Composition
Ezevent tablet: Each film coated tablet contains Montelukast Sodium USP 10.40 mg equivalent to Montelukast 10 mg.

Pharmacology
Montelukast is a selective and orally active leukotriene receptor antagonist that specifically inhibits cysteinyl leukotriene receptor.

Indication
Montelukast is indicated for the prophylaxis and chronic treatment of asthma. It is also indicated for the relief of seasonal allergic rhinitis in adults and pediatric patients and exercise induced bronchoconstriction.

Dosage & administration
Prophylaxis of Asthma:
Adults and Children (over 15 years): 10 mg once daily in the evening.

Seasonal Allergic Rhinitis:
Adults and Children (over 15 years): 10 mg once daily in the evening.

Exercise Induced Bronchoconstriction: 10 mg tablet at least 2 hours before exercise.

Contra-indication
Hypersensitivity to Montelukast or any component of this product.

Warning & precaution
Do not prescribe Montelukast to treat an acute asthma attack. Patients with known aspirin sensitivity should continue to avoid aspirin or NSAID agents while taking Montelukast.

Side effects
Montelukast appears to be well tolerated. The most common adverse effects reported are headache, rash, dyspepsia, dizziness, edema, tremor, suicidal thoughts and abdominal pain.

Use in pregnancy & lactation
Pregnancy: Montelukast has been assigned to pregnancy category B.
It should be used during pregnancy only if clearly needed.
Lactation: It is not known if Montelukast is excreted in human milk.

Use in children & adolescents
Montelukast has been studied in pediatric patients (2 to 14 years of age). Studies have shown that Montelukast does not affect the growth rate of pediatric patients.

Drug interaction
Montelukast may be administered with therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug interaction studies, the recommended clinical dose of Montelukast did not have clinically important effects on the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin and warfarin. Caution should be exercised, particularly in children, when Montelukast is co-administered with phenytoin, phenobarbital and rifampicin.

Overdose
No specific information is available on the treatment of overdosage with Montelukast. In chronic asthma studies, Montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and, in short-term studies, up to 900 mg/day to patients for approximately a week without clinically important adverse experiences. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Storage
Keep out of the reach of children. Keep below 30°C, protect from light.

Packing
Ezevent tablet: Each box contains 3x10's tablet in blister pack.