Ddavp Tablets

— THERAPEUTIC CATEGORIES —
  • Overactive bladder/enuresis
  • Pituitary disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ddavp Tablets Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Desmopressin acetate 0.1mg, 0.2mg; scored tabs.

    Pharmacological Class

    Vasopressin (synthetic).

    See Also

      How Supplied

      Tabs—100

      Storage

      DDAVP Tablets

      • Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. Avoid exposure to excessive heat or light. This product should be dispensed in a container with a child-resistant cap.

      Manufacturer

      Ferring Pharmaceuticals, Inc.

      Ddavp Tablets Indications

      Indications

      Primary nocturnal enuresis.

      Indications

      Management of primary nocturnal enuresis.

      • May be used alone or as an adjunct to behavioral conditional or other non-pharmacologic intervention.

      Limitations of Use

      Use is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

      Ddavp Tablets Dosage and Administration

      Adults and Children

      <6yrs: not recommended. Individualize. ≥6yrs: initially 0.2mg once daily at bedtime; max 0.6mg.

      Elderly

      Use caution for dose selection in elderly patients, 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.

      Ddavp Tablets Contraindications

      Contraindications

      Moderate to severe renal impairment (CrCl <50mL/min). Hyponatremia, or history of.

      Ddavp Tablets Boxed Warnings

      Not Applicable

      Ddavp Tablets Warnings/Precautions

      Warnings/Precautions

      Monitor fluid intake, urine volume and osmolality. Fluid/electrolyte imbalance (eg, cystic fibrosis). Habitual or psychogenic polydipsia. Coronary artery insufficiency. Hypertension. Supervise admin in children. Elderly. Pregnancy. Nursing mothers.

      Warnings/Precautions

      DDAVP Tablets

      • Can cause hyponatremia, which may be life-threatening if not promptly diagnosed and treated. Administration of DDAVP may lead to water intoxication and/or hyponatremia. 

      • Fluid restriction is recommended, and careful medical supervision is required. When DDAVP Tablets are administered, especially in pediatric and elderly patients, adjust fluid intake downward to decrease the potential for water intoxication and hyponatremia.

      • Monitor all patients for signs or symptoms of hyponatremia, especially for the rare occurrence of an extreme decrease in plasma osmolality resulting in seizures and possibly coma.

      • Use caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, which increases the risk of hyponatremia.

      • Use caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease due to a possible increase in blood pressure. 

      • Use caution in patients with conditions associated with fluid and electrolyte imbalance (eg, cystic fibrosis, heart failure, renal disorders) due to increased risk of hyponatremia.

      • Severe allergic reactions including anaphylaxis have been reported rarely with IV and intranasal administration of DDAVP but not with DDAVP Tablets.

      • Monitor laboratory tests for patients with central diabetes insipidus or postsurgical or head trauma-related polyuria and polydipsia, including urine volume and osmolality.

      Pregnancy Considerations

      DDAVP Tablets

      Pregnancy Category B

      • There have been no adequate and well-controlled studies in pregnant women.

      • DDAVP Tablets should be used during pregnancy only if clearly needed because animal studies are not always predictive of human response.

       

      Nursing Mother Considerations

      DDAVP Tablets

      • There have been no controlled studies in nursing mothers.

      • It is not known whether the drug is excreted in human milk. 

      • Exercise caution when DDAVP is administered to nursing mothers.

      Pediatric Considerations

      DDAVP Tablets

      Primary Nocturnal Enuresis

      • DDAVP Tablets were used safely in pediatric patients 6 years of age and older for period up to 6 months. Some patients may response to 0.2 mg dose, but increased responses are seen at 0.4–0.6 mg doses.

      • Individually adjust dose for optimal results.

      • Interrupt treatment during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (eg, systemic infections, fever, recurrent vomiting or diarrhea) or under conditions of extremely hot weather, vigorous exercise or other conditions associated with increased water intake.

      Geriatric Considerations

      Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. May be useful to monitor renal function.

      Use in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient.

      Renal Impairment Considerations

      Desmopressin acetate is substantially excreted by the kidney. 

      DDAVP is contraindicated in patients with CrCl<50mL/min.

      Ddavp Tablets Pharmacokinetics

      Absorption

      Bioavailability of DDAVP oral tablets is ~5% compared to intranasal DDAVP, and ~0.16% compared to DDAVP IV. The time to reach maximum plasma DDAVP levels ranged from 0.9 to 1.5 hours following oral or intranasal administration, respectively.

      Elimination

      Renal. Mean terminal half-life is 2.8 hours.

      Ddavp Tablets Interactions

      Interactions

      Caution with other pressor agents, drugs that may increase the risk of water intoxication with hyponatremia (eg, tricyclic antidepressants, SSRIs, chlorpromazine, opiates, NSAIDs, lamotrigine, carbamazepine). Possible convulsions with oxybutynin, imipramine.

