Desmopressin (injection)

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# Overview
Desmopressin (injection) is a hemostatic and endocrine-metabolic agent that is FDA approved for the treatment of central diabetes insipidus and primary nocturnal enuresis.   Common adverse reactions include fatigue and rhinitis.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Central Cranial Diabetes Insipidus
- Dosage:
Injection: 0.5mL - 1.0mL at 4 mcg/mL IV or SC, usually divided in two doses
Tablets: 0.05 mcg PO q12h. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis.
Nasal Spray: 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses.
- Injection: 0.5mL - 1.0mL at 4 mcg/mL IV or SC, usually divided in two doses
- Tablets: 0.05 mcg PO q12h. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis.
- Nasal Spray: 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses.

### Hemophilia A with factor VIII Coagulant Activity > 5%
- Dosage
Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.
- Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.

### Von Willebrand's Disease
- Dosage:
Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.
- Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Desmopressin (patient information) in adult patients.

### NonGuideline-Supported Use

### Diagnosis of Cushing's Syndrome
- Dosage: 5-10 mcg IV has proven ability to stimulate the pituitary-adrenal axis in a set of patients with Cushing's Syndrome, being useful in the differential diagnosis of the given pathology. 

### Ehlers-Danlos Syndrome
Evidence: profilaxis during labour against bleeding. 

### Hemorrhage-Uremia
- Dosage: 0.4 microgram/kg IV infusion in patients with chronic renal failure, shortened bleeding time. 

### Nocturia
- Dosage: 100 mcg (men) and 25 mcg (women) reduces nocturnal voids in 33%. 

### Urine Concentration Test
- Dosage: 10 mcg intranasally after 12 hours of water depravation concentrated urine in patients as if they were on 24-36 hours of water depravation.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Primary Nocturnal Enuresis
- Dosage:
Tablets: (Patients >6 years): Initial dose of 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response.
- Tablets: (Patients >6 years): Initial dose of 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response.

### Central Cranial Diabetes Insipidus
- Dosage:
Nasal Spray: (Patients 3 months - 12 years old), 0.05 to 0.3 mL daily, either as a single dose or divided into two doses.
- Nasal Spray: (Patients 3 months - 12 years old), 0.05 to 0.3 mL daily, either as a single dose or divided into two doses.

### Hemophilia A with factor VIII Coagulant Activity > 5%
- Dosage:
Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.
- Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.

### Von Willebrand's Disease
- Dosage:
Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.
- Injection: 4 mcg/mL IV at 0.3 mcg/kg of body weight infused in 15-30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Desmopressin (patient information) in pediatric patients.

### NonGuideline-Supported Use

### Urinary Incontinence
- Dosage: Desmopressin administered at bedtime at increasing dosages from 10 to 30 mcg with intranasal spray until effective. 

### Urine Concentration Test
- Dosage: 50 mcg intranasally in children, optimal urine concentration was achieved by 3-5 hours .

# Contraindications
Contraindicated in:
- Individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP tablets.
- Patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
- Patients with hyponatremia

# Warnings
- Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with desmopressin acetate. Desmopressin acetate 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 desmopressin acetate injection is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. All patients receiving desmopressin acetate therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium (hyponatremia), 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.
- Desmopressin acetate should not be used to treat patients with Type IIB von Willebrands disease since platelet aggregation may be induced.
- Desmopressin acetate should be used with caution in patients with habitual 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

### Cardiovascular Effects
- Chest pain: Presented in use of nasal spray.
- Edema: Presented in use of nasal spray.
- Hypotension
- Hypertension
- Increased heart rate
- Myocardial infarction 
- Palpitations: Present in use of nasal spray .

