Desmopressin Acetate Injection USP is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitations of Use: Desmopressin Acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

Desmopressin Acetate Injection USP is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to:

Desmopressin Acetate Injection USP is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to:

Limitations of Use Desmopressin Acetate is not indicated for the treatment of severe von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [see Warnings and Precautions (5.2)] .

Diabetes Insipidus Prior to treatment with Desmopressin Acetate, assess serum sodium, urine volume and osmolality. Intermittently during treatment, assess serum sodium, urine volume and osmolality or plasma osmolality.

Hemophilia A Prior to treatment with Desmopressin Acetate Injection USP, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies. Also assess serum sodium and aPTT prior to treatment. In certain clinical situations, it may be justified to try Desmopressin Acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

von Willebrand’s Disease (Type I) Prior to treatment with Desmopressin Acetate Injection USP, verify that factor VIII coagulant activity levels are >5% and exclude severe von Willebrand’s disease (Type I) and presence of abnormal molecular form of factor VIII antigen. During treatment with Desmopressin Acetate Injection USP, assess serum sodium, bleeding time, factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand antigen to ensure that adequate levels are being achieved.

For All Patients Receiving Repeated Doses:Restrict free water intake and monitor for hyponatremia. Ensure that serum sodium is normal prior to initiating or resuming treatment with Desmopressin Acetate Injection USP.

Initiate fluid restriction during treatment with Desmopressin Acetate Injection USP [see Warning and Precaution (5.1), Use in Specific Populations (8.4, 8.5)] .

Diabetes Insipidus: Treatment naïve patients: The recommended starting daily dosage is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. Do not dilute Desmopressin Acetate Injection USP for the Diabetes Insipidus population. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. Adjust dose based upon response to treatment estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

Patients changing from intranasal desmopressin:The recommended starting dose of Desmopressin Acetate Injection USP is 1/10 ththe daily maintenance intranasal dose administered by subcutaneous or intravenous injection as one or two divided doses.

Hemophilia A and von Willebrand’s Disease (Type I):

The recommended dosage is 0.3 mcg/kg actual body weight (to a maximum of 20 mcg) administered by intravenous infusion over 15 minutes to 30 minutes. If used preoperatively, administer 30 minutes prior to the procedure. If used to reduce spontaneous or traumatic bleeding, doses may be repeated after 8 hours to 12 hours and once daily thereafter, if needed, based upon clinical condition and von Willebrand factor and factor VIII levels. The necessity for repeat administration of Desmopressin Acetate or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient.

Tachyphylaxis (lessening of response) with repeated administration (i.e., given more frequently than every 48 hours) may occur. The initial response is reproducible if Desmopressin Acetate is administered every 2 to 3 days.

Prepare the solution for infusion using aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw the necessary volume of Desmopressin Acetate Injection USP from the vial and dilute by adding to the infusion bag of 0.9% Sodium Chloride Injection, USP per Table 1. Dilute Desmopressin Acetate Injection USP in sterile 0.9% Sodium Chloride Injection, USP and infuse slowly over 15 minutes to 30 minutes.

The volume of diluent is weight-based. See Table 1 for volume of diluent to use.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 1: Volume of Diluent Required </span> </caption> <tbody class="Headless"> <tr class="First"> <td align="center" valign="top">Patient Weight</td><td align="center" valign="top">Volume of 0.9% Sodium Chloride Injection, USP for dilution</td> </tr> <tr> <td align="center">10 kg or less</td><td align="center">10 mL</td> </tr> <tr class="Last"> <td align="center">More than 10 kg</td><td align="center">50 mL</td> </tr> </tbody> </table></div>

Monitor blood pressure and pulse during infusion.

Desmopressin Acetate is also available as nasal spray and tablet dosage forms.

When switching between formulations, the below text is meant as guidance for starting dose. However, dose should always be titrated individually according to the diuresis (antidiuretic response) and electrolyte status (serum sodium) of the patient.

When switching from Desmopressin Acetate Nasal Spray to Desmopressin Acetate Injection USP, the starting dose is one-tenth times the Desmopressin Acetate Nasal Spray dose.

When switching from Desmopressin Acetate Tablets to Desmopressin Acetate Injection USP, titrate dose individually according to the diuresis (antidiuretic response) and electrolyte status (serum sodium) due to the large variability in both PK and PD. Monitor patients closely during the initial dose titration period.

Injection: Desmopressin Acetate Injection USP is a sterile, aqueous, colorless solution available as:

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{ "type": "ul", "children": [ "4 mcg/mL in single-dose vial", "40 mcg/10 mL (4 mcg/mL) in multiple-dose vial" ], "text": "" }

Desmopressin Acetate Injection USP is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection USP [see Warnings and Precautions (5.4), Adverse Reactions (6), Description (11)] . Desmopressin Acetate Injection USP is contraindicated in patients with the following conditions due to an increased risk of hyponatremia:

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{ "type": "ul", "children": [ "Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min\n \n [see\n \n Use in Specific Populations (8.5, 8.6)and\n \n Clinical Pharmacology (12.3)]\n \n .\n \n ", "Hyponatremia or a history of hyponatremia\n \n [see\n \n Warnings and Precautions (5.1),\n \n Drug Interactions (7.1)],\n \n Use in Specific Populations (8.4,\n \n 8.5)]\n \n .\n \n ", "Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion\n \n [see\n \n Warnings and Precautions (5.1)]\n \n .\n \n ", "Polydipsia\n \n [see\n \n Warnings and Precautions (5.1)]\n \n .\n \n ", "Concomitant use with loop diuretics\n \n [see\n \n Boxed Warning]\n \n .\n \n ", "Concomitant use with systemic or inhaled glucocorticoids\n \n [see\n \n Boxed Warning]\n \n .\n \n ", "During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection\n \n [see\n \n Boxed Warning]\n \n .\n \n " ], "text": "" }

Desmopressin Acetate Injection USP is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition:

{ "type": "p", "children": [], "text": "Desmopressin Acetate Injection USP is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition:" }

{ "type": "ul", "children": [ "Heart failure", "Uncontrolled hypertension" ], "text": "" }

Desmopressin Acetate Injection USP can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death [see Boxed Warning] .

Desmopressin Acetate Injection USP is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances [see Contraindications (4), Drug Interactions (7)] . Avoid concomitant treatments that also cause hyponatremia. Prior to starting or resuming Desmopressin Acetate Injection USP, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of Desmopressin Acetate Injection USP without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.

Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating Desmopressin Acetate Injection USP, and periodically thereafter [see Dosage and Administration (2.1)] . Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia.

Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia [see Contraindications (4)] .

If hyponatremia occurs, Desmopressin Acetate Injection USP may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.

Desmopressin Acetate may cause hypotension (with compensatory increase in heart rate) or hypertension. Monitor blood pressure during Desmopressin Acetate administration, particularly in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease [see Adverse Reactions (6), Drug Interactions (7.2)].

Use of Desmopressin Acetate in patients with Type IIB von Willebrand’s disease may result in platelet aggregation, thrombocytopenia, and possibly thrombosis.

Hypersensitivity reactions including anaphylaxis have been reported with intravenous and intranasal Desmopressin Acetate, including cases of fatal anaphylaxis with intravenous Desmopressin Acetate. Desmopressin Acetate Injection USP is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection USP [see Contraindications (4)] . It is not known whether antibodies to Desmopressin Acetate Injection USP are produced after repeated injections. Monitor patients for signs or symptoms of hypersensitivity reactions during administration, interrupt treatment should a reaction occur, and manage medically. Permanently discontinue for serious hypersensitivity reaction [see Adverse Reactions (6)] .

Desmopressin Acetate Injection USP can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status. Patients with heart failure or uncontrolled hypertension may be at increased risk. Desmopressin Acetate Injection USP is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention. Advise patients to limit fluid intake [see Patient Counseling Information (17)] .

The following clinically significant adverse reactions are described elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following clinically significant adverse reactions are described elsewhere in the labeling:" }

{ "type": "ul", "children": [ "Hyponatremia\n \n [see\n \n Contraindications, Warnings and Precautions (5.1)]\n \n \n", "Hypotension and Hypertension\n \n [see\n \n Warnings and Precautions (5.2)]\n \n \n", "Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB\n \n [see\n \n Warnings and Precautions (5.3)]\n \n \n", "Hypersensitivity reactions\n \n [see\n \n Warnings and Precautions (5.4)]\n \n \n", "Fluid retention\n \n [see\n \n Warnings and Precautions (5.5)]\n \n \n" ], "text": "" }

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

{ "type": "p", "children": [], "text": "The following adverse reactions have been identified during post-approval use of Desmopressin Acetate Injection USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure." }

Cardiovascular: Hypertension, hypotension, tachycardia, thrombotic events, fluid retention Digestive: Nausea, abdominal cramps Immune: Hypersensitivity reactions Integumentary: Erythema, swelling, burning pain, facial flushing Laboratory: Hyponatremia Nervous: Headache, hyponatremic seizures

{ "type": "p", "children": [], "text": "Cardiovascular: Hypertension, hypotension, tachycardia, thrombotic events, fluid retention \n \n Digestive: Nausea, abdominal cramps \n Immune: Hypersensitivity reactions \n Integumentary: Erythema, swelling, burning pain, facial flushing \n Laboratory: Hyponatremia \n Nervous: Headache, hyponatremic seizures\n " }

The concomitant administration of Desmopressin Acetate Injection USP with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, sulfonylureas, particularly chlorpropamide, oxybutynin and carbamazepine), requires more frequent serum sodium monitoring. Monitor serum sodium more frequently in patients taking Desmopressin Acetate Injection USP concomitantly with these drugs and when doses of these drugs are increased [see Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7.1), Use in Specific Populations (8.4, 8.5)] .

