Montelukast Sodium (Singulair)

Trade Name : SINGULAIR

Merck Sharp & Dohme Corp.

TABLET, CHEWABLE

Strength 4 mg/1

MONTELUKAST SODIUM Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Montelukast Sodium (Singulair) which is also known as SINGULAIR and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 4 mg/1 per ml. Read more

Montelukast Sodium (Singulair) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

No data

SINGULAIR is a leukotriene receptor antagonist indicated for:

Prophylaxis and chronic treatment of asthma in patients 12u00a0months of age and older ().
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ().
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 ().

Administration (by indications):
Dosage (by age) ():
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (). For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food) ().

No data

SINGULAIR 10-mg Film-Coated Tablets
SINGULAIR 5-mg and 4-mg Chewable Tablets
SINGULAIR 4-mg Oral Granules ()

No data

Hypersensitivity to any component of this product ().

No data

Do not prescribe SINGULAIR to treat an acute asthma attack ().
Advise patients to have appropriate rescue medication available ().
Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute SINGULAIR for inhaled or oral corticosteroids ().
Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR ().
Neuropsychiatric events have been reported with SINGULAIR. Instruct patients to be alert for neuropsychiatric events. Evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur ( and ).
Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events have been sometimes associated with the reduction of oral corticosteroid therapy ( and ).
Inform patients with phenylketonuria that the 4-mg and 5-mg chewable tablets contain phenylalanine ().

Most common adverse reactions (incidence u22655% 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 ().
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No dose adjustment is needed when SINGULAIR is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers n

No data

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.

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 [-()]-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 CHClNNaOS, 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.

No data

No evidence of tumorigenicity was seen in carcinogenicity studies of either 2 years in Sprague-Dawley rats or 92 weeks in mice at oral gavage doses up to 200u00a0mg/kg/day or 100 mg/kg/day, respectively. The estimated exposure in rats was approximately 120 and 75u00a0times the AUC for adults and children, respectively, at the maximum recommended daily oral dose. The estimated exposure in mice was approximately 45 and 25u00a0times the AUC for adults and children, respectively, at the maximum recommended daily oral dose.
Montelukast demonstrated no evidence of mutagenic or clastogenic activity in the following assays: the microbial mutagenesis assay, the V-79 mammalian cell mutagenesis assay, the alkaline elution assay in rat hepatocytes, the chromosomal aberration assay in Chinese hamster ovary cells, and in the mouse bone marrow chromosomal aberration assay.
In fertility studies in female rats, montelukast produced reductions in fertility and fecundity indices at an oral dose of 200 mg/kg (estimated exposure was approximately 70 times the AUC for adults at the maximum recommended daily oral dose). No effects on female fertility or fecundity were observed at an oral dose of 100 mg/kg (estimated exposure was approximately 20 times the AUC for adults at the maximum recommended daily oral dose). Montelukast had no effects on fertility in male rats at oral doses up to 800 mg/kg (estimated exposure was approximately 160 times the AUC for adults at the maximum recommended daily oral dose).

No data

No. 3841 u2014 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
No. 6628 u2014 SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other. They are supplied as follows:
NDC
No. 6543 u2014 SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets, with code MSD 275 on one side and SINGULAIR on the other. They are supplied as follows:
NDC
No. 6558 u2014 SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other. They are supplied as follows:
NDC
NDC
Storage
Store SINGULAIR 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 25u00b0C (77u00b0F), excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Information for Patients

Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1998-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk0476-mf-1902r039

Patient InformationSINGULAIR (SING-u-lair)(montelukast sodium)Tablets
SINGULAIRn (montelukast sodium)Chewable Tablets
SINGULAIRn (montelukast sodium)Oral Granules
Read the Patient Information Leaflet that comes with SINGULAIR before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is SINGULAIR?
SINGULAIR is used to:
Who should not take SINGULAIR?
Do not take SINGULAIR if you are allergic to any of its ingredients.
See the end of this leaflet for a complete list of the ingredients in SINGULAIR.
What should I tell my healthcare provider before taking SINGULAIR?
Before taking SINGULAIR, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how SINGULAIR works, or SINGULAIR may affect how your other medicines work.
How should I take SINGULAIR?
For anyone who takes SINGULAIR:
For adults and children 12 months of age and older with asthma:
For patients 6 years of age and older for the prevention of exercise-induced asthma:
For adults and children 2 years of age and older with seasonal allergic rhinitis, or for adults and children 6 months of age and older with perennial allergic rhinitis:
How should I give SINGULAIR oral granules to my child?
Give SINGULAIR oral granules to your child exactly as instructed by your healthcare provider.
Do not open the packet until ready to use.
SINGULAIR 4-mg oral granules can be given:
Give the child all of the mixture right away, within 15 minutes.
Do not store any leftover SINGULAIR mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time.
Do not mix SINGULAIR oral granules with any liquid drink other than baby formula or breast milk.
What is the dose of SINGULAIR?
The dose of SINGULAIR prescribed for your or your child's condition is based on age:
What should I avoid while taking SINGULAIR?
If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking SINGULAIR.
What are the possible side effects of SINGULAIR?
SINGULAIR may cause serious side effects.
The most common side effects with SINGULAIR include:
Other side effects with SINGULAIR include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of SINGULAIR. For more information ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SINGULAIR?
General Information about the safe and effective use of SINGULAIR
Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. Do not use SINGULAIR for a condition for which it was not prescribed. Do not give SINGULAIR to other people even if they have the same symptoms you have. It may harm them. n
This leaflet summarizes information about SINGULAIR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about SINGULAIR that is written for health professionals. For more information, call the Merck National Service Center at 1-800-NSC-Merck (1-800-672-6372).
What are the ingredients in SINGULAIR?
Active ingredient:
Inactive ingredients:

Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1998-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 02/2019
usppi-mk0476-mf-1902r035

Singulairn- 4 mg(Montelukast Sodium)ORAL GRANULES
NDC
For Pediatric Patients 6 months to 5 years of age.
Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn n Whitehouse Station, NJ 08889, USA
Manuf. by: Patheon Manufacturing Services LLCGreenville, NC 27834, USA
Montelukast Sodium (active ingred.) Made in IrelandFormulated in USA
DIRECTIONS FOR USE: See accompanying Package Insert. Once opened, use the contents of this packet within 15 minutes (with or without mixing with food). Discard any unused portion.
Rx only

NDC 0006-1711-31
Singulairn- (Montelukast Sodium) CHEWABLE Tablets
4 mg
For Pediatric Patients 2-5 Years of Age
Phenylketonurics:
Rx only
30 Tablets

NDC 0006-9275-31
Singulairn- (Montelukast Sodium)CHEWABLE Tablets
5 mg
For Pediatric Patients 6-14 Years of Age
Phenylketonurics:
Rx only
30 Tablets

NDC 0006-9117-31
Singulairn- (Montelukast Sodium) Tablets
10 mg
For Adults 15 Years of Age and Older
Each tablet contains 10.4 mg Montelukast Sodium equivalent to 10 mg Montelukast.
Rx only
30 Tablets

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Montelukast Sodium (Singulair)

Trade Name : SINGULAIR

TABLET, CHEWABLE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Montelukast Sodium (Singulair)

Trade Name : SINGULAIR

TABLET, CHEWABLE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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