Desmopressin (injection)

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Desmopressin (injection)
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: Alberto Plate [2]

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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.

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.

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.

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.

Non–Guideline-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. [1]

Ehlers-Danlos Syndrome

Evidence: profilaxis during labour against bleeding. [2]

Hemorrhage-Uremia

  • Dosage: 0.4 microgram/kg IV infusion in patients with chronic renal failure, shortened bleeding time. [3]

Nocturia

  • Dosage: 100 mcg (men) and 25 mcg (women) reduces nocturnal voids in 33%. [4]

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[5].

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.

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.

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.

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.

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.

Non–Guideline-Supported Use

Urinary Incontinence

  • Dosage: Desmopressin administered at bedtime at increasing dosages from 10 to 30 mcg with intranasal spray until effective. [6]

Urine Concentration Test

  • Dosage: 50 mcg intranasally in children, optimal urine concentration was achieved by 3-5 hours [7].

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 or a history of 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, 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 Willebrand’s disease since platelet aggregation may be induced.
  • Desmopressin acetate 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

Cardiovascular Effects

  • Chest pain: Presented in use of nasal spray[8].
  • Edema: Presented in use of nasal spray[9].
  • Hypotension
  • Hypertension
  • Increased heart rate
  • Myocardial infarction [10]
  • Palpitations: Present in use of nasal spray [11].

Dermatological Effects

  • Balanitis: Presented in use of nasal spray[12].
  • Burning pain
  • Erythema
  • Flushing
    • During intranasal treatment for Hemophilia A and von Willebrand's disease[13].
    • Presented in use of nasal spray[14]. Although, flushing reduces as the dosis of desmopressin is reduced [15]
  • Swelling

Endocrine/Metabolic Effects

  • Hyponatremia: present in people with electrolytic imbalance or psycogenic polydipsia in treatment with desmoressin [16].
    • Associated symptoms: headache, nausea, vomiting, fatigue, depressed reflexes, muscle weakness, weight gain, restlessnes, spasms, or cramps, disorientation, decreased consciousness, and confusion
    • Associated severe symptoms: seizure, coma, and respiratory arrest [17] [18].
  • Hyposmolality[19] [20].
  • Water intoxication syndrome
    • Risk factors in patients:
      • Previous condition which caused electrolytic imbalance [21] [22].
        • Cystic Fibrosis
        • Heart Failure
        • Renal Disorders
      • Drugs[23] [24].
        • NSAIDs
        • Lamotrignine
        • Opioid analgesics
        • SSRIs

Gastrointestinal Effects

  • Abdominal cramps: evidenced during Nocturnal Primary Enuresis treatment by desmopressin intranasally [25]
  • Abdominal pain
  • Indigestion: dyspepsia has been reported during nasal vasopressin use Presented in use of nasal spray[26].
  • Nausea: present during Hemophilia A and von Wilebrand's disease treatment with intranasal vasopressin [13]
  • Vomiting: Presented in use of nasal spray[27].

Hematologic Effects

Hepatic Effects

  • Transient increase in AST/SGOT levels [29]

Immunological Effects==

  • Anaphylaxis
  • Hypersensitivity reaction

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Desmopressin (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Desmopressin (injection) in women who are pregnant.
Pregnancy Category (AUS): 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 is no FDA guidance on the use of Desmopressin (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Desmopressin (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Desmopressin (injection) in geriatric settings.

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

There is no FDA guidance on the use of Desmopressin (injection) in patients with renal impairment.

Hepatic Impairment

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

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Desmopressin (injection) in women of reproductive potentials and males.

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

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

There is limited information regarding Desmopressin (injection) How Supplied in the drug label.

Storage

There is limited information regarding Desmopressin (injection) 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 (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

There is limited information regarding Desmopressin (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Desmopressin (injection) 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.

  1. ↑ Malerbi DA, Mendonça BB, Liberman B, Toledo SP, Corradini MC, Cunha-Neto MB; et al. (1993). "The desmopressin stimulation test in the differential diagnosis of Cushing's syndrome". Clin Endocrinol (Oxf). 38 (5): 463–72. PMID 8330442.
  2. ↑ Rochelson B, Caruso R, Davenport D, Kaelber A (1991). "The use of prophylactic desmopressin (DDAVP) in labor to prevent hemorrhage in a patient with Ehlers-Danlos syndrome". N Y State J Med. 91 (6): 268–9. PMID 1861812.
  3. ↑ Watson AJ, Keogh JA (1984). "1-Deamino-8-d-arginine vasopressin (DDAVP): a potential new treatment for the bleeding diathesis of acute renal failure". Pharmatherapeutica. 3 (9): 618–22. PMID 6728864.
  4. ↑ Weiss JP, Zinner NR, Klein BM, Nørgaard JP (2012). "Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial". Neurourol Urodyn. 31 (4): 441–7. doi:10.1002/nau.22243. PMID 22447415.
  5. ↑ Nadvorníková H, Schück O, Cort JH (1980). "A standardized desmopressin test of renal concentrating ability". Clin Nephrol. 14 (3): 142–7. PMID 7418281.
  6. ↑ Caione P, Nappo S, De Castro R, Prestipino M, Capozza N (1999). "Low-dose desmopressin in the treatment of nocturnal urinary incontinence in the exstrophy-epispadias complex". BJU Int. 84 (3): 329–34. PMID 10468731.
  7. ↑ Helin I (1982). "Intranasal DDAVP test in children". J Urol. 127 (1): 78–9. PMID 7057511.
  8. ↑ "Chest pain in pediatric population by desmopressin nasally" (PDF).
  9. ↑ "Chest pain in pediatric population by desmopressin nasally" (PDF).
  10. ↑ 10.0 10.1 Pape E, Béné J, Buchdahl AL, Gautier S, Hatron PY, Lambert M (2013). "Desmopressin-related myocardial infarction in a patient with Wegener's granulomatosis: a case report and review of the literature". J Mal Vasc. 38 (1): 43–6. doi:10.1016/j.jmv.2012.11.001. PMID 23265678.
  11. ↑ "Chest pain in pediatric population by desmopressin nasally" (PDF).
  12. ↑ "Patient Information" (PDF).
  13. ↑ 13.0 13.1 Dunn AL, Powers JR, Ribeiro MJ, Rickles FR, Abshire TC (2000). "Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patients". Haemophilia. 6 (1): 11–4. PMID 10632735.
  14. ↑ "Patient Information" (PDF).
  15. ↑ "Product Information" (PDF).
  16. ↑ "Patient Information" (PDF).
  17. ↑ "Patien Information" (PDF).
  18. ↑ "Patient Information" (PDF).
  19. ↑ "Patien Information" (PDF).
  20. ↑ "Patient Information" (PDF).
  21. ↑ "Patien Information" (PDF).
  22. ↑ "Patient Information" (PDF).
  23. ↑ "Patien Information" (PDF).
  24. ↑ "Patient Information" (PDF).
  25. ↑ "Patien Information" (PDF).
  26. ↑ "Patient Information" (PDF).
  27. ↑ "Patient Information" (PDF).
  28. ↑ Sun HL, Chien CC (1998). "Thrombocytopenia and subdural hemorrhage after desmopressin administration". Anesthesiology. 88 (4): 1115–7. PMID 9579523.
  29. ↑ "Patient Information" (PDF).
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