Desmopressin Acetate Injection USP can elevate blood pressure. Use of Desmopressin Acetate Injection USP with other vasoconstrictors may require a reduction of the Desmopressin Acetate Injection USP dosage [see Warnings and Precautions (5.2), Adverse Reactions (6)].

Risk Summary Prolonged experience with Desmopressin Acetate Injection USP in pregnant women over several decades, based on the available published literature and case reports, have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In addition, in vitrostudies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproductive and developmental studies following administration of desmopressin acetate during organogenesis to pregnant rats and rabbits, at doses 130- and 110- times, respectively, the recommended dose of 18 mcg for a 60 kg patient, based on body surface area (mg/m 2). The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease Associated Maternal and Embryo-fetal Risk:

Pregnant women with Hemophilia A or von Willebrand’s disease may be at an increased risk for bleeding diatheses and hemorrhagic events at delivery. An affected newborn may also be at risk of bleeding diatheses.

Data Animal Data In a developmental toxicity study in rats, desmopressin acetate was administered intravenously at doses of 9.68, 48.4, or 241 mcg/kg/day during the period of organogenesis (gestations days 7 to 17). Laparohysterectomy for fetal examinations were conducted on gestation day 20 for twenty females in each group; the remaining 10 females were allowed to litter in order to determine any postnatal effects that might be attributable to pre-natal treatment. No effects were seen on maternal and fetal survival, growth and morphology or post-natal offspring survival, growth, development, behavior and reproductive performance up to 241 mcg/kg/day (130 times the 18 mcg dose received by a 60 kg patient based on body surface area). In an embryo-fetal development study and a pre- and postnatal development study in rabbits, desmopressin acetate was administered subcutaneously at doses of 2, 20 or 200 mcg/kg/day (embryo-fetal development) and 0.1, 1 or 10 mcg/kg/day (pre- and postnatal development) during the period of organogenesis (gestation days 6 to 18). No effects on maternal and fetal survival or morphology were observed in both studies at doses of up to 200 mcg/kg/day (215x the 18 mcg dose received by a 60 kg patient based on body surface area) nor were there effects in the pre- and postnatal development study on parturition, postnatal survival, growth, development or behavior, up to the highest dose tested of 10 mcg/kg/day (11 times the 18 mcg dose received by a 60 kg patient, based on body surface area).

Risk Summary Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal administration. Desmopressin is poorly transferred into human breastmilk at negligible amounts ( see Data). There is no information on the effects of desmopressin on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Desmopressin Acetate Injection USP and any potential adverse effects on the breastfed child from Desmopressin Acetate Injection USP or from the underlying maternal condition.

Data The breast milk of lactating women was collected over 8 hours following administration of 300 mcg desmopressin nasal spray. The expected area under the plasma concentration time curve (AUC) of desmopressin following 300 mcg nasal spray is 2.4-fold higher to that of 4 mcg Desmopressin Acetate Injection USP. Based on the measured concentrations of desmopressin following intranasal administration, the amounts of desmopressin that may be transferred to a breastfed infant correspond to 0.0001-0.005% of the dose administered.

The safety and effectiveness of Desmopressin Acetate have been established in pediatric patients 3 months of age and older with hemophilia A and von Willebrand’s disease and pediatric patients aged 12 years and older with diabetes insipidus. The safety and effectiveness of Desmopressin Acetate have not been established in infants less than 3 months of age with hemophilia A or von Willebrand’s disease or pediatric patients under 12 years of age with diabetes insipidus. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian [see Warnings and Precautions (5.1)] .

Clinical studies of Desmopressin Acetate Injection USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin Acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min) [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)] .

Use of Desmopressin Acetate Injection USP in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient [see Warnings and Precautions (5.1)] .

Desmopressin acetate is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment than patients with normal renal function. Desmopressin Acetate is contraindicated in patients with estimated CLcr by Cockcroft-Gault equation less than 50 mL/min [see Contraindications (4), Clinical Pharmacology (12.3)] .

Overdosage of Desmopressin Acetate Injection USP leads to prolonged duration of action with an increased risk of water retention and hyponatremia. Signs of overdose may include headaches, abdominal cramps, nausea, facial flushing, confusion, drowsiness, problems with passing urine and rapid weight gain due to fluid retention [see Warnings and Precautions (5.1)] . In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition, serum sodium assessed, and hyponatremia treated appropriately.

{ "type": "p", "children": [], "text": "Overdosage of Desmopressin Acetate Injection USP leads to prolonged duration of action with an increased risk of water retention and hyponatremia. Signs of overdose may include headaches, abdominal cramps, nausea, facial flushing, confusion, drowsiness, problems with passing urine and rapid weight gain due to fluid retention\n \n [see\n \n Warnings and Precautions (5.1)]\n \n . In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition, serum sodium assessed, and hyponatremia treated appropriately.\n\n " }

There is no known specific antidote for desmopressin acetate or Desmopressin Acetate Injection USP 4 mcg/mL.

{ "type": "p", "children": [], "text": "There is no known specific antidote for desmopressin acetate or Desmopressin Acetate Injection USP 4 mcg/mL." }

Desmopressin Acetate Injection USP (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:

{ "type": "p", "children": [], "text": "Desmopressin Acetate Injection USP (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:" }

Mol. Wt. 1129.27 Empirical Formula: C 46H 64N 14O 12S 2•C 2H 4O 2

{ "type": "p", "children": [], "text": "Mol. Wt. 1129.27 \n Empirical Formula: C\n \n 46H\n \n 64N\n \n 14O\n \n 12S\n \n 2•C\n \n 2H\n \n 4O\n \n 2\n" }

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt)

{ "type": "p", "children": [], "text": "1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt)" }

Desmopressin Acetate solution for injection is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.

{ "type": "p", "children": [], "text": "Desmopressin Acetate solution for injection is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH." }

Desmopressin Acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.

{ "type": "p", "children": [], "text": "Desmopressin Acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH." }

Desmopressin acetate increases plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I.

The antidiuretic effects of desmopressin acetate are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin acetate is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in increased duration of action and a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.

The response to Desmopressin Acetate of factor VIII activity and plasminogen activator is dose-related, with maximal plasma levels of 300 to 400 percent change from baseline obtained after infusion of 0.4 mcg/kg. The increase of factor VIII is rapid and evident within 30 minutes, reaching a maximum at a point ranging from 90 minutes to two hours. The duration of the hemostatic effect depends on the half-life for VIII:C which is about 8-12 hours. The percentage increase of factor VIII levels in patients with mild hemophilia A and von Willebrand’s disease was not significantly different from that observed in normal healthy individuals when treated with 0.3 mcg/kg of Desmopressin Acetate infused over 10 minutes.

The use of Desmopressin Acetate Injection USP in patients with central diabetes insipidus reduces urinary output, increases urine osmolality, and decreases plasma osmolality.

Elimination

The geometric mean terminal half-life is 2.8 hours.

Metabolism

Desmopressin is not metabolized by human CYP450 system.

Excretion

After intravenous administration of 2 mcg, 52% of the dose was recovered in the urine within 24 hours as unchanged desmopressin.

Drug Interaction Studies

In vitrostudies in human liver microsome preparations have shown that desmopressin does not inhibit the human CYP450 system. No in vivointeraction studies have been performed with Desmopressin Acetate Injection USP.

Specific Populations

Patients with Renal Impairment

A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single 2 mcg dose of desmopressin acetate intravenous injection. The geometric mean terminal half-life was 2.8 hours in subjects with normal renal function, and 4, 6.6, and 8.7 hours in patients with mild, moderate, and severe renal impairment, respectively. In patients with mild, moderate and severe renal impairment, mean desmopressin area under the plasma drug concentration time curve (AUC) was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function.

Studies with desmopressin have not been performed to evaluate carcinogenic potential. Desmopressin was not mutagenic in bacterial mutagenicity (Ames) and mouse lymphoma assays.

Desmopressin Acetate Injection USP is available as a sterile solution supplied as 4 mcg/mL in cartons of ten 1 mL single-dose, type 1 glass vials with rubber stopper and a flip off seal (NDC 72843-461-10) and 40 mcg/10 mL (4 mcg/mL) in 10 mL multiple-dose vials, type 1 glass vial with rubber stopper and a flip off seal, (NDC 72843-440-01), each containing 4 mcg Desmopressin Acetate per mL.

Store refrigerated 2° to 8°C (36° to 46°F).

Hyponatremia and Fluid Restriction

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

{ "type": "ul", "children": [ "Inform patients that Desmopressin Acetate may cause severe hyponatremia, which may be life-threatening, if it is not promptly diagnosed and treated\n \n [see\n \n Warning and Precaution (5.1)]\n \n .\n \n ", "Inform them about the signs and symptoms associated with hyponatremia, to undergo recommended serum sodium measurements, and to inform their health care provider about new medications.", "Advise patients to contact a healthcare provider if symptoms of hyponatremia occur.", "Discuss adjustment of fluid intake and monitoring of urine output with patients." ], "text": "" }

Manufactured for: UBI Pharma Inc. No. 45 Guangfu N. Rd., Hukou, Hsinchu 303036, Taiwan

{ "type": "p", "children": [], "text": "Manufactured for: \n UBI Pharma Inc. \n No. 45 Guangfu N. Rd., \n Hukou, Hsinchu 303036, \n Taiwan\n " }

1mL container label

{ "type": "p", "children": [], "text": "1mL container label" }

1mL carton label

{ "type": "p", "children": [], "text": "1mL carton label" }

10mL container label

{ "type": "p", "children": [], "text": "10mL container label" }

10mL carton label

{ "type": "p", "children": [], "text": "10mL carton label" }

Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older.

