Montelukast Paediatric Aurobindo Pharma (Malta) Limited (Montelukast)

Montelukast acts on the leukotriene pathway to control airway inflammation and bronchoconstriction.

• Asthma: improves control of chronic asthma symptoms and reduces the frequency of exacerbations in pediatric patients.
• Exercise‑induced bronchoconstriction: prevents narrowing of the airways that occurs during or after physical activity.
• Allergic rhinitis: alleviates nasal congestion, sneezing and itching caused by seasonal or perennial allergens.

• Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotrienes D4, C4 and E4 from binding. This inhibition reduces bronchial smooth‑muscle contraction, vascular permeability, and inflammatory cell recruitment, thereby mitigating airway narrowing and allergic inflammation.

Montelukast is generally well tolerated, but adverse reactions can occur.

Common Side Effects

• Headache: mild to moderate pain in the head region.
• Abdominal pain: discomfort or cramping in the stomach area.
• Cough: occasional dry or productive cough.
• Nasopharyngitis: mild upper respiratory tract infection symptoms.
• Rash: transient skin redness or itching.

Serious or Rare Side Effects

• Mood changes: agitation, aggression, or depressive symptoms.
• Hepatotoxicity: elevated liver enzymes or jaundice.
• Allergic reactions: hives, swelling, or anaphylaxis.
• Stevens‑Johnson syndrome: severe skin blistering and detachment.
• Angioedema: rapid swelling of lips, tongue or face.

Before prescribing Montelukast, clinicians should consider patient‑specific factors and safety measures.

• Age limitation: confirm the product is approved for the pediatric age group indicated.
• Hepatic function: assess liver status in patients with known liver disease.
• Neuropsychiatric monitoring: watch for mood or behavioral changes, especially in children.
• Drug hypersensitivity: avoid in individuals with known hypersensitivity to montelukast or any excipients.
• Concomitant asthma therapy: continue inhaled corticosteroids or bronchodilators as directed; Montelukast is not a rescue medication.
• Store at ambient temperature: keep below 25°C, retain in the original container, and protect from moisture.

Montelukast may interact with other medicines, altering efficacy or safety.

Major Interactions (Avoid)

• Phenobarbital: enzyme induction may reduce montelukast plasma levels.
• Rifampin: strong CYP3A4 inducer that can markedly lower drug exposure.

Moderate Interactions (Monitor Closely)

• Warfarin: potential increase in INR; monitor coagulation parameters.
• Theophylline: additive CNS effects may require dose adjustment.
• Antidepressants (SSRIs, SNRIs): monitor for enhanced neuropsychiatric symptoms.
• Antihistamines: may increase sedation when combined with sedating agents.
• CYP2C9 inhibitors (e.g., fluconazole): may modestly raise montelukast concentrations.