Montelukast Sodium (Montelukast Sodium)

Trade Name : Montelukast Sodium

Teva Pharmaceuticals USA, Inc.

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 (Montelukast Sodium) which is also known as Montelukast Sodium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 4 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
  • Warnings and Precautions, Neuropsychiatric Events () 08/2019
  • Montelukast sodium is a leukotriene receptor antagonist indicated for:
  • Prophylaxis and chronic treatment of asthma in patients 2 years 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 2 years 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 ().
  • No data
  • Montelukast sodium tablets, 10 mg (montelukast)
  • Montelukast sodium chewable tablets, 4 mg (montelukast) and 5 mg (montelukast)
  • No data
  • Hypersensitivity to any component of this product ().
  • No data
  • Do not prescribe montelukast sodium to treat an acute asthma attack ().
  • Advise patients to have appropriate rescue medication available ().
  • Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids ().
  • Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium ().
  • Neuropsychiatric events have been reported with montelukast sodium. Instruct patients to be alert for neuropsychiatric events. Evaluate the risks and benefits of continuing treatment with montelukast sodium 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 u2265 5% 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 Teva Pharmaceuticals USA, Inc. at 1-888-838-2872; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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 [].
  • 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 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 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, USP the active ingredient in Montelukast Sodium Tablets USP and Montelukast Sodium Chewable Tablets USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT receptor.
  • Montelukast sodium, USP 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 structural formula is:
  • CHClNNaOS M.W. 608.17
  • Montelukast sodium, USP is a hygroscopic, optically active, white to off-white to light yellow powder. Montelukast sodium, USP is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.
  • Each 10 mg Montelukast Sodium Tablet USP contains 10.4 mg montelukast sodium, USP which is equivalent to 10 mg of montelukast, and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, pregelatinized maize starch, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.
  • Each 4 mg and 5 mg Montelukast Sodium Chewable Tablet USP contains 4.2 and 5.2 mg montelukast sodium, USP respectively, which is equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavoring [which contains maltodextrins (maize) and starch modified (waxy maize)], ferric oxide red, hydroxypropyl cellulose, magnesium stearate, mannitol granulate, sodium lauryl sulfate, and sodium starch glycolate.
  • 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 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 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
  • Montelukast Sodium Tablets USP are available as:
  • 10 mg (montelukast) u2013 beige, standard convex round, film-coated, unscored tablets, debossed with u201cTVu201d on one side of the tablet and u201c7426u201d on the other side, in bottles of 30 (NDC 0093-7426-56), 90 (NDC 0093-7426-98), and 1000 (NDC 0093-7426-10).
  • Montelukast Sodium Chewable Tablets USP are available as:
  • 4 mg (montelukast) u2013 mottled pink, arc triangle-shaped, unscored tablets, debossed with u201cTVu201d on one side of the tablet and u201c7424u201don the other side, in bottles of 30 (NDC 0093-7424-56) and 90 (NDC 0093-7424-98).
  • 5 mg (montelukast) u2013 mottled pink, square-shaped, unscored tablets, debossed with u201cTVu201d on one side of the tablet and u201c7425u201d on the other side, in bottles of 30 (NDC 0093-7425-56) and 90 (NDC 0093-7425-98).
  • Store 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
  • When product container is subdivided, repackage into a well-closed, light-resistant container.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. P 10/2019
  • Montelukast (mon-te-LOO-kast) Sodium Tablets and Chewable Tablets
  • Read the Patient Information Leaflet that comes with montelukast sodium tablets and chewable tablets before you start taking them 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 tablets and chewable tablets.
  • 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.
  • Tell your healthcare provider right away if you get one or more of these symptoms:
  • 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?
  • 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 1-888-838-2872.
  • What are the ingredients in montelukast sodium tablets and chewable tablets?
  • Active ingredient:
  • Inactive ingredients:
  • People with Phenylketonuria: Montelukast sodium chewable tablets, 4 mg (montelukast) contain 0.28 mg of phenylalanine, and montelukast sodium chewable tablets, 5 mg (montelukast) contain 0.28 mg of phenylalanine.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. M 10/2019
  • No data
  • No data
  • No data

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