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Asmont (Montelukast Sodium)

COMPOSITION:

ASMONT 10 Tablet : Each tablet contains Montelukast Sodium INN equivalent to Montelukast 10 mg.

ASMONT 5 Tablet: Each tablet contains Montelukast Sodium INN equivalent to Montelukast 5 mg.

ASMONT 4 Chewable Tablet: Each Chewable tablet contains Montelukast Sodium INN equivalent to Montelukast 4 mg.

PHARMACOLOGY:

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Cysteinyl leukotriene and leukotriene receptor occupation have been correlated with the pathophysiology of asthma (such as airway edema, smooth muscle contraction and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma).

INDICATION:

ASMONT is indicated for the prophylaxis and chronic treatment of asthma in adults and paediatric patients. It is also indicated for the relief of symptoms of seasonal allergic rhinitis.

DOSAGE AND ADMINISTRATION:

Prophylaxis of asthma:

Adults and child over 15 years : 10 mg once daily in the evening.
Child 6-15 years                     : 5 mg once daily in the evening.
Child 6 months-6 years           : 4 mg once daily in the evening.

Seasonal allergic rhinitis:

Adult and child over 15 years: 10mg once daily in the evening.

SIDE EFFECT:

Generally, Montelukast is well tolerated. Side effects include dizziness, headache, diarrhoea, restlessness, abdominal pain, cough, fever, asthenia, rash and upper respiratory tract infection.

CONTRAINDICATION:

Montelukast is contraindicated to patients with hypersensitivity to any component of this product.

PRECAUTION:

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus).

Patients with known aspirin sensitivity should continue avoidance of aspirin or other NSAIDs, while taking Montelukast.

In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with churg-strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. Physician should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications or neuropathy presenting in their patients.

USE IN PREGNANCY AND LACTATION:

Pregnancy: Pregnancy category B drug. Montelukast should be used during pregnancy only if clearly needed.

Lactation: There are no data on the excretion of montelukast into human milk. But many drugs are excreted in human milk, so caution should be exercised when Montelukast is given to a nursing mother.

DRUG INTERACTION:

Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no appropriate increase in adverse reactions. Cytochrome P-450 inducers: Although Phenobarbital induces hepatic metabolism, no dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P-450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast.

STORAGE:

· Store in cool & dry place, protected from light.

· Keep out of reach of children.

PACKAGING:

ASMONT 10 Tablet : Each box contains 2x10 tablets in Alu-Alu blister pack.

ASMONT 5 Tablet   : Each box contains 1x10 tablets in Alu-Alu blister pack.

ASMONT 4 Chewable Tablet : Each box contains 2x10 tablets in Alu-Alu blister pack.

 

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