Montelukast Teva Italia (Montelukast Sodium)

Montelukast acts on the leukotriene pathway and is indicated for several respiratory and allergic conditions.

• Asthma: Improves long‑term control and reduces the frequency of exacerbations in patients requiring maintenance therapy.
• Allergic rhinitis: Alleviates nasal congestion, sneezing and itching associated with seasonal or perennial allergic rhinitis.
• Exercise‑induced bronchoconstriction: Prevents airway narrowing that occurs during or after physical activity.

• Montelukast Sodium selectively blocks the cysteinyl leukotriene receptor CysLT1 located on airway smooth‑muscle cells, mast cells and eosinophils. By antagonizing this receptor, it prevents leukotriene D4‑mediated bronchoconstriction, vascular permeability and inflammatory cell recruitment, thereby reducing airway edema and hyper‑responsiveness associated with asthma and allergic diseases. The inhibition is dose‑dependent and contributes to improved pulmonary function and symptom control over time.

Montelukast is generally well tolerated, but several adverse reactions have been reported.

Common Side Effects

• Headache: mild to moderate pain often occurring early in therapy.
• Abdominal pain: discomfort or cramping in the stomach region.
• Cough: transient irritation of the airways.
• Nausea: feeling of queasiness that may resolve without intervention.

Serious or Rare Side Effects

• Angioedema: swelling of the face, lips, tongue or throat that may compromise breathing.
• Neuropsychiatric events: mood changes, anxiety, depression or suicidal thoughts.
• Anaphylaxis: severe, rapid‑onset allergic reaction requiring immediate medical attention.

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

• Hepatic function: Evaluate liver enzymes before initiating therapy in patients with known hepatic impairment.
• Neuropsychiatric monitoring: Observe for mood alterations, depression or suicidal ideation throughout treatment.
• Severe asthma: Use with caution in patients with uncontrolled or severe asthma, as it is not a rescue medication.
• Drug hypersensitivity: Avoid in individuals with documented hypersensitivity to Montelukast or any component of the formulation.
• Concomitant medications: Review potential interactions, especially with enzyme‑inducing or inhibiting agents.
• Store at below 25°C: Keep tablets in the original container, protect from moisture and direct sunlight.

Montelukast may interact with other medicines that affect its metabolism or pharmacodynamic profile.

Major Interactions (Avoid)

• Phenobarbital: Strong enzyme inducer that can reduce Montelukast plasma concentrations.
• Rifampin: Potent CYP3A4 inducer leading to decreased therapeutic effect.
• Ketoconazole: Strong CYP3A4 inhibitor that may increase Montelukast exposure and risk of adverse events.

Moderate Interactions (Monitor Closely)

• Warfarin: Potential alteration of anticoagulant effect; monitor INR.
• Oral contraceptives: May experience reduced efficacy; advise additional contraceptive measures.
• β‑agonists: Combined use may enhance bronchodilation but requires clinical assessment.