Montelukast Accord Healthcare (Montelukast Sodium)

Montelukast is a leukotriene receptor antagonist used to manage conditions driven by leukotriene‑mediated inflammation and bronchoconstriction.

• Asthma: improves control of chronic airway inflammation and reduces frequency of exacerbations.
• Exercise‑induced bronchoconstriction: prevents narrowing of airways triggered by physical activity.
• Allergic rhinitis: alleviates nasal congestion, sneezing and itching caused by allergic inflammation.

• Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth‑muscle cells, mast cells and eosinophils. By antagonizing this receptor, it inhibits the actions of leukotriene D4 and related mediators that cause bronchoconstriction, mucus secretion, vascular permeability and inflammatory cell recruitment, thereby reducing airway narrowing and allergic inflammation. The effect is dose‑dependent and contributes to long‑term improvement in respiratory symptoms.

Montelukast may be associated with a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

• Headache: mild to moderate intensity.
• Upper respiratory tract infection: transient symptoms.
• Nasopharyngitis: sore throat or nasal congestion.
• Cough: occasional dry cough.
• Abdominal pain: mild discomfort.

Serious or Rare Side Effects

• Allergic reactions: rash, urticaria, or angioedema.
• Neuropsychiatric events: agitation, anxiety, or mood changes.
• Hepatic enzyme elevation: abnormal liver function tests.
• Stevens‑Johnson syndrome: severe skin reaction (very rare).

When prescribing Montelukast, clinicians should consider several precautionary measures to ensure safe use.

• Pregnancy: use only if potential benefit justifies potential risk; consult obstetric guidance.
• Breastfeeding: assess risk versus benefit as drug may be excreted in milk.
• Hepatic impairment: monitor liver function, dose adjustment may be required.
• Concomitant asthma therapy: continue other controller medications; Montelukast is not a rescue drug.
• Drug hypersensitivity: avoid in patients with known allergy to Montelukast or excipients.
• Store at room temperature: keep in original container, protect from moisture and direct sunlight.

Montelukast can interact with other medicines, influencing its efficacy or safety profile.

Major Interactions (Avoid)

• Phenobarbital, phenytoin, carbamazepine: enzyme inducers that may reduce montelukast plasma levels.
• Ritonavir: strong CYP3A4 inhibitor that can increase montelukast exposure.

Moderate Interactions (Monitor Closely)

• Warfarin: potential alteration of anticoagulant effect; monitor INR.
• Theophylline: additive bronchodilator effect; observe for increased side effects.
• Antidepressants (SSRIs): rare reports of neuropsychiatric events; watch for mood changes.