FDA LABEL RECORD
DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE. FDA prescribing information for this product, as published on the retrieval date below.
AS THE LABEL RECORDS IT
Product details
| Brand name | DESMOPRESSIN ACETATE |
|---|---|
| Generic name | DESMOPRESSIN ACETATE |
| Labeller | Apotex Corp. |
| Route | NASAL |
| Label version | 12 |
| Effective | 2025-08-22 |
| Retrieved by this site | 2026-08-31 |
| Full label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ac423b8-27a6-4cef-4a82-c50bf81b4f49 |
INDICATIONS AND USAGE
Quoted from the FDA label
1 INDICATIONS AND USAGE Desmopressin nasal spray 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 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 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 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 )
What this page is
A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.
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