MONTELUKAST SODIUM tablet chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM - MONTELUKAST SODIUM TABLET, CHEWABLE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM.
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
MONTELUKAST SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age
and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in
patients 6 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic
rhinitis (SAR) in patients 2 years of age and older, and
perennial allergic rhinitis (PAR) in patients 2 years of age and older
(1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma (2.1): Once daily in the evening for patients 2 years and
older.
Acute prevention of EIB (2.2): 10 mg at least 2 hours before exercise
for patients 6 years of age and older.
Seasonal allergic rhinitis (2.3): Once daily for patients 2 years and
older.
Perennial allergic rhinitis (2.3): Once daily for patients 2 years and
older.
Dosage (by age) (2):
15 years and older: one 10 mg tablet.
6 to 14 years: one 5 mg chewable tablet.
2 to 5 years: one 4 mg chewable tablet.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4).
DOSAGE FORMS AND STRENGTHS
Montelukast Sodium 10 mg film-coated tablets
Montelukast Sodium 5 mg and 4 mg Chewable Tablets
CONTRAINDICATIONS
Hypersensitivity to any component of this product (4).
WARNINGS AND PRECAUTIONS
Do not prescribe montelukast sodium to treat an acute asthma attack
(5.1).
Advise patients to have appropriate rescue medication available (5.1).
Inhaled corticosteroid may be reduced gradually. Do not abruptly
substitute montelukast sodium for inhaled or oral
corticoster