Take orally, once daily in the evening, with or without food. For asthma, it should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs. For both conditions, evening administration is generally preferred.

Montelukast selectively blocks the cysteinyl leukotriene 1 (CysLT1) receptor, thereby inhibiting the actions of leukotrienes (LTC4, LTD4, LTE4). These leukotrienes are potent inflammatory mediators involved in the pathophysiology of asthma and allergic rhinitis.

• •Known hypersensitivity to montelukast or any component of the formulation.

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

In cases of overdose, the most common adverse events were abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. Management is symptomatic and supportive. No specific antidote is known.

Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. Montelukast is excreted in breast milk; caution should be exercised when administered to a nursing woman.