NASONEX mometasone furoate monohydrate spray metered

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

MOMETASONE FUROATE MONOHYDRATE (UNII: MTW0WEG809) (MOMETASONE - UNII:8HR4QJ6DW8)

Commercializzato da:

REMEDYREPACK INC.

INN (Nome Internazionale):

MOMETASONE FUROATE MONOHYDRATE

Composizione:

MOMETASONE FUROATE 50 ug

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

NASONEX- MOMETASONE FUROATE MONOHYDRATE SPRAY, METERED
REMEDYREPACK INC.
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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,