SINGULAIR- montelukast sodium tablet, chewable

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Bryant Ranch Prepack

ИНН (Международная Имя):

MONTELUKAST SODIUM

состав:

MONTELUKAST 4 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. SINGULAIR 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. 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, SINGULAIR 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 marketing experience, congenital limb

Обзор продуктов:

No. 3841 — SINGULAIR Oral Granules, 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: NDC 0006-3841-30 unit of use carton with 30 packets. SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets. They are supplied as either No. 3796 or No. 6628: No. 3796 — with code MRK 711 on one side and SINGULAIR on the other: NDC 0006-0711-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-0711-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-0711-28 unit dose paper and aluminum foil-backed aluminum foil peelable blister packs of 100. No. 6628 — with code MSD 711 on one side and SINGULAIR on the other: NDC 0006-1711-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-1711-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets. They are supplied as either No. 3760 or No. 6543: No. 3760 — with code MRK 275 on one side and SINGULAIR on the other: NDC 0006-0275-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-0275-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-0275-28 unit dose paper and aluminum foil-backed aluminum foil peelable blister packs of 100 NDC 0006-0275-82 bulk packaging high-density polyethylene (HDPE) bottles of 1000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant. No. 6543 — with code MSD 275 on one side and SINGULAIR on the other: NDC 0006-9275-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-9275-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-9275-82 bulk packaging high-density polyethylene (HDPE) bottles of 1000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant. SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets. They are supplied as either No. 3761 or No. 6558: No. 3761 — with code MRK 117 on one side and SINGULAIR on the other: NDC 0006-0117-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-0117-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-0117-28 unit dose paper and aluminum foil-backed aluminum foil peelable blister pack of 100 NDC 0006-0117-80 bulk packaging high-density polyethylene (HDPE) bottles of 8000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant. No. 6558 — with code MSD 117 on one side and SINGULAIR on the other: NDC 0006-9117-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-9117-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-9117-80 bulk packaging high-density polyethylene (HDPE) bottles of 8000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant. Storage Store SINGULAIR 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°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.

Статус Авторизация:

New Drug Application

Характеристики продукта

SINGULAIR- MONTELUKAST SODIUM TABLET, CHEWABLE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SINGULAIR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SINGULAIR.
SINGULAIR (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL
GRANULES
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage
Exercise-Induced Bronchoconstriction (EIB) (1.2)
03/2012
Dosage and Administration
Exercise-Induced Bronchoconstriction (EIB) (2.2)
03/2012
Warnings and Precautions
Neuropsychiatric Events (5.4)
11/2012
INDICATIONS AND USAGE
SINGULAIR is 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 or one packet of 4-mg oral
granules.
6 to 23 months: one packet of 4-mg oral granules.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4). For oral granules: Must
administer within 15 minutes after opening the packet (with or without
mixing with food) (2.5).
DOSAGE FORMS AND STRENGTHS
SINGULAIR 10-mg Film-Coated Tablets
SINGULAIR 5-mg and 4-mg Chewable Table