Desmopressin (injection): Difference between revisions
m (Protected "Desmopressin" ([edit=sysop] (indefinite) [move=sysop] (indefinite))) |
No edit summary |
||
| Line 1: | Line 1: | ||
{{DrugProjectFormSinglePage | |||
|authorTag={{AP}} | |||
|genericName=desmopressin acetate | |||
|aOrAn=a | |||
|drugClass=hemostatic and endocrine-metabolic agent | |||
|indicationType=treatment | |||
|indication=[[central diabetes insipidus]] and [[primary nocturnal enuresis]] | |||
|adverseReactions=[[fatigue]] and [[rhinitis]] | |||
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | |||
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | |||
|fdaLIADAdult=====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. | |||
**Rhinal 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. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Desmopressin (patient information) in adult patients. | |||
|offLabelAdultNoGuideSupport=====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. <ref name="pmid8330442">{{cite journal| author=Malerbi DA, Mendonça BB, Liberman B, Toledo SP, Corradini MC, Cunha-Neto MB et al.| title=The desmopressin stimulation test in the differential diagnosis of Cushing's syndrome. | journal=Clin Endocrinol (Oxf) | year= 1993 | volume= 38 | issue= 5 | pages= 463-72 | pmid=8330442 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=8330442 }} </ref> | |||
====Ehlers-Danlos Syndrome==== | |||
Evidence: profilaxis during labour against bleeding. <ref name="pmid1861812">{{cite journal| author=Rochelson B, Caruso R, Davenport D, Kaelber A| title=The use of prophylactic desmopressin (DDAVP) in labor to prevent hemorrhage in a patient with Ehlers-Danlos syndrome. | journal=N Y State J Med | year= 1991 | volume= 91 | issue= 6 | pages= 268-9 | pmid=1861812 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=1861812 }} </ref> | |||
====Hemorrhage-Uremia===== | |||
*Dosage: 0.4 microgram/kg IV infusion in patients with chronic renal failure, shortened bleeding time. <ref name="pmid6728864">{{cite journal| author=Watson AJ, Keogh JA| title=1-Deamino-8-d-arginine vasopressin (DDAVP): a potential new treatment for the bleeding diathesis of acute renal failure. | journal=Pharmatherapeutica | year= 1984 | volume= 3 | issue= 9 | pages= 618-22 | pmid=6728864 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=6728864 }} </ref> | |||
====Nocturia==== | |||
*Dosage: 100 mcg (men) and 25 mcg (women) reduces nocturnal voids in 33%. <ref name="pmid22447415">{{cite journal| author=Weiss JP, Zinner NR, Klein BM, Nørgaard JP| title=Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. | journal=Neurourol Urodyn | year= 2012 | volume= 31 | issue= 4 | pages= 441-7 | pmid=22447415 | doi=10.1002/nau.22243 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=22447415 }} </ref> | |||
|fdaLIADPed=====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: | |||
**Rhinal 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. | |||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Desmopressin (patient information) in pediatric patients. | |||
|offLabelPedNoGuideSupport=====Urinary Incontinence==== | |||
*Dosage: Desmopressin administered at bedtime at increasing dosages from 10 to 30 mcg with intranasal spray until effective. <ref name="pmid10468731">{{cite journal| author=Caione P, Nappo S, De Castro R, Prestipino M, Capozza N| title=Low-dose desmopressin in the treatment of nocturnal urinary incontinence in the exstrophy-epispadias complex. | journal=BJU Int | year= 1999 | volume= 84 | issue= 3 | pages= 329-34 | pmid=10468731 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10468731 }} </ref> | |||
|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. | |||
|alcohol=Alcohol-Desmopressin (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |||
}} | |||
Revision as of 21:29, 17 December 2014
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.
- Rhinal 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]
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:
- Rhinal 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. [5]
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
There is limited information regarding Desmopressin (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Desmopressin (injection) Clinical Trials Experience in the drug label.
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
{{#ask: Page Name::Desmopressin (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Desmopressin (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.