MOMETASONE FUROATE MONOHYDRATE spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Mometasone Furoate Monohydrate (UNII: MTW0WEG809) (Mometasone - UNII:8HR4QJ6DW8)

Available from:

Sandoz Inc.

INN (International Name):

Mometasone Furoate Monohydrate

Composition:

MOMETASONE FUROATE 50 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone Furoate Monohydrate Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. Mometasone Furoate Monohydrate Nasal Spray is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older. Mometasone Furoate Monohydrate Nasal Spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. Mometasone Furoate Monohydrate Nasal Spray is indicated for the treatment of nasal polyps in patients 18 years of age and older. Mometasone Furoate Monohydrate Nasal Spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients. Risk Summary There are no adequate and well-controlled clinical studies of Mometasone Furoate Monohydrate Nasal Spray in pregnant women. In animal reproducti

Product summary:

Mometasone Furoate Monohydrate Nasal Spray: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. When Mometasone Furoate Monohydrate Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable. SHAKE WELL BEFORE EACH USE. Keep out of reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MOMETASONE FUROATE MONOHYDRATE- MOMETASONE FUROATE MONOHYDRATE SPRAY,
METERED
SANDOZ INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE MONOHYDRATE NASAL
SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOMETASONE FUROATE MONOHYDRATE NASAL
SPRAY.
MOMETASONE FUROATE MONOHYDRATE NASAL SPRAY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Mometasone Furoate Monohydrate Nasal Spray is a corticosteroid
indicated for:
Treatment of Nasal Symptoms of Allergic Rhinitis in patients ≥2
years of age (1.1)
Treatment of Nasal Congestion Associated with Seasonal Allergic
Rhinitis in patients ≥2 years of age (1.2)
Prophylaxis of Seasonal Allergic Rhinitis in patients ≥12 years of
age (1.3)
Treatment of Nasal Polyps in patients ≥18 years of age (1.4)
DOSAGE AND ADMINISTRATION
For Nasal Use Only
Recommended Dosage for Treatment of Nasal Symptoms of 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
Recommended Dosage for Treatment of Nasal Congestion Associated with
Seasonal Allergic Rhinitis (2.3)
Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril
once daily
Children (2-11 yrs.): 1 spray in each nostril once daily
Recommended Dosage for Prophylaxis of Seasonal Allergic Rhinitis (2.4)
Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril
once daily
Recommended Dosage for Treatment of Nasal Polyps (2.5)
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 spray (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to mometasone furoate or any of
the ingredients of Mometasone Furoate
Monohydrate Nasal Spray. (4)
WARNINGS AND PRECAUTIONS
Epistaxis, nasal ulceration, _Candida albicans_ infection, nasal
septal perforati