{ "type": "p", "children": [], "text": "Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older." }

Limitations of Use: Desmopressin nasal spray solution is not indicated for:

{ "type": "p", "children": [], "text": "\nLimitations of Use:\n Desmopressin nasal spray solution is not indicated for:\n\n " }

{ "type": "ul", "children": [ "Treatment of nephrogenic diabetes insipidus,", "Treatment of primary nocturnal enuresis [\n \n seeWarnings and Precautions (5.1)],\n \n ", "Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy)\n \n [seeWarnings and Precautions (5.2)],\n", "Use in patients with an impaired level of consciousness,", "Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg\n \n [see\n \n Dosage Forms and Strengths(\n \n 3)]\n \n \n" ], "text": "" }

Administer desmopressin nasal spray solution by intranasal use only. Instruct patients about appropriate fluid restriction during desmopressin nasal spray solution treatment [seeWarnings and Precautions (5.1)].

Must prime the spray pump prior to the first use. Instruct patients to:

The use of desmopressin nasal spray solution is not indicated for patients who require less than 10 mcg doses or doses that are not multiples of 10 mcg because the spray pump can only deliver doses of 10 mcg [seeIndications and Usage( 1)] . If other doses are required, use another desmopressin acetate product.

Individualize the dosage of desmopressin nasal spray solution for each patient with particular attention in pediatric and elderly patients and adjust according to the diurnal pattern of response to limit nocturia and to ensure fluid intake with respect to urine output is not excessive [seeWarnings and Precautions (5.1)].Monitor continued response to desmopressin nasal spray solution by urine volume and osmolality to ensure adequate diuresis to limit the risk of hyponatremia, and include measurements of serum sodium and plasma osmolality as needed.

Adults

The recommended dosage in adults is 10 mcg once daily into one nostril up to 40 mcg once daily (or 40 mcg divided into two or three daily doses). If administered more than once a day, adjust for an adequate diurnal rhythm of urine output.

Pediatric Patients

Because administration of desmopressin acetate can be associated with decreased responsiveness with prolonged use, consider increasing the dosage of desmopressin nasal spray solution if patients demonstrate decreased response over a long period of time.

When switching from the desmopressin acetate injection to desmopressin nasal spray solution, administer 10 times the amount of desmopressin acetate, rounding down to the nearest 10 mcg.

When switching from the desmopressin acetate tablets to desmopressin nasal spray solution, individual dose titration is required because intranasal desmopressin is approximately 10 to 40 fold more potent than oral (tablet) desmopressin.

Desmopressin Nasal Spray Solution, USP pump delivers 10 mcg (0.1 mL) of desmopressin acetate per spray.

{ "type": "p", "children": [], "text": "Desmopressin Nasal Spray Solution, USP pump delivers 10 mcg (0.1 mL) of desmopressin acetate per spray." }

Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle with spray pump delivering 50 sprays.

{ "type": "p", "children": [], "text": "Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle with spray pump delivering 50 sprays." }

Desmopressin nasal spray solution is contraindicated in patients with:

{ "type": "p", "children": [], "text": "Desmopressin nasal spray solution is contraindicated in patients with:" }

{ "type": "ul", "children": [ "Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray solution. Severe allergic reactions and anaphylaxis have been reported\n \n [seeAdverse Reactions(\n \n 6)].\n \n \n", "Renal impairment defined as estimated creatinine clearance (CLcr) by Cockcroft-Gault equation less than 50 mL/min\n \n [seeUse in Specific Populations (8.6)and\n \n Clinical Pharmacology (12.3)].\n \n ", "Hyponatremia or a history of hyponatremia\n \n [seeWarnings and Precautions (5.1)].\n \n " ], "text": "" }

Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated, hyponatremia can be fatal.

All patients receiving desmopressin nasal spray solution should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness, and confusion. Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma, and/or respiratory arrest.

In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. Careful fluid intake restriction is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [seeUse in Specific Populations (8.4, 8.5)]. More frequent monitoring of serum sodium levels is recommended in the following patients: those with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, renal disorders, habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia [seeDrug Interactions (7.1)].

Desmopressin nasal spray solution is not an indicated formulation for the treatment of primary nocturnal enuresis due to a higher risk of hyponatremia and hyponatremic convulsions with the use of the nasal spray formulation compared to desmopressin tablets seen in postmarketing reports [see Indications and Usage( 1)].

Chronic administration of desmopressin nasal spray solution may result in changes to nasal mucosa. Nasal mucosa abnormalities (such as scarring and edema) due to chronic administration, or due to other causes (nasal blockage, nasal mucosal atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) may cause erratic, unreliable absorption. Avoid use of desmopressin nasal spray solution in such patients [see Indications and Usage( 1)] and consider use of other formulations of desmopressin acetate given by other routes of administration.

The following serious reactions are described below and elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following serious reactions are described below and elsewhere in the labeling:" }

{ "type": "ul", "children": [ "Hyponatremia\n \n [seeWarnings and Precautions (5.1)].\n", "Altered Absorption in Patients with Changes in Nasal Mucosa\n \n [seeWarnings and Precautions (5.2)].\n \n " ], "text": "" }

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

{ "type": "p", "children": [], "text": "The following adverse reactions have been identified during post-approval use of desmopressin acetate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:" }

Increase in blood pressure, headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and abdominal cramps.

{ "type": "p", "children": [], "text": "Increase in blood pressure, headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and abdominal cramps." }

Water intoxication with hyponatremia.

{ "type": "p", "children": [], "text": "Water intoxication with hyponatremia." }

Hyponatremic convulsions associated with concomitant use of the following medications: oxybutynin and imipramine [seeDrug Interactions (7.1)].

{ "type": "p", "children": [], "text": "Hyponatremic convulsions associated with concomitant use of the following medications: oxybutynin and imipramine\n \n [seeDrug Interactions (7.1)].\n\n " }

Severe allergic reactions and anaphylaxis [seeContraindications (4)].

{ "type": "p", "children": [], "text": "Severe allergic reactions and anaphylaxis\n \n [seeContraindications (4)].\n" }

The concomitant administration of desmopressin nasal spray solution with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine, oxybutynin and carbamazepine) requires more frequent serum sodium monitoring [seeWarnings and Precautions (5.1)and Adverse Reactions( 6)] .

Desmopressin acetate can elevate blood pressure. Use of large doses of desmopressin nasal spray solution with other vasoconstrictors may require a reduction of the desmopressin nasal spray solution dosage [seeAdverse Reactions( 6)].

Risk Summary

Prolonged experience with desmopressin in pregnant women over several decades, based on the available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects. Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m 2).

Risk Summary

Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal intranasal administration. Desmopressin is poorly transferred into human breastmilk at negligible amounts (see Data).There is no information on the effects of desmopressin on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for desmopressin nasal spray solution and any potential adverse effects on the breastfed infant from desmopressin nasal spray solution or from the underlying maternal condition.

Data

A trial was conducted in six healthy lactating women, at greater than 4 months postpartum, to evaluate intranasal administration of 300 mcg single dose of another desmopressin product (7.5 times the recommended adult dose of desmopressin nasal spray solution). Samples of maternal plasma and breastmilk were obtained at 0, 30, 60, 120, 240, 360 and 480 min after the drug administration. At 8 hours after dose intake, the levels in the milk ranged between 4.16 and 101 pg/ml, and the plasma levels ranged between 40 and 242 pg/ml. The total amount of desmopressin present in the milk over the 8 hours ranged between 491 pg and 16 ng, which corresponds to 0.0001 - 0.005% of the administered dose to the breastfeeding mother.

Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in pediatric patients 4 years of age and older. Desmopressin nasal spray solution is not indicated in pediatric patients less than 4 years of age.

Use of desmopressin nasal spray solution in pediatric patients 4 years of age and older is supported by evidence from adults and pediatric patients with central diabetes insipidus. Use in pediatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [seeWarnings and Precautions (5.1)].

Clinical studies of desmopressin nasal spray solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at a low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Because elderly patients are more likely to have renal impairment, care should be taken in dose selection, and monitoring renal function is recommended [seeContraindications (4),Use in Specific Populations (8.6)].

Use of desmopressin nasal spray solution in geriatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [seeWarnings and Precautions (5.1)].

Desmopressin acetate is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment than patients with normal renal function. Desmopressin nasal spray solution is contraindicated in patients with estimated CLcr by Cockcroft-Gault equation less than 50 mL/min [see Clinical Pharmacology( 12.1, 12.3), Contraindications(4)].

Signs of desmopressin acetate overdosage may include confusion, drowsiness, continuing headache, problems with passing urine, and rapid weight gain due to fluid retention [seeWarnings and Precautions (5.1)].In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue desmopressin nasal spray solution. There is no known specific antidote for desmopressin acetate.

{ "type": "p", "children": [], "text": "Signs of desmopressin acetate overdosage may include confusion, drowsiness, continuing headache, problems with passing urine, and rapid weight gain due to fluid retention\n \n [seeWarnings and Precautions (5.1)].In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue desmopressin nasal spray solution. There is no known specific antidote for desmopressin acetate.\n\n " }

Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:

{ "type": "p", "children": [], "text": "Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:" }

Molecular weight: 1183.34

{ "type": "p", "children": [], "text": "Molecular weight: 1183.34" }

Empirical formula: C 46H 64N 14O 12S 2•C 2H 4O 2•3H 2O

{ "type": "p", "children": [], "text": "Empirical formula: C\n \n 46H\n \n 64N\n \n 14O\n \n 12S\n \n 2•C\n \n 2H\n \n 4O\n \n 2•3H\n \n 2O\n\n " }

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

{ "type": "p", "children": [], "text": "1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate." }

Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use. Each mL contains: ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%.

