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Montelukast
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].
