Montelukast

Montelukast 10mg Film-coated Tablets are indicated in the treatment of asthma as add-on therapy in those patients 15 years of age and older with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.

In those asthmatic patients 15 years of age and older in whom Montelukast 10mg Film-coated Tablets are indicated in asthma, Montelukast 10mg Film-coated Tablets can also provide symptomatic relief of seasonal allergic rhinitis. Montelukast 10mg Film-coated Tablets are also indicated in the prophylaxis of asthma in patients 15 years of age and older in which the predominant component is exercise-induced bronchoconstriction.

AND CLINICAL USE....................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................

5 ADVERSE REACTIONS ........................................................................................................ 7 DRUG INTERACTIONS ......................................................................................................

10 DOSAGE AND ADMINISTRATION .................................................................................... 12 OVERDOSAGE ..................................................................................................................

13 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 13 STORAGE AND STABILITY ................................................................................................ 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................

1 ). 2 ). • 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 2 years of age and older. 3 ). 1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.

2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 3 Allergic Rhinitis sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 of age and older.

Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis , use for patients who have an inadequate response or intolerance to alternative therapies.