{ "type": "p", "children": [], "text": "Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use. Each mL contains: \n ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%.\n " }

The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.

The use of desmopressin nasal spray solution in patients with central diabetes insipidus reduces urinary output, increases urine osmolality, and decreases plasma osmolality.

Absorption:Desmopressin acetate is absorbed through the nasal mucosa.

Elimination:Desmopressin acetate exhibits a biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes for the initial and terminal phases, respectively.

Specific Populations

Renal Impairment: Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single 2 mcg dose of desmopressin acetate injection (this results in approximately 20 times the exposure of 10 mcg of desmopressin nasal spray solution). The terminal half-life was 2.8 hours in subjects with normal renal function, 4.0 hours in mild renal impairment, 6.6 hours in moderate renal impairment and 8.7 hours in severe renal impairment. In patients with mild, moderate and severe renal impairment, mean desmopressin exposure was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function [seeContraindications (4),Use in Specific Populations (8.6)].

Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

How Supplied

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

Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle containing an aqueous solution with the spray pump delivering 50 sprays of 10 mcg (0.1 mL) (NDC 68682-342-05).

{ "type": "p", "children": [], "text": "Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle containing an aqueous solution with the spray pump delivering 50 sprays of 10 mcg (0.1 mL) (NDC 68682-342-05)." }

Storage and Handling

{ "type": "p", "children": [], "text": "\nStorage and Handling\n" }

Store in refrigerator at 2° to 8°C (36° to 46°F).

{ "type": "p", "children": [], "text": "Store in refrigerator at 2° to 8°C (36° to 46°F)." }

When traveling, product will maintain stability for up to 3 weeks when stored at room temperature, 22°C (72°F).

{ "type": "p", "children": [], "text": "When traveling, product will maintain stability for up to 3 weeks when stored at room temperature, 22°C (72°F)." }

STORE BOTTLE IN UPRIGHT POSITION.

{ "type": "p", "children": [], "text": "STORE BOTTLE IN UPRIGHT POSITION." }

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

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

{ "type": "ul", "children": [ "\nAdministration\n", "Inform caregivers for pediatric patients that administration should be supervised to ensure the patient receives the prescribed dose.", "Inform patients that the pump must be primed prior to first use and again if not used for greater than one week. Inform patients that the desmopressin nasal spray solution bottle delivers 50 sprays of 10 mcg each following the initial 5 priming pumps.", "Inform patients to discard any solution remaining after 50 sprays since the amount delivered thereafter may be substantially less than 10 mcg of drug.", "\nMonitoring\n", "Educate patients about the signs and symptoms of hyponatremia and advise them to contact a healthcare provider if such symptoms occur.", "Discuss downward adjustment of fluid intake and monitoring of urine output with patients." ], "text": "" }

Distributed by:

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

Oceanside Pharmaceuticals, a division of

{ "type": "p", "children": [], "text": "Oceanside Pharmaceuticals, a division of" }

Bausch Health US, LLC

{ "type": "p", "children": [], "text": "Bausch Health US, LLC" }

Bridgewater, NJ 08807 USA

{ "type": "p", "children": [], "text": "Bridgewater, NJ 08807 USA" }

Manufactured by:

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

Bausch Health Companies Inc.

{ "type": "p", "children": [], "text": "Bausch Health Companies Inc." }

Laval, Quebec H7L 4A8, Canada

{ "type": "p", "children": [], "text": "Laval, Quebec H7L 4A8, Canada" }

© 2025 Bausch Health Companies Inc. or its affiliates

{ "type": "p", "children": [], "text": "© 2025 Bausch Health Companies Inc. or its affiliates" }

90005300

{ "type": "p", "children": [], "text": "90005300" }

Desmopressin (DEZ-mo-press-in) Nasal Spray Solution, USP 10 mcg per 0.1 mL For Intranasal Use Only

{ "type": "p", "children": [], "text": "\nDesmopressin (DEZ-mo-press-in) Nasal Spray Solution, USP\n\n10 mcg per 0.1 mL\n\nFor Intranasal Use Only\n" }

What is desmopressin nasal spray solution, 0.01%?

{ "type": "p", "children": [], "text": "\nWhat is desmopressin nasal spray solution, 0.01%?\n" }

Desmopressin nasal spray solution is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus.

{ "type": "p", "children": [], "text": "Desmopressin nasal spray solution is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus." }

{ "type": "ul", "children": [ "Desmopressin nasal spray solution is not effective in the treatment of nephrogenic diabetes insipidus.", "Desmopressin nasal spray solution should not be used in people with nasal problems that may keep them from using a nasal spray." ], "text": "" }

Who should not use desmopressin nasal spray solution, 0.01%? Do not use desmopressin nasal spray solution if you:

{ "type": "p", "children": [], "text": "\nWho should not use desmopressin nasal spray solution, 0.01%?\n\nDo not use desmopressin nasal spray solution if you:\n" }

{ "type": "ul", "children": [ "are allergic to desmopressin nasal spray solution or any of the ingredients in desmopressin nasal spray solution. Some people have had severe allergic reactions while taking desmopressin nasal spray solution. See the end of this Patient Information for a complete list of ingredients in desmopressin nasal spray solution.", "have kidney problems", "have or have had low levels of sodium in your blood (hyponatremia)" ], "text": "" }

What should I tell my healthcare provider before using desmopressin nasal spray solution, 0.01%? Before using desmopressin nasal spray solution, tell your healthcare provider about all your medical conditions including if you:

{ "type": "p", "children": [], "text": "\nWhat should I tell my healthcare provider before using desmopressin nasal spray solution, 0.01%?\n\nBefore using desmopressin nasal spray solution, tell your healthcare provider about all your medical conditions including if you:\n" }

{ "type": "ul", "children": [ "have or have had nasal sores, nasal surgery, nasal injury, or have problems such as a stuffy nose or trouble breathing through your nose.", "have or have had any heart, blood circulation, or blood pressure problems", "have a condition that causes fluid or water imbalance problems such as cystic fibrosis, or heart failure.", "have or have had a condition that causes you to be very thirsty", "are pregnant or plan to become pregnant. It is not known if desmopressin nasal spray solution will harm your unborn baby.", "are breastfeeding or plan to breastfeed. It is not known if desmopressin nasal spray solution passes into your breast milk. You and your healthcare provider should decide if you will use desmopressin nasal spray solution." ], "text": "" }

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

{ "type": "p", "children": [], "text": "Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements." }

How should I use desmopressin nasal spray solution, 0.01?

{ "type": "p", "children": [], "text": "\nHow should I use desmopressin nasal spray solution, 0.01?\n" }

{ "type": "ul", "children": [ "Read the\n \n Instructions for Usethat comes with your desmopressin nasal spray solution.\n \n ", "Use desmopressin nasal spray solution exactly as your healthcare provider tells you to use it.", "Your healthcare provider may change your dose of desmopressin nasal spray solution if needed." ], "text": "" }

What are the possible side effects of desmopressin nasal spray solution, 0.01%? Desmopressin nasal spray solution may cause serious side effects including:

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of desmopressin nasal spray solution, 0.01%?\n\nDesmopressin nasal spray solution may cause serious side effects including:\n" }

{ "type": "ul", "children": [ "\nlow levels of sodium in the blood (hyponatremia).People using desmopressin nasal spray solution are at risk for low sodium levels in the blood, water intoxication, and fluid overload. Follow your healthcare provider’s instructions on limiting the amount of fluid you can drink when using desmopressin nasal spray solution.\n \n ", "\nDo notdrink more than you need to satisfy your thirst. You can have serious side effects such as seizures, coma, and death from drinking too much fluid.\n \n ", "Children and the elderly are at higher risk for these problems and should follow their healthcare provider’s limits on drinking fluids.", "Call your healthcare provider right away if you have any of the following symptoms while using desmopressin nasal spray solution. They may mean that your blood sodium level is too low." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="34%"/> <col width="33%"/> <col width="33%"/> <tbody class="Headless"> <tr> <td valign="top"> <ul> <li>headache</li> </ul> </td><td valign="top"> <ul> <li>nausea, vomiting</li> </ul> </td><td valign="top"> <ul> <li>weight gain</li> </ul> </td> </tr> <tr> <td valign="top"> <ul> <li>restlessness</li> </ul> </td><td valign="top"> <ul> <li>tiredness</li> </ul> </td><td valign="top"> <ul> <li>sleepiness</li> </ul> </td> </tr> <tr> <td valign="top"> <ul> <li>disorientation</li> </ul> </td><td valign="top"> <ul> <li>loss of appetite</li> </ul> </td><td valign="top"> <ul> <li>muscle cramps</li> </ul> </td> </tr> <tr> <td valign="top"> <ul> <li>feeling irritable</li> </ul> </td><td valign="top"> <ul> <li>feeling weak</li> </ul> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <ul> <li>hallucinations</li> </ul> </td><td valign="top"> <ul> <li>confusion</li> </ul> </td><td valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"34%\"/>\n<col width=\"33%\"/>\n<col width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td valign=\"top\">\n<ul>\n<li>headache</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>nausea, vomiting</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>weight gain</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<ul>\n<li>restlessness</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>tiredness</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>sleepiness</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<ul>\n<li>disorientation</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>loss of appetite</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>muscle cramps</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<ul>\n<li>feeling irritable</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>feeling weak</li>\n</ul>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<ul>\n<li>hallucinations</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>confusion</li>\n</ul>\n</td><td valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "\nnasal scarring or swelling.Some people using desmopressin nasal spray solution for long periods of time may have nasal problems such as scarring or swelling. This may affect how well desmopressin nasal spray solution works for you.\n \n " ], "text": "" }

The most common side effects of desmopressin nasal spray solution include: headache, stuffy nose, runny nose, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and stomach cramps. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "The most common side effects of desmopressin nasal spray solution include: headache, stuffy nose, runny nose, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and stomach cramps. \n Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n " }

General information about the safe and effective use of desmopressin nasal spray solution, 0.01%.

