Montelukast Pre Deti Vo Veku Od 6 Mesiacov Do 5 Rokov Teva (Montelukast Sodium)

Montelukast is indicated for conditions involving leukotriene‑mediated inflammation, primarily in the respiratory tract.

• Asthma (children 6 months–5 years): prophylaxis and chronic treatment to reduce airway inflammation and prevent symptoms.
• Allergic rhinitis (children): management of nasal congestion, sneezing and itching caused by seasonal or perennial allergens.
• Exercise‑induced bronchoconstriction (children): prevention of airway narrowing triggered by physical activity.

• Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1, inhibiting the binding of leukotriene D4 and related mediators. By preventing leukotriene‑induced bronchoconstriction, mucus secretion, vascular permeability and eosinophil recruitment, the drug reduces airway inflammation and hyper‑responsiveness, contributing to improved respiratory function in asthma and allergic rhinitis.

Montelukast may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

• Headache: mild to moderate pain in the head.
• Abdominal pain: discomfort or cramps in the stomach area.
• Cough: occasional dry or productive cough.
• Nasopharyngitis: inflammation of the nasal passages and throat.
• Fever: transient elevation of body temperature.

Serious or Rare Side Effects

• Allergic reactions: rash, angioedema or anaphylaxis requiring immediate medical attention.
• Neuropsychiatric events: agitation, anxiety, depression or suicidal thoughts.
• Hepatic enzyme elevation: increased liver transaminases indicating possible liver stress.
• Stevens‑Johnson syndrome: severe skin blistering and mucosal involvement.
• Eosinophilic granulomatosis with polyangiitis: rare systemic vasculitis with eosinophilia.

Before prescribing Montelukast, healthcare professionals should consider several safety aspects.

• Assess asthma control: ensure patient is on appropriate baseline therapy before adding Montelukast.
• Monitor neuropsychiatric symptoms: watch for mood changes, depression or suicidal ideation.
• Use with caution in hepatic impairment: dose adjustment may be required in patients with liver disease.
• Not for acute asthma attacks: Montelukast does not provide immediate bronchodilation.
• Avoid in known hypersensitivity: discontinue if allergic reaction occurs.
• Store at below 25°C: keep in the original packaging, protect from moisture and light.

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

Major Interactions (Avoid)

• Rifampin: strong enzyme inducer that reduces Montelukast plasma levels.
• Ketoconazole: potent CYP3A4 inhibitor that may increase Montelukast exposure.
• Phenobarbital: induces metabolism leading to decreased effectiveness.
• St. John’s wort: herbal inducer that lowers drug concentrations.
• Antiretroviral protease inhibitors (e.g., ritonavir): may raise Montelukast levels.

Moderate Interactions (Monitor Closely)

• Warfarin: possible alteration of anticoagulant effect; monitor INR.
• Beta‑agonists (e.g., albuterol): additive bronchodilator effect; assess response.
• NSAIDs: may increase risk of gastrointestinal irritation.
• Oral contraceptives: slight increase in Montelukast levels; observe for side effects.
• Antidepressants (SSRIs): monitor for neuropsychiatric symptoms.