not identified differences in responses between geriatric and younger patients. However, as experience with trazodone hydrochloride in geriatric patients is limited, RALDESY should be used with caution in these patients.

Serotonergic antidepressants 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 (5.11)].

Trazodone has not been studied in patients with renal impairment. RALDESY should be used with caution in this population.

Trazodone has not been studied in patients with hepatic impairment. RALDESY should be used with caution in this population.

Trazodone hydrochloride is not a controlled substance.

Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).

{ "type": "p", "children": [], "text": "Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate)." }

The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.

{ "type": "p", "children": [], "text": "The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions." }

There is no specific antidote for trazodone hydrochloride overdose. Consider contacting the Poison Help line 1-888-222-1222 or a medical toxicologist for additional overdose management recommendations.

{ "type": "p", "children": [], "text": "There is no specific antidote for trazodone hydrochloride overdose. Consider contacting the Poison Help line 1-888-222-1222 or a medical toxicologist for additional overdose management recommendations." }

RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:

{ "type": "p", "children": [], "text": "RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2\n \n H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:\n\n " }

Molecular Formula: C 19H 22CIN 5O • HCL

{ "type": "p", "children": [], "text": "\nMolecular Formula: C\n \n 19H\n \n 22CIN\n \n 5O • HCL\n\n " }

Molecular Weight:408.33

{ "type": "p", "children": [], "text": "\nMolecular Weight:408.33\n\n " }

RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8.

{ "type": "p", "children": [], "text": "RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8." }

The mechanism of trazodone’s antidepressant action is unclear, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone’s antidepressant effect is unknown.

Preclinical studies have shown that trazodone selectively inhibits neuronal reuptake of serotonin (Ki = 367 nM) and acts as an antagonist at 5-HT-2A (Ki = 35.6 nM) serotonin receptors. Trazodone is also an antagonist at several other monoaminergic receptors including 5-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5- HT1A (Ki = 118 nM) receptor.

Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.

No clinically significant difference in pharmacokinetics of trazodone was observed between RALDESY and immediate-release trazodone hydrochloride tablet administered under fed conditions.

Absorption Peak plasma levels occur approximately one hour after administration under fed conditions.

Effect of Food Ingestion of a high-fat meal with RALDESY lowers mean C maxof trazodone by 31% and increases mean AUC by 8%. Median T maxwas similar between fed and fasted conditions.

Distribution Trazodone is 89% to 95% protein bound in vitroat concentrations attained with therapeutic doses in humans.

Metabolism In vitro studies in human liver microsomes show that trazodone is metabolized, via oxidative cleavage, to an active metabolite, m-chlorophenylpiperazine (mCPP) by CYP3A4. Other metabolic pathways that may be involved in the metabolism of trazodone have not been well characterized. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted unchanged in the urine.

Elimination The average terminal elimination half-life of RALDESY under fed state is 18 hours.

Carcinogenesis No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to 7.3 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2basis.

Mutagenesis No genotoxicity studies were conducted with trazodone.

Impairment of Fertility Trazodone has no effect on fertility in rats at doses up to 7.3 times the MRHD in adults on a mg/m 2basis.

The efficacy of RALDESY for the treatment of MDD in adults is based on studies of trazodone hydrochloride tablets.

{ "type": "p", "children": [], "text": "The efficacy of RALDESY for the treatment of MDD in adults is based on studies of trazodone hydrochloride tablets." }

How Supplied RALDESY TMcontains 10 mg/mL of trazodone hydrochloride. It is a clear, colorless solution and is supplied as:

{ "type": "p", "children": [], "text": "\nHow Supplied\n RALDESY\n \n TMcontains 10 mg/mL of trazodone hydrochloride. It is a clear, colorless solution and is supplied as:\n\n " }

150 mL white, opaque, high-density polyethylene (HDPE) bottle

{ "type": "p", "children": [], "text": "150 mL white, opaque, high-density polyethylene (HDPE) bottle" }

{ "type": "ul", "children": [ "NDC 30698-455-02 with child-resistant cap along with a 10 mL calibrated oral dosing syringe and bottle adapter." ], "text": "" }

300 mL white, opaque, HDPE bottle

{ "type": "p", "children": [], "text": "300 mL white, opaque, HDPE bottle" }

{ "type": "ul", "children": [ "NDC 30698-455-01 with child-resistant cap along with a 10 mL calibrated oral dosing syringe and bottle adapter." ], "text": "" }

The bottle, bottle adapter and the dosing syringe are placed in a carton.

{ "type": "p", "children": [], "text": "The bottle, bottle adapter and the dosing syringe are placed in a carton." }

Storage and Handling Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Discard any unused RALDESY remaining in the bottle 30 days after first opening the bottle.

{ "type": "p", "children": [], "text": "\nStorage and Handling\n\nStore at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. \n Protect from light. Discard any unused RALDESY remaining in the bottle 30 days after first opening the bottle.\n\n " }

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

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

Suicidal Thoughts and Behaviors 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 Box Warningand Warnings and Precautions (5.1)].

{ "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 [\n \n see\n \n Box Warningand\n \n Warnings and Precautions (5.1)].\n\n " }

Dosage and Administration Advise patients that RALDESY should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2)] .

{ "type": "p", "children": [], "text": "\nDosage and Administration\n Advise patients that RALDESY should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions\n \n [see\n \n Dosage and Administration (2)]\n \n .\n\n " }

Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of RALDESY with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, 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). Patients should 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)and Drug Interactions (7)] .

{ "type": "p", "children": [], "text": "\nSerotonin Syndrome\n Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of RALDESY with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, 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). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome\n \n [see\n \n Warnings and Precautions (5.2)and\n \n Drug Interactions (7)]\n \n .\n\n " }

Increased Risk of Bleeding Inform patients about the concomitant use of RALDESY with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them 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": "\nIncreased Risk of Bleeding\n Inform patients about the concomitant use of RALDESY with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them 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\n \n Warnings and Precautions (5.5)]\n \n .\n\n " }

Activation of Mania or Hypomania 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 (5.7)].

{ "type": "p", "children": [], "text": "\nActivation of Mania or 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\n \n [see\n \n Warnings and Precautions (5.7)].\n \n \n" }

Discontinuation Syndrome Advise patients not to abruptly discontinue RALDESY and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when RALDESY is discontinued [see Warnings and Precautions (5.8)].

{ "type": "p", "children": [], "text": "\nDiscontinuation Syndrome\n Advise patients not to abruptly discontinue RALDESY and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when RALDESY is discontinued\n \n [see\n \n Warnings and Precautions (5.8)].\n \n \n" }

Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1)].

{ "type": "p", "children": [], "text": "\nConcomitant Medications\n Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions\n \n [see\n \n Drug Interactions (7.1)].\n \n \n" }

Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with RALDESY. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RALDESY during pregnancy [see Use in Special Populations (8.1)].

{ "type": "p", "children": [], "text": "\nPregnancy\n Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with RALDESY. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RALDESY during pregnancy\n \n [see\n \n Use in Special Populations (8.1)].\n \n \n" }

Manufactured for and distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054

{ "type": "p", "children": [], "text": "\nManufactured for and distributed by:\n Validus Pharmaceuticals LLC \n Parsippany, NJ 07054\n\n " }

