MONTELUKAST tablet, chewable

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Preferred Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years 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 2 years of age and older. Hypersensitivity to any component of this product. Pregnancy  Category  B: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. Teratogenic  Effect: No teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on AUCs [see  Nonclinical Toxicology (13.2)]. During worldwide marke

Descriptif du produit:

Montelukast sodium chewable tablets, 5 mg, are pink, rounded, bi-convex-shaped, debossed with "AUM102" on one side and plain on the other side. They are supplied as follows: Bottles of 10 NDC 68788-7387-1 Bottles of 14 NDC 68788-7387-4 Bottles of 20 NDC 68788-7387-2 Bottles of 30 NDC 68788-7387-3 Bottles of 60 NDC 68788-7387-6 Bottles of 90 NDC 68788-7387-9 Storage Store montelukast sodium 10 mg film coated tablets, 5-mg chewable tablets and 4-mg chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1000 montelukast sodium-10 mg film coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well- closed, light-resistant container.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MONTELUKAST- MONTELUKAST TABLET, CHEWABLE
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS AND
MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS.
MONTELUKAST SODIUM TABLETS, FOR ORAL USE.
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Eosinophilic Conditions (5.5) 06/2013
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist
indicated for:
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DOSAGE AND ADMINISTRATION
Administration (by indications):
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Dosage (by age) (2)
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Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and greater than
placebo listed in descending order of frequency): upper
respiratory infection, fever, headache, pharyngitis, cough, abdominal
pain, diarrhea, otitis media, influenza, rhinorrhea,
sinusitis, otitis (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIONPHARMA INC. AT
1-888-235-2466 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Asthma
1.2 Exercise-Induced Bronchoconstriction (EIB)
1.3 Allergic Rhinitis
2 DOSAGE AND ADMINISTRATION
2.1 Asthma
2.2 Exercise-Induced Bronchoconstriction (EIB)
2.3 Allergic Rhinitis
2.4 Asthma and Allergic Rhinitis
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Acute Asthma
5.2 Concomitant Corticosteroid Use
5.3 Aspirin Sensitivity
5.4 Neuropsychiatric Events
5.5 Eosinophilic Conditions
Prophylaxis and chronic treatment of asthma in patients