      Ddavp Tablets Adverse Reactions

      Adverse Reactions

      Headache, water intoxication, hyponatremia; rare: seizures in children from plasma hypoosmolality.

      Adverse Reactions

      DDAVP Tablets

      Central Diabetes Insipidus

      • Long-term clinical studies for periods up to 44 months with DDAVP Tablets have occasionally shown transient increases in AST (SGOT) no higher than 1.5 times the ULN. The elevated AST (SGOT) levels returned to the normal range despite continued use of DDAVP Tablets.

      Primary Nocturnal Enuresis

      • Only adverse event probably, possibly, or remotely related to DDAVP Tablets in clinical trials was headache (4% DDAVP; 3% placebo).

      Other

      • Abnormal thinking, diarrhea, and edema-weight gain have been reported, but their relationship to DDAVP has not been established.

      • Possibility of water intoxication and hyponatremia.

      Post-Marketing

      • Rare reports of hyponatremic convulsions have been reported and associated with concomitant use with oxybutynin and imipramine.

      Ddavp Tablets Clinical Trials

      Clinical Trials

      DDAVP Tablets

      Primary Nocturnal Enuresis – 2 double-bind, randomized, placebo-controlled studies

      • DDAVP Tablets was evaluated in 340 patients 5 to 17 years of age with primary nocturnal enuresis. A total of 329 patients were evaluated for efficacy. Patients were randomly assigned to receive 0.2, 0.4, or 0.6 mg of DDAVP or placebo.

      • The DDAVP Tablets treatment arm achieved a statistically significant reduction in the number of wet nights compared with the placebo arm. There was a greater response observed with increasing doses up to 0.6 mg.

      Primary Nocturnal Enuresis – Open-label extension study

      • In the 6-month study, a total of 230 patients who completed the placebo-controlled studies were evaluated for efficacy starting on 0.2 mg/day DDAVP. The dose was increased until the optimal response was achieved (max 0.6 mg/day). 86% of patients required titration to the highest dose.

      • 25 patients (11%) achieved a complete or near complete response (less than or equal to 2 wet nights every 2 weeks) and did not require titration to 0.6 mg/day.

      • 128 patients (56%) showed at least a 50% reduction from baseline in the number of wet nights every 2 weeks, and 87 patients (38%) achieved a complete or near complete response.

      Ddavp Tablets Note

      Not Applicable

      Ddavp Tablets Patient Counseling

      See Literature

      Ddavp Tablets Generic Name & Formulations

      Legal Class

      Rx

      General Description

      Desmopressin acetate 0.1mg, 0.2mg; scored tabs.

      Pharmacological Class

      Vasopressin (synthetic).

      See Also

      How Supplied

      Tabs—100; Amp (1mL)—10; Multi-dose vial (10mL)—1; Nasal spray—Contact generic supplier

      Storage

      DDAVP Tablets

      • Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. Avoid exposure to excessive heat or light. This product should be dispensed in a container with a child-resistant cap.

      Manufacturer

      Ferring Pharmaceuticals, Inc.

      Ddavp Tablets Indications

      Indications

      Central (cranial) diabetes insipidus. Temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

      Indications

      Management of central diabetes insipidus. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus. 

      • Select patients based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to DDAVP can be monitored by measuring urine volume and osmolality.

      Limitations of Use

      Use is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

      Ddavp Tablets Dosage and Administration

      Adults and Children

      <4yrs: not recommended. Individualize. ≥4yrs: Initially 0.05mg twice daily. Adjust in the range of 0.1–1.2mg/day in 2–3 divided doses.

      Elderly

      Use caution for dose selection in elderly patients, 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.

      Ddavp Tablets Contraindications

      Contraindications

      Moderate to severe renal impairment (CrCl <50mL/min). Hyponatremia, or history of.

      Ddavp Tablets Boxed Warnings

      Not Applicable

      Ddavp Tablets Warnings/Precautions

      Warnings/Precautions

      Monitor fluid intake, urine volume and osmolality. Fluid/electrolyte imbalance (eg, cystic fibrosis). Habitual or psychogenic polydipsia. Coronary artery insufficiency. Hypertension. Inj: Predisposition to thrombosis. Nasal mucosal abnormalities (nasal forms). Young children. Elderly. Pregnancy. Nursing mothers.

      Warnings/Precautions

      DDAVP Tablets

      • Can cause hyponatremia, which may be life-threatening if not promptly diagnosed and treated. Administration of DDAVP may lead to water intoxication and/or hyponatremia. 

      • Fluid restriction is recommended, and careful medical supervision is required. When DDAVP Tablets are administered, especially in pediatric and elderly patients, adjust fluid intake downward to decrease the potential for water intoxication and hyponatremia.

      • Monitor all patients for signs or symptoms of hyponatremia, especially for the rare occurrence of an extreme decrease in plasma osmolality resulting in seizures and possibly coma.