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0"> <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> <span class="Bold">RALDESY <span class="Sup">TM</span>(ral DEH see) </span> </p> <p> <span class="Bold">(trazodone hydrochloride)</span> </p> <p> <span class="Bold">oral solution</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What is the most important information I should know about RALDESY?</span> </p> <p> <span class="Bold">RALDESY can cause serious side effects, including:</span> </p> <p> • <span class="Bold">Increased risk of suicidal thoughts or actions.</span>RALDESY and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, <span class="Bold">especially within the first few months of treatment or when the dose is changed. RALDESY is not for use in children.</span> </p> <p>     ◦ <span class="Bold">Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.</span> </p> <p> <span class="Bold">How can I watch for and try to prevent suicidal thoughts and actions?</span> </p> <p>      ◦ Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.</p> <p>      ◦ 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.</p> <p>      ◦ Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.</p> <span class="Bold">Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span> <p> • attempts to commit suicide                                                • acting on dangerous impulses             • acting aggressive or violent</p> <p> • thoughts about suicide or dying                                         • new or worse depression                     • a new or worse anxiety or panic attacks</p> <p> • feeling agitated, restless, angry, or irritable                       • trouble sleeping                                   • an increase in activity or talking more than what is normal for you</p> <p> • other unusual changes in behavior and mood</p> <p></p> <p>See <span class="Bold">“What are the possible side effects of RALDESY?”</span>for more information about side effects. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What is RALDESY?</span> </p> <p>RALDESY is a prescription medicine used in adults to treat major depressive disorder (MDD).</p> <p>It is not known if RALDESY is safe and effective for use in children.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Who should not take RALDESY?</span> </p> <p> <span class="Bold">Do not take RALDESY if you:</span> </p> <p> • are taking, or have stopped taking within the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue</p> <p>Ask your healthcare provider or pharmacist is you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous blue.</p> <p> <span class="Bold">Do not start taking an MAOI for at least 14 days after you stop treatment with RALDESY.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Before taking RALDESY tell your healthcare provider about all of your medical conditions, including if you:</span> </p> <p> • have or have a family history of heart problems, including fast or slow heartbeat, or changes in the electrical activity of your heart (QT prolongation)</p> <p> • have ever had a heart attack</p> <p> • have or have had bleeding problems</p> <p> • are male and have conditions that may cause a prolonged or painful erection (priapism) such as sickle cell anemia, multiple myeloma, leukemia, or a deformed penis</p> <p> • have or have a family history of bipolar disorder, mania, or hypomania</p> <p> • have high pressure in the eye (glaucoma)</p> <p> • have low sodium levels in your blood</p> <p> • are pregnant or plan to become pregnant. It is not known if RALDESY will harm your unborn baby. Talk to your healthcare provider about the risks to you or your unborn baby if you take RALDESY during pregnancy.</p> <p>     ◦ Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with RALDESY.</p> <p>     ◦ There is a pregnancy registry for females who are exposed to RALDESY during pregnancy. The purpose of this registry is to collect information about the health of females exposed to RALDESY and their baby. <br/>         If you become pregnant during treatment with RALDESY, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. </p> <p> • are breastfeeding or plan to breastfeed. RALDESY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with RALDESY.</p> <p> <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. </p> <p>RALDESY and some other medicines may affect each other causing serious side effects. RALDESY may affect the way other medicines work and other medicines may affect the way RALDESY works.</p> <p> <span class="Bold">Especially tell your healthcare provider if you take:</span> </p> <p> • MAOIs</p> <p> • medicines used to treat migraine headache called triptans</p> <p> • medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclic antidepressants, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), buspirone, or antipsychotics</p> <p> • tramadol, fentanyl, or other opioids</p> <p> • over-the-counter supplements such as tryptophan or St. John’s Wort</p> <p> • medicines used to treat high blood pressure</p> <p> • medicines used to treat irregular heartbeats</p> <p> • medicines that affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin or other blood thinners</p> <p> • digoxin</p> <p> • medicines used to treat seizures or convulsions</p> <p> • diuretics</p> <p>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 RALDESY with your other medicines.</p> <p> <span class="Bold">Do not</span>start or stop any other medicines during treatment with RALDESY without talking to your healthcare provider first. Stopping RALDESY suddenly may cause you to have serious side effects. See, <span class="Bold">“What are the possible side effects of RALDESY?”</span> </p> <p>Know the medicines you take. Keep a list of them to show it to your healthcare provider and pharmacist when you get a new medicine.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">How should I take RALDESY?</span> </p> <p> <span class="Bold">See the detailed Instructions for Use that comes with RALDESY for information on how to take RADELSY oral solution.</span> </p> <p> • Take RALDESY exactly as your healthcare provider tells you. Your healthcare provider may need to change your dose of RALDESY until it is the right dose for you.</p> <p> • If you feel sleepy after taking RALDESY, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your RALDESY.</p> <p> • Take RALDESY after a meal or light snack.</p> <p> • Do not stop taking RALDESY without talking to your healthcare provider.</p> <p> • If you take too much RALDESY, call your healthcare provider, your Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What should I avoid while taking RALDESY?</span> </p> <p> • <span class="Bold">Do not</span>drive, operate heavy machinery, or do other dangerous activities until you know how RALDESY affects you. RALDESY can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. </p> <p> • <span class="Bold">Do not</span>drink alcohol or take other medicines that make you sleepy or dizzy during treatment with RALDESY until you talk with your healthcare provider. RALDESY may make your sleepiness or dizziness worse if you drink alcohol or take other medicines that cause sleepiness or dizziness. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of RALDESY?</span> </p> <p> <span class="Bold">RALDESY can cause serious side effects, including:</span> </p> <p> • <span class="Bold">See “What is the most important information I should know about RALDESY?”</span> </p> <p> <span class="Bold">Serotonin syndrome</span>. A potentially life-threating problem called serotonin syndrome can happen when you take RALDESY with certain other medicines. See <span class="Bold">“Who should not take RALDESY?” 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: </p> <p>       ◦ agitation                                                                                            ◦ flushing</p> <p>       ◦ seeing or hearing things that are not real (hallucinations)               ◦ high body temperature (hyperthermia)</p> <p>       ◦ confusion                                                                                          ◦ shaking (tremors), stiff muscles, or muscle twitching</p> <p>       ◦ coma                                                                                                 ◦ loss of coordination</p> <p>       ◦ fast heartbeat                                                                                    ◦ seizures</p> <p>       ◦ changes in blood pressure                                                                ◦ nausea, vomiting, diarrhea</p> <p>       ◦ sweating                                                                                           ◦ dizziness</p> <p></p> <p> • <span class="Bold">Changes in the electrical activity of your heart (QT prolongation).</span>Call your healthcare provider right away if you have any of the following symptoms: abnormal heartbeats, dizziness, feel lightheaded or faint. </p> <p> • <span class="Bold">Low blood pressure and fainting.</span>Low blood pressure can happen when you change positions from sitting to standing or laying down. You may feel dizzy, lightheaded, or faint. </p> <p> • <span class="Bold">Increased risk of bleeding.</span>Taking RALDESY with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising. </p> <p> • <span class="Bold">Painful erection lasting for more than 6 hours (priapism).</span>If you have an erection that lasts more than 4 hours, get medical help right away. </p> <p> • <span class="Bold">Manic episodes.</span>Manic episodes may happen in people with bipolar disorder who take RALDESY. Symptoms may include: </p> <p>       ◦ greatly increased energy                          ◦ severe problems sleeping</p> <p>       ◦ racing thoughts                                        ◦ reckless behavior</p> <p>       ◦ unusually grand ideas                             ◦ excessive happiness or irritability</p> <p>       ◦ talking more or faster than usual</p> <p> • <span class="Bold">Discontinuation syndrome.</span>Suddenly stopping RALDESY may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include: </p> <p>         ◦ nausea                                 ◦ electric shock feeling (paresthesia)              ◦ tiredness</p> <p>         ◦ sweating                             ◦ tremor                                                            ◦ problems sleeping</p> <p>         ◦ changes in your mood        ◦ anxiety                                                           ◦ hypomania</p> <p>         ◦ irritability and agitation      ◦ confusion                                                       ◦ ringing in the ears (tinnitus)</p> <p>         ◦ dizziness                             ◦ headache                                                         ◦ seizures</p> <p> • <span class="Bold">Eye problems (angle-closure glaucoma).</span>RALDESY can cause a type of eye problem called angle-closure glaucoma in people with certain 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 changes in your vision, eye pain, or swelling or redness in or around the eye. </p> <p> • <span class="Bold">Low sodium in your blood (hyponatremia).</span>Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with RALDESY. Elderly people and people who take certain medicines may be at greater risk for this. Signs and symptoms may include: </p> <p>       ◦ headache                                                              ◦ confusion</p> <p>       ◦ difficulty concentrating                                       ◦ weakness and unsteadiness on your feet, which can lead to falls</p> <p>       ◦ memory changes</p> <p>       ◦ talking more or faster than usual</p> <p> <span class="Bold">In more severe or sudden cases, signs and symptoms include:</span> </p> <p>       ◦ seeing or hearing things that are not real                          ◦ coma</p> <p>         (hallucinations)                                                                  ◦ stopping breathing (respiratory arrest) to falls</p> <p>       ◦ fainting</p> <p>       ◦ seizures</p> <p> <span class="Bold">The most common side effects of RALDESY include:</span> </p> <p>       • swelling                        • tiredness</p> <p>       • blurred vision               • diarrhea</p> <p>       • fainting                         • stuffy nose</p> <p>       • sleepiness                     • weight loss</p> <p>These are not all of the possible side effects of RALDESY.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">How should I store RALDESY?</span> </p> <p> • Store RALDESY at room temperature between 68°F to 77°F (20°C to 25°C).</p> <p> • RALDESY comes in a bottle with a child-resistant cap.</p> <p> • Keep RALDESY out of the light.</p> <p> • Throw away (discard) RALDESY 30 days after first opening the bottle.</p> <p> • Safely throw away medicine that is out of date or no longer needed.</p> <p> <span class="Bold">Keep RALDESY 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 RALDESY.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RALDESY for a condition for which it was not prescribed. Do not give RALDESY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RALDESY that is written for health professional.</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 RALDESY?</span> </p> <p> <span class="Bold">Active ingredient:</span>trazodone hydrochloride, USP </p> <p> <span class="Bold">Inactive ingredients</span>: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, and sucralose. </p> <br/> <p> <span class="Bold">Manufactured for and distributed by:</span> </p> <p>Validus Pharmaceuticals LLC</p> <p>Parsippany, NJ 07054</p> <p>For more information, go to www.RALDESY.com or call <span class="Bold">Validus Pharmaceuticals LLC at 1-866-982-5438.</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\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>\n<span class=\"Bold\">RALDESY\n \n <span class=\"Sup\">TM</span>(ral DEH see)\n \n </span>\n</p>\n<p>\n<span class=\"Bold\">(trazodone hydrochloride)</span>\n</p>\n<p>\n<span class=\"Bold\">oral solution</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\">What is the most important information I should know about RALDESY?