Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
MOMETASONE FUROATE MONOHYDRATE (UNII: MTW0WEG809) (MOMETASONE - UNII:8HR4QJ6DW8)
REMEDYREPACK INC.
MOMETASONE FUROATE MONOHYDRATE
MOMETASONE FUROATE 50 ug
PRESCRIPTION DRUG
New Drug Application
NASONEX- MOMETASONE FUROATE MONOHYDRATE SPRAY, METERED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NASONEX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NASONEX. NASONEX (MOMETASONE FUROATE MONOHYDRATE) NASAL SPRAY, 50 MCG CALCULATED ON THE ANHYDROUS BASIS INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE NASONEX is a corticosteroid indicated for: 1. Treatment of Nasal Symptoms of Allergic Rhinitis in patients ≥2 years of age ( 1.1) 2. Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis in patients ≥2 years of age ( 1.2) 3. Prophylaxis of Seasonal Allergic Rhinitis in patients ≥12 years of age ( 1.3) 4. Treatment of Nasal Polyps in patients ≥18 years of age ( 1.4) DOSAGE AND ADMINISTRATION For Intranasal Use Only Treatment of Nasal Symptoms of Allergic Rhinitis ( 2.1) Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily Children (2-11 yrs.): 1 spray in each nostril once daily Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis ( 2.2) Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily Children (2-11 yrs.): 1 spray in each nostril once daily Prophylaxis of Seasonal Allergic Rhinitis ( 2.3) Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily Treatment of Nasal Polyps ( 2.4) Adults (18 yrs. and older): 2 sprays in each nostril twice daily. 2 sprays in each nostril once daily may also be effective in some patients. DOSAGE FORMS AND STRENGTHS Nasal Spray: 50 mcg of mometasone furoate in each 100-microliter spray ( 3) CONTRAINDICATIONS Patients with known hypersensitivity to mometasone furoate or any of the ingredients of NASONEX. ( 4) WARNINGS AND PRECAUTIONS Epistaxis, nasal ulceration, _Candida albicans_ infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, Прочитайте повний документ