SINGULAIR- montelukast sodium tablet, chewable SINGULAIR- montelukast sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dispensing Solutions Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 in patients 15 years of age and older. SINGULAIR is indicated for the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older). Hypersensitivity to any component of this product.

Product summary:

No. 3841 — SINGULAIR Oral Granules, 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil packet. No. 3796 — SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets, with code MRK 711 on one side and SINGULAIR on the other. No. 3760 — SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets, with code MRK 275 on one side and SINGULAIR on the other. No. 3761 — SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets, with code MRK 117 on one side and SINGULAIR on the other. They are supplied by Dispensing Solutions Inc. as follows: This product was Manufactured By: MERCK SHARP & DOHME LTD. Cramlington, Northumberland, UK NE23 3JU Distributed by: MERCK & CO., INC. Whitehouse Station, NJ 08889, USA And Repackaged By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States 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. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

SINGULAIR - MONTELUKAST SODIUM TABLET, CHEWABLE
SINGULAIR - MONTELUKAST SODIUM TABLET, FILM COATED
DISPENSING SOLUTIONS INC.
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SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR , is a
selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT
receptor.
Montelukast sodium is described chemically as [_R _-(_E
_)]-1-[[[1-[3-[2-(7-chloro-2-
quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-
methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid,
monosodium salt.
The empirical formula is C
H ClNNaO S, and its molecular weight is 608.18. The structural
formula is:
Montelukast sodium is a hygroscopic, optically active, white to
off-white powder. Montelukast sodium
is freely soluble in ethanol, methanol, and water and practically
insoluble in acetonitrile.
Each 10-mg film-coated SINGULAIR tablet contains 10.4 mg montelukast
sodium, which is equivalent
to 10 mg of montelukast, and the following inactive ingredients:
microcrystalline cellulose, lactose
monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and
magnesium stearate. The film
coating consists of: hydroxypropyl methylcellulose, hydroxypropyl
cellulose, titanium dioxide, red
ferric oxide, yellow ferric oxide, and carnauba wax.
Each 4-mg and 5-mg chewable SINGULAIR tablet contains 4.2 and 5.2 mg
montelukast sodium,
respectively, which are equivalent to 4 and 5 mg of montelukast,
respectively. Both chewable tablets
contain the following inactive ingredients: mannitol, microcrystalline
cellulose, hydroxypropyl
cellulose, red ferric oxide, croscarmellose sodium, cherry flavor,
aspartame, and magnesium stearate.
Each packet of SINGULAIR 4-mg oral granules contains 4.2 mg
montelukast sodium, which is
equivalent to 4 mg of montelukast. The oral granule formulation
contains the following inactive
ingredients: mannitol, hydroxypropyl cellulose, and magnesium
stearate.
1
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The