      • Use caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, which increases the risk of hyponatremia.

      • Use caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease due to a possible increase in blood pressure. 

      • Use caution in patients with conditions associated with fluid and electrolyte imbalance (eg, cystic fibrosis, heart failure, renal disorders) due to increased risk of hyponatremia.

      • Severe allergic reactions including anaphylaxis have been reported rarely with IV and intranasal administration of DDAVP but not with DDAVP Tablets.

      • Monitor laboratory tests for patients with central diabetes insipidus or postsurgical or head trauma-related polyuria and polydipsia, including urine volume and osmolality.

      Pregnancy Considerations

      DDAVP Tablets

      Pregnancy Category B

      • There have been no adequate and well-controlled studies in pregnant women.

      • DDAVP Tablets should be used during pregnancy only if clearly needed because animal studies are not always predictive of human response.

       

      Nursing Mother Considerations

      DDAVP Tablets

      • There have been no controlled studies in nursing mothers.

      • It is not known whether the drug is excreted in human milk. 

      • Exercise caution when DDAVP is administered to nursing mothers.

      Pediatric Considerations

      DDAVP Tablets

      Central Diabetes Insipidus

      • DDAVP Tablets were used safely in pediatric patients 4 years of age and older for period up to 44 months.

      • Adjust dose in patients younger than 4 years of age to prevent an excessive decrease in plasma osmolality. Initiate dosing at 0.05 mg (half of the 0.1 mg tablet).

      • Use in pediatric patients requires careful fluid restrictions to prevent hyponatremia and water intoxication.

      Geriatric Considerations

      Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. May be useful to monitor renal function.

      Use in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient.

      Renal Impairment Considerations

      Desmopressin acetate is substantially excreted by the kidney. 

      DDAVP is contraindicated in patients with CrCl<50mL/min.

      Ddavp Tablets Pharmacokinetics

      Absorption

      Bioavailability of DDAVP oral tablets is ~5% compared to intranasal DDAVP, and ~0.16% compared to DDAVP IV. The time to reach maximum plasma DDAVP levels ranged from 0.9 to 1.5 hours following oral or intranasal administration, respectively.

      Elimination

      Renal. Mean terminal half-life is 2.8 hours.

      Ddavp Tablets Interactions

      Interactions

      Caution with other pressor agents, drugs that may increase the risk of water intoxication with hyponatremia (eg, tricyclic antidepressants, SSRIs, chlorpromazine, opiates, NSAIDs, lamotrigine, carbamazepine). Possible convulsions with oxybutynin, imipramine.

      Ddavp Tablets Adverse Reactions

      Adverse Reactions

      Headache, nausea, flushing, abdominal cramps, vulval pain, water intoxication, hyponatremia, nasal congestion or rhinitis (nasal forms), inj site reaction; rare: changes in BP, severe allergic reactions, seizures in children from plasma hypoosmolality, thrombotic events (inj).

      Adverse Reactions

      DDAVP Tablets

      Central Diabetes Insipidus

      • Long-term clinical studies for periods up to 44 months with DDAVP Tablets have occasionally shown transient increases in AST (SGOT) no higher than 1.5 times the ULN. The elevated AST (SGOT) levels returned to the normal range despite continued use of DDAVP Tablets.

      Primary Nocturnal Enuresis

      • Only adverse event probably, possibly, or remotely related to DDAVP Tablets in clinical trials was headache (4% DDAVP; 3% placebo).

      Other

      • Abnormal thinking, diarrhea, and edema-weight gain have been reported, but their relationship to DDAVP has not been established.

      • Possibility of water intoxication and hyponatremia.

      Post-Marketing

      • Rare reports of hyponatremic convulsions have been reported and associated with concomitant use with oxybutynin and imipramine.

      Ddavp Tablets Clinical Trials

      Clinical Trials

      DDAVP Tablets

      Central Diabetes Insipidus

      • Dose response studies showed that oral doses of 0.025 mg to 0.4 mg achieved clinically significant antidiuretic effects. Most patients had optimal antidiuretic effects with 0.1 mg to 0.2 mg doses lasting up to 8 hours. 

      • In one study, the pharmacodynamic characteristics of DDAVP Tablets were compared with intranasal formulation over a 12-hour period. 10 fluid-controlled patients under 18 years of age were administered tablet doses of 0.2 mg and 0.4 mg, and intranasal doses of 0.01 mg and 0.02 mg. All 4 dose formulations reported similar pharmacodynamic effects on urine volume and urine osmolality.

      • In another study, adults previously controlled on DDAVP intranasal spray, after 1 week of self-titration from spray to tablets, patients’ diuresis was controlled with 0.1 mg DDAVP Tablets 3 times daily.

      Ddavp Tablets Note

      Not Applicable

      Ddavp Tablets Patient Counseling

      See Literature

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