Montelukast Mini Ratiopharm (Montelukast Sodium)

• 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.
• Allergic rhinitis: relieves nasal congestion, sneezing and itching associated with seasonal or perennial allergic rhinitis.
• Exercise‑induced bronchoconstriction: prevents airway narrowing triggered by physical activity.
• Chronic asthma in adults: reduces daily symptoms and improves lung function.
• Chronic asthma in children: helps control symptoms and decrease nighttime awakenings.

• Montelukast selectively blocks the cysteinyl leukotriene receptor type 1 (CysLT1) on airway smooth‑muscle cells, mast cells and eosinophils. By preventing leukotriene D4 and related mediators from binding, it inhibits leukotriene‑induced bronchoconstriction, vascular permeability and inflammatory cell recruitment, thereby reducing airway edema and hyper‑responsiveness. The antagonism is reversible and does not affect prostaglandin pathways, allowing normal bronchodilator response to β2‑agonists. Montelukast reaches peak plasma concentrations within 3–4 hours and is extensively bound to plasma proteins.

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

Common Side Effects

• Headache: mild to moderate intensity, often transient.
• Abdominal pain: discomfort or cramps in the stomach area.
• Nausea: feeling of queasiness, sometimes leading to vomiting.
• Dyspepsia: indigestion with bloating or heartburn.
• Fatigue: unusual tiredness without exertion.
• Cough: dry or productive cough episodes.

Serious or Rare Side Effects

• Angioedema: swelling of the face, lips, tongue or throat requiring immediate medical attention.
• Neuropsychiatric events: mood changes, depression, anxiety or suicidal thoughts.
• Severe allergic reactions: rash, urticaria, or anaphylaxis.
• Stevens‑Johnson syndrome: rare skin disorder with blistering and detachment.
• Hepatic dysfunction: abnormal liver enzymes or hepatitis.
• Blood dyscrasias: rare cases of neutropenia or eosinophilia.

• Before initiating Montelukast therapy, consider the following precautions.
• Assess liver function: monitor hepatic enzymes before initiating therapy in patients with liver disease.
• Monitor neuropsychiatric symptoms: watch for mood changes, depression or suicidal thoughts.
• Use with caution in renal impairment: adjust dose in severe renal dysfunction.
• Avoid in patients with known hypersensitivity to montelukast or any component of the formulation.
• Consider drug‑interaction potential: review concomitant CYP3A4 inhibitors or inducers.
• Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture.

Montelukast may interact with other medicines; review patient medication lists carefully.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): may increase montelukast plasma levels.
• CYP3A4 inducers (e.g., phenobarbital, rifampin): may reduce therapeutic effect.

Moderate Interactions (Monitor Closely)

• Warfarin: monitor INR as montelukast can affect anticoagulation control.
• Theophylline: observe for altered bronchodilator response.
• β2‑agonists: potential additive bronchodilation; assess clinical response.