Arovent 5 mg Chewable Tablet: Each tablet contains Montelukast Sodium BP equivalent to Montelukast 5 mg.

Arovent ®-4 mg Oro-Dispersible Tablet: Each tablet contains Montelukast Sodium BP equivalent to Montelukast 4 mg.

Arovent 10 mg Tablet: Each tablet contains Montelukast Sodium BP equivalent to Montelukast 10 mg.

BP

Antiasthmatic

Montelukast is indicated for the prophylaxis & chronic treatment of asthma in adults & pediatric patients.

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

Pediatric patients (6 months to 5 years of age): One 4 mg Oro-dispersible tablet/oral granules in the evening.

Pediatric patients (6 to14 years of age): One 5 mg chewable tablet in the evening.

Adolescents & adults (15 years of age or older): One 10 mg tablet in the evening.

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

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 casual association between Montelukast & these underlying conditions has not been established.

Montelukast has been administered with other therapies routinely in the prophylaxis & chronic treatment of asthma with no 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-450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast.

 Arovent ®-4 mg Oro-dispersible tablet: Each box contains 3x10 tablets in  alu-alu blister pack.

Arovent ®-5 mg Chewable Tablet: Each box contains 2x10 tablets in  alu-alu blister pack.

Arovent ®-10 mg Tablet: Each box contains 3x10 tablets in alu-alu blister pack.

Safety & efficacy of Montelukast has been established in adequate & well controlled studies in pediatric patients with asthma & allergic rhinitis between age 6 months to 14 years. 

There were no adverse experiences reported in the majority of overdosage 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.

Store below 30 oC & in a dry place. Keep away from light. Keep all medicine out of the reach of children.