Montelukast Sodium (Montelukast Sodium)

Trade Name : Montelukast Sodium

Teva Pharmaceuticals USA, Inc.

GRANULE

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.

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 () 8/2019
  • Montelukast sodium oral granules are a leukotriene receptor antagonist indicated for:
  • Prophylaxis and chronic treatment of asthma in patients 12 months 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
  • Montelukast sodium oral granules, 4 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 ).
  • 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 coadministered 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 postmarketing 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 Oral Granules USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT receptor.
  • Montelukast sodium is described chemically as sodium 1-[[[(R)-m-[(E)-2-(7-chloro-2-quinolyl)vinyl]-u03b1-[o-(1-hydroxy-1-methylethyl)phenethyl]benzyl]thio]-methyl]cyclopropaneaceacetate.
  • 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 to very soluble in alcohol; freely soluble in water and in methylene chloride.
  • Each packet of Montelukast Sodium Oral Granules USP 4 mg contains 4.2 mg montelukast sodium, USP, which is equivalent to 4 mg of montelukast. The oral granule formulation contains the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, mannitol, and sodium lauryl sulfate.
  • This product meets USP .
  • 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 Oral Granules USP, 4 mg (montelukast) are white to slightly yellow granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows:
  • 4 mg u2013 unit of use carton with 30 packets (NDC 0093-7487-56).
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [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
  • For patent information: www.tevagenerics.com
  • Distributed By:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. J 8/2019
  • Montelukast (monu2032n- u2032 te loon- u2032 kast soen- u2032 dee um) Sodium Oral Granules
  • Read the Patient Information Leaflet that comes with montelukast sodium oral granules 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 are montelukast sodium oral granules?
  • Montelukast sodium oral granules are used to:
  • Who should not take montelukast sodium oral granules?
  • Do not take montelukast sodium oral granules if you are allergic to any of their ingredients.
  • See the end of this leaflet for a complete list of the ingredients in montelukast sodium oral granules.
  • What should I tell my healthcare provider before taking montelukast sodium oral granules?
  • Before taking montelukast sodium oral granules, 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 oral granules work, or montelukast sodium oral granules may affect how your other medicines work.
  • How should I take montelukast sodium oral granules?
  • For anyone who takes montelukast sodium oral granules:
  • For adults and children 12 months of age and older with 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 montelukast sodium oral granules to my child?
  • Give montelukast sodium oral granules to your child exactly as instructed by your healthcare provider.
  • Do not open the packet until ready to use.
  • Montelukast sodium oral granules, 4 mg can be given:
  • Give the child all of the mixture right away, within 15 minutes.
  • Do not store any leftover montelukast sodium oral granule mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time.
  • Do not mix montelukast sodium oral granules with any liquid drink other than baby formula or breast milk.
  • What is the dose of montelukast sodium oral granules?
  • The dose of montelukast sodium oral granules prescribed for your or your child's condition is based on age:
  • What should I avoid while taking montelukast sodium oral granules?
  • 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 oral granules.
  • What are the possible side effects of montelukast sodium oral granules?
  • Montelukast sodium oral granules 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 oral granules include:
  • Other side effects with montelukast sodium oral granules 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 oral granules. 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 oral granules?
  • General Information about the safe and effective use of montelukast sodium oral granules
  • Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. Do not use montelukast sodium oral granules for a condition for which they were not prescribed. Do not give montelukast sodium oral granules to other people even if they have the same symptoms you have. They may harm them. n
  • This leaflet summarizes information about montelukast sodium oral granules. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about montelukast sodium oral granules that is written for health professionals. For more information, call 1-888-838-2872.
  • What are the ingredients in montelukast sodium oral granules?
  • Active ingredient:
  • Inactive ingredients:
  • For patent information: www.tevagenerics.com
  • Distributed By:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. I 8/2019
  • NDCn- 7487
  • Montelukast Sodium
  • Oral Granules USP, 4 mg*
  • *Each packet contains 4.2 mg montelukast sodium, USP equivalent to 4mg montelukast.
  • For Pediatric Patients 6 months to 5 years of age.
  • DIRECTIONS FOR USE: See package insert for full prescribing information. Once opened, use the contents
  • of this packet within 15 minutes (with or without mixing with food). Discard any unused portion.
  • PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET
  • Rx only
  • 30 Packets
  • TEVA
  • No data

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