Product image of Montelukast Paediatric (Montelukast) supplied by GNH India

Montelukast Paediatric

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Paediatric (Montelukast)

Montelukast, the active ingredient in Montelukast Paediatric, is a leukotriene receptor antagonist presented as an oral dosage form for pediatric use. It helps manage asthma, exercise‑induced bronchoconstriction and allergic rhinitis in children and adolescents, to improve breathing and reduce inflammation.

GNH India supplies Montelukast Paediatric as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with consistent quality and regulatory compliance. The product meets EU standards and is available for bulk and individual orders.

Manufacturer / TM Owner

Relon Chem Limited

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Indications & Clinical Uses

Montelukast is used to treat conditions mediated by leukotrienes, primarily within the respiratory and allergic disease spectrum.

  • Asthma: reduces frequency of attacks and improves symptom control in pediatric patients.
  • Exercise‑induced bronchoconstriction: prevents airway narrowing triggered by physical activity.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itching caused by seasonal allergens.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth‑muscle cells, mast cells and eosinophils. By antagonizing this receptor, it prevents leukotriene‑mediated bronchoconstriction, mucus secretion and inflammatory cell recruitment, thereby reducing airway hyper‑responsiveness and allergic inflammation. The inhibition is reversible and does not affect prostaglandin pathways, allowing normal physiological responses to persist while specifically targeting the leukotriene cascade implicated in asthma and allergic rhinitis.

Side Effects

Montelukast may be associated with a range of adverse reactions, which are classified by frequency and severity.

Common Side Effects

  • Headache: mild to moderate headache reported in many patients.
  • Abdominal pain: occasional stomach discomfort or cramps.
  • Cough: transient cough without infection.
  • Diarrhoea: loose stools occurring during treatment.
  • Nausea: feeling of sickness.
  • Fever: low‑grade temperature elevation.

Serious or Rare Side Effects

  • Neuropsychiatric events: agitation, anxiety, depression or suicidal thoughts.
  • Allergic reactions: rash, urticaria or angioedema.
  • Hepatic enzyme elevation: rare increase in liver transaminases.

Precautions & Warnings

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

  • Assess asthma control: verify that the patient’s asthma is not uncontrolled before initiating therapy.
  • Monitor mental health: observe for changes in mood, behavior or suicidal thoughts.
  • Evaluate liver function: consider baseline hepatic enzymes in patients with liver disease.
  • Use with caution in the elderly: adjust monitoring as pharmacokinetics may differ.
  • Avoid in known hypersensitivity: discontinue if rash or angioedema develops.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and keep in original packaging.

Avoid Interactions

Montelukast can interact with other medicines, altering its effectiveness or increasing the risk of adverse effects.

Major Interactions (Avoid)

  • Phenobarbital: enzyme induction may reduce montelukast plasma concentrations.
  • Rifampin: strong CYP3A4 inducer that can lower therapeutic levels.
  • St. John’s wort: herbal inducer that may decrease drug exposure.

Moderate Interactions (Monitor Closely)

  • Antidepressants (e.g., fluoxetine): may increase risk of neuropsychiatric side effects.
  • Antihistamines: additive sedative effects are uncommon but should be observed.
  • Warfarin: occasional reports of altered INR; monitor coagulation parameters.

Frequently Asked Questions

Montelukast Paediatric is indicated for the management of asthma, exercise‑induced bronchoconstriction and allergic rhinitis in children. It helps reduce airway inflammation and bronchospasm, improving breathing and symptom control as part of a broader asthma or allergy treatment plan.

Montelukast works by selectively blocking the cysteinyl leukotriene receptor CysLT1 on airway cells. This antagonism prevents leukotriene‑driven bronchoconstriction, mucus production and inflammatory cell recruitment, thereby decreasing airway hyper‑responsiveness and allergic inflammation.

The appropriate dose of Montelukast Paediatric is set by the prescribing healthcare professional based on the child’s age, weight, severity of disease and clinical response. No fixed dosing regimen is provided here; the prescriber tailors therapy to each patient.

Montelukast is classified as pregnancy category unknown, and limited data exist for use during lactation. Clinicians should weigh potential benefits against unknown risks and consider alternative therapies when treating pregnant or nursing mothers.

To order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Montelukast provides an oral, leukotriene‑targeted approach, whereas inhaled corticosteroids act locally to suppress airway inflammation. Montelukast is often used as add‑on therapy or for patients who cannot tolerate steroids, but inhaled corticosteroids remain first‑line for persistent asthma due to broader anti‑inflammatory effects.

Montelukast Paediatric should be stored at ambient temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

The medication is taken orally, usually as a tablet or chewable granule, with a glass of water. It can be given with or without food, and the exact administration instructions are provided by the prescribing clinician.

Serious risks include neuropsychiatric events such as agitation, anxiety, depression or suicidal thoughts, severe allergic reactions like rash or angioedema, and rare hepatic enzyme elevations. Patients should be monitored for these signs and advised to seek medical attention promptly if they occur.

Montelukast Paediatric should be avoided in individuals with known hypersensitivity to montelukast or any excipients in the formulation. Caution is also advised for patients with uncontrolled asthma, severe liver disease, or those who have experienced serious neuropsychiatric reactions to the drug.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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