</span>\n</p>\n<p>\n<span class=\"Bold\">RALDESY can cause serious side effects, including:</span>\n</p>\n<p> •\n \n <span class=\"Bold\">Increased risk of suicidal thoughts or actions.</span>RALDESY and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger,\n \n <span class=\"Bold\">especially within the first few months of treatment or when the dose is changed. RALDESY is not for use in children.</span>\n</p>\n<p>     ◦\n \n <span class=\"Bold\">Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.</span>\n</p>\n<p>\n<span class=\"Bold\">How can I watch for and try to prevent suicidal thoughts and actions?</span>\n</p>\n<p>      ◦ Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.</p>\n<p>      ◦ 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.</p>\n<p>      ◦ Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.</p>\n<span class=\"Bold\">Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span>\n<p> • attempts to commit suicide                                                • acting on dangerous impulses             • acting aggressive or violent</p>\n<p> • thoughts about suicide or dying                                         • new or worse depression                     • a new or worse anxiety or panic attacks</p>\n<p> • feeling agitated, restless, angry, or irritable                       • trouble sleeping                                   • an increase in activity or talking more than what is normal for you</p>\n<p> • other unusual changes in behavior and mood</p>\n<p></p>\n<p>See\n \n <span class=\"Bold\">“What are the possible side effects of RALDESY?”</span>for more information about side effects.\n \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\">What is RALDESY?</span>\n</p>\n<p>RALDESY is a prescription medicine used in adults to treat major depressive disorder (MDD).</p>\n<p>It is not known if RALDESY is safe and effective for use in children.</p>\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 RALDESY?</span>\n</p>\n<p>\n<span class=\"Bold\">Do not take RALDESY if you:</span>\n</p>\n<p> • are taking, or have stopped taking within the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue</p>\n<p>Ask your healthcare provider or pharmacist is you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous blue.</p>\n<p>\n<span class=\"Bold\">Do not start taking an MAOI for at least 14 days after you stop treatment with RALDESY.</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\">Before taking RALDESY tell your healthcare provider about all of your medical conditions, including if you:</span>\n</p>\n<p> • have or have a family history of heart problems, including fast or slow heartbeat, or changes in the electrical activity of your heart (QT prolongation)</p>\n<p> • have ever had a heart attack</p>\n<p> • have or have had bleeding problems</p>\n<p> • are male and have conditions that may cause a prolonged or painful erection (priapism) such as sickle cell anemia, multiple myeloma, leukemia, or a deformed penis</p>\n<p> • have or have a family history of bipolar disorder, mania, or hypomania</p>\n<p> • have high pressure in the eye (glaucoma)</p>\n<p> • have low sodium levels in your blood</p>\n<p> • are pregnant or plan to become pregnant. It is not known if RALDESY will harm your unborn baby. Talk to your healthcare provider about the risks to you or your unborn baby if you take RALDESY during pregnancy.</p>\n<p>     ◦ Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with RALDESY.</p>\n<p>     ◦ There is a pregnancy registry for females who are exposed to RALDESY during pregnancy. The purpose of this registry is to collect information about the health of females exposed to RALDESY and their baby. \n <br/>         If you become pregnant during treatment with RALDESY, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.\n </p>\n<p> • are breastfeeding or plan to breastfeed. RALDESY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with RALDESY.</p>\n<p>\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 \n </p>\n<p>RALDESY and some other medicines may affect each other causing serious side effects. RALDESY may affect the way other medicines work and other medicines may affect the way RALDESY works.</p>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider if you take:</span>\n</p>\n<p> • MAOIs</p>\n<p> • medicines used to treat migraine headache called triptans</p>\n<p> • medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclic antidepressants, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), buspirone, or antipsychotics</p>\n<p> • tramadol, fentanyl, or other opioids</p>\n<p> • over-the-counter supplements such as tryptophan or St. John’s Wort</p>\n<p> • medicines used to treat high blood pressure</p>\n<p> • medicines used to treat irregular heartbeats</p>\n<p> • medicines that affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin or other blood thinners</p>\n<p> • digoxin</p>\n<p> • medicines used to treat seizures or convulsions</p>\n<p> • diuretics</p>\n<p>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 RALDESY with your other medicines.</p>\n<p>\n<span class=\"Bold\">Do not</span>start or stop any other medicines during treatment with RALDESY without talking to your healthcare provider first. Stopping RALDESY suddenly may cause you to have serious side effects. See,\n \n <span class=\"Bold\">“What are the possible side effects of RALDESY?”</span>\n</p>\n<p>Know the medicines you take. Keep a list of them to show it to your healthcare provider and pharmacist when you get a new medicine.</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 RALDESY?</span>\n</p>\n<p>\n<span class=\"Bold\">See the detailed Instructions for Use that comes with RALDESY for information on how to take RADELSY oral solution.</span>\n</p>\n<p> • Take RALDESY exactly as your healthcare provider tells you. Your healthcare provider may need to change your dose of RALDESY until it is the right dose for you.</p>\n<p> • If you feel sleepy after taking RALDESY, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your RALDESY.</p>\n<p> • Take RALDESY after a meal or light snack.</p>\n<p> • Do not stop taking RALDESY without talking to your healthcare provider.</p>\n<p> • If you take too much RALDESY, call your healthcare provider, your Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.</p>\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 avoid while taking RALDESY?</span>\n</p>\n<p> •\n \n <span class=\"Bold\">Do not</span>drive, operate heavy machinery, or do other dangerous activities until you know how RALDESY affects you. RALDESY can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Do not</span>drink alcohol or take other medicines that make you sleepy or dizzy during treatment with RALDESY until you talk with your healthcare provider. RALDESY may make your sleepiness or dizziness worse if you drink alcohol or take other medicines that cause sleepiness or dizziness.\n \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\">What are the possible side effects of RALDESY?</span>\n</p>\n<p>\n<span class=\"Bold\">RALDESY can cause serious side effects, including:</span>\n</p>\n<p> •\n \n <span class=\"Bold\">See “What is the most important information I should know about RALDESY?”</span>\n</p>\n<p>\n<span class=\"Bold\">Serotonin syndrome</span>. A potentially life-threating problem called serotonin syndrome can happen when you take RALDESY with certain other medicines. See\n \n <span class=\"Bold\">“Who should not take RALDESY?” 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 \n </p>\n<p>       ◦ agitation                                                                                            ◦ flushing</p>\n<p>       ◦ seeing or hearing things that are not real (hallucinations)               ◦ high body temperature (hyperthermia)</p>\n<p>       ◦ confusion                                                                                          ◦ shaking (tremors), stiff muscles, or muscle twitching</p>\n<p>       ◦ coma                                                                                                 ◦ loss of coordination</p>\n<p>       ◦ fast heartbeat                                                                                    ◦ seizures</p>\n<p>       ◦ changes in blood pressure                                                                ◦ nausea, vomiting, diarrhea</p>\n<p>       ◦ sweating                                                                                           ◦ dizziness</p>\n<p></p>\n<p> •\n \n <span class=\"Bold\">Changes in the electrical activity of your heart (QT prolongation).</span>Call your healthcare provider right away if you have any of the following symptoms: abnormal heartbeats, dizziness, feel lightheaded or faint.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Low blood pressure and fainting.</span>Low blood pressure can happen when you change positions from sitting to standing or laying down. You may feel dizzy, lightheaded, or faint.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Increased risk of bleeding.</span>Taking RALDESY with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Painful erection lasting for more than 6 hours (priapism).</span>If you have an erection that lasts more than 4 hours, get medical help right away.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Manic episodes.</span>Manic episodes may happen in people with bipolar disorder who take RALDESY. Symptoms may include:\n \n </p>\n<p>       ◦ greatly increased energy                          ◦ severe problems sleeping</p>\n<p>       ◦ racing thoughts                                        ◦ reckless behavior</p>\n<p>       ◦ unusually grand ideas                             ◦ excessive happiness or irritability</p>\n<p>       ◦ talking more or faster than usual</p>\n<p> •\n \n <span class=\"Bold\">Discontinuation syndrome.</span>Suddenly stopping RALDESY may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:\n \n </p>\n<p>         ◦ nausea                                 ◦ electric shock feeling (paresthesia)              ◦ tiredness</p>\n<p>         ◦ sweating                             ◦ tremor                                                            ◦ problems sleeping</p>\n<p>         ◦ changes in your mood        ◦ anxiety                                                           ◦ hypomania</p>\n<p>         ◦ irritability and agitation      ◦ confusion                                                       ◦ ringing in the ears (tinnitus)</p>\n<p>         ◦ dizziness                             ◦ headache                                                         ◦ seizures</p>\n<p> •\n \n <span class=\"Bold\">Eye problems (angle-closure glaucoma).</span>RALDESY can cause a type of eye problem called angle-closure glaucoma in people with certain 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 changes in your vision, eye pain, or swelling or redness in or around the eye.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Low sodium in your blood (hyponatremia).</span>Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with RALDESY. Elderly people and people who take certain medicines may be at greater risk for this. Signs and symptoms may include:\n \n </p>\n<p>       ◦ headache                                                              ◦ confusion</p>\n<p>       ◦ difficulty concentrating                                       ◦ weakness and unsteadiness on your feet, which can lead to falls</p>\n<p>       ◦ memory changes</p>\n<p>       ◦ talking more or faster than usual</p>\n<p>\n<span class=\"Bold\">In more severe or sudden cases, signs and symptoms include:</span>\n</p>\n<p>       ◦ seeing or hearing things that are not real                          ◦ coma</p>\n<p>         (hallucinations)                                                                  ◦ stopping breathing (respiratory arrest) to falls</p>\n<p>       ◦ fainting</p>\n<p>       ◦ seizures</p>\n<p>\n<span class=\"Bold\">The most common side effects of RALDESY include:</span>\n</p>\n<p>       • swelling                        • tiredness</p>\n<p>       • blurred vision               • diarrhea</p>\n<p>       • fainting                         • stuffy nose</p>\n<p>       • sleepiness                     • weight loss</p>\n<p>These are not all of the possible side effects of RALDESY.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.</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 RALDESY?</span>\n</p>\n<p> • Store RALDESY at room temperature between 68°F to 77°F (20°C to 25°C).</p>\n<p> • RALDESY comes in a bottle with a child-resistant cap.</p>\n<p> • Keep RALDESY out of the light.</p>\n<p> • Throw away (discard) RALDESY 30 days after first opening the bottle.</p>\n<p> • Safely throw away medicine that is out of date or no longer needed.</p>\n<p>\n<span class=\"Bold\">Keep RALDESY 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 RALDESY.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RALDESY for a condition for which it was not prescribed. Do not give RALDESY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RALDESY that is written for health professional.</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 RALDESY?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span>trazodone hydrochloride, USP\n \n </p>\n<p>\n<span class=\"Bold\">Inactive ingredients</span>: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, and sucralose.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">Manufactured for and distributed by:</span>\n</p>\n<p>Validus Pharmaceuticals LLC</p>\n<p>Parsippany, NJ 07054</p>\n<p>For more information, go to www.RALDESY.com or call\n \n <span class=\"Bold\">Validus Pharmaceuticals LLC at 1-866-982-5438.</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Medication Guide has been approved by the U.S. Food and Drug Administration                                                                                                                                                                             Issued: 03/2025

