Full Prescribing Info
Montelukast sodium.
Each Chewable Tablet contains: Montelukast (as sodium) 4 mg.
Each Film-coated Tablet contains: Montelukast (as sodium) 10 mg.
Montelukast is a selective leukotriene receptor antagonist. It works by blocking the reaction of substance that causes the inflammation, fluid retention, mucous secretion and constriction in the lungs.
Pharmacology: Pharmacokinetics: Peak plasma concentrations of montelukast are achieved in 2 to 4 hours after oral administration. The mean oral bioavailability is 64%. Montelukast is more than 99% bound to plasma proteins. It is extensively metabolized in the liver by cytochrome P450 isoenzymes CYP3A4, CYP2A6 and CYP2C9, and is excreted principally in the feces via the bile. Metabolism was reduced and the elimination half-life prolonged in patients with mild to moderate hepatic impairment.
For the treatment of bronchial asthma and allergic rhinitis.
Dosage/Direction for Use
Adult more than 15 years old: 10 mg tablet daily.
6-4 years old: 5 mg tablet.
2-5 years old: 4 mg tablet.
To be taken once daily at bedtime or as prescribed by the physician.
Montelukast is not indicated for the treatment of acute asthma attacks.
Special Precautions
Montelukast sodium and other leukotriene antagonist should not be used for the treatment of acute asthma attack. They are contraindicated in patients with hepatic impairment or cirrhosis.
Adverse Reactions
Adverse effects include headache, increased incidence of respiratory tract infection (in the elderly), and gastrointestinal disturbances. Other adverse effects have included generalized pain, arthralgia and myalgia, fever and dizziness. Hypersensitivity reactions including urticaria and angioedema has been reported. There have also been rare reports of agranulocytosis, bleeding, bruising and edema.
Drug Interactions
Clinical monitoring is recommended when potent hepatic enzyme inducers such as phenytoin, phenobarbital or rifampicin are given with montelukast. Aspirin and other NSAIDs.
Store at temperatures not exceeding 30°C.
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Chewable tab 4 mg x 30's. FC tab 10 mg x 30's.
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