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MontrilMontrilMontril

Montril

Montelukast Sodium

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT4 receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma.

Product Details

Presentation

Montril-4 Oroflash Tablet: Each Oroflash tablet contains Montelukast Sodium USP equivalent to Montelukast 4 mg.
Montril-5 Chewable Tablet: Each chewable tablet contains Montelukast Sodium USP equivalent to Montelukast 5 mg.
Montril-10 Tablet: Each film coated tablet contains Montelukast Sodium USP equivalent to Montelukast 10 mg.

Pharmacology

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT4 receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma.

Indication

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

Dosage & Administration

Prophylaxis of asthma

Adult and child over 15 years: 10 mg once daily in the evening
Children 6–15 years: 5 mg once daily in the evening
Children 6 months–6 years: 4 mg once daily in the evening.

Seasonal allergic rhinitis

Adult and children over 15 years: 10 mg once daily in the evening
No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency or mild to moderate hepatic impairment.

Contraindications

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

Warning & Precautions

Montelukast should not be used in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus). Patients should be advised never to use oral tablets of Montelukast to treat acute asthma attacks. Montelukast should not be substituted for inhaled or oral corticosteroids. Patients with known aspirin sensitivity should continue avoidance of aspirin or other NSAID, 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, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established.

Side effects

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

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.

Use in special groups

Since there are no controlled studies in pregnant or nursing women, Montelukast should not be used during pregnancy or in nursing mothers unless it is considered to be clearly essential.

Packing

Montril-4 Oroflash Tablet:Each box contains 30’s tablets in blister pack.
Montril-5 Chewable Tablet:Each box contains 30’s tablets in blister pack.
Montril-10 Tablet:Each box contains 20’stablets in blister pack.

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