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration                                                                                                                                                                             Issued: 03/2025" }

<div class="scrollingtable"><table cellspacing="0" width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">INSTRUCTIONS FOR USE</span> </p> <p> <span class="Bold">RALDESY <span class="Sup">TM</span>(ral DEH see) </span> </p> <p> <span class="Bold">(trazodone hydrochloride)</span> </p> <p> <span class="Bold">oral solution</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold">This Instructions for Use contains information on how to take RALDESY.</span> </p> <p>Read this Instructions for Use before you start taking RALDESY for the first time 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.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Supplies needed to take RALDESY</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-1.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Each carton of RALDESY contains:</span> </p> <ul class="Disc"> <li>1 bottle of RALDESY oral solution</li> <li>1 plastic adapter</li> <li>One 10 mL oral dosing syringe</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold">Important Information You Need to Know Before Taking RALDESY</span> </p> <p> • For oral use only (taken by mouth).</p> <p> • Use the plastic adapter and oral dosing syringe that comes in the carton. If you did not receive the plastic adapter and oral dosing syringe, contact your pharmacist.</p> <p> • Ask your pharmacist how to measure your prescribed doses.</p> <p> • Take RALDESY exactly as prescribed by your healthcare provider. <span class="Bold">Do not</span>stop taking RALDESY without first talking to your healthcare provider. </p> <p> • Take RALDESY after a meal or light snack.</p> <p> • Check the expiration date on the bottle. If you have not opened the RALDESY bottle, <span class="Bold">do not</span>use RALDESY if the expiration date on the bottle has passed. Contact your healthcare provider or pharmacist. </p> <p> • <span class="Bold">Do not</span>use RALDESY 30 days after first opening the bottle. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold"> Preparing the RALDESY bottle</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-2.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Step 1.</span>Remove the child-resistant cap by pushing it <span class="Bold">firmly</span> <br/>                down and turning it counterclockwise (to the left), as <br/>                shown on the top of the child-resistant cap. <br/> <br/> <span class="Bold">Note:</span>Save the child-resistant cap so you can close <br/>                the bottle after each use. </p> <br/> <p> <span class="Bold">  Step 2.</span>Hold the open bottle upright on a table and push the <br/>                ribbed end of the plastic adapter firmly into the neck of <br/>                the bottle as far as you can. </p> <br/> <p> <span class="Bold"><span class="Bold">  Step 3.</span>Put the child-resistant cap back on the bottle to make <br/>                sure the plastic adapter has been fully inserted into <br/>                the neck of the bottle. </span> <br/> <br/> <span class="Bold">               Note:</span>You may not be able to push the plastic adapter <br/>                all the way down, but it will be forced into the bottle <br/>                when you put the child-resistant cap back on. <br/>                Now the bottle is ready to use with the oral dosing <br/>                syringe. <br/> <br/> <span class="Bold">              Do not</span>remove the adapter. The plastic adapter must <br/>               always stay in the bottle. The child-resistant cap <br/>               should seal the bottle in between use. <br/>               Write the date of first opening the RALDESY bottle. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"> Preparing the dose of RALDESY oral solution</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-3.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Step 4.</span>Push down and turn the child-resistant cap to the left <br/>                to open the bottle. <br/> <br/> <span class="Bold">               Note:</span>Always replace the cap after use. </p> <br/> <p> <span class="Bold">  Step 5.</span>Check that the plunger is all the way down inside the <br/>                barrel of the oral dosing syringe. </p> <br/> <p> <span class="Bold">  Step 6.</span>Keep the bottle upright and push the tip of the oral <br/>               dosing syringe <span class="Bold">firmly</span>into the plastic adapter. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-4.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Step 7.</span>Hold the syringe in place and carefully turn the bottle <br/>                upside down. </p> <br/> <p> <span class="Bold">  Step 8.</span>Slowly pull down the plunger to fill the oral dosing <br/>                syringe slightly past your prescribed dose line to help <br/>                remove any air bubbles. </p> <br/> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-5.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Step 9.</span>Tap oral dosing syringe to move air bubbles to the <br/>                top. Doing this helps set the correct dose. </p> <br/> <p> <span class="Bold">  Step 10.</span>Push the plunger back slowly just far enough to <br/>                   completely push out any large or small air bubbles <br/>                   that may be trapped in the oral dosing syringe. </p> <br/> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-6.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Step 11.</span>Slowly pull the plunger down until the top edge of the <br/>                  plunger is level with the marker on the syringe barrel <br/>                  for the prescribed dose. <br/> <br/> <span class="Bold">                 Note:</span>If the prescribed dose is more than 10 mL, you <br/>                  will need to refill the oral dosing syringe to make up the <br/>                  full dose. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-7.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Step 12.</span>Carefully turn the bottle upright. Take out the oral <br/>                 dosing syringe by gently twisting it out of the plastic <br/>                 adapter. The plastic adapter should stay in the bottle. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"> Taking the dose of RALDESY oral solution</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold"><img alt='"Image Description"' src="/dailymed/image.cfm?name=trazodone-hydrochloride-fig-8.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9"/></span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">  Note: Sit up straight while taking RALDESY.</span> </p> <br/> <p> <span class="Bold">  Step 13.</span>Place the oral dosing syringe gently into your mouth. <br/>                  Push the plunger <span class="Bold">slowly</span>until the plunger moves all of <br/>                  the medicine out of the oral dosing syringe. </p> <br/> <p> <span class="Bold">  Step 14.</span>Swallow all of the medicine. </p> <br/> <p> <span class="Bold">  Step 15.</span>Close the bottle by screwing the child-resistant cap <br/>                  back on the bottle after use. Make sure the child- <br/>                  resistant cap is tightly closed </p> <br/> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 16.</span><span class="Bold">Cleaning:</span>After use, rinse the oral dosing syringe with warm water and allow it to dry thoroughly. </p> <p> <span class="Bold">Step 17.</span><span class="Bold">Throw away (discard):</span>Safely throw away medicine that is expired or no longer needed. Do not throw away any medicine down the <br/>               sink or in your household trash. Ask your pharmacist how to throw away medicines you no longer use. </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Storing RALDESY</span> </p> <ul class="Disc"> <li>Store RALDESY at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>RALDESY comes in a bottle with a child-resistant cap.</li> <li>Keep RALDESY out of the light.</li> <li>Throw away (discard) RALDESY 30 days after first opening the bottle.</li> <li>Safely throw away medicine that is out of date or no longer needed.</li> </ul> <p> <span class="Bold">Keep RALDESY and all medicines out of the reach of children.</span> </p> <br/> <p> <span class="Bold">Manufactured for and distributed by:</span> </p> <p>Validus Pharmaceuticals LLC</p> <p>Parsippany, NJ 07054</p> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Approved: 02/2025</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellspacing=\"0\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">INSTRUCTIONS FOR USE</span>\n</p>\n<p>\n<span class=\"Bold\">RALDESY\n \n <span class=\"Sup\">TM</span>(ral DEH see)\n \n </span>\n</p>\n<p>\n<span class=\"Bold\">(trazodone hydrochloride)</span>\n</p>\n<p>\n<span class=\"Bold\">oral solution</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">This Instructions for Use contains information on how to take RALDESY.</span>\n</p>\n<p>Read this Instructions for Use before you start taking RALDESY for the first time 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.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\"> Supplies needed to take RALDESY</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-1.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Each carton of RALDESY contains:</span>\n</p>\n<ul class=\"Disc\">\n<li>1 bottle of RALDESY oral solution</li>\n<li>1 plastic adapter</li>\n<li>One 10 mL oral dosing syringe</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Important Information You Need to Know Before Taking RALDESY</span>\n</p>\n<p> • For oral use only (taken by mouth).</p>\n<p> • Use the plastic adapter and oral dosing syringe that comes in the carton. If you did not receive the plastic adapter and oral dosing syringe, contact your pharmacist.</p>\n<p> • Ask your pharmacist how to measure your prescribed doses.</p>\n<p> • Take RALDESY exactly as prescribed by your healthcare provider.\n \n <span class=\"Bold\">Do not</span>stop taking RALDESY without first talking to your healthcare provider.\n \n </p>\n<p> • Take RALDESY after a meal or light snack.</p>\n<p> • Check the expiration date on the bottle. If you have not opened the RALDESY bottle,\n \n <span class=\"Bold\">do not</span>use RALDESY if the expiration date on the bottle has passed. Contact your healthcare provider or pharmacist.\n \n </p>\n<p> •\n \n <span class=\"Bold\">Do not</span>use RALDESY 30 days after first opening the bottle.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\"> Preparing the RALDESY bottle</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-2.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Step 1.</span>Remove the child-resistant cap by pushing it\n \n <span class=\"Bold\">firmly</span>\n<br/>                down and turning it counterclockwise (to the left), as \n <br/>                shown on the top of the child-resistant cap. \n <br/>\n<br/>\n<span class=\"Bold\">Note:</span>Save the child-resistant cap so you can close \n <br/>                the bottle after each use.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 2.</span>Hold the open bottle upright on a table and push the \n <br/>                ribbed end of the plastic adapter firmly into the neck of \n <br/>                the bottle as far as you can.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\"><span class=\"Bold\">  Step 3.</span>Put the child-resistant cap back on the bottle to make \n <br/>                sure the plastic adapter has been fully inserted into \n <br/>                the neck of the bottle.\n \n </span>\n<br/>\n<br/>\n<span class=\"Bold\">               Note:</span>You may not be able to push the plastic adapter \n <br/>                all the way down, but it will be forced into the bottle \n <br/>                when you put the child-resistant cap back on. \n <br/>                Now the bottle is ready to use with the oral dosing \n <br/>                syringe. \n <br/>\n<br/>\n<span class=\"Bold\">              Do not</span>remove the adapter. The plastic adapter must \n <br/>               always stay in the bottle. The child-resistant cap \n <br/>               should seal the bottle in between use. \n <br/>               Write the date of first opening the RALDESY bottle.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"> Preparing the dose of RALDESY oral solution</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-3.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Step 4.</span>Push down and turn the child-resistant cap to the left \n <br/>                to open the bottle. \n <br/>\n<br/>\n<span class=\"Bold\">               Note:</span>Always replace the cap after use.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 5.</span>Check that the plunger is all the way down inside the \n <br/>                barrel of the oral dosing syringe.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 6.</span>Keep the bottle upright and push the tip of the oral \n <br/>               dosing syringe\n \n <span class=\"Bold\">firmly</span>into the plastic adapter.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-4.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Step 7.</span>Hold the syringe in place and carefully turn the bottle \n <br/>                upside down.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 8.</span>Slowly pull down the plunger to fill the oral dosing \n <br/>                syringe slightly past your prescribed dose line to help \n <br/>                remove any air bubbles.\n \n </p>\n<br/>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-5.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Step 9.</span>Tap oral dosing syringe to move air bubbles to the \n <br/>                top. Doing this helps set the correct dose.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 10.</span>Push the plunger back slowly just far enough to \n <br/>                   completely push out any large or small air bubbles \n <br/>                   that may be trapped in the oral dosing syringe.\n \n </p>\n<br/>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-6.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Step 11.</span>Slowly pull the plunger down until the top edge of the \n <br/>                  plunger is level with the marker on the syringe barrel \n <br/>                  for the prescribed dose. \n <br/>\n<br/>\n<span class=\"Bold\">                 Note:</span>If the prescribed dose is more than 10 mL, you \n <br/>                  will need to refill the oral dosing syringe to make up the \n <br/>                  full dose.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-7.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Step 12.</span>Carefully turn the bottle upright. Take out the oral \n <br/>                 dosing syringe by gently twisting it out of the plastic \n <br/>                 adapter. The plastic adapter should stay in the bottle.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"> Taking the dose of RALDESY oral solution</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\"><img alt='\"Image Description\"' src=\"/dailymed/image.cfm?name=trazodone-hydrochloride-fig-8.jpg&amp;setid=34708cc1-b0b2-4fd0-b9f3-7f008b457fc9\"/></span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">  Note: Sit up straight while taking RALDESY.</span>\n</p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 13.</span>Place the oral dosing syringe gently into your mouth. \n <br/>                  Push the plunger\n \n <span class=\"Bold\">slowly</span>until the plunger moves all of \n <br/>                  the medicine out of the oral dosing syringe.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 14.</span>Swallow all of the medicine.\n \n </p>\n<br/>\n<p>\n<span class=\"Bold\">  Step 15.</span>Close the bottle by screwing the child-resistant cap \n <br/>                  back on the bottle after use. Make sure the child- \n <br/>                  resistant cap is tightly closed\n \n </p>\n<br/>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 16.</span><span class=\"Bold\">Cleaning:</span>After use, rinse the oral dosing syringe with warm water and allow it to dry thoroughly.\n \n </p>\n<p>\n<span class=\"Bold\">Step 17.</span><span class=\"Bold\">Throw away (discard):</span>Safely throw away medicine that is expired or no longer needed. Do not throw away any medicine down the \n <br/>               sink or in your household trash. Ask your pharmacist how to throw away medicines you no longer use.\n \n </p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Storing RALDESY</span>\n</p>\n<ul class=\"Disc\">\n<li>Store RALDESY at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>RALDESY comes in a bottle with a child-resistant cap.</li>\n<li>Keep RALDESY out of the light.</li>\n<li>Throw away (discard) RALDESY 30 days after first opening the bottle.</li>\n<li>Safely throw away medicine that is out of date or no longer needed.</li>\n</ul>\n<p>\n<span class=\"Bold\">Keep RALDESY and all medicines out of the reach of children.</span>\n</p>\n<br/>\n<p>\n<span class=\"Bold\">Manufactured for and distributed by:</span>\n</p>\n<p>Validus Pharmaceuticals LLC</p>\n<p>Parsippany, NJ 07054</p>\n<p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Approved: 02/2025</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

                                                                                                                                                                                                                                                                                                                                         Rev. 03, 03/2025

{ "type": "p", "children": [], "text": "                                                                                                                                                                                                                                                                                                                                         Rev. 03, 03/2025" }

RALDESY TM(trazodone hydrochloride) Oral Solution 10 mg/mL - NDC 30698-455-02 - 150 mL HDPE Carton Label

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RALDESY TM(trazodone hydrochloride) Oral Solution 10 mg/mL - NDC 30698-455-02 - 150 mL HDPE Bottle Label

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RALDESY TM(trazodone hydrochloride) Oral Solution 10 mg/mL - NDC 30698-455-01 - 300 mL Carton Label

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RALDESY TM(trazodone hydrochloride) Oral Solution 10 mg/mL - NDC 30698-455-01 - 300 mL Bottle Label

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RALDESY TM(trazodone hydrochloride) Oral Solution 10 mg/mL - NDC 30698-455-05 - 150 mL Bottle Label Physician Sample Not for Sale

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Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.

The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.

Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.

Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.

Prior to initiating treatment with trazodone hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.7)].

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

Coadministration with Strong CYP3A4 Inhibitors

Consider reducing trazodone dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions ( 7.1)].

Coadministration with Strong CYP3A4 Inducers

Consider increasing trazodone dose based on therapeutic response when trazodone is coadministered with a strong CYP3A4 inducer [see Drug Interactions ( 7.1)].

Adverse reactions may occur upon discontinuation of trazodone [See Warnings and Precautions ( 5.8)]. Gradually reduce the dosage rather than stopping trazodone abruptly whenever possible.

Trazodone hydrochloride tablets, USP are available in the following strengths:

Trazodone hydrochloride tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect.

Trazodone hydrochloride tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect.

Trazodone hydrochloride tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments.

Trazodone hydrochloride tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment.

Trazodone hydrochloride tablets are contraindicated in:

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1 Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients</span> </caption> <col width="35%"/> <col width="64%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Age Range</span> <br/> <span class="Bold">(years)</span> <br/> </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold">Drug-Placebo Difference in Number of Patients of</span> <br/> <span class="Bold">Suicidal Thoughts or Behaviors per 1,000 Patients Treated</span> <br/> </td> </tr> <tr> <td class="Botrule Lrule"></td><td align="center" class="Botrule Rrule"><span class="Bold">Increases Compared to Placebo</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">&lt; 18 <br/> </td><td align="center" class="Botrule Rrule">14 additional patients <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">18 to 24 <br/> </td><td align="center" class="Botrule Rrule">5 additional patients <br/> </td> </tr> <tr> <td class="Botrule Lrule"></td><td align="center" class="Botrule Rrule"><span class="Bold">Decreases Compared to Placebo</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">25 to 64 <br/> </td><td align="center" class="Botrule Rrule">1 fewer patient <br/> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule">≥ 65 <br/> </td><td align="center" class="Botrule Rrule">6 fewer patients <br/> </td> </tr> </tbody> </table></div>

It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients 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.

Monitor all antidepressant-treated patients 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 trazodone, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including trazodone, 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, tryptophan, buspirone, 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 signs and 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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of trazodone with MAOIs is contraindicated. In addition, do not initiate trazodone 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). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking trazodone, discontinue trazodone before initiating treatment with the MAOI [see Contraindications ( 4), Drug Interactions ( 7.1)].

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

Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease. Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes. Postmarketing events, including torsade de pointes have been reported at doses of 100 mg or less with the immediate-release form of trazodone. Trazodone should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. Trazodone is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering trazodone to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including trazodone) may cause cardiac arrhythmias [see Adverse Reactions ( 6.2)] .

Trazodone prolongs the QT/QTc interval. The use of trazodone should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia [see Drug Interactions ( 7.1)].

Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.

Drugs that interfere with serotonin reuptake inhibition, including trazodone, 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. Bleeding events related to drugs that interfere with serotonin reuptake 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 trazodone and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing trazodone.

Cases of priapism (painful erections greater than 6 hours in duration) have been reported in men receiving trazodone. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention [see Adverse Reactions ( 6.2), Overdosage ( 10)].

Trazodone should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease).

In patients with bipolar disorder, treating a depressive episode with trazodone or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with trazodone, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration ( 2.3)] .

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 ( 2.6)].

Trazodone may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

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

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including trazodone. 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 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, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue trazodone 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 and SNRIs [see Use in Specific Populations ( 8.5)] .

