Montelukast is indicated for the prophylaxis & chronic treatment of asthma in adults & pediatric patients.
Composition: Ventilast 10 Tablet: Each film coated tablet contains Montelukast Sodium USP 10.40 mg equivalent to Montelukast 10 mg.
Therapeutic Class: Leukotriene receptor antagonist
Generic Name: Montelukast USP
Pharmacology: The cysteinyl lekotrienes (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 receptors (CysLT) found in the human airway. Montelukast is a selective & orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLTI receptor. Cysteinyl leukotriene receptor occupation have been correlated with the pathophysiology of asthma ( such as, airway edema, smooth muscle contraction & altered cellular activity associated with the inflammatory process, which contribute to the signs & symptoms of asthma).
Dose & Administration:
Adults (15 years of age or over): 10 mg tablet daily to be taken in the evening. The safety & 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.
Warning & Precaution: Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmatics). 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 casual association between Montelukast & these underlying conditions has not been established. Side effects:
a) Common: Generally, Montelukast is well-tolerated. Side effects include dizziness, headache, diarrhea, restlessness, abdominal pain, cough, fever, asthenia and rash.
b) Rare: Rare Side effects of Montelukast is upper respiratory tract infection.
Use in pregnancy & lactation: There are no adequate & well-controlled studies of Montelukast in pregnant woman. Because animal reproductive studies are not always predictive of human response so Montelukast should be used during pregnancy only if clearly needed. 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.
Use in children & adolescents: Ventilast 10 mg tablet in not indicated for children below 15 years of age.
a) With medicine: Montelukast has been administered with other therapies routinely used in the prophylaxis & chronic treatment of asthma with on appropriate increase in adverse reactions. Cytochrome P-450 inducers: Although Phenobarbital induces hepatic metabolism, no dose adjustment for montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent Cytochrome P-450enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast.
b) With Food and others: Montelukast should not co-administrated with alcohol or tobacco. Alcohol or tobacco use can decrease the bioavailability of Montelukast.
Overdose: There were no adverse experiences reported in the majority of over dosage reports. The most frequent adverse experiences observed were thirst, mydriasis hyperkinesia & abdominal pain. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g. remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring & institute supportive therapy, if required.
Storage: Store below 30°C, protected from light & moisture.
Keep away from the reach of the children.
Packaging: Ventilast 10 tablet: Each box contains 3 x10’s tablets in Alu-Alu blister pack.