desmopressin acetate

FDA Drug Profile — Stimate, desmopressin acetate, Desmopressin Acetate

desmopressin acetate is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including Stimate, desmopressin acetate, Desmopressin Acetate. Available dosage forms: spray, injection, solution, tablet.

Drug Details

Generic Name
desmopressin acetate
Brand Names
Stimate, desmopressin acetate, Desmopressin Acetate
Application Number
NDA020355
Sponsor
Ferring Pharmaceuticals Inc.
NDC Codes
17
Dosage Forms
SPRAY, INJECTION, SOLUTION, TABLET
Routes
NASAL, INTRAVENOUS, SUBCUTANEOUS, ORAL
Active Ingredients
DESMOPRESSIN ACETATE

Indications and Usage

1 INDICATIONS AND USAGE Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use: Desmopressin nasal spray solution is not indicated for: Treatment of nephrogenic diabetes insipidus, Treatment of primary nocturnal enuresis [ see Warnings and Precautions (5.1) ], Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2) ], Use in patients with an impaired level of consciousness, Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths ( 3 )] Desmopressin nasal spray solution is a vasopressin analog indicated as antidiuretic replacement therapy in the management of central diabetes insipidus for adults and pediatric patients 4 years of age and older. ( 1 ) Limitations of Use: Desmopressin nasal spray solution is not indicated for: Treatment of nephrogenic diabetes insipidus ( 1 ) Treatment of primary nocturnal enuresis ( 1 , 5.1 ) Use in patients with conditions that compromise intranasal route of administration ( 1 , 5.2 ) Use in patients with an impaired level of consciousness ( 1 ) Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg ( 1 , 3 )