Montelukast for Children From 6 To 14 Years Accord Healthcare (Montelukast)

Montelukast is used to manage conditions that involve leukotriene‑mediated airway inflammation and nasal symptoms.

• Asthma: improves control of persistent asthma and reduces the frequency of exacerbations in children.
• Allergic rhinitis: relieves 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 selectively blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotrienes D4, C4 and E4 from binding. This inhibition reduces bronchoconstriction, vascular permeability, and inflammatory cell recruitment in the airways, leading to decreased airway resistance and inflammation.

Montelukast may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

• Headache: mild to moderate pain often reported during the first weeks of therapy.
• Abdominal pain: intermittent discomfort or cramping in the stomach region.
• Cough: non‑productive cough without signs of infection.
• Nausea: feeling of queasiness that may resolve without intervention.

Serious or Rare Side Effects

• Allergic reactions: rash, angioedema or anaphylaxis requiring immediate medical attention.
• Neuropsychiatric events: mood changes, agitation, or suicidal thoughts, especially in adolescents.
• Hepatic enzyme elevation: abnormal liver function tests that may need monitoring.

Before initiating Montelukast, consider the following safety measures.

• Neuropsychiatric monitoring: observe for mood changes, anxiety or suicidal ideation, particularly in adolescents.
• Hepatic function: assess baseline liver enzymes in patients with known liver disease.
• Severe asthma: do not replace rescue inhalers; continue short‑acting bronchodilators as needed.
• Hypersensitivity: avoid use in individuals with documented allergy to Montelukast or any excipients.
• Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

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

Major Interactions (Avoid)

• Phenobarbital: induces hepatic enzymes, reducing Montelukast plasma levels.
• Rifampin: strong enzyme inducer that may diminish therapeutic effect.
• Ketoconazole: potent CYP3A4 inhibitor that can increase Montelukast exposure.

Moderate Interactions (Monitor Closely)

• Warfarin: potential alteration of anticoagulant effect; monitor INR.
• Theophylline: may experience altered bronchodilator response; observe clinical response.