Take Orinex once daily in the evening, with or without food. Chewable tablets should be chewed completely before swallowing. Granules can be administered directly into the mouth, or mixed with a spoonful of cold or room temperature soft food (e.g., applesauce, ice cream, carrots) or infant formula. Do not open the sachet until ready to use.

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

• •Hypersensitivity to montelukast or any component of the formulation.
• •Not indicated for the treatment of acute asthma attacks, including status asthmaticus.

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

In cases of overdose, the most frequently reported adverse events include abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. There is no specific antidote; treatment should be symptomatic and supportive.

Pregnancy Category B. Studies in animals have not shown harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is not known whether montelukast is excreted in human milk; use with caution in nursing mothers.