MONTIGET Tablet

Indications:

MONTIGET (Montelukast sodium) Is Indicated in adult and paediatric patients 6 months or age and older for the prophylaxis and chronic treatment of asthma including:

- The prevention of day and night time symptoms.

- The treatment of aspinn-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 sodium) 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 dally.

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.

Paediatric patient 2 to 5 Years of Age with Asthma or Seasonal Allergic Rhinitis:

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.

Use of MONTIGET (Montelukast sodium) in relation to other treatment for asthma

MONTIGET can be added to a patient's existing treatment regimen.

Reduction in concomitant therapy

- Bronchodilator Treatment: MONTIGET (Montelukast sodium) can be added to the treatment of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the first dose), the patient's bronchodilator therapy can be reduced as tolerated.

- Inhaled Corticosteroids: Treatment with MONTIGET (Montelukast sodium) provides additional clinical benefit to patients treated with inhaled corticosteroids. A reduction in the corticosteroid dose can be made as tolerated. The dose should be reduced gradually with medical supervision. In some patients, the dose of the inhaled corticosteroids can be tapered off completely. MONTIGET (Montelukast sodium) should not be abruptly substituted for inhaled corticosteroids.

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.

Montelukast sodium is generally well tolerated. However, 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 eosinophilic 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.

Pregnancy

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

Nursing Mothers

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 MINTIGET 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, caution and appropriate clinical monitoring is recommended when systemic corticosteroid reduction is considered in patients receiving montelukast sodium.

- 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-agonists as prophylaxis and should have it available as and when required.

- Montelukast sodium does not block bronchoconstrictor response to aspirin or non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients. Such patients should continue to avoid aspirin and other non-steroidal anti-􀄶inflammatory drugs.

- 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 competitive, selective and orally active leukotriene D4 (cysteinyl leukotriene CysL T1) receptor antagonist. The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysL T) receptors. Binding of cysteinyl leukotrienes to leukotriene receptors has been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, factors that contribute to the signs and symptoms of asthma. Thus, montelukast sodium inhibits physiologic actions or LTD4 at the CysL T1 receptors, without any agonist activity.