Desmopressin acetate nasal spray

Desmopressin acetate nasal spray
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Desmopressin acetate nasal spray is a hormone analog that is FDA approved for the treatment of as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Common adverse reactions include fatigue, rhinitis, myocardial infarction, hyponatremia, hyposmolality, water intoxication syndrome, anaphylaxis, seizure.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Central Cranial Diabetes Insipidus

• DDAVP Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus.
• The use of DDAVP Nasal Spray in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.
• There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.
• Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal DDAVP can be monitored by urine volume and osmolality.
• DDAVP is also available as a solution for injection when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.

Central Cranial Diabetes Insipidus

• DDAVP Nasal Spray dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP.
• The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses.
• The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed.
• The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.
• The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray.
• Discard DDAVP Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Vasopressin equivalent antidiuretic activity

• (Solution for injection) 4 mcg is equivalent to 16 international units of vasopressin; (DDAVP(R) nasal spray) 0.1 mL (10 mcg) per spray equivalent to 40 international units; (rhinal tube) 1 mL (0.1 mg) equivalent to 400 international units; (Stimate(R) nasal spray) 0.1 mL (150 mcg) per spray equivalent to 600 international units

• Hemophilia A, With factor VIII levels greater than 5%: 0.3 mcg/kg diluted in 50 mL sterile physiological saline, infused IV slowly over 15 to 30 minutes; monitor patient to determine necessity of further doses; tachyphylaxis may occur if given more often than every 48 hours
• Hemophilia A, With factor VIII levels greater than 5%: (Stimate(R)) less than 50 kg, 1 spray (150 mcg) INTRANASALLY in 1 nostril only, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response
• Hemophilia A, With factor VIII levels greater than 5%: (Stimate(R)) 50 kg and over, 1 spray (150 mcg) INTRANASALLY in each nostril, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response
• Neurohypophyseal diabetes insipidus: (DDAVP(R)) 10 to 40 mcg/day (0.1 mL to 0.4 mL) INTRANASALLY, either as a single dose or 2 to 3 divided doses
• Neurohypophyseal diabetes insipidus

• 2 to 4 mcg/day IV or SUBQ in 2 divided doses; comparable antidiuretic dose of the injection is about one-tenth (1/10) the intranasal dose

• Neurohypophyseal diabetes insipidus

• initial, 0.05 mg (one-half of the 0.1-mg tablet) ORALLY twice daily; maintenance 0.1 to 0.8 mg/day in divided doses

• Nocturia

• (Men) Orally disintegrating tablet, 100 mcg ORALLY once daily 1 hour before bedtime

• Nocturia

• (Women) Orally disintegrating tablet, 25 to 100 mcg ORALLY once daily 1 hour before bedtime

• Primary nocturnal enuresis

• Initial, 0.2 mg ORALLY at bedtime; dose may be titrated up to 0.6 mg if necessary

• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: 0.3 mcg/kg diluted in 50 mL sterile physiological saline, infused IV slowly over 15 to 30 minutes; monitor patient to determine necessity of further doses; tachyphylaxis may occur if given more often than every 48 hours
• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: (Stimate(R)) less than 50 kg, 1 spray (150 mcg) INTRANASALLY in one nostril only, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response
• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: (Stimate(R)) 50 kg and over, 1 spray (150 mcg) INTRANASALLY in each nostril, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response

Non–Guideline-Supported Use

• Hemorrhage

• Uremia

• Nocturia
• Urinary incontinence
• Urine concentration test

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Central Cranial Diabetes Insipidus

• DDAVP Nasal Spray has been used in children with diabetes insipidus. Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication.
• The dose must be individually adjusted to the patient with attention in the very young to the danger of an extreme decrease in plasma osmolality with resulting convulsions. Dose should start at 0.05 mL or less.
• Since the spray cannot deliver less than 0.1 mL (10 mcg), smaller doses should be administered using the rhinal tube delivery system. Do not use the nasal spray in pediatric patients requiring less than 0.1 mL (10 mcg) per dose.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• Nasal spray formulations should not be used in pediatric patients requiring less than 0.1 mL or 10 mcg per dose.
• Vasopressin equivalent antidiuretic activity

• (Solution for injection) 4 mcg is equivalent to 16 international units of vasopressin; (DDAVP(R) nasal spray) 0.1 mL (10 mcg) per spray equivalent to 40 international units; (rhinal tube) 1 mL (0.1 mg) equivalent to 400 international units; (Stimate(R) nasal spray) 0.1 mL (150 mcg) per spray equivalent to 600 international units

• Hemophilia A, With factor VIII levels greater than 5%

• 3 months or older (10 kg or less), 0.3 mcg/kg diluted in 10 mL sterile physiological saline, infused IV slowly over 15 to 30 minutes; monitor patient to determine necessity of further doses; tachyphylaxis may occur if given more often than every 48 hours

Hemophilia A, With factor VIII levels greater than 5%: 3 months or older (more than 10 kg), 0.3 mcg/kg diluted in 50 mL sterile physiological saline, infused IV slowly over 15 to 30 minutes; monitor patient to determine necessity of further doses; tachyphylaxis may occur if given more than every 48 hours

• Hemophilia A, With factor VIII levels greater than 5%

• (Stimate(R)) 11 months or older (less than 50 kg), 1 spray (150 mcg) INTRANASALLY in one nostril only, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response.

