Indications
Montelukast Sodium is indicated for:
Prophylaxis and chronic treatment of asthma
Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic Class
Leukotriene receptor antagonists
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. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Dosage
Adults & adolescents (15 years & older)-
Asthma & Allergic Rhinitis: 10 mg/day
Exercise-Induced Bronchoconstriction: 10 mg/day
Pediatric patients (6 to 14 years)-
Asthma & Allergic Rhinitis: 5 mg/day
Exercise-Induced Bronchoconstriction: 5 mg/day
Pediatric patients (6 months to 5 years)-
Asthma & Allergic Rhinitis: 4 mg/day
Exercise-Induced Bronchoconstriction: Not recommended
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.
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Administration
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
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Interaction
With medicine: 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.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Contraindications
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Side Effects
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during
pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Precautions & Warnings
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status
asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
Overdose Effects
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. 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, and institute supportive therapy, if required.
Storage Conditions
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.