Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (Desmopressin - UNII:ENR1LLB0FP)
Apotex Corp.
NASAL
PRESCRIPTION DRUG
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 contraindicated in patients with: - Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray. Severe
Desmopressin nasal spray, USP is available in a 5 mL bottle with a nasal spray pump dispenser with dust cover and patient instruction sheet delivering 50 sprays of 10 mcg (NDC 60505-0815-0). Store at 25°C (77°F) [see USP Controlled Room Temperature]; excursions permitted from 15°C to 30°C (59°F to 86°F). AFTER ASSEMBLY, STORE UPRIGHT. Keep out of the reach of children.
Abbreviated New Drug Application
DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SPRAY APOTEX CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DESMOPRESSIN NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESMOPRESSIN NASAL SPRAY. DESMOPRESSIN NASAL SPRAY INITIAL U.S. APPROVAL: 1978 INDICATIONS AND USAGE 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) 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 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 PRECAUTIONS Hyponatremia: Instruct patients about proper fluid restriction and monitor serum sodium as needed (2.1, 5.1) Altered Absorption in Patients with Nasal Mucosa Abnorma Perskaitykite visą dokumentą