Description :

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.  Cysteinyl leukotrienes 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).

Composition :

Arokast®  4 chewable tablet: Each tablet contains Montelukast Sodium USP equivalent to Montelukast 4 mg.

Arokast®  5 chewable tablet: Each tablet contains Montelukast Sodium USP equivalent to Montelukast 5 mg.

Arokast®  10 tablet: Each film coated tablet contains Montelukast Sodium USP equivalent to Montelukast 10 mg.

Indication :

Montelukast is indicated for the prophylaxis of asthma and management of chronic asthma; symptomatic relief of seasonal allergic rhinitis in patients with asthma.

Dosage & Administration :

Prophylaxis of asthma :

Adult 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, 10 mg once daily in the evening.

The safety and efficacy of Montelukast was demonstrated in clinical trials where it was administered in the evening without regard to the time of food ingestion.

Contraindication :

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

Side Effects :

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

Precautions :

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 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.

Drug Interaction :

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 induces, such as Phenobarbital or Rifampin are co-administered with Montelukast.

Use in Pregnancy and Lactation :

Pregnancy: There are no adequate and well-controlled studies of Montelukast in pregnant women. Because animal reproductive studies are not always predictive of human response, so Montelukast should be used during pregnancy only if clearly needed.

Lactation: It is not known if Montelukast is excreted in human milk.  Because many drugs are excreted in human milk, so caution should be exercised when Montelukast is given to a nursing mother.

Over Dose :

There were no adverse experiences reported in the majority of overdosage reports. In the event of overdose, it is reasonable to employ the usual supportive measures.

Commercial Supply :

Arokast®  4 : Each box containing 3x10's chewable tablets.

Arokast®  5 : Each box containing 3x10's chewable tablets.

Arokast®  10 : Each box containing 3x10's film coated tablets.