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of desmopressin nasal spray solution, 0.01%.\n" }

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use desmopressin nasal spray solution for a condition for which it was not prescribed. Do not give desmopressin nasal spray solution to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about desmopressin nasal spray solution that is written for health professionals. For more information call 1-800-321-4576.

{ "type": "p", "children": [], "text": "Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use desmopressin nasal spray solution for a condition for which it was not prescribed. Do not give desmopressin nasal spray solution to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about desmopressin nasal spray solution that is written for health professionals. For more information call 1-800-321-4576." }

What are the ingredients in desmopressin nasal spray solution, 0.01%? Active ingredient:desmopressin acetate Inactive ingredients:purified water and sodium chloride; hydrochloric acid may be added to adjust pH (3.5 – 6.0) Preservative:chlorobutanol

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in desmopressin nasal spray solution, 0.01%?\n\nActive ingredient:desmopressin acetate \n \nInactive ingredients:purified water and sodium chloride; hydrochloric acid may be added to adjust pH (3.5 – 6.0) \n \nPreservative:chlorobutanol\n\n " }

Distributed by: Oceanside Pharmaceuticals, a division of

{ "type": "p", "children": [], "text": "\nDistributed by:\n Oceanside Pharmaceuticals, a division of\n\n " }

Bausch Health US, LLC

{ "type": "p", "children": [], "text": "Bausch Health US, LLC" }

Bridgewater, NJ 08807 USA

{ "type": "p", "children": [], "text": "Bridgewater, NJ 08807 USA" }

Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada

{ "type": "p", "children": [], "text": "\nManufactured by:\n Bausch Health Companies Inc. \n Laval, Quebec H7L 4A8, Canada\n\n " }

© 2025 Bausch Health Companies Inc. or its affiliates

{ "type": "p", "children": [], "text": "© 2025 Bausch Health Companies Inc. or its affiliates" }

This Patient Information has been approved by the U.S. Food and Drug Administration.

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

90005300 Revised: May 2025

{ "type": "p", "children": [], "text": "90005300 Revised: May 2025" }

Desmopressin Nasal Spray Solution, 10 mcg per 0.1 mL

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray Solution, 10 mcg per 0.1 mL\n" }

For Intranasal Use Only

{ "type": "p", "children": [], "text": "\nFor Intranasal Use Only\n" }

Read these instructions before using desmopressin nasal spray solution, 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.

{ "type": "p", "children": [], "text": "Read these instructions before using desmopressin nasal spray solution, 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." }

Children should be helped by an adult when using desmopressin nasal spray solution, to make sure the right amount of medicine is used.

{ "type": "p", "children": [], "text": "\nChildren should be helped by an adult when using desmopressin nasal spray solution, to make sure the right amount of medicine is used.\n" }

The parts of your desmopressin nasal spray solution pump(see Figure A):

{ "type": "p", "children": [], "text": "\nThe parts of your desmopressin nasal spray solution pump(see Figure A):\n\n " }

Priming your desmopressin nasal spray solution:

{ "type": "p", "children": [], "text": "\nPriming your desmopressin nasal spray solution:\n" }

Your desmopressin nasal spray pump must be primed before you use it for the first time.

{ "type": "p", "children": [], "text": "Your desmopressin nasal spray pump must be primed before you use it for the first time." }

{ "type": "ul", "children": [ "Remove the protective cap (see Figure B)." ], "text": "" }

{ "type": "ul", "children": [ "Press down on the shoulders at the top of your desmopressin nasal spray solution pump 5 times. Hold the spray nozzle tip away from your face and eyes (see Figure C)." ], "text": "" }

{ "type": "ul", "children": [ "After your desmopressin nasal spray pump is primed, it will spray 10 micrograms (1 dose) of medicine each time it is pressed." ], "text": "" }

Using your desmopressin nasal spray:

{ "type": "p", "children": [], "text": "\nUsing your desmopressin nasal spray:\n" }

{ "type": "ul", "children": [ "\nStep 1.Remove the protective cap.\n \n ", "\nStep 2.To make sure you get the right dose of medicine,\n \n hold bottle uprightas shown in\n \n Figure Dand place the spray nozzle tip of your desmopressin nasal spray solution into your nostril. Press the spray pump 1 time for 1 dose. If 2 doses are prescribed, spray each nostril 1 time.\n \n It is very important that you hold the bottle upright while giving the medicine. You may need to lean your head slightly forward to prevent tilting the bottle. Tilting the bottle, especially when less than half of the solution is left in the bottle, may cause the pump to not work the right way(see Figure E).\n \n " ], "text": "" }

{ "type": "ul", "children": [ "\nStep 3.Put the spray nozzle tip of your desmopressin nasal spray solution into your nostril and press the spray pump 1 time for 1 dose (see Figure F). If 2 doses are prescribed, spray each nostril 1 time.\n \n " ], "text": "" }

{ "type": "ul", "children": [ "\nStep 4.Put the protective cap back on the spray nozzle tip when you finish using your desmopressin nasal spray.\n \n " ], "text": "" }

Keeping track of your Nasal Sprays:

{ "type": "p", "children": [], "text": "\nKeeping track of your Nasal Sprays:\n" }

{ "type": "ul", "children": [ "Use the check-off chart to help you keep track of the number of sprays of desmopressin nasal spray solution used (see Figure G)." ], "text": "" }

{ "type": "ul", "children": [ "Keep this chart with your desmopressin nasal spray solution or put it in a place where you can easily get it.", "Check off number 1 on the chart with your first dose of desmopressin nasal spray solution. Check off the numbers after each use of your desmopressin nasal spray solution. If your healthcare provider prescribed a dose of 2 sprays, then 2 numbers should be checked off.", "Your desmopressin nasal spray solution holds 50 sprays with the right amount of medicine in each spray.", "If any medicine is left in your desmopressin nasal spray solution after 50 sprays,\n \n do notuse it. You may not get the right amount of medicine.\n \n ", "Throw away your desmopressin nasal spray solution after 50 sprays.", "\nDo notcount the priming sprays. Your desmopressin nasal spray solution has been filled with extra medicine for your priming sprays.\n \n ", "\nDo nottry to remove any medicine from your desmopressin nasal spray solution pump and place it in another bottle.\n \n " ], "text": "" }

How should I store desmopressin nasal spray solution?

{ "type": "p", "children": [], "text": "\nHow should I store desmopressin nasal spray solution?\n" }

{ "type": "ul", "children": [ "Store desmopressin nasal spray solution in the refrigerator between 36°F to 46°F (2°C to 8°C).", "When traveling, desmopressin nasal spray solution can be stored at room temperature up to 72°F (22°C) for up to 3 weeks.", "Store desmopressin nasal spray solution standing upright." ], "text": "" }

Distributed by:

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

Oceanside Pharmaceuticals, a division of

{ "type": "p", "children": [], "text": "Oceanside Pharmaceuticals, a division of" }

Bausch Health US, LLC

{ "type": "p", "children": [], "text": "Bausch Health US, LLC" }

Bridgewater, NJ 08807 USA

{ "type": "p", "children": [], "text": "Bridgewater, NJ 08807 USA" }

Manufactured by:

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

Bausch Health Companies Inc.

{ "type": "p", "children": [], "text": "Bausch Health Companies Inc." }

Laval, Quebec H7L 4A8, Canada

{ "type": "p", "children": [], "text": "Laval, Quebec H7L 4A8, Canada" }

© 2025 Bausch Health Companies Inc. or its affiliates Revised: May 2025

{ "type": "p", "children": [], "text": "© 2025 Bausch Health Companies Inc. or its affiliates Revised: May 2025" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration. 90005300

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration. 90005300" }

NDC68682-342-05

{ "type": "p", "children": [], "text": "\nNDC68682-342-05\n\n " }

Desmopressin Nasal Spray Solution USP, 10 mcg/0.1 mL

{ "type": "p", "children": [], "text": "\nDesmopressin\n\nNasal Spray\n\nSolution USP,\n\n10 mcg/0.1 mL\n" }

FOR INTRANASAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR INTRANASAL\n\nUSE ONLY\n" }

50 sprays 10 mcg per spray

{ "type": "p", "children": [], "text": "\n50 sprays\n\n10 mcg per spray\n" }

Rx only

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

5 mL

{ "type": "p", "children": [], "text": "\n5 mL\n" }

Oceanside Pharmaceuticals

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

Desmopressin nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older

{ "type": "p", "children": [], "text": "Desmopressin nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older\n" }

Limitations of Use:

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

Desmopressin nasal spray is not indicated for:

{ "type": "p", "children": [], "text": " Desmopressin nasal spray is not indicated for:" }

{ "type": "ul", "children": [ "Treatment of nephrogenic diabetes insipidus,", "Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)],\n", "Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)].\n", "Use in patients with an impaired level of consciousness,", "Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)].\n" ], "text": "" }

Administer desmopressin nasal spray by intranasal use only. Instruct patients about appropriate fluid restriction during desmopressin nasal spray treatment [see Warnings and Precautions (5.1)].

Must prime the spray pump prior to the first use. Instruct patients to:

The use of desmopressin nasal spray is not indicated for patients who require less than 10 mcg doses or doses that are not multiples of 10 mcg because the spray pump can only deliver doses of 10 mcg [see Indications and Usage (1)]. If other doses are required, use another desmopressin acetate product.

