SINGULAIR®, (MONTELUKAST SODIUM), TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES

/SINGULAIR®, (MONTELUKAST SODIUM), TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
SINGULAIR®, (MONTELUKAST SODIUM), TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES2018-09-06T09:12:40+00:00

Prescription Drug Name:

SINGULAIR®, (MONTELUKAST SODIUM), TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES

ID:

6f5962a5-487d-4d7d-a3eb-ec9d1e77caca

Code:

34391-3

DESCRIPTION


id: e522e183-446f-4742-a11a-3b9dbb3be791
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Montelukast sodium, the active ingredient in SINGULAIR Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 1998-2009 MERCK & CO., Inc.
All rights reserved
, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 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 C35H35ClNNaO3S, 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.

INDICATIONS AND USAGE


id: 2e9b0371-b594-4e25-aabf-2717fa169b3d
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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).

CONTRAINDICATIONS


id: 749131d7-2a17-4849-be8e-77e3b90277e3
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Hypersensitivity to any component of this product.

OVERDOSAGE


id: 2fccc97c-67c9-442e-9f95-d446b79e3d25
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

No mortality occurred following single oral doses of montelukast up to 5000 mg/kg in mice (estimated exposure was approximately 335 and 210 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose) and rats (estimated exposure was approximately 230 and 145 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose). No specific information is available on the treatment of overdosage with SINGULAIR. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and, in short-term studies, up to 900 mg/day to patients for approximately a week without clinically important adverse experiences. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. There have been reports of acute overdosage in post-marketing experience and clinical studies with SINGULAIR. These include reports in adults and children with a dose as high as 1000 mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients. There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of SINGULAIR and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.

HOW SUPPLIED


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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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:

NDC Strength Quantity/Form Color Source NDC
68258-3032-03 5 mg 30 TABLET pink 0006-0275-31
68258-3033-03 10 mg 30 TABLET beige 0006-0117-31
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

PATIENT PACKAGE INSERT


id: 4ed78d3d-8275-45f6-b0c5-1f68fc522b2f
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Patient Information
SINGULAIR® (SING-u-lair) Tablets, Chewable Tablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium
Read this information before you start taking SINGULAIR®. Also, read the leaflet you get each time you refill SINGULAIR, since there may be new information in the leaflet since the last time you saw it. This leaflet does not take the place of talking with your doctor about your medical condition and/or your treatment.

PRINCIPAL DISPLAY PANEL – CHEWABLE TABLETS – BOTTLE LABEL – 5 mg


id: 4ede29ce-5c54-4773-acca-f7e8f6af74b3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Singulair® 5 mg
(Montelukast Sodium) CHEWABLE TABLETS
For Pediatric Patients 6-14 Years of Age
Phenylketonurics: contains phenylalanine (a component of aspartame) 0.842 mg per 5-mg chewable tablet. Each tablet contains 5.2 mg Montelukast Sodium equivalent to 5 mg Montelukast. 30 Tablets NDC 68258-3032-03 Store 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.
USUAL DOSAGE: See accompanying circular. Keep this and all drugs out of the reach of children Rx only

PRINCIPAL DISPLAY PANEL – TABLETS – BOTTLE LABEL – 10 mg


id: cfcd51ec-226d-4b42-bfa9-5c8c469b4df3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Singulair® 10 mg
(Montelukast Sodium) TABLETS
For Adults 15 Years of Age and Older
Each tablet contains 10.4 mg Montelukast Sodium equivalent to 10 mg Montelukast. 30 Tablets NDC 68258-3033-03 Store 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.
USUAL DOSAGE: See accompanying circular. Rx only