DESMOPRESSIN ACETATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Available from:

Bauch & Lomb Incorporated

INN (International Name):

DESMOPRESSIN ACETATE

Composition:

DESMOPRESSIN ACETATE 0.1 mg in 1 mL

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: Desmopressin nasal spray solution is contraindicated in patients with: Risk Summary Prolonged experience with desmopressin in pregnant women over several decades, based on the available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m2 ) (see Data). The estimated ba

Product summary:

Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle containing an aqueous solution with the spray pump delivering 50 sprays of 10 mcg (0.1 mL) (NDC 24208-342-05). Store in refrigerator at 2° to 8°C (36° to 46°F). When traveling, product will maintain stability for up to 3 weeks when stored at room temperature, 22°C (72°F). STORE BOTTLE IN UPRIGHT POSITION.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SOLUTION
BAUCH & LOMB INCORPORATED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN NASAL
SPRAY SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DESMOPRESSIN
NASAL SPRAY SOLUTION.
DESMOPRESSIN NASAL SPRAY SOLUTION
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal Spray: 10 mcg per 0.1 mL spray, available in a 5 mL bottle with
spray pump delivering 50 sprays (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions that have been identified in patients administered
desmopressin nasal spray solution
are headache, nasal congestion, rhinitis, nosebleed, sore throat,
cough, upper respiratory infections,
nausea, flushing, and mild abdominal cramps (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH & LOMB
INCORPORATED AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
For intranasal use only (2.1)
Instruct patients to prime pump prior to use (2.1)
Adults: 10 mcg to 40 mcg daily (either as a single dose or divided
into two or three daily doses) (2.2)
Pediatrics: 10 mcg once daily into one nostril up to 30 mcg once daily
(or 30 mcg divided as 20 mcg
during the morn