MONTIGET PAEDIATRIC Ganules

THERAPEUTIC INDICATIONS

•MONTIGET (Montelukast sodium) is indicated in adult and paediatric patients 6 months of age and older for the prophylaxis and chronic treatment of asthma including:

-The prevention of day and night time symptoms.

- The treatment of aspirin-sensitive asthmatic patients.

-The prevention of exercise-induced bronchoconstriction.

•MONTIGET (Montelukast sodium) is also indicated in adults and paediatric patients 2 years of age and older for the relief of symptoms of seasonal allergic rhinitis.

DOSAGE AND ADMINISTRATION

The therapeutic effect of montelukast sodium on parameters of asthma control occurs within one day. MONTIGET (Montelukast scxJium) tablets, and paediatric granules can be taken with or without food. Patients should be advised to continue taking the drug while their asthma is controlled as well as during periods of worsened asthma.

MONTIGET (Montelukast sodium) should be taken once daily. For asthma, the dose should be taken In the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet or sachet daily in the evening.

Adults and Adolescents 15 Years of Age and Older with Asthma or Seasonal Allergic Rhinitis:

The dosage for adults and adolescents 15 years of age and older is one 10mg tablet daily.

Paediatric Patients 6 to 14 Years of Age with Asthma or Seasonal Allergic Rhinitis:

The dosage for paediatric patients 6 to 14 years of age is one 5mg chewable tablet daily.

The dosage for paediatric patients 2 to 5 years of age is one 4mg chewable tablet or one sachet of paediatric granules 4mg daily.

Paediatric Patients 6 Months to 2 years of Age with Asthma

The dosage for paediatric patients 6 months to 2 years of age is one

sachet of paediatric granules 4mg daily to be taken in the evening.

Montelukast sodium is contraindicated in a patient who has shown hypersensitivity to the drug or any of its components.

Montelukast sodium is not indicated for use in acute asthma attacks including status asthmaticus.

Following are the adverse effects reported which usually were mild and did not require discontinuation of therapy.

•Hypersensitivity reactions (Including anaphylaxis, angioedema, rash, pruritus, urticaria and very rarely, hepatic eosinophillic infiltration);

•Dream abnormalities, hallucinations, palpitations, drowsiness, irritability, restlessness, insomnia, increased sweating, headache;

•Nausea, vomiting, dyspepsia, diarrhea, abdominal pain;

•Myalgia including muscle cramps;

•Increased bleeding tendency, bruising edema;

•Tremor, dry mouth, vertigo, arthralgia.

It Is recommended that clinical monitoring, particularly in children, be conducted when potent hepatic enzyme inducers such as phenytoin,phenobarbital, or rifampicin are given with montelukast sodium. No dosage adjustment for MONTIGET (Montelukast sodium) is recommended.

Montelukast sodium has not been studied in pregiinant women. It should be used during pregnancy only if clearly needed.

It is not known if montelukast sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MONTIGET is given to a nursing mother.

- Montelukast sodium should not be abruptly substituted for inhaled or oral corticosteroids. However the dose of inhaled corticosteroid may be reduced gradually under medical supervision.

- Although a casual relationship with leukotriene receptor antagonism has not been established when systemic corticosteroid reduction is considered in patients receiving montelukast sodium.

Special populations:

Elderly, paediatric, males, females, and patients with renal insufficiency have similar plasma pharmacokinetic profiles as young adults.

Hepatic Insufficiency/Paediatric Patients

See the package insert about details.

- Montelukast sodium should not be used as monotherapy for the treatment and management of exercise-induced asthma. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled beta-agonists as prophylaxis and should have it available as and when required.

- Montelukast sodium does not block bronchoconstrictor response to aspirin or NSAIDs in aspirin-sensitive asthmatic patients. Such patients should continue to avoid aspirin and other NSAIDs.

- Caution should be exercised when using montelukast sodium with bronchodilator therapy. When clinical response is apparent the bronchodilator therapy should be reduced.

MONTIGET (Montelukast sodium) is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLTI receptor