• Hemophilia A, With factor VIII levels greater than 5%

• (Stimate(R)) 11 months or older (50 kg or over), 1 spray (150 mcg) INTRANASALLY in each nostril, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response

• Neurohypophyseal diabetes insipidus

• (DDAVP(R)) 3 months to 12 years, 5 to 30 mcg (0.05 mL to 0.3 mL) INTRANASALLY, either as a single dose or 2 to 3 divided doses; for doses less than 10 mcg use the rhinal tube system.

• Neurohypophyseal diabetes insipidus

• (DDAVP(R)) 13 years or older, 10 to 40 mcg/day (0.1 mL to 0.4 mL) INTRANASALLY, either as a single dose or 2 to 3 divided doses.

• Neurohypophyseal diabetes insipidus

• 12 years or older, 2 to 4 mcg/day IV or SUBQ in 2 divided doses; comparable antidiuretic dose of the injection is about one-tenth (1/10) the intranasal dose.

• Neurohypophyseal diabetes insipidus

• 4 years or older, initial, 0.05 mg (one-half of the 0.1-mg tablet) ORALLY twice daily; maintenance, 0.1 to 0.8 mg/day in divided doses.

• Primary nocturnal enuresis

• 6 years or older: initial, 0.2 mg ORALLY at bedtime, dose may be titrated up to 0.6 mg if necessary.

• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: 3 months or older (10 kg or less), 0.3 mcg/kg diluted in 10 mL sterile physiological saline, infused IV slowly over 15 to 30 minutes; monitor patient to determine necessity of further doses; tachyphylaxis may occur if given more often than every 48 hours.
• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: 3 months or older (more than 10 kg), 0.3 mcg/kg diluted in 50 mL sterile physiological saline, infused IV slowly over 15 to 30 minutes; monitor patient to determine necessity of further doses; tachyphylaxis may occur if given more than every 48 hours.
• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: (Stimate(R)) 11 months or older (less than 50 kg), 1 spray (150 mcg) INTRANASALLY in 1 nostril only, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response.
• von Willebrand disease type 1 (Mild to Moderate), With factor VIII levels greater than 5%: (Stimate(R)) 11 months or older (50 kg or over), 1 spray (150 mcg) INTRANASALLY in each nostril, may be repeated based on laboratory response and clinical condition; perform test dose prior to therapeutic use to confirm appropriate coagulation profile response.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Desmopressin acetate in pediatric patients.

Contraindications

• DDAVP Nasal Spray is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Nasal Spray.
• DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
• DDAVP is contraindicated in patients with hyponatremia or a history of hyponatremia.

Warnings

For intranasal use only

• DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible.
• Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). DDAVP is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia.
• Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.
• When DDAVP Nasal Spray is administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia.
• All patients receiving DDAVP therapy 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 of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion.
• Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.
• DDAVP should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Desmopressin acetate nasal spray Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Desmopressin acetate nasal spray Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Desmopressin acetate nasal spray Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Desmopressin acetate nasal spray in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Desmopressin acetate nasal spray in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Desmopressin acetate nasal spray during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Desmopressin acetate nasal spray in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Desmopressin acetate nasal spray in pediatric settings.

Geriatic Use

• This drug is known to be substantially excreted by the kidney, and the risk of toxic 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.

Gender

There is no FDA guidance on the use of Desmopressin acetate nasal spray with respect to specific gender populations.

Race

There is no FDA guidance on the use of Desmopressin acetate nasal spray with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Desmopressin acetate nasal spray in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Desmopressin acetate nasal spray in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Desmopressin acetate nasal spray in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Desmopressin acetate nasal spray in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Desmopressin acetate nasal spray Administration in the drug label.

Monitoring

There is limited information regarding Desmopressin acetate nasal spray Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Desmopressin acetate nasal spray and IV administrations.

Overdosage

There is limited information regarding Desmopressin acetate nasal spray overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Desmopressin acetate nasal spray Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Desmopressin acetate nasal spray Mechanism of Action in the drug label.

Structure

There is limited information regarding Desmopressin acetate nasal spray Structure in the drug label.

Pharmacodynamics

There is limited information regarding Desmopressin acetate nasal spray Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Desmopressin acetate nasal spray Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Desmopressin acetate nasal spray Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Desmopressin acetate nasal spray Clinical Studies in the drug label.

How Supplied

There is limited information regarding Desmopressin acetate nasal spray How Supplied in the drug label.

Storage

There is limited information regarding Desmopressin acetate nasal spray Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Desmopressin acetate nasal spray Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Desmopressin acetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Desmopressin acetate nasal spray Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Desmopressin acetate nasal spray Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.