DESMOPRESSIN ACETATE spray

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Vía de administración:

NASAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Desmopressin acetate nasal solution (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 acetate nasal solution (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 acetate nasal solution (nasal spray) is contraindicated in patients with: -   Known hypersensitivity to desmopres

Resumen del producto:

Desmopressin acetate nasal solution (nasal spray), 10 mcg/ 0.1 mL per spray is available in a 5 mL bottle with the spray pump delivering 50 sprays of 10 mcg. NDC 68382-384-01 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. STORE BOTTLE IN UPRIGHT POSITION.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE SPRAY
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN ACETATE
NASAL SOLUTION (NASAL SPRAY) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
DESMOPRESSIN ACETATE NASAL SOLUTION (NASAL SPRAY).
DESMOPRESSIN ACETATE NASAL SOLUTION (NASAL SPRAY)
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
Desmopressin acetate nasal solution (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 acetate nasal solution (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)
DOSAGE AND ADMINISTRATION
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 morning and 10 mcg at night) (2.2)
See the Full Prescribing Information for recommendations for switching
between desmopressin acetate
formulations (2.3)
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
Known hypersensitivity to desmopressin acetate or to any of the
components of desmopressin acetate
nasal solution (nasal spray) (4, 6)
Patients with renal impairment (creatinine clearance below 50 mL/min)
(4, 8.6, 12.3)
Hyponatremia or a history of hyponatremia (4, 5.1)
WARNINGS AND PRECAUT