### Dermatological Effects
- Balanitis: Presented in use of nasal spray.
- Burning pain
- Erythema
- Flushing
During intranasal treatment for Hemophilia A and von Willebrand's disease.
Presented in use of nasal spray. Although, flushing reduces as the dosis of desmopressin is reduced 
- During intranasal treatment for Hemophilia A and von Willebrand's disease.
- Presented in use of nasal spray. Although, flushing reduces as the dosis of desmopressin is reduced 
- Swelling

### Endocrine/Metabolic Effects
- Hyponatremia: present in people with electrolytic imbalance or psycogenic polydipsia in treatment with desmoressin .
Associated symptoms: headache, nausea, vomiting, fatigue, depressed reflexes, muscle weakness, weight gain, restlessnes, spasms, cramps, disorientation, decreased consciousness and confusion
Associated severe symptoms: seizure, coma, and respiratory arrest  .
- Associated symptoms: headache, nausea, vomiting, fatigue, depressed reflexes, muscle weakness, weight gain, restlessnes, spasms, cramps, disorientation, decreased consciousness and confusion
- Associated severe symptoms: seizure, coma, and respiratory arrest  .
- Hyposmolality .
- Water intoxication syndrome
Risk factors in patients:
Previous condition which caused electrolytic imbalance  .
Cystic Fibrosis
Heart Failure 
Renal Disorders
Drugs .
NSAIDs
Lamotrigine
Opioid analgesics
SSRIs
- Risk factors in patients:
Previous condition which caused electrolytic imbalance  .
Cystic Fibrosis
Heart Failure 
Renal Disorders
Drugs .
NSAIDs
Lamotrigine
Opioid analgesics
SSRIs
- Previous condition which caused electrolytic imbalance  .
Cystic Fibrosis
Heart Failure 
Renal Disorders
- Cystic Fibrosis
- Heart Failure
- Renal Disorders
- Drugs .
NSAIDs
Lamotrigine
Opioid analgesics
SSRIs
- NSAIDs
- Lamotrigine
- Opioid analgesics
- SSRIs

### Gastrointestinal Effects
- Abdominal cramps: evidenced during  Nocturnal Primary Enuresis treatment by desmopressin intranasally 
- Abdominal pain
- Indigestion: dyspepsia has been reported during nasal vasopressin use Presented in use of nasal spray.
- Nausea: present during Hemophilia A and von Wilebrand's disease treatment with intranasal vasopressin 
- Vomiting: Presented in use of nasal spray.

### Hematologic Effects
- Thrombocytopenia.
- Thrombosis 

### Hepatic Effects
- Transient increase in AST/SGOT levels 

### Immunological Effects
- Anaphylaxis
- Hypersensitivity reaction

### Neurological Effects
- Asthenia
- Thrombotic cerebrovascular accident
Case report of 7-year old patient, who received desmopressin preoperatively. Partial recovery after some weeks
Case report of 7-year old patient who developed an cerebrovascular accident within 48 hours of initiated the therapy for enuresis .
- Case report of 7-year old patient, who received desmopressin preoperatively. Partial recovery after some weeks
- Case report of 7-year old patient who developed an cerebrovascular accident within 48 hours of initiated the therapy for enuresis .
- Dizziness
- Fatigue
- Headache
- Insomnia
- Seizure
- Somnolence
- Vertigo: presented during intranasal treatment with desmopressin for Hemophilia A and von Willebrand's disease .

### Ophthalmic effects
- Conjunctivitis
- Eye edema
- Eyes sensitive to light
- Finding of lacrimation
- Itching of eye

### Psychiatric Effects
- Agitation.
- Excitability: case report of paranoid behavior in 53-year old patient, treated with vasopressin with medical history of Alzheimer's disease. 
Unusual change in behavior

### Respiratory Effects
- Cough
- Cyanosis
- Dyspnea
- Epistaxis
- Nasal congestion
- Pain in throat
- Respiratory failure
- Rhinitis
- Sore nostril
- Upper respiratory infection

### Other General Effects
- Warm feeling
- Shivering

## Postmarketing Experience
There is limited information regarding Desmopressin (injection) Postmarketing Experience in the drug label.

