Generic

Montelukast Sodium

Indications

Prophylaxis and chronic treatment of asthma

Acute prevention of Exercise-Induced Bronchoconstriction (EIB)

Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Pharmacology

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils.

Dosage & Administration

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Interaction

No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

Contraindications

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Side Effects

Diarrhea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed.

Precautions & Warnings

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic.

Therapeutic Class

Leukotriene receptor antagonists

Storage Conditions

Store in a cool & dry place below 30°C, protect from light & moisture.

Pharmaceutical Name

ACME Laboratories Ltd.