The following serious adverse reactions are described elsewhere in the labeling:

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.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 2 Common Adverse Reactions Occurring in ≥ 2% of Trazodone-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies</span> </caption> <col width="27%"/> <col width="18%"/> <col width="18%"/> <col width="18%"/> <col width="18%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Inpatients</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Outpatients</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Trazodone</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">Trazodone</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Placebo</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">N=142</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">N=95</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">N=157</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">N=158</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Allergic</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Skin Condition/Edema <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">7% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Autonomic</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Blurred Vision <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td><td align="center" class="Botrule Rrule" valign="top">15% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Constipation <br/> </td><td align="center" class="Botrule Rrule" valign="top">7% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td><td align="center" class="Botrule Rrule" valign="top">8% <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dry Mouth <br/> </td><td align="center" class="Botrule Rrule" valign="top">15% <br/> </td><td align="center" class="Botrule Rrule" valign="top">8% <br/> </td><td align="center" class="Botrule Rrule" valign="top">34% <br/> </td><td align="center" class="Botrule Rrule" valign="top">20% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Cardiovascular</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hypertension <br/> </td><td align="center" class="Botrule Rrule" valign="top">20% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Sup">*</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hypotension <br/> </td><td align="center" class="Botrule Rrule" valign="top">7% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <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="Botrule Lrule Rrule" valign="top">Syncope <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">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">CNS</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Confusion <br/> </td><td align="center" class="Botrule Rrule" valign="top">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">8% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Decreased Concentration <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">1% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Disorientation <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"><span class="Sup">*</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dizziness/Light-Headedness <br/> </td><td align="center" class="Botrule Rrule" valign="top">20% <br/> </td><td align="center" class="Botrule Rrule" valign="top">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">28% <br/> </td><td align="center" class="Botrule Rrule" valign="top">15% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Drowsiness <br/> </td><td align="center" class="Botrule Rrule" valign="top">24% <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">41% <br/> </td><td align="center" class="Botrule Rrule" valign="top">20% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Fatigue <br/> </td><td align="center" class="Botrule Rrule" valign="top">11% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Headache <br/> </td><td align="center" class="Botrule Rrule" valign="top">10% <br/> </td><td align="center" class="Botrule Rrule" valign="top">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">20% <br/> </td><td align="center" class="Botrule Rrule" valign="top">16% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nervousness <br/> </td><td align="center" class="Botrule Rrule" valign="top">15% <br/> </td><td align="center" class="Botrule Rrule" valign="top">11% <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">8% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Gastrointestinal</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Abdominal/Gastric Disorder <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Diarrhea <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">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nausea/Vomiting <br/> </td><td align="center" class="Botrule Rrule" valign="top">10% <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td><td align="center" class="Botrule Rrule" valign="top">13% <br/> </td><td align="center" class="Botrule Rrule" valign="top">10% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Musculoskeletal</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Aches/Pains <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <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="Botrule Lrule Rrule" valign="top"><span class="Bold">Neurological</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Incoordination <br/> </td><td align="center" class="Botrule Rrule" valign="top">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">2% <br/> </td><td align="center" class="Botrule Rrule" valign="top">* <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Tremors <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">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">4% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Other</span> <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> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Eyes Red/Tired/Itching <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Head Full-Heavy <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Malaise <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nasal/Sinus Congestion <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Weight Gain <br/> </td><td align="center" class="Botrule Rrule" valign="top">1% <br/> </td><td align="center" class="Botrule Rrule" valign="top">0 <br/> </td><td align="center" class="Botrule Rrule" valign="top">5% <br/> </td><td align="center" class="Botrule Rrule" valign="top">2% <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Weight Loss <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Sup">*</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td><td align="center" class="Botrule Rrule" valign="top">6% <br/> </td><td align="center" class="Botrule Rrule" valign="top">3% <br/> </td> </tr> </tbody> </table></div>

Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.

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

Blood and lymphatic system disorders:hemolytic anemia, leukocytosis

Cardiac disorders:cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions ( 5.3)].

Endocrine disorders:inappropriate ADH syndrome

Eye disorders:diplopia

Gastrointestinal disorders:increased salivation, nausea/vomiting

General disorders and administration site conditions:chills, edema, unexplained death, weakness

Hepatobiliary disorders:cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations

Investigations:increased amylase

Metabolism and nutrition disorders:methemoglobinemia

Nervous system disorders:aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo

Psychiatric disorders:abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor

Renal and urinary disorders:urinary incontinence, urinary retention

Reproductive system and breast disorders:breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions ( 5.6)]

Respiratory, thoracic and mediastinal disorders:apnea

Skin and subcutaneous tissue disorders:alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria

Vascular disorders:vasodilation

<div class="scrollingtable"><table class="Noautorules" width="638"> <caption> <span>Table 3 Clinically Important Drug Interactions with Trazodone</span> </caption> <col width="157"/> <col width="481"/> <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="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of MAOIs and serotonergic drugs including trazodone increases the risk of serotonin syndrome. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Trazodone is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[see Contraindications (4), Dosage and Administration (2.3, 2.4), and Warnings and Precautions (5.2)].</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> </td><td align="left" class="Botrule Rrule" valign="top">isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine <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="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of serotonergic drugs including trazodone and other serotonergic drugs increases the risk of serotonin syndrome. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> </td><td align="left" class="Botrule Rrule" valign="top">Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone initiation. If serotonin syndrome occurs, consider discontinuation of trazodone and/or concomitant serotonergic drugs <span class="Italics">[see Warnings and Precautions (5.2)].</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Antiplatelet Agents and Anticoagulants</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with trazodone may potentiate the risk of bleeding. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Inform patients of the increased risk of bleeding with the concomitant use of trazodone and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing trazodone <span class="Italics">[see Warnings and Precautions (5.5)].</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> </td><td align="left" class="Botrule Rrule" valign="top">warfarin, rivaroxaban, dabigatran, clopidogrel <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Strong CYP3A4 Inhibitors</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of trazodone and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of trazodone alone <span class="Italics">.</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> </td><td align="left" class="Botrule Rrule" valign="top">If trazodone is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of trazodone should be considered <span class="Italics">[see Dosage and Administration (2.5), Warnings and Precautions (5.3)].</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> </td><td align="left" class="Botrule Rrule" valign="top">itraconazole, ketoconazole, clarithromycin, indinavir <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Strong CYP3A4 Inducers</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> </td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of trazodone and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of trazodone alone <span class="Italics">.</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking CYP3A4 inducers <span class="Italics">[see Dosage and Administration (2.5)].</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> </td><td align="left" class="Botrule Rrule" valign="top">rifampin, carbamazepine, phenytoin, St. John's wort <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Digoxin and Phenytoin</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> </td><td align="left" class="Botrule Rrule" valign="top">Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone can increase digoxin or phenytoin concentrations. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> </td><td align="left" class="Botrule Rrule" valign="top">Measure serum digoxin or phenytoin concentrations before initiating concomitant use of trazodone. Continue monitoring and reduce digoxin or phenytoin dose as necessary. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> </td><td align="left" class="Botrule Rrule" valign="top">digoxin, phenytoin <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Central Nervous System (CNS) Depressants</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> </td><td align="left" class="Botrule Rrule" valign="top">Trazodone may enhance the response CNS depressants. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> </td><td align="left" class="Botrule Rrule" valign="top">Patients should be counseled that trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> </td><td align="left" class="Botrule Rrule" valign="top">alcohol, barbiturates <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">QT Interval Prolongation</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Clinical Impact <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Concomitant use of drugs that prolong the QT interval may add to the QT effects of trazodone and increase the risk of cardiac arrhythmia. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Intervention <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Avoid the use of trazodone in combination with other drugs known to prolong QTc <span class="Italics">[see Warnings and Precautions (5.3)]</span>. <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">Examples <br/> <br/> </td><td align="left" class="Botrule Rrule" valign="top">Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; <br/> Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: gatifloxacin <br/> </td> </tr> </tbody> </table></div>

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/ pregnancyregistry/ antidepressants/

Risk Summary

Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 times to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 times to 22 times the MRHD on a mg/m 2basis (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. 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

A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Data

Human Data

While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All available studies have methodological limitations, including small sample size and inconsistent comparator groups.

Animal Data

No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 11 times and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2basis. Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 times to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 times to 22 times the MRHD on a mg/m 2basis were observed. No further details on these studies are available.

Risk Summary

Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trazodone hydrochloride tablets and any potential adverse effects on the breastfed child from trazodone hydrochloride tablets or from the underlying maternal condition.

Safety and effectiveness in the pediatric population have not been established.  Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [ see Boxed Warning, Warnings and Precautions ( 5.1) ].

Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients.

Serotonergic antidepressants 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 ( 5.11) ].

Trazodone has not been studied in patients with renal impairment. Trazodone should be used with caution in this population.

Trazodone has not been studied in patients with hepatic impairment. Trazodone should be used with caution in this population.

Trazodone hydrochloride tablets are not a controlled substance.

Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).

{ "type": "p", "children": [], "text": "\nDeath from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate)." }

The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.

{ "type": "p", "children": [], "text": "The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions." }

There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).

{ "type": "p", "children": [], "text": "There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org)." }

Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist.  Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows:

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Molecular Formula:C 19H 22C lN 5O•HCl

{ "type": "p", "children": [], "text": "\nMolecular Formula:C\n \n 19H\n \n 22C\n \n lN\n \n 5O•HCl\n\n " }

Molecular Weight:408.32

{ "type": "p", "children": [], "text": "\nMolecular Weight:408.32\n\n " }

Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate.

{ "type": "p", "children": [], "text": "Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate." }

The product meets USP Dissolution Test #2.

{ "type": "p", "children": [], "text": "The product meets USP Dissolution Test #2." }

The mechanism of trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone's antidepressant effect is unknown.

Preclinical studies have shown that trazodone selectively inhibits neuronal reuptake of serotonin (Ki = 367 nM) and acts as an antagonist at 5-HT-2A (Ki = 35.6 nM) serotonin receptors. Trazodone is also an antagonist at several other monoaminergic receptors including 5-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5HT1A (Ki = 118 nM) receptor.

Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.

Absorption

In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When trazodone hydrochloride is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food.

Metabolism

In vitrostudies in human liver microsomes show that trazodone is metabolized, via oxidative cleavage, to an active metabolite, m-chlorophenylpiperazine (mCPP) by CYP3A4. Other metabolic pathways that may be involved in the metabolism of trazodone have not been well characterized. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted unchanged in the urine.

Elimination

In some patients trazodone may accumulate in the plasma.

Protein Binding

Trazodone is 89 to 95% protein bound in vitroat concentrations attained with therapeutic doses in humans.

Carcinogenesis

No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to 7.3 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2basis.

Mutagenesis

No genotoxicity studies were conducted with trazodone.

Impairment of Fertility

Trazodone has no effect on fertility in rats at doses up to 7.3 times the MRHD in adults on a mg/m 2basis.

The efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder.

