Composition:

Lukast 4 mg: Each chewable tablet contains 4.2 mg montelukast sodium, equivalent to 4 mg of montelukast.

Lukast 5 mg: Each chewable tablet contains 5.2 mg montelukast sodium, equivalent to 5 mg of montelukast.

Lukast 10 mg: Each film coated tablet contains 10.4 mg montelukast sodium, equivalent to 10 mg of montelukast.

Mechanism of action:

The Cysteinyl leukotrines (LTC4, LTD4, and LTE4) are products of arachidonic acid metabolism and released from various cells, including mast cells and eosinophils. CysL.Ts have been correlated with the pathophysiology of asthma and allergic rhinitis. Montelukast binds with high affinity and selectivity to the CysL.T1 receptor in preference to other pharmacologically important airway receptors. Montelukast inhibits physiologic actions of LTD4 at the CysL.T1 receptor without any agonist activity.

Indications:

• Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
• It is indicated for the prevention of exercise induced bronchoconstriction in patients 6 years of age and older.
• It is indicated for the relief of symptoms of seasonal allergic rhinitis in patient 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.

Contraindications:

Hypersensitivity to any component of this product

Dosage and administrations:

Asthma:

Montelukast should be taken once daily in the evening. The following doses are recommended:

• For adults and adolescents 15 years of age and older: one 10-mg tablet.
• For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
• For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg (oral granules).
• For pediatric patients 12 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

Exercise-Induced Bronchoconstriction (EIB)

For prevention of EIB, a single dose of Montelukast should be taken at least 2 hours before exercise.

• For adults and adolescents 15 years of age and older: one 10-mg tablet.
• For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

Allergic Rhinitis: the dose should be taken once daily (in the evening or in the morning)

The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

• For adults and adolescents 15 years of age and older: one 10-mg tablet.
• For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
• For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg (oral granules).

The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

For adults and adolescents 15 years of age and older: one 10-mg tablet.

For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg (oral granules).

For pediatric patients 6 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

How supplied:

Lukast 4 mg: Pack of 20 chewable tablets.

Lukast 5 mg: Pack of 20 chewable tablets.

Lukast 10 mg: Pack of 20 film coated tablets.