
Xyflo4 mg
Radiant Pharmaceuticals Ltd.
Montelukast Sodium is a leukotriene receptor antagonist used for the following FDA-approved indications: Prophylaxis and chronic treatment of asthma in adults and children 12 months of age and older…
Montelukast Sodium is a leukotriene receptor antagonist used for the following FDA-approved indications:
Montelukast Sodium is often used as an adjunct/add-on to inhaled corticosteroids when asthma control is inadequate, and it is a guideline-recognized alternative (not first-line) controller option in patients who cannot or will not use inhaled corticosteroids.
Important: Montelukast Sodium is not indicated for the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. It has no role as a rescue medication.
| Indication | Age Group | Recommended Dose |
|---|---|---|
| Asthma (maintenance) | Adults and adolescents ≥15 years | 10 mg film-coated tablet once daily, in the evening |
| Children 6–14 years | 5 mg chewable tablet once daily, in the evening | |
| Children 2–5 years | 4 mg chewable tablet or 4 mg oral granules once daily, in the evening | |
| Children 12–23 months | 4 mg oral granules once daily, in the evening | |
| Seasonal allergic rhinitis | Adults and children ≥2 years | Same age-based doses as above, once daily (timing may be given any time of day if only for rhinitis) |
| Children 6 months–2 years | 4 mg oral granules once daily (perennial allergic rhinitis) | |
| Prevention of exercise-induced bronchoconstriction (EIB) | Adults and adolescents ≥15 years | 10 mg at least 2 hours before exercise; no additional dose within 24 hours |
| Children 6–14 years | 5 mg chewable at least 2 hours before exercise; no additional dose within 24 hours |
Renal impairment: No dosage adjustment is required.
Hepatic impairment: No dosage adjustment is required for mild-to-moderate hepatic impairment; Montelukast Sodium has not been studied in severe hepatic impairment, so it should be used with caution in that setting.
Missed dose: If a dose of Montelukast Sodium is missed, it should not be doubled; resume the normal once-daily schedule.
Common side effects of Montelukast Sodium (occurring in clinical trials) include headache, abdominal pain, cough, dyspepsia, dizziness, fatigue, fever, and, in children, ear infection (otitis media), sinusitis, and influenza-like symptoms.
Serious but less common effects include neuropsychiatric events (see Precautions and Warnings for the boxed warning), hepatic effects such as eosinophilic hepatitis (rare), hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and rare severe skin reactions (Stevens-Johnson syndrome, erythema multiforme), and rare eosinophilic conditions such as Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis), particularly in patients whose oral corticosteroid dose is being reduced (see Precautions and Warnings).
Montelukast Sodium is contraindicated in patients with known hypersensitivity to montelukast or to any component of the formulation.
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