 Individualize the dosage of desmopressin nasal spray for each patient with particular attention in pediatric and elderly patients and adjust according to the diurnal pattern of response to limit nocturia and to ensure fluid intake with respect to urine output is not excessive [see Warnings and Precautions (5.1)]. Monitor continued response to desmopressin nasal spray by urine volume and osmolality to ensure adequate diuresis to limit the risk of hyponatremia, and include measurements of serum sodium and plasma osmolality as needed.  

Adults 

The recommended dosage in adults is 10 mcg once daily into one nostril up to 40 mcg once daily (or 40 mcg divided into two or three daily doses). If administered more than once a day, adjust for an adequate diurnal rhythm of urine output.  

Pediatric Patients 

Because administration of desmopressin acetate can be associated with decreased responsiveness with prolonged use, consider increasing the dosage of desmopressin nasal spray if patients demonstrate decreased response over a long period of time.

When switching from the desmopressin acetate injection to desmopressin nasal spray, administer 10 times the amount of desmopressin acetate, rounding down to the nearest 10 mcg.   When switching from the desmopressin acetate tablets to desmopressin nasal spray individual dose titration is required because intranasal desmopressin is approximately 10 to 40 fold more potent than oral (tablet) desmopressin.

Desmopressin nasal spray pump delivers 10 mcg (0.1 mL) of desmopressin acetate per spray. Desmopressin nasal spray is available as a 5 mL bottle with spray pump delivering 50 sprays.

{ "type": "p", "children": [], "text": "Desmopressin nasal spray pump delivers 10 mcg (0.1 mL) of desmopressin acetate per spray. Desmopressin nasal spray is available as a 5 mL bottle with spray pump delivering 50 sprays." }

Desmopressin nasal spray is contraindicated in patients with:

{ "type": "p", "children": [], "text": "Desmopressin nasal spray is contraindicated in patients with:" }

{ "type": "ul", "children": [ "Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray. Severe allergic reactions and anaphylaxis have been reported [see Adverse Reactions (6)].", "Renal impairment defined as estimated creatinine clearance (CLcr) by Cockcroft-Gault equation less than 50 mL/min [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].\n", "Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)].\n" ], "text": "" }

Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated, hyponatremia can be fatal.  

All patients receiving desmopressin nasal spray should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness, and confusion. Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma, and/or respiratory arrest.  

In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. Careful fluid intake restriction is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [see Use in Specific Populations (8.4, 8.5)]. More frequent monitoring of serum sodium levels is recommended in the following patients: those with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, renal disorders, habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia [see Drug Interactions (7.1)].

Desmopressin nasal spray is not an indicated formulation for the treatment of primary nocturnal enuresis due to a higher risk of hyponatremia and hyponatremic convulsions with the use of the nasal spray formulation compared to desmopressin tablets seen in postmarketing reports [see Indications and Usage (1)].

Chronic administration of desmopressin nasal spray may result in changes to nasal mucosa. Nasal mucosa abnormalities (such as scarring and edema) due to chronic administration, or due to other causes (nasal blockage, nasal mucosal atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) may cause erratic, unreliable absorption. Avoid use of desmopressin nasal spray in such patients [see Indications and Usage (1)] and consider use of other formulations of desmopressin acetate given by other routes of administration.

The following serious reactions are described below and elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following serious reactions are described below and elsewhere in the labeling:" }

{ "type": "ul", "children": [ "Hyponatremia [see Warnings and Precautions (5.1)].\n", "Altered Absorption in Patients with Changes in Nasal Mucosa [see Warnings and Precautions (5.2)].\n" ], "text": "" }

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

{ "type": "p", "children": [], "text": "The following adverse reactions have been identified during post-approval use of desmopressin acetate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:   " }

Increase in blood pressure, headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and abdominal cramps.  

{ "type": "p", "children": [], "text": " Increase in blood pressure, headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and abdominal cramps.   " }

Water intoxication with hyponatremia  

{ "type": "p", "children": [], "text": "Water intoxication with hyponatremia   " }

Hyponatremic convulsions associated with concomitant use of the following medications: oxybutinin and imipramine [see Drug Interactions (7.1)].  

{ "type": "p", "children": [], "text": " Hyponatremic convulsions associated with concomitant use of the following medications: oxybutinin and imipramine [see Drug Interactions (7.1)].   " }

Severe allergic reactions and anaphylaxis [see Contraindications (4)]

{ "type": "p", "children": [], "text": "Severe allergic reactions and anaphylaxis [see Contraindications (4)]\n" }

The concomitant administration of desmopressin nasal spray with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine, oxybutynin and carbamazepine) requires more frequent serum sodium monitoring [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

Desmopressin acetate can elevate blood pressure. Use of large doses of desmopressin nasal spray with other vasoconstrictors may require a reduction of the desmopressin dosage [see Adverse Reactions (6)].

Risk summary 

Prolonged experience with desmopressin in pregnant women over several decades, based on the available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m2) (see Data).  

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.  

Data 

Animal Data Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects. Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m2).

Risk Summary   

Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal intranasal administration. Desmopressin is poorly transferred into human breastmilk at negligible amounts (see Data). There is no information on the effects of desmopressin on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for desmopressin nasal spray and any potential adverse effects on the breastfed infant from desmopressin nasal spray or from the underlying maternal condition.

Data

A trial was conducted in six healthy lactating women, at greater than 4 months postpartum, to evaluate intranasal administration of 300 mcg single dose of another desmopressin product (7.5 times the recommended adult dose of desmopressin nasal spray). Samples of maternal plasma and breastmilk were obtained at 0, 30, 60, 120, 240, 360 and 480 min after the drug administration. At 8 hours after dose intake, the levels in the milk ranged between 4.16 and 101 pg/ml, and the plasma levels ranged between 40 and 242 pg/ml. The total amount of desmopressin present in the milk over the 8 hours ranged between 491 pg and 16 ng, which corresponds to 0.0001 to 0.005% of the administered dose to the breastfeeding mother.

Desmopressin nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in pediatric patients 4 years of age and older. Desmopressin nasal spray is not indicated in pediatric patients less than 4 years of age.  

Use of desmopressin nasal spray in pediatric patients 4 years of age and older is supported by evidence from adults and pediatric patients with central diabetes insipidus. Use in pediatric patients requires careful fluid intakerestriction to prevent possible waterintoxication with hyponatremia [see Warnings and Precautions (5.1)].

Clinical studies ofdesmopressin nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at a low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.  

Because elderly patients are more likely to have renal impairment, care should be taken in dose selection, and monitoring renal function is recommended [see Contraindications (4), Use in Specific Populations (8.6)].  

Use of desmopressin nasal spray in geriatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions (5.1)].

Desmopressin acetate is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment than patients with normal renal function. Desmopressin nasal spray is contraindicated in patients with estimated CLcr by Cockcroft-Gault equation less than 50 mL/min [see Clinical Pharmacology (12.1, 12.3), Contraindications (4)].

Signs of desmopressin acetate overdosage may include confusion, drowsiness, continuing headache, problems with passing urine, and rapid weight gain due to fluid retention [see Warnings and Precautions (5.1)]. In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue desmopressin nasal spray. There is no known specific antidote for desmopressin acetate.

{ "type": "p", "children": [], "text": "Signs of desmopressin acetate overdosage may include confusion, drowsiness, continuing headache, problems with passing urine, and rapid weight gain due to fluid retention [see Warnings and Precautions (5.1)]. In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue desmopressin nasal spray. There is no known specific antidote for desmopressin acetate." }

Desmopressin nasal spray, USP is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:

{ "type": "p", "children": [], "text": "Desmopressin nasal spray, USP is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:" }

Mol. wt. 1183.34 g/mol  

{ "type": "p", "children": [], "text": "Mol. wt. 1183.34 g/mol   " }

Molecular formula: C46H64N14O12S2 • C2H4O2 • 3H2O

{ "type": "p", "children": [], "text": " Molecular formula: C46H64N14O12S2 • C2H4O2 • 3H2O\n" }

Chemical name: 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.  

{ "type": "p", "children": [], "text": " Chemical name: 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.  " }

Desmopressin nasal spray, USP is provided as an aqueous solution for intranasal use.

{ "type": "p", "children": [], "text": " Desmopressin nasal spray, USP is provided as an aqueous solution for intranasal use." }

<div class="scrollingtable"><table frame="box" rules="all"> <tbody class="Headless"> <tr class="First"> <td> Each mL contains: </td> </tr> <tr> <td> Desmopressin acetate 0.1 mg </td> </tr> <tr> <td></td> </tr> <tr> <td> Inactive: </td> </tr> <tr> <td></td> </tr> <tr> <td> Benzalkonium chloride solution (50% w/v) 0.2 mg </td> </tr> <tr> <td> Citric acid monohydrate 1.7 mg </td> </tr> <tr> <td> Sodium chloride 7.5 mg </td> </tr> <tr> <td> Sodium phosphate dibasic heptahydrate  4.52 mg </td> </tr> <tr class="Last"> <td> Purified water to 1 mL </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table frame=\"box\" rules=\"all\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td> Each mL contains: </td>\n</tr>\n<tr>\n<td> Desmopressin acetate 0.1 mg </td>\n</tr>\n<tr>\n<td></td>\n</tr>\n<tr>\n<td> Inactive: </td>\n</tr>\n<tr>\n<td></td>\n</tr>\n<tr>\n<td> Benzalkonium chloride solution (50% w/v) 0.2 mg </td>\n</tr>\n<tr>\n<td> Citric acid monohydrate 1.7 mg </td>\n</tr>\n<tr>\n<td> Sodium chloride 7.5 mg </td>\n</tr>\n<tr>\n<td> Sodium phosphate dibasic heptahydrate  4.52 mg </td>\n</tr>\n<tr class=\"Last\">\n<td> Purified water to 1 mL </td>\n</tr>\n</tbody>\n</table></div>" }

The desmopressin nasal spray, USP compression pump delivers 0.1 mL (10 mcg) of desmopressin acetate per spray.

