Product image of Montelukast Paediatric Aurobindo Pharma (Malta) (Montelukast) supplied by GNH India

Montelukast Paediatric Aurobindo Pharma (Malta)

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Paