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What is Singulair? Montelukast sodium, the active ingredient in Singulair, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. In clinical studies, Singulair improved asthma control in many patients by significantly decreasing asthma attacks, preventing daytime and night-time asthma symptoms, and reducing reliance on other asthma medicines, such as quick-relieving bronchodilators. Side effects seen in adults and children during the clinical trials were similar for the groups treated with Singulair and for those treated with placebo. The most commonly reported side effects in adults for both placebo and Singulair were headache, influenza and abdominal pain.
What Is The Usual Dosage?If your asthma is sensitive to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), continue to avoid those medicines as directed by your doctor. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Montelukast while you are pregnant. It is not known if Montelukast is found in breast milk. If you are or will be breast-feeding while you are using Montelukast , check with your doctor. After you begin taking Singulair, your doctor may be able to slowly reduce the dosage of other asthma medications such as inhaled steroids. Dosage And AdministrationIf Singulair is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Singulair should be used during pregnancy only if clearly needed. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known whether Singulair appears in breast milk. In rare cases, patients with asthma on therapy with Singulair may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. Singulair PrecautionsSide effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Little is known about the effects of Singulair overdose. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. No teratogenicity was observed in rats at oral doses up to 400 mg/kg/day (estimated exposure was approximately 100 times the AUC for adults at the maximum recommended daily oral dose) and in rabbits at oral doses up to 300 mg/kg/day (estimated exposure was approximately 110 times the AUC for adults at the maximum recommended daily oral dose). Montelukast crosses the placenta following oral dosing in rats and rabbits. Singulair Adverse ReactionsIn placebo-controlled clinical trials, the following event was reported with Singulair with a frequency greater than 1% and at an incidence greater than placebo, regardless of causality assessment: upper respiratory infection, 1.9% of patients receiving Singulair vs. 1.5% of patients receiving placebo. Singulair administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. Singulair has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received Singulair in two, 6-week, clinical studies. Singulair administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. |