{ "type": "p", "children": [], "text": "The desmopressin nasal spray, USP compression pump delivers 0.1 mL (10 mcg) of desmopressin acetate per spray." }

The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.

The use of desmopressin nasal spray in patients with central diabetes insipidus reduces urinary output, increases urine osmolality, and decreases plasma osmolality.

Absorption: Desmopressin acetate is absorbed through the nasal mucosa.  

Elimination: Desmopressin acetate exhibits a biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes for the initial and terminal phases, respectively.  

Specific Populations

Renal Impairment: Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single 2 mcg dose of desmopressin acetate injection (this results in approximately 20 times the exposure of 10 mcg of desmopressin nasal spray). The terminal half-life was 2.8 hours in subjects with normal renal function, 4.0 hours in mild renal impairment, 6.6 hours in moderate renal impairment and 8.7 hours in severe renal impairment. In patients with mild, moderate and severe renal impairment, mean desmopressin exposure was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function [see Contraindications (4), Use in Specific Populations (8.6)].

Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

16.1 How Supplied

{ "type": "p", "children": [], "text": "16.1 How Supplied" }

Desmopressin nasal spray, USP is available in a 5 mL bottle with a nasal spray pump dispenser with dust cover and patient instruction sheet delivering 50 sprays of 10 mcg.

{ "type": "p", "children": [], "text": "Desmopressin nasal spray, USP is available in a 5 mL bottle with a nasal spray pump dispenser with dust cover and patient instruction sheet delivering 50 sprays of 10 mcg." }

NDC: 72162-2129-2: 50 Sprays (5 mL) in a BOTTLE, SPRAY.

{ "type": "p", "children": [], "text": "NDC: 72162-2129-2: 50 Sprays (5 mL) in a BOTTLE, SPRAY." }

16.2 Storage and Handling

{ "type": "p", "children": [], "text": "16.2 Storage and Handling" }

Store at 25°C (77°F) [see USP Controlled Room Temperature]; excursions permitted from 15°C to 30°C (59°F to 86°F).AFTER ASSEMBLY, STORE UPRIGHT.

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

Keep out of the reach of children.

{ "type": "p", "children": [], "text": "Keep out of the reach of children." }

Repackaged/Relabeled by:

{ "type": "p", "children": [], "text": "Repackaged/Relabeled by:" }

Bryant Ranch Prepack, Inc.

{ "type": "p", "children": [], "text": "Bryant Ranch Prepack, Inc." }

Burbank, CA 91504

{ "type": "p", "children": [], "text": "Burbank, CA 91504" }

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)  

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

Administration

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

{ "type": "ul", "children": [ "Inform caregivers for pediatric patients that administration should be supervised to ensure the patient receives the prescribed dose. ", "Inform patients that the pump must be primed prior to first use and again if not used for greater than one week. Inform patients that thedesmopressin nasal spraybottle delivers 50 sprays of 10 mcg each following the initial 4 priming pumps.", "Inform patients to discard any solution remaining after 50 sprays since the amount delivered thereafter may be substantially less than 10 mcg of drug.\nMonitoring\n\n" ], "text": "" }

{ "type": "ul", "children": [ "Educate patients about the signs and symptoms of hyponatremia and advise them to contact a healthcare provider if such symptoms occur.", "Discuss downward adjustment of fluid intake and monitoring of urine output with patients.\n" ], "text": "" }

APOTEX INC.

{ "type": "p", "children": [], "text": "\nAPOTEX INC.\n" }

Desmopressin Nasal Spray, USP

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray, USP \n" }

10 mcg/ 0.1 mL 

{ "type": "p", "children": [], "text": "\n10 mcg/ 0.1 mL \n" }

<div class="scrollingtable"><table frame="box" rules="all"> <tbody class="Headless"> <tr class="First Last"> <td><span class="Bold">Manufactured by</span> <br/>Apotex Inc. Toronto, <br/>Ontario Canada M9L 1T9 </td><td><span class="Bold">Manufactured for</span> <br/> Apotex Corp. Weston, <p class="First"></p>Florida 33326 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table frame=\"box\" rules=\"all\">\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td><span class=\"Bold\">Manufactured by</span>\n<br/>Apotex Inc. Toronto, <br/>Ontario Canada M9L 1T9 </td><td><span class=\"Bold\">Manufactured for</span>\n<br/> Apotex Corp. Weston, <p class=\"First\"></p>Florida 33326 </td>\n</tr>\n</tbody>\n</table></div>" }

September 2022

{ "type": "p", "children": [], "text": "September 2022\n" }

Desmopressin Nasal Spray, USP 10 mcg per 0.1 mL

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray, USP 10 mcg per 0.1 mL \n" }

(des·mo·pres·sin)

{ "type": "p", "children": [], "text": "\n(des·mo·pres·sin)\n" }

For Intranasal Use Only

{ "type": "p", "children": [], "text": " For Intranasal Use Only" }

What is desmopressin nasal spray?

{ "type": "p", "children": [], "text": "\nWhat is desmopressin nasal spray? \n" }

Desmopressin nasal spray is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus.

{ "type": "p", "children": [], "text": " Desmopressin nasal spray is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus." }

{ "type": "ul", "children": [ "Desmopressin nasal spray is not effective in the treatment of nephrogenic diabetes insipidus.", "Desmopressin nasal spray should not be used in people with nasal problems that may keep them from using a nasal spray." ], "text": "" }

Who should not use desmopressin nasal spray?

{ "type": "p", "children": [], "text": "\nWho should not use desmopressin nasal spray?\n" }

Do not use desmopressin nasal spray if you:

{ "type": "p", "children": [], "text": "\nDo not use desmopressin nasal spray if you:\n" }

{ "type": "ul", "children": [ "are allergic to desmopressin or any of the ingredients in desmopressin nasal spray. Some people have had severe allergic reactions while taking desmopressin nasal spray. See the end of this Patient Information for a complete list of ingredients in desmopressin nasal spray.", "have kidney problems\n", "have or have had low levels of sodium in your blood (hyponatremia)" ], "text": "" }

What should I tell my healthcare provider before using desmopressin nasal spray? Before using desmopressin nasal spray, tell your healthcare provider about all your medical conditions including if you:

{ "type": "p", "children": [], "text": "\nWhat should I tell my healthcare provider before using desmopressin nasal spray? Before using desmopressin nasal spray, tell your healthcare provider about all your medical conditions including if you:\n" }

{ "type": "ul", "children": [ "have or have had nasal sores, nasal surgery, nasal injury, or have problems such as a stuffy nose or trouble breathing through your nose.", "have or have had any heart, blood circulation, or blood pressure problems", "have a condition that causes fluid or water imbalance problems such as cystic fibrosis, or heart failure.", "have or have had a condition that causes you to be very thirsty", "are pregnant or plan to become pregnant. It is not known if desmopressin will harm your unborn baby.", "are breastfeeding or plan to breastfeed. It is not known if desmopressin passes into your breast milk. You and your healthcare provider should decide if you will use desmopressin nasal spray." ], "text": "" }

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  

{ "type": "p", "children": [], "text": "Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.   \n" }

How should I use desmopressin nasal spray?

{ "type": "p", "children": [], "text": "\nHow should I use desmopressin nasal spray?\n" }

{ "type": "ul", "children": [ " Read the Instructions for Use that comes with your desmopressin nasal spray. ", " Use desmopressin nasal spray exactly as your healthcare provider tells you to use it. ", " Your healthcare provider may change your dose of desmopressin nasal spray if needed." ], "text": "" }

What are the possible side effects of desmopressin nasal spray?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of desmopressin nasal spray?\n" }

Desmopressin nasal spray may cause serious side effects including:

{ "type": "p", "children": [], "text": "\nDesmopressin nasal spray may cause serious side effects including:\n" }

{ "type": "ul", "children": [ "\nlow levels of sodium in the blood (hyponatremia). People using desmopressin nasal spray are at risk for low sodium levels in the blood, water intoxication, and fluid overload. Follow your healthcare provider’s instructions on limiting the amount of fluid you can drink when using desmopressin nasal spray. ", "\nDo not drink more than you need to satisfy your thirst. You can have serious side effects such as seizures, coma, and death from drinking too much fluid. ", "Children and the elderly are at higher risk for these problems and should follow their healthcare provider’s limits on drinking fluids. ", "Call your healthcare provider right away if you have any of the following symptoms while using desmopressin nasal spray. They may mean that your blood sodium level is too low.   ", "headache ", "nausea, vomiting ", " weight gain ", " restlessness ", " tiredness ", "sleepiness ", "disorientation ", " loss of appetite ", "feeling irritable ", " feeling weak ", "muscle cramps ", "hallucinations ", " confusion ", "\nnasal scarring or swelling. Some people using desmopressin nasal spray for long periods of time may have nasal problems such as scarring or swelling. This may affect how well desmopressin nasal spray works for you. The most common side effects of desmopressin nasal spray include: headache, stuffy nose, runny nose, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and stomach cramps. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." ], "text": "" }

General information about the safe and effective use of desmopressin nasal spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use desmopressin nasal spray for a condition for which it was not prescribed. Do not give desmopressin nasal spray to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about desmopressin nasal spray that is written for health professionals. For more information call Apotex Corp. at 1-800-706-5575.  

