Desmopressin

FDA Drug Profile

Drug Details

Generic Name
Desmopressin
Brand Names
N/A
Application Number
Sponsor
Piramal Pharma Limited
NDC Codes
19
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
DESMOPRESSIN, 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 )