# Drug Interactions
- Although the pressor activity of desmopressin acetate is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of desmopressin acetate with other pressor agents should be done only with careful patient monitoring.
- The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia:
Tricyclic antidepressants
Selective serotonin re-uptake inhibitors (SSRI's)
Chlorpromazine
Opiate analgesics
NSAIDs
Lamotrigine
Carbamazepine
- Tricyclic antidepressants
- Selective serotonin re-uptake inhibitors (SSRI's)
- Chlorpromazine
- Opiate analgesics
- NSAIDs
- Lamotrigine
- Carbamazepine

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
There is no FDA guidance on usage of Desmopressin (injection) in women who are pregnant.
Pregnancy Category (AUS): B2
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Desmopressin (injection) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Desmopressin (injection) during labor and delivery.

### Nursing Mothers
There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable desmopressin acetate in breast milk following an intranasal dose of 10 mcg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when desmopressin acetate is administered to a nursing woman.

### Pediatric Use
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. Desmopressin acetate injection 4 mcg/mL should not be used in infants less than three months of age in the treatment of hemophilia A or von Willebrands disease; safety and effectiveness in pediatric patients under 12 years of age with diabetes insipidus have not been established.

### Geriatic Use
Clinical studies of desmopressin acetate injection 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.

### Gender
There is no FDA guidance on the use of Desmopressin (injection) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Desmopressin (injection) with respect to specific racial populations.

### Renal Impairment
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. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

### Hepatic Impairment
There is no FDA guidance on the use of Desmopressin (injection) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

### Immunocompromised Patients
There is no FDA guidance one the use of Desmopressin (injection) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
von Willebrands Disease: Laboratory tests for assessing patient status include levels of factor VIII coagulant activity, *Factor VIII ristocetin cofactor activity, and factor VIII von Willebrand factor antigen. The skin bleeding time may be helpful in following these patients.
- Diabetes Insipidus: Laboratory tests for monitoring the patient include urine volume and osmolality. In some cases, plasma osmolality may be required.

# IV Compatibility
There is limited information regarding the compatibility of Desmopressin (injection) and IV administrations.

# Overdosage
Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate or desmopressin acetate injection 4 mcg/mL. An oral LD 50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

# Pharmacology

## Mechanism of Action
There is limited information regarding Desmopressin (injection) Mechanism of Action in the drug label.

## Structure

## Pharmacodynamics
There is limited information regarding Desmopressin (injection) Pharmacodynamics in the drug label.

## Pharmacokinetics
Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose desmopressin acetate (2 mcg) injection demonstrated a difference in desmopressin acetate terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment.

## Nonclinical Toxicology
There is limited information regarding Desmopressin (injection) Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Desmopressin (injection) Clinical Studies in the drug label.

# How Supplied
- Injection: Desmopressin acetate injection, USP 4 mcg/mL is available as a sterile solution in 10 mL multiple-dose vials, each containing 4 mcg desmopressin acetate, USP per mL.
- Tablets:
Flasks containing 100 0.1mcg Desmopressin tablets
Flasks containing 100 0.2mcg Desmopressin tablets
- Flasks containing 100 0.1mcg Desmopressin tablets
- Flasks containing 100 0.2mcg Desmopressin tablets
- Nasal spray (solution): Desmopressin Nasal Spray Solution USP, 0.01% 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

## Storage
- Injection: Store refrigerated 2 to 8C (36 to 46F). Preserve in tight containers, protected from light.
- Tablets: Store at Controlled Room Temperature 20 to 25C (68 to 77F). Avoid exposure to excessive heat or light. This product should be dispensed in a container with a child-resistant cap.
- Nasal spray (solution): Store at 25C (77F); excursions permitted to 15-30C (59-86F). Store bottle in upright position.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Desmopressin (injection) Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Desmopressin (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- DDAVP
- Minirin
- Stimate
- DDAVP Nasal

# Look-Alike Drug Names
There is limited information regarding Desmopressin (injection) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price