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
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.
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.
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
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
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.