Full Prescribing Info
Montelukast sodium.
Each Chewable tablet contains: Montelukast (equivalent to Montelukast Sodium 4.16 mg) 4 mg.
Montelukast (equivalent to Montelukast Sodium 5.2 mg) 5 mg.
Pharmacology: Pharmacodynamics: 4 mg: Montelukast causes potent inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatic patients. Doses as low as 5 mg cause substantial blockage of LTD4-induced bronchoconstriction. Montelukast causes bronchodilation within 2 hours of oral administration; these effects were additive to the bronchodilation caused by β-agonist.
Pharmacokinetics: Peak plasma concentrations of montelukast are achieved in 3 to 4 hours after oral administration. The mean oral bioavailability is 64%. Montelukast is more than 99% bound to plasma proteins. It is extensively metabolised in the liver by cytochrome P450 isoenzyme CYP3A4, CYP2A6, and CYP2C9, and is excreted principally in the faeces via the bile. Metabolism was reduced and the elimination half-life prolonged in patients with mild to moderate hepatic impairment.
4 mg: Indicated in the treatment of asthma as add-on therapy in those 2 to 5 years old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids, and in whom "as-needed" short-acting beta-agonists provide inadequate clinical control of asthma. Indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercised-induced bronchoconstriction.
5 mg: It is used for prophylaxis and chronic treatment of asthma, prevention of exercise-induced bronchoconstriction in patients, and relief of symptoms of allergic rhinitis.
10 mg: It is used for the management of chronic asthma, allergic rhinitis, and as prophylaxis for exercise indicated asthma
Dosage/Direction for Use
4 mg: The recommended dose for paediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken orally in the evening. If taken with food, it should be taken 1 hour before or 2 hours after food. Montelukast 4 mg chewable tablet formulation is not recommended below 2 years of age.
Children aged 6-14 years: 5 mg daily to be taken orally in the evening, or as prescribed by the physician.
Adult: 10 mg once daily to be taken orally in the evening, or as prescribed by the physician.
5 mg & 10 mg: 6 months-6 years: 4 mg daily, taken in the evening or as prescribed by the physician.
Children aged 6-14 years: 5 mg daily taken in the evening.
Adult: 10 mg once daily, taken in the evening.
4 mg: No specific information is available on the treatment of over dosage of montelukast.
4 mg: Montelukast is contraindicated in patients with hepatic impairment or cirrhosis and for patients with hypersensitivity to the active substance or to any of the excipients Mannitol, Carbosil, Microcrystalline Cellulose, Tutti frutti (doxo) and Magnesium Stearate.
5 mg & 10 mg: Montelukast is contraindicated in patients with hepatic impairment or cirrhosis.
4 mg: The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, oral tablets of montelukast should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
Special Precautions
Montelukast and other leukotriene antagonists should not be used for the treatment of acute asthma attacks.
4 mg: Should not be abruptly substituted for inhaled or oral corticosteroids.
Use In Pregnancy & Lactation
4 mg: Pregnancy: Montelukast has not been studied in pregnant woman. Montelukast (Terrakast) should be used during pregnancy only if clearly needed.
Breast feeding: It is not known if montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when montelukast is given to a nursing mother.
Adverse Reactions
Headache, an increased incidence of respiratory-tract infection, and gastrointestinal disturbances have been reported with montelukast and other leukotriene antagonists. Other adverse effects have included generalised pain, arthralgia, myalgia, fever and dizziness. Elevations in liver enzyme values have occurred, and rarely, symptomatic hepatitis or hyperbilirubinemia.
Drug Interactions
4 mg: Licensed product information recommends caution when potent inducers of the cytochrome P450 isoenzyme CYP3A4 such as phenytoin, phenobarbital, or rifampicin are given with montelukast.
Corticosteroids: For a report of peripheral oedema in a patient given montelukast and prednisone.
Phenobarbital: Peak serum concentrations after a single dose of montelukast 10 mg were reduced by 20% in 14 healthy subjects who tool phenobarbital 100 mg daily for 14 days, and area under the serum concentration-time curve was reduced by 38%. However, it was not thought that montelukast doses would need adjustment if given with phenobarbital.
Store at temperatures not exceeding 30°C.
4 mg: Protect from light.
5 mg & 10 mg: Protect from moisture and light.
MIMS Class
Antiasthmatic & COPD Preparations
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 (white, round, bi-convex, size 8 mm) x 100's. 5 mg x 100's. FC tab 10 mg x 100's.
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