{ "type": "p", "children": [], "text": "\nThe efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder." }

Trazodone Hydrochloride Tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect and are supplied as follows:

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NDC: 70518-1204-00

{ "type": "p", "children": [], "text": "NDC: 70518-1204-00" }

NDC: 70518-1204-01

{ "type": "p", "children": [], "text": "NDC: 70518-1204-01" }

NDC: 70518-1204-02

{ "type": "p", "children": [], "text": "NDC: 70518-1204-02" }

NDC: 70518-1204-03

{ "type": "p", "children": [], "text": "NDC: 70518-1204-03" }

NDC: 70518-1204-04

{ "type": "p", "children": [], "text": "NDC: 70518-1204-04" }

PACKAGING: 90 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 90 in 1 BOTTLE PLASTIC" }

PACKAGING: 30 in 1 BOTTLE PLASTIC

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

PACKAGING: 30 in 1 BLISTER PACK

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

PACKAGING: 30 in 1 BOTTLE PLASTIC

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

PACKAGING: 90 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 90 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]." }

Dispense with a child-resistant closure in a tight, light-resistant container.

{ "type": "p", "children": [], "text": "Dispense with a child-resistant closure in a tight, light-resistant container." }

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": "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 Box 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 see Box Warning and Warnings and Precautions ( \n 5.1) \n ].\n " }

Dosage and Administration

{ "type": "p", "children": [], "text": "\nDosage and Administration\n" }

Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration ( 2)] .

{ "type": "p", "children": [], "text": "Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions \n [see Dosage and Administration ( \n 2)] \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 trazodone hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, 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). Patients should 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) and Drug Interactions ( 7)] .

{ "type": "p", "children": [], "text": "Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of trazodone hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, 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). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome \n [see Warnings and Precautions ( \n 5.2) and Drug Interactions ( \n 7)] \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 ( 5.7)] .

{ "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 [see Warnings and Precautions ( \n 5.7)] \n .\n " }

Increased Risk of Bleeding

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

Inform patients about the concomitant use of trazodone hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them 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 trazodone hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them 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 [see Warnings and Precautions ( \n 5.5)] \n .\n " }

Discontinuation Syndrome

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

Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when trazodone hydrochloride tablets are discontinued [see Warnings and Precautions ( 5.8)].

{ "type": "p", "children": [], "text": "Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when trazodone hydrochloride tablets are discontinued \n [see Warnings and Precautions ( \n 5.8)]. \n \n" }

Concomitant Medications

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

Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions ( 7.1)].

{ "type": "p", "children": [], "text": "Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions \n [see Drug Interactions ( \n 7.1)]. \n \n" }

Pregnancy

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

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy [see Use in Special Populations ( 8.1)] .

