Drug ingredients Database singulair

Singulair (montelukast) is a leukotriene (loo-koe-TRY-een) inhibitor. The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18. Both chewable tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.
Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. We comply with the HONcode standard for trustworthy health information - This may help to improve symptoms of 1. SINGULAIR 4-mg Oral Granules are white granules with 500 mg net weight, packed in a child-resistant foil packet. Hypersensitivity to any component of this product. Because the benefits of SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see SINGULAIR should be taken once daily in the evening. SINGULAIR does not contain a steroid. The median age in this trial was 35.0 years (range 15 to 81); 65.4% were females and 34.6% were males. * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). eHealthMe is studying from 91,285 Singulair users now. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The primary endpoint was the mean maximum percent fall in FEVThe efficacy of SINGULAIR 5-mg chewable tablets, when given as a single dose 2 hours before exercise for the prevention of EIB, was investigated in one multinational, randomized, double-blind, placebo-controlled crossover study that included a total of 64 pediatric patients 6 to 14 years of age with EIB. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The following doses are recommended:For adults and adolescents 15 years of age and older: one 10-mg tablet.For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Montelukast Sodium is the orally bioavailable monosodium salt of montelukast, a selective cysteinyl leukotriene receptor antagonist with anti-inflammatory and bronchodilating activities. Safety and efficacy profiles in this age group are similar to those seen in adults [see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY, Special Populations, and Clinical Studies]. 6628 — with code MSD 711 on one side and SINGULAIR on the other: NDC 0006-1711-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0006-1711-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant. The packet should not be opened until ready to use. However, liquids may be taken subsequent to administration. Read the Singulair Drug Interactions Center for a complete guide to possible interactions Learn More » Dist. At clinically relevant concentrations, 2C8 appears to play a major role in the metabolism of montelukast. The mean changes from baseline in daytime nasal symptoms score in the treatment groups that received SINGULAIR tablets, loratadine, and placebo are shown in TABLE 5.

Global MDs & Clinics: 2,676,614  |  Millions of Patients & Consumers! They are supplied as follows: NDC 0006-3841-30 unit of use carton with 30 packets. If you are using the chewable tablets, chew them thoroughly before swallowing. SINGULAIR 10-mg tablets once daily was shown to significantly reduce symptoms of perennial allergic rhinitis over a 6-week treatment period (TABLE 6); in this study the primary outcome variable was mean change from baseline in daytime nasal symptoms score (the average of individual scores of nasal congestion, rhinorrhea, and sneezing).The other 6-week study evaluated SINGULAIR 10 mg (n=626), placebo (n=609), and an active-control (cetirizine 10 mg; n=120).
SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets. It is reasonable to employ appropriate clinical monitoring when potent CYP enzyme inducers, such as phenobarbital or rifampin, are co-administered with SINGULAIR.Montelukast is a potent inhibitor of CYP2C8 in vitro. Patients 15 to 82 years of age with perennial allergic rhinitis as confirmed by history and a positive skin test to at least one relevant perennial allergen (dust mites, animal dander, and/or mold spores), who had active symptoms at the time of study entry, were enrolled.In the study in which efficacy was demonstrated, the median age was 35 years (range 15 to 81); 64.1% were females and 35.9% were males.

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