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Montelukast

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Overview

What is Montelukast?

Montelukast sodium USP, the active ingredient in montelukast sodium tablets 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 empirical formula is CHCINNaOS, and its molecular weight is 608.18. The structural formula is:

      Montelukast sodium USP is a white or almost white, hygroscopic powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol.       Each 10 mg film-coated montelukast tablet contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.



What does Montelukast look like?



What are the available doses of Montelukast?

•Montelukast sodium (equivalent to 10 mg montelukast) Film-Coated Tablets

What should I talk to my health care provider before I take Montelukast?

How should I use Montelukast?

Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent patients 15 years of age and older.

Montelukast sodium tablet should be taken once daily in the evening. The following doses are recommended:

For adults and adolescents15 years of age and older: one 10 mg tablet.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

    There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.


What interacts with Montelukast?

Sorry No Records found


What are the warnings of Montelukast?

Sorry No Records found


What are the precautions of Montelukast?

Sorry No Records found


What are the side effects of Montelukast?

Sorry No records found


What should I look out for while using Montelukast?

•Hypersensitivity to any component of this product ().


What might happen if I take too much Montelukast?

No specific information is available on the treatment of overdosage with montelukast sodium tablets. 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 tablets. These include reports in adults with a dose as high as 1000 mg. The clinical and laboratory findings observed were consistent with the safety profile in adults. 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 tablets and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity.


How should I store and handle Montelukast?

TALTZ is sterile and preservative-free. Discard any unused portion. Montelukast sodium (equivalent to 10 mg montelukast) tablets are beige, rounded square-shaped, film coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows:         Unit of Use Bottles of 30                                   NDC 68645-560-54 Storage        Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Montelukast sodium (equivalent to 10 mg montelukast) tablets are beige, rounded square-shaped, film coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows:         Unit of Use Bottles of 30                                   NDC 68645-560-54 Storage        Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Montelukast sodium (equivalent to 10 mg montelukast) tablets are beige, rounded square-shaped, film coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows:         Unit of Use Bottles of 30                                   NDC 68645-560-54 Storage        Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Montelukast sodium (equivalent to 10 mg montelukast) tablets are beige, rounded square-shaped, film coated tablets debossed with 'I' on one side and '114' on the other side. They are supplied as follows:         Unit of Use Bottles of 30                                   NDC 68645-560-54 Storage        Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The cysteinyl leukotrienes (LTC, LTD, LTE) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1. (CysLT) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early-and late-phase reactions and are associated with symptoms of allergic rhinitis.   Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or β-adrenergic receptor). Montelukast inhibits physiologic actions of LTD at the CysLT receptor without any agonist activity.

Non-Clinical Toxicology
•Hypersensitivity to any component of this product ().

Montelukast sodium tablet is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with montelukast sodium tablet can be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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