{ "type": "p", "children": [], "text": "Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy \n [see Use in Special Populations ( \n 8.1)] \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="638"/> </colgroup> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">MEDICATION GUIDE</span> <br/> <span class="Bold">Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide)</span> <br/> <span class="Bold">Tablets USP, for oral use</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">What is the most important information I should know about trazodone hydrochloride tablets?</span> <br/> Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about: <ul class="Disc"> <li>All risks and benefits of treatment with antidepressant medicines</li> <li>All treatment choices for depression or other serious mental illnesses</li> </ul> <ol class="Arabic"> <li> <span class="Bold">Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.</span> </li> <li> <span class="Bold">Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions.</span> </li> <li> <span class="Bold">How can I watch for and try to prevent suicidal thoughts and actions?</span> </li> </ol> <ul class="Disc"> <li>Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. 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.</li> <li>Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.</li> </ul> <span class="Bold">Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span> <ul class="Disc"> <li>Thoughts about suicide or dying</li> <li>Attempts to commit suicide</li> <li>New or worse depression</li> <li>New or worse anxiety</li> <li>Feeling very agitated or restless</li> <li>Panic attacks</li> <li>Trouble sleeping (insomnia)</li> <li>New or worse irritability</li> <li>Acting aggressive, being angry or violent</li> <li>Acting on dangerous impulses</li> <li>An extreme increase in activity and talking (mania)</li> <li>Other unusual changes in behavior or mood</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">What else do I need to know about antidepressant medicines?</span> <ul class="Disc"> <li> <span class="Bold">Never stop an antidepressant medicine without first talking to a healthcare provider.</span>Stopping an antidepressant medicine suddenly can cause other symptoms. </li> <li> <span class="Bold">Antidepressants are medicines used to treat depression and other illnesses.</span>It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. </li> <li> <span class="Bold">Antidepressant medicines have other side effects.</span>Talk to your healthcare provider about the side effects of your medicines. </li> <li> <span class="Bold">Antidepressant medicines can interact with other medicines.</span>Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider. </li> </ul> It is not known if trazodone hydrochloride tablets are safe and effective in children. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">What are trazodone hydrochloride tablets?</span> <br/> Trazodone hydrochloride tablets are prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone hydrochloride tablets belong to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors). </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Do not take trazodone hydrochloride tablets:</span> <ul class="Disc"> <li>If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid, and intravenous methylene blue.</li> <li>Do not take an MAOI within 2 weeks of stopping trazodone hydrochloride tablets unless directed to do so by your healthcare provider.</li> <li>Do not start trazodone hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Before you take trazodone hydrochloride tablets tell your healthcare provider about all of your medical conditons, including if you:</span> <ul class="Disc"> <li>have heart problems, including QT prolongation or a family history of it</li> <li>have ever had a heart attack</li> <li>have bipolar disorder</li> <li>have liver or kidney problems</li> <li>have other serious medical conditions</li> <li>are pregnant or plan to become pregnant. Trazodone hydrochloride tablets may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.</li> <li>are pregnant or plan to become pregnant. It is not known if trazodone hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take trazodone hydrochloride tablets.</li> </ul> <ul class="Circle"> <li>If you become pregnant during treatment with trazodone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.</li> </ul> <ul class="Disc"> <li>are breastfeeding or plan to breastfeed. Trazodone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take trazodone hydrochloride tablets.</li> <li>have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks.</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. Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects. <br/> Especially tell your healthcare provider if you take: <ul class="Disc"> <li>triptans used to treat migraine headache</li> <li>medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics</li> <li>tramadol</li> <li>over-the-counter supplements such as tryptophan or St. John's Wort</li> <li>nonsteroidal anti-inflammatory drugs (NSAIDS)</li> <li>aspirin</li> <li>warfarin (Coumadin, Jantoven)</li> <li>phenytoin (Mesantoin)</li> <li>diuretics</li> </ul> Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">How should I take trazodone hydrochloride tablets?</span> <ul class="Disc"> <li>Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.</li> <li>Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.</li> <li>If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.</li> <li>Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.</li> <li>Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet.</li> <li>If you take too much trazodone hydrochloride tablets, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">What should I avoid while taking trazodone hydrochloride tablets?</span> <ul class="Disc"> <li>Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.</li> <li>Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">What are the possible side effects of trazodone hydrochloride tablets?</span> <br/> <span class="Bold">Trazodone hydrochloride tablets can cause serious side effects or death, including:</span> <ul class="Disc"> <li> <span class="Bold">See "What is the most important information I should know about Trazodone?"</span> </li> <li> <span class="Bold">Serotonin syndrome.</span>Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea. </li> <li> <span class="Bold">Irregular or fast heartbeat or faint (QT prolongation)</span> </li> <li> <span class="Bold">Low blood pressure.</span>You feel dizzy or faint when you change positions (go from sitting to standing) </li> <li> <span class="Bold">Unusual bruising or bleeding</span> </li> <li> <span class="Bold">Erection lasting for more than 6 hours (priapism)</span> </li> <li> <span class="Bold">Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).</span> </li> <li> <span class="Bold">Withdrawal symptoms.</span>Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone without talking to your healthcare provider. </li> <li> <span class="Bold">Visual problems.</span> </li> </ul> <ul class="Circle"> <li>eye pain</li> <li>changes in vision</li> <li>swelling or redness in or around the eye</li> </ul> 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. <ul class="Disc"> <li> <span class="Bold">Low sodium in your blood (hyponatremia).</span>Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk. </li> </ul> Get medical help right away, if you have any of the symptoms listed above. <br/> <br/> <span class="Bold">The most common side effects of trazodone hydrochloride tablets include:</span> <ul class="Disc"> <li>swelling</li> <li>blurred vision</li> <li>dizziness</li> <li>sleepiness</li> <li>tiredness</li> <li>diarrhea</li> <li>stuffy nose</li> <li>weight loss</li> </ul> These are not all the possible side effects of trazodone hydrochloride tablets. 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" valign="top"><span class="Bold">How should I store trazodone hydrochloride tablets?</span> <ul class="Disc"> <li>Store trazodone hydrochloride tablets between 68°F to 77°F (20°C to 25°C).</li> <li>Keep in tight container</li> <li>Keep out of the light</li> <li>Safely throw away medicine that is out of date or no longer needed.</li> <li>Drug trazodone hydrochloride tablets come in child-resistant bottles of 30's and 90's.</li> </ul> <span class="Bold">Keep trazodone hydrochloride tablets and all medicines out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">General information about the safe and effective use of trazodone hydrochloride tablets.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionals <span class="Bold">.</span> <br/> Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">What are the ingredients in trazodone hydrochloride tablets?</span> <br/> <span class="Bold">Active ingredient:</span>trazodone hydrochloride, USP <br/> <span class="Bold">Inactive ingredients:</span>colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. <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" valign="top"></td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="top">Rev.: 11/22</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">This Medication Guide has been approved by the U.S. Food and Drug Administration.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"638\">\n<colgroup>\n<col width=\"638\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">MEDICATION GUIDE</span>\n<br/>\n<span class=\"Bold\">Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide)</span>\n<br/>\n<span class=\"Bold\">Tablets USP, for oral use</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">What is the most important information I should know about trazodone hydrochloride tablets?</span>\n<br/>\n\t\t\tAntidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:\n\t\t\t\n <ul class=\"Disc\">\n<li>All risks and benefits of treatment with antidepressant medicines</li>\n<li>All treatment choices for depression or other serious mental illnesses</li>\n</ul>\n<ol class=\"Arabic\">\n<li>\n<span class=\"Bold\">Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.</span>\n</li>\n<li>\n<span class=\"Bold\">Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions.</span>\n</li>\n<li>\n<span class=\"Bold\">How can I watch for and try to prevent suicidal thoughts and actions?</span>\n</li>\n</ol>\n<ul class=\"Disc\">\n<li>Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. 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.</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 are worried about symptoms.</li>\n</ul>\n<span class=\"Bold\">Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:</span>\n<ul class=\"Disc\">\n<li>Thoughts about suicide or dying</li>\n<li>Attempts to commit suicide</li>\n<li>New or worse depression</li>\n<li>New or worse anxiety</li>\n<li>Feeling very agitated or restless</li>\n<li>Panic attacks</li>\n<li>Trouble sleeping (insomnia)</li>\n<li>New or worse irritability</li>\n<li>Acting aggressive, being angry or violent</li>\n<li>Acting on dangerous impulses</li>\n<li>An extreme increase in activity and talking (mania)</li>\n<li>Other unusual changes in behavior or mood</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">What else do I need to know about antidepressant medicines?</span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Never stop an antidepressant medicine without first talking to a healthcare provider.</span>Stopping an antidepressant medicine suddenly can cause other symptoms.\n </li>\n<li>\n<span class=\"Bold\">Antidepressants are medicines used to treat depression and other illnesses.</span>It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.\n </li>\n<li>\n<span class=\"Bold\">Antidepressant medicines have other side effects.</span>Talk to your healthcare provider about the side effects of your medicines.\n </li>\n<li>\n<span class=\"Bold\">Antidepressant medicines can interact with other medicines.</span>Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.\n </li>\n</ul>\n\t\t\tIt is not known if trazodone hydrochloride tablets are safe and effective in children.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">What are trazodone hydrochloride tablets?</span>\n<br/>\n\t\t\tTrazodone hydrochloride tablets are prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone hydrochloride tablets belong to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors).\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Do not take trazodone hydrochloride tablets:</span>\n<ul class=\"Disc\">\n<li>If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid, and intravenous methylene blue.</li>\n<li>Do not take an MAOI within 2 weeks of stopping trazodone hydrochloride tablets unless directed to do so by your healthcare provider.</li>\n<li>Do not start trazodone hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">Before you take trazodone hydrochloride tablets tell your healthcare provider about all of your medical conditons, including if you:</span>\n<ul class=\"Disc\">\n<li>have heart problems, including QT prolongation or a family history of it</li>\n<li>have ever had a heart attack</li>\n<li>have bipolar disorder</li>\n<li>have liver or kidney problems</li>\n<li>have other serious medical conditions</li>\n<li>are pregnant or plan to become pregnant. Trazodone hydrochloride tablets may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.</li>\n<li>are pregnant or plan to become pregnant. It is not known if trazodone hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take trazodone hydrochloride tablets.</li>\n</ul>\n<ul class=\"Circle\">\n<li>If you become pregnant during treatment with trazodone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.</li>\n</ul>\n<ul class=\"Disc\">\n<li>are breastfeeding or plan to breastfeed. Trazodone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take trazodone hydrochloride tablets.</li>\n<li>have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks.</li>\n</ul>\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. Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.\n <br/>\n\t\t\tEspecially tell your healthcare provider if you take:\n\t\t\t\n <ul class=\"Disc\">\n<li>triptans used to treat migraine headache</li>\n<li>medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics</li>\n<li>tramadol</li>\n<li>over-the-counter supplements such as tryptophan or St. John's Wort</li>\n<li>nonsteroidal anti-inflammatory drugs (NSAIDS)</li>\n<li>aspirin</li>\n<li>warfarin (Coumadin, Jantoven)</li>\n<li>phenytoin (Mesantoin)</li>\n<li>diuretics</li>\n</ul>\n\t\t\tKnow the medicines you take. Keep a list of them and show it 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\" valign=\"top\"><span class=\"Bold\">How should I take trazodone hydrochloride tablets?</span>\n<ul class=\"Disc\">\n<li>Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.</li>\n<li>Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.</li>\n<li>If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.</li>\n<li>Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.</li>\n<li>Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet.</li>\n<li>If you take too much trazodone hydrochloride tablets, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">What should I avoid while taking trazodone hydrochloride tablets?</span>\n<ul class=\"Disc\">\n<li>Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.</li>\n<li>Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">What are the possible side effects of trazodone hydrochloride tablets?</span>\n<br/>\n<span class=\"Bold\">Trazodone hydrochloride tablets can cause serious side effects or death, including:</span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">See \"What is the most important information I should know about Trazodone?\"</span>\n</li>\n<li>\n<span class=\"Bold\">Serotonin syndrome.</span>Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea.\n </li>\n<li>\n<span class=\"Bold\">Irregular or fast heartbeat or faint (QT prolongation)</span>\n</li>\n<li>\n<span class=\"Bold\">Low blood pressure.</span>You feel dizzy or faint when you change positions (go from sitting to standing)\n </li>\n<li>\n<span class=\"Bold\">Unusual bruising or bleeding</span>\n</li>\n<li>\n<span class=\"Bold\">Erection lasting for more than 6 hours (priapism)</span>\n</li>\n<li>\n<span class=\"Bold\">Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).</span>\n</li>\n<li>\n<span class=\"Bold\">Withdrawal symptoms.</span>Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone without talking to your healthcare provider.\n </li>\n<li>\n<span class=\"Bold\">Visual problems.</span>\n</li>\n</ul>\n<ul class=\"Circle\">\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\t\t\tOnly 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.\n\n\t\t\t\n <ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Low sodium in your blood (hyponatremia).</span>Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk.\n </li>\n</ul>\n\t\t\tGet medical help right away, if you have any of the symptoms listed above.\n <br/>\n<br/>\n<span class=\"Bold\">The most common side effects of trazodone hydrochloride tablets include:</span>\n<ul class=\"Disc\">\n<li>swelling</li>\n<li>blurred vision</li>\n<li>dizziness</li>\n<li>sleepiness</li>\n<li>tiredness</li>\n<li>diarrhea</li>\n<li>stuffy nose</li>\n<li>weight loss</li>\n</ul>\n\t\t\tThese are not all the possible side effects of trazodone hydrochloride tablets. Call 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\" valign=\"top\"><span class=\"Bold\">How should I store trazodone hydrochloride tablets?</span>\n<ul class=\"Disc\">\n<li>Store trazodone hydrochloride tablets between 68°F to 77°F (20°C to 25°C).</li>\n<li>Keep in tight container</li>\n<li>Keep out of the light</li>\n<li>Safely throw away medicine that is out of date or no longer needed.</li>\n<li>Drug trazodone hydrochloride tablets come in child-resistant bottles of 30's and 90's.</li>\n</ul>\n<span class=\"Bold\">Keep trazodone hydrochloride tablets and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">General information about the safe and effective use of trazodone hydrochloride tablets.</span>\n<br/>\n\t\t\tMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionals \n <span class=\"Bold\">.</span>\n<br/>\n\t\t\tPlease address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.\n </td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\">What are the ingredients in trazodone hydrochloride tablets?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span>trazodone hydrochloride, USP\n <br/>\n<span class=\"Bold\">Inactive ingredients:</span>colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate.\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\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"right\" class=\"Botrule Lrule Rrule\" valign=\"top\">Rev.: 11/22</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">This Medication Guide has been approved by the U.S. Food and Drug Administration.</td>\n</tr>\n</tbody>\n</table></div>" }

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: Trazodone Hydrochloride

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

GENERIC: Trazodone Hydrochloride

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

DOSAGE: TABLET

{ "type": "p", "children": [], "text": "DOSAGE: TABLET" }

ADMINSTRATION: ORAL

{ "type": "p", "children": [], "text": "ADMINSTRATION: ORAL" }

NDC: 70518-1204-0

{ "type": "p", "children": [], "text": "NDC: 70518-1204-0" }

NDC: 70518-1204-1

{ "type": "p", "children": [], "text": "NDC: 70518-1204-1" }

NDC: 70518-1204-2

{ "type": "p", "children": [], "text": "NDC: 70518-1204-2" }

NDC: 70518-1204-3

{ "type": "p", "children": [], "text": "NDC: 70518-1204-3" }

NDC: 70518-1204-4

{ "type": "p", "children": [], "text": "NDC: 70518-1204-4" }

COLOR: white

{ "type": "p", "children": [], "text": "COLOR: white" }

SHAPE: ROUND

{ "type": "p", "children": [], "text": "SHAPE: ROUND" }

SCORE: Two even pieces

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

SIZE: 10 mm

{ "type": "p", "children": [], "text": "SIZE: 10 mm" }

IMPRINT: 8;06

{ "type": "p", "children": [], "text": "IMPRINT: 8;06" }

PACKAGING: 90 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 90 in 1 BOTTLE PLASTIC" }

PACKAGING: 30 in 1 BOTTLE PLASTIC

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

PACKAGING: 30 in 1 BLISTER PACK

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

PACKAGING: 30 in 1 BOTTLE PLASTIC

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

PACKAGING: 90 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 90 in 1 BOTTLE PLASTIC" }

ACTIVE INGREDIENT(S):

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

{ "type": "ul", "children": [ "TRAZODONE HYDROCHLORIDE 100mg in 1" ], "text": "" }

INACTIVE INGREDIENT(S):

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

{ "type": "ul", "children": [ "SILICON DIOXIDE", "MAGNESIUM STEARATE", "CELLULOSE, MICROCRYSTALLINE", "STARCH, CORN", "SODIUM LAURYL SULFATE", "SODIUM STARCH GLYCOLATE TYPE A POTATO" ], "text": "" }