Desmopressin (injection)

Jump to navigation Jump to search
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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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

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:

Warnings

Adverse Reactions

Clinical Trials Experience

Cardiovascular Effects

Dermatological Effects

Endocrine/Metabolic Effects

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

Immunological Effects

Neurological Effects

Ophthalmic effects

Psychiatric Effects

  • Agitation[32].
  • Excitability: case report of paranoid behavior in 53-year old patient, treated with vasopressin with medical history of Alzheimer's disease. [33]

Unusual change in behavior

Respiratory Effects

Other General Effects

Postmarketing Experience

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

Drug Interactions

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 Willebrand’s 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

Monitoring

von Willebrand’s 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

Template:Px
Template:Px
Desmopressin (injection)
Systematic (IUPAC) name
(2S)-N-[(2R)-1-[(2-amino-2-oxoethyl)amino]-5-
(diaminomethylideneamino)-1-oxopentan-2-yl]-1-
[(4R,7S,10S,13S,16S)-7-(2-amino-2-oxoethyl)-10-
(3-amino-3-oxopropyl)-16-[(4-hydroxyphenyl)methyl]-
6,9,12,15,18-pentaoxo-13-(phenylmethyl)1,2-dithia-
5,8,11,14,17-pentazacycloicosane-4-carbonyl]
pyrrolidine-2-carboxamide
Identifiers
CAS number 16679-58-6
ATC code H01BA02
PubChem 5311065
DrugBank DB00035
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 1069.22 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability Variable; 0.08–0.16% (oral)
Protein binding 50%
Metabolism ?
Half life 1.5–2.5 hours
Excretion Renal
Therapeutic considerations
Pregnancy cat.

B2(AU) B(US)

Legal status

POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes IV, IM, SC, intranasal, oral

Mechanism of Action

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

Structure

Desmopressin Acetate Structure.png

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
  • 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 8°C (36° to 46°F). Preserve in tight containers, protected from light.
  • Tablets: Store at Controlled Room Temperature 20 to 25°C (68 to 77°F). 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 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store bottle in upright position.

Images

Drug Images

Package and Label Display Panel

Desmopressin Acetate Package1.png
Desmopressin Acetate Package2.png
Desmopressin Acetate Appearance.png

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

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 13.2 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).
  30. Grunwald Z, Sather SD (1995). "Intraoperative cerebral infarction after desmopressin administration in infant with end-stage renal disease". Lancet. 345 (8961): 1364–5. PMID 7752768.
  31. Wieting JM, Dykstra DD, Ruggiero MP, Robbins GB, Galusha K (1997). "Central nervous system ischemia after varicella infection and desmopressin therapy for enuresis". J Am Osteopath Assoc. 97 (5): 293–5. PMID 9195793.
  32. "Patient Information" (PDF).
  33. Collins GB, Marzewski DJ, Rollins MB (1981). "Paranoid psychosis after DDAVP therapy for Alzheimer's dementia". Lancet. 2 (8250): 808. PMID 6116932.