Singulair (montelukast)
SINGULAIR (montelukast) – a leukotriene receptor antagonist commonly used to treat asthma, bronchoconstriction and certain allergic conditions. Leukotrienes have been correlated with the pathophysiology of asthma and allergic rhinitis. Montelukast inhibits physiologic actions of leukotrienes on airways, bronchial smooth muscle, and cells associated with the inflammatory process in asthma or the allergic process in allergic rhinitis.
FDA approved uses: Singulair is indicated for:
Prophylaxis and chronic treatment of asthma in patients 12 months of age and older; Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years 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.
Available dosage forms: Film Coated Tablets – 10 mg; chewable tablets – 4 and 5 mg; oral granules 4 mg.
Usual dosage: Asthma – once daily in the evening for patients 12 months and older; Acute prevention of EIB – one tablet at least 2 hours before exercise for patients 6 years and older; Seasonal allergic rhinitis – once daily for patients 2 years and older; Perennial allergic rhinitis – once daily for patients 6 months and older. Dosing varies by age: 15 years and older – one 10 mg tablet; 6 to 14 years – one 5 mg chewable tablet; 2 to 5 years – one 4 mg chewable tablet; 6 to 23 months one packet of 4 mg oral granules.
Contraindications: Do not administer to patients with hypersensitivity to any component of this product.
Special Warnings: Singulair is not used to treat an acute asthma attack. Patients should have appropriate rescue medication available. Neuropsychiatric events have been reported with Singulair. Contact physician if psychiatric symptoms develop. Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events usually but not always have been associated with the reduction of oral corticosteroid therapy. Inform patients with phenylketonuria that the 4 mg and 5 mg tablets contain phenylalanine.
Adverse reactions (side effects) of these medications: The most common side effects of Singulair include upper respiratory infection, fever, headache, pharyingitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, and otitis. Other adverse reactions seen in clinical trials or post-marketing include: Asthenia/fatigue, dental pain, dyspepsia, dizziness, nasal congestion, increased AST, increased ALT, pyuria, eczema, urticaria, psychiatric disorders and skin rashes.
Common drug interactions: The manufacturer states that no dosage adjustment is necessary when Singulair is used with theophylline, prednisone, prednisolone, oral contraceptives, terfanadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory drugs, benzodiazepines, decongestants, and Cytochrome P450 (CYP) inducers.
Special instructions for patients: SINGULAIR is not treatment for acute asthma attacks, have appropriate rescue medication available to treat acute attacks. Take Singulair daily as prescribed, even when you do not feel symptoms of asthma. Do not decrease the dose or stop taking any other asthma medications unless instructed by the physician. Seek medical attention if short-acting bronchodilators (SABAs) are used more often than usual, or if greater than the maximum recommended daily inhalations are needed. Notify physician if neuropsychiatric events occur while using Singulair. If you have known sensitivity to aspirin, you should continue to avoid aspirin while on Singulair. The 4 mg and 5 mg chewable tablets contain phenylalanine, a component of aspartame.
Full prescribing information may be found at the manufacturer‘s official website Singulair.com or at the U.S. Food and Drug Administration’s website at Singulair Info at Drugs@FDA
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