MONTELUKAST SODIUM- montelukast sodium tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] . In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD)

Product summary:

Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-725-30 Bottles of 90                                       NDC 55111-725-90 Bottles of 100                                     NDC 55111-725-01 Bottles of 1000                                  NDC 55111-725-10 Unit Dosage Package of 100 (10x10) NDC 55111-725-78  Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-593-30 Bottles of 90                                       NDC 55111-593-90 Bottles of 500                                    NDC 55111-593-05 Unit Dosage Package of 100 (10x10) NDC 55111-593-78  Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                       NDC 55111-594-30 Bottles of 90                                       NDC 55111-594-90 Bottles of 500                                    NDC 55111-594-05 Unit Dosage Package of 100 (10x10) NDC 55111-594-78 Storage Store montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, COATED
REMEDYREPACK INC.
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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 TABLETS, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Neuropsychiatric Events ( 5.4) 12/2018
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
• Prophylaxis and chronic treatment of asthma in patients 12 months
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 6 months of age and
older (1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma (2.1): Once daily in the evening for patients 12 months and
older.
Acute prevention of EIB (2.2): One tablet 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 6 months
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 (montelukast) Film-Coated Tablets (3)
• Montelukast sodium 5 mg and 4 mg (montelukast) Chewable Tablets
(3)
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 medicatio