Montelukast Sodium (Montelukast Sodium)

Trade Name : Montelukast Sodium

West-Ward Pharmaceuticals Corp.

TABLET

Strength 10 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 (Montelukast Sodium) which is also known as Montelukast Sodium and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 10 mg/1 per ml. Read more

Montelukast Sodium (Montelukast Sodium) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • u00a0
  • 5.4
  • Montelukast sodium is a leukotriene receptor antagonist indicated for:
  • Administration (by indications):
  • Dosage (by age) (2):
  • Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ().
  • No data
  • Hypersensitivity to any component of this product.
  • u2022
  • 4
  • No data
  • 5.4n- 6.2
  • 5.5n- 6.2
  • 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 West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or .
  • No dose adjustment is needed when montelukast sodium 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 montelukast sodium. 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 montelukast sodium. These include reports in adults and children with a dose as high as 1,000 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 montelukast sodium 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 Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets 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-2u2011quinolinyl)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 USP is a hygroscopic, optically active, white to off-white to light yellow powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.
  • Each 10 mg film-coated Montelukast Sodium Tablet contains montelukast sodium USP equivalent to 10 mg montelukast (base). Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry II Yellow and sodium starch glycolate. Opadry II Yellow contains: polyvinyl alcohol, polyethylene glycol, red iron oxide, yellow iron oxide, talc and titanium dioxide.
  • Each 4 mg and 5 mg Montelukast Sodium Chewable Tablet contains montelukast sodium USP equivalent to 4 mg or 5 mg of montelukast (base), respectively. Each tablet contains the following inactive ingredients: copovidone, iron oxide (red), magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, sucralose and wild cherry flavor.
  • No data
  • No evidence of tumorigenicity was seen in carcinogenicity studies of either 2 years in Spragueu2011Dawley rats or 92 weeks in mice at oral gavage doses up to 200 mg/kg/day or 100 mg/kg/day, respectively. The estimated exposure in rats was approximately 120 and 75 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose. The estimated exposure in mice was approximately 45 and 25 times 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 Vu201179 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
  • Montelukast Sodium Tablets
  • The 10 mg (base) tablets are supplied as light tan, round, biconvex film-coated tablets; with product identification u201c54u201d over u201c157u201d on one side and plain on the other side.
  • NDC 0054-0259-13: Bottle of 30 Tablets
  • NDC 0054-0259-22: Bottle of 90 Tablets
  • NDC 0054-0259-31: Bottle of 1,000 Tablets
  • Montelukast Sodium Chewable Tablets
  • The 4 mg (base) tablets are supplied as pink, speckled, oval, biconvex tablets with product identification u201c54u201d over u201c144u201d on one side and plain on the other side.
  • NDC 0054-0288-13: Bottle of 30 Tablets
  • NDC 0054-0288-22: Bottle of 90 Tablets
  • The 5 mg (base) tablets are supplied as pink, speckled, round, biconvex tablets with product identification u201c54u201d over u201c741u201d on one side and plain on the other side.
  • NDC 0054-0289-13: Bottle of 30 Tablets
  • NDC 0054-0289-22: Bottle of 90 Tablets
  • NDC 0054-0289-29: Bottle of 500 Tablets
  • Storage
  • Store Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from moisture and light. Store in original package.
  • Storage for Bulk Bottles
  • Store Montelukast Sodium Tablets bottle of 1,000 tablets and Montelukast Sodium Chewable Tablets bottle of 500 tablets at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a wellu2011closed, light-resistant container.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Information for Patients
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006150/06
  • Revised October 2019
  • Montelukast Sodium Tablets
  • and
  • Montelukast Sodium Chewable Tablets
  • (monu201du00a0te loou2019u00a0kast soeu2019u00a0dee um)
  • Rx Only
  • Read the Patient Information Leaflet that comes with montelukast sodium 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 montelukast sodium?
  • Montelukast sodium is used to:
  • Who should not take montelukast sodium?
  • Do not take montelukast sodium if you are allergic to any of its ingredients.
  • See the end of this leaflet for a complete list of the ingredients in montelukast sodium.
  • What should I tell my healthcare provider before taking montelukast sodium?
  • Before taking montelukast sodium, 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 montelukast sodium works, or montelukast sodium may affect how your other medicines work.
  • How should I take montelukast sodium?
  • For anyone who takes montelukast sodium:
  • For adults and children 2 years 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 2 years of age and older with perennial allergic rhinitis:
  • What is the dose of montelukast sodium?
  • The dose of montelukast sodium prescribed for your or your child's condition is based on age:
  • What should I avoid while taking montelukast sodium?
  • 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 montelukast sodium.
  • What are the possible side effects of montelukast sodium?
  • Montelukast sodium may cause serious side effects.
  • The most common side effects with montelukast sodium include:
  • Other side effects with montelukast sodium 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 montelukast sodium. 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 Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets?
  • General Information about the safe and effective use of montelukast sodium
  • Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. Do not use montelukast sodium for a condition for which it was not prescribed. Do not give montelukast sodium to other people even if they have the same symptoms you have. It may harm them. n
  • This leaflet summarizes information about montelukast sodium. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about montelukast sodium that is written for health professionals. For more information call West-Ward Pharmaceuticals Corp. at 1-800-962-8364.
  • What are the ingredients in Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006150/06
  • Revised October 2019
  • No data
  • No data
  • No data

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