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of desmopressin nasal spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use desmopressin nasal spray for a condition for which it was not prescribed. Do not give desmopressin nasal spray to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about desmopressin nasal spray that is written for health professionals. For more information call Apotex Corp. at 1-800-706-5575.   \n" }

What are the ingredients in desmopressin nasal spray?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in desmopressin nasal spray? \n" }

Active ingredient: desmopressin acetate  

{ "type": "p", "children": [], "text": "\nActive ingredient: desmopressin acetate   \n" }

Inactive ingredients: benzalkonium chloride solution (50% w/v), citric acid monohydrate, sodium chloride, sodium phosphate dibasic heptahydrate, and purified water  

{ "type": "p", "children": [], "text": "\nInactive ingredients: benzalkonium chloride solution (50% w/v), citric acid monohydrate, sodium chloride, sodium phosphate dibasic heptahydrate, and purified water   " }

This Patient Information has been approved by the Food and Drug Administration   

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the Food and Drug Administration    \n" }

APOTEX INC.

{ "type": "p", "children": [], "text": "\nAPOTEX INC.\n" }

Desmopressin Nasal Spray, USP 10 mcg/ 0.1 mL

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray, USP 10 mcg/ 0.1 mL \n" }

<div class="scrollingtable"><table frame="box" rules="all"> <tbody class="Headless"> <tr class="First Last"> <td><span class="Bold">Manufactured by</span> <br/> Apotex Inc. Toronto, <br/>Ontario Canada M9L 1T9 </td><td><span class="Bold">Manufactured for</span> <br/> Apotex Corp. <br/> Weston, Florida <br/>33326 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table frame=\"box\" rules=\"all\">\n<tbody class=\"Headless\">\n<tr class=\"First Last\">\n<td><span class=\"Bold\">Manufactured by</span>\n<br/> Apotex Inc. Toronto, <br/>Ontario Canada M9L 1T9 </td><td><span class=\"Bold\">Manufactured for</span>\n<br/> Apotex Corp. <br/> Weston, Florida <br/>33326 </td>\n</tr>\n</tbody>\n</table></div>" }

September 2022

{ "type": "p", "children": [], "text": "September 2022\n" }

Desmopressin Nasal Spray, USP 10 mcg per 0.1 mL

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray, USP 10 mcg per 0.1 mL\n" }

For Intranasal Use Only

{ "type": "p", "children": [], "text": "\nFor Intranasal Use Only \n" }

Read these instructions before using desmopressin nasal spray, 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.  

{ "type": "p", "children": [], "text": " Read these instructions before using desmopressin nasal spray, 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.   \n" }

Instruction For Assembly of Spray Pump

{ "type": "p", "children": [], "text": "\nInstruction For Assembly of Spray Pump\n" }

Assemble desmopressin nasal spray, USP, 0.01% prior to dispensing to the patient, according to the following instructions:

{ "type": "p", "children": [], "text": " Assemble desmopressin nasal spray, USP, 0.01% prior to dispensing to the patient, according to the following instructions: " }

1. Open the carton and remove the spray pump and solution bottle. 

{ "type": "p", "children": [], "text": "1. Open the carton and remove the spray pump and solution bottle. " }

2. Assemble the desmopressin nasal spray solution by unscrewing the white cap from the solution bottle and screwing the spray pump tightly onto the bottle. Make sure the protective cap is on the spray pump.

{ "type": "p", "children": [], "text": "2. Assemble the desmopressin nasal spray solution by unscrewing the white cap from the solution bottle and screwing the spray pump tightly onto the bottle. Make sure the protective cap is on the spray pump." }

3. Return desmopressin nasal spray solution bottle to the carton for dispensing to the patient.

{ "type": "p", "children": [], "text": "3. Return desmopressin nasal spray solution bottle to the carton for dispensing to the patient. " }

Children should be helped by an adult when using desmopressin nasal spray, to make sure the right amount of medicine is used.

{ "type": "p", "children": [], "text": "\nChildren should be helped by an adult when using desmopressin nasal spray, to make sure the right amount of medicine is used. \n" }

The parts of your desmopressin nasal spray pump (see Figure A):

{ "type": "p", "children": [], "text": "\nThe parts of your desmopressin nasal spray pump (see Figure A):\n" }

Priming your desmopressin nasal spray:

{ "type": "p", "children": [], "text": "\nPriming your desmopressin nasal spray: \n" }

Your desmopressin nasal spray pump must be primed before you use it for the first time.

{ "type": "p", "children": [], "text": " Your desmopressin nasal spray pump must be primed before you use it for the first time.\n" }

{ "type": "ul", "children": [ "Remove the protective cap (see Figure B).\n\n\n" ], "text": "" }

{ "type": "ul", "children": [ "Press down on the shoulders at the top of your desmopressinnasal spray pump 4 times. Hold the spray tip away from your face and eyes (see Figure C).\n\n\n\n" ], "text": "" }

{ "type": "ul", "children": [ "After your desmopressin nasal spray pump is primed, it will spray 10micrograms (1 dose) of medicine each time it is pressed. \n" ], "text": "" }

Using your desmopressin nasal spray:

{ "type": "p", "children": [], "text": "\nUsing your desmopressin nasal spray:\n" }

Step 1. Remove the protective cap.

{ "type": "p", "children": [], "text": "\nStep 1. Remove the protective cap. \n" }

Step 2. To make sure you get the right dose of medicine tilt your desmopressin nasal spray pump so the dip tubeinside the bottle draws the medicine up from the deepest part of themedicine inside the bottle (see Figures D and E).

{ "type": "p", "children": [], "text": "\nStep 2. To make sure you get the right dose of medicine tilt your desmopressin nasal spray pump so the dip tubeinside the bottle draws the medicine up from the deepest part of themedicine inside the bottle (see Figures D and E)." }

Step 3. Put the spray nozzle tip of your desmopressin nasal spray into your nostril and press the spray pump 1 time for 1 dose. (see Figure F). If 2 doses are prescribed, spray each nostril 1 time.

{ "type": "p", "children": [], "text": "\nStep 3. Put the spray nozzle tip of your desmopressin nasal spray into your nostril and press the spray pump 1 time for 1 dose. (see Figure F). If 2 doses are prescribed, spray each nostril 1 time. " }

Step 4. Put the protective cap back on the spray nozzle tip when you finish using your desmopressin nasal spray.  

{ "type": "p", "children": [], "text": "\nStep 4. Put the protective cap back on the spray nozzle tip when you finish using your desmopressin nasal spray.   \n" }

Keeping track of your Nasal Sprays:

{ "type": "p", "children": [], "text": "\nKeeping track of your Nasal Sprays: \n" }

{ "type": "ul", "children": [ "Use the check-off chartto help you keep track of your desmopressin nasal sprays used (see Figure G)." ], "text": "" }

Desmopressin Nasal Spray

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray \n" }

50-Spray Check-off Chart

{ "type": "p", "children": [], "text": "\n50-Spray Check-off Chart \n" }

{ "type": "ul", "children": [ "Keep this chart with your desmopressin nasal spray or put it someplace where you can easily get it.", "Check off number 1 on the chart with your first dose of desmopressin nasal spray. Check off the numbers after each use of your desmopressin nasal spray. If your healthcare provider prescribed a 2-spray dose, then 2 numbers should be checked off.", "Your desmopressin nasal spray holds 50 sprays with the right amount of medicine in each spray.", "If any medicine is left in your desmopressin nasal spray after 50 sprays, do not use it. You may not get the right amount of medicine.", "Throw away your desmopressin nasal spray after 50 sprays.\n", "\nDo not count the priming sprays. Your desmopressin nasal spray has been filled with extra medicine for your priming sprays.\n", "\nDo not try toremove any medicine from your desmopressin nasal spray pump and place it in another bottle." ], "text": "" }

How should I store desmopressinnasal spray?

{ "type": "p", "children": [], "text": "\nHow should I store desmopressinnasal spray? \n" }

Store at 25°C (77°F) [see USP Controlled Room Temperature]; excursions permitted from 15°C to 30°C (59°F to 86°F).AFTER ASSEMBLY, STORE UPRIGHT.

{ "type": "p", "children": [], "text": " Store at 25°C (77°F) [see USP Controlled Room Temperature]; excursions permitted from 15°C to 30°C (59°F to 86°F).AFTER ASSEMBLY, STORE UPRIGHT.\n" }

Keep out of the reach of children. 

{ "type": "p", "children": [], "text": "Keep out of the reach of children.  \n" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "\nThis Instructions for Use has been approved by the U.S. Food and Drug Administration. \n" }

APOTEX INC.

{ "type": "p", "children": [], "text": "\nAPOTEX INC.\n" }

Desmopressin Nasal Spray, USP 10 mcg/ 0.1 mL

{ "type": "p", "children": [], "text": "\nDesmopressin Nasal Spray, USP 10 mcg/ 0.1 mL\n" }

<div class="scrollingtable"><table frame="box" rules="all"> <tbody class="Headless"> <tr class="First Last"> <td><span class="Bold">Manufactured by</span> <br/>Apotex Inc. Toronto, <br/>Ontario Canada M9L 1T9 </td><td><span class="Bold">Manufactured for</span> <br/> Apotex Corp. Weston, <br/>Florida 33326 </td> </tr> </tbody> </table></div>

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September 2022

{ "type": "p", "children": [], "text": "September 2022\n" }

Desmopressin 10 mcg/0.1 mL Spray #5mL

{ "type": "p", "children": [], "text": "Desmopressin 10 mcg/0.1 mL Spray #5mL" }