Montelukast Hexal (Montelukast)

Montelukast is a leukotriene receptor antagonist that modulates inflammatory pathways in the respiratory tract and is used to treat conditions involving airway inflammation.

• Asthma: reduces airway inflammation and bronchoconstriction, helping to improve symptom control and decrease the frequency of asthma attacks.
• Allergic rhinitis: alleviates nasal congestion, rhinorrhea, sneezing and itchy eyes by blocking leukotriene‑mediated inflammation in the nasal passages.
• Exercise‑induced bronchoconstriction: prevents exercise‑triggered airway narrowing, allowing better tolerance of physical activity in susceptible individuals.
• Prevention of asthma exacerbations: used as add‑on therapy to reduce risk of severe attacks.

• Montelukast selectively antagonizes the cysteinyl leukotriene receptor CysLT1 located on airway smooth‑muscle cells, mast cells and eosinophils. By blocking binding of leukotriene D4 and related mediators, it prevents the cascade that leads to bronchoconstriction, mucus secretion, vascular permeability and inflammatory cell recruitment, thereby stabilizing airway tone and reducing inflammation. The effect is dose‑dependent and contributes to long‑term control of respiratory symptoms.

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

Common Side Effects

• Headache: mild to moderate headache that may resolve without treatment.
• Upper respiratory tract infection: symptoms such as sore throat, nasal congestion or mild fever.
• Abdominal pain: occasional stomach discomfort, cramps or dyspepsia.
• Cough: transient cough episodes, often unrelated to asthma.

Serious or Rare Side Effects

• Neuropsychiatric events: agitation, anxiety, depression, sleep disturbances or suicidal thoughts reported in rare cases.
• Allergic reactions: rash, urticaria, angioedema or anaphylactic response requiring immediate medical attention.
• Hepatotoxicity: elevated liver enzymes, hepatitis or jaundice, observed infrequently.

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

• Assess asthma control: confirm that the patient’s asthma is stable before initiating therapy.
• Monitor psychiatric symptoms: watch for mood changes, depression or suicidal ideation during treatment.
• Evaluate liver function: consider baseline liver tests in patients with hepatic disease.
• Use in children: adjust dosing according to age and weight as directed by the prescriber.
• Contraindications: avoid use in patients with known hypersensitivity to montelukast or its excipients.
• Store at ambient temperature: keep below 25°C in the original packaging, protected from moisture.

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

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

• Warfarin: potential increase in INR; monitor coagulation parameters.
• Antidepressants (SSRIs): possible additive neuropsychiatric effects; observe mood changes.
• Beta‑agonists: concurrent use may enhance bronchodilation but requires clinical assessment.