Montelukast Rudipharm (Montelukast)

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

• Asthma: improves long‑term control and reduces the frequency of exacerbations.
• Allergic rhinitis: relieves nasal congestion, sneezing and itching caused by seasonal allergens.
• Exercise‑induced bronchoconstriction: prevents airway narrowing triggered by physical activity.

• Montelukast selectively antagonizes the cysteinyl leukotriene receptor CysLT1, blocking the binding of leukotrienes D4, C4 and E4. This inhibition prevents leukotriene‑mediated bronchoconstriction, vascular permeability, and eosinophilic inflammation in the respiratory tract, thereby improving airway patency and reducing inflammatory symptoms.

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

Common Side Effects

• Headache: mild to moderate intensity.
• Upper respiratory tract infection: transient symptoms.
• Abdominal pain: occasional discomfort.
• Cough: non‑productive.
• Diarrhea: mild episodes.
• Rash: mild skin irritation.

Serious or Rare Side Effects

• Neuropsychiatric events: mood changes, depression, or suicidal thoughts.
• Allergic reactions: angioedema, urticaria, or anaphylaxis.
• Hepatotoxicity: elevated liver enzymes.
• Severe skin reactions: Stevens‑Johnson syndrome.
• Blood dyscrasias: eosinophilia or neutropenia.

Before prescribing Montelukast, consider the following precautions.

• Pregnancy: safety data are limited; use only if the potential benefit justifies the risk.
• Breastfeeding: excreted in milk; weigh benefits against potential infant exposure.
• Hepatic impairment: monitor liver function in patients with existing liver disease.
• Neuropsychiatric monitoring: observe for mood changes, especially in adolescents.
• Drug interactions: review concomitant medications for potential interactions.
• Store at ambient temperature: keep below 25°C, retain in original packaging, and protect from moisture.

Montelukast may interact with several drug classes; assess patient medication profiles.

Major Interactions (Avoid)

• Phenobarbital: may reduce montelukast plasma concentrations.
• Rifampin: induces metabolism, potentially lowering efficacy.

Moderate Interactions (Monitor Closely)

• Antidepressants (e.g., fluoxetine): may increase risk of neuropsychiatric effects.
• Warfarin: occasional reports of altered INR; monitor coagulation parameters.
• CYP2C9 inhibitors (e.g., fluconazole): may modestly increase montelukast levels.
• Herbal supplements (e.g., St. John’s wort): could induce metabolism, reducing effectiveness.