Take orally, once daily in the evening, with or without food. For asthma, take in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs.

Montelukast selectively antagonizes the CysLT1 receptor, blocking the action of leukotrienes (LTC4, LTD4, LTE4). Leukotrienes are potent inflammatory mediators released from various cells, including mast cells and eosinophils, which contribute to the pathophysiology of asthma and allergic rhinitis.

• •Hypersensitivity to Montelukast or any component of the formulation.

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

In post-marketing experience and clinical studies, there have been reports of acute overdose. The most frequently occurring adverse events were abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. Treatment is symptomatic and supportive. It is not known whether Montelukast is dialyzable by peritoneal or hemodialysis.

Pregnancy Category B. Should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk; caution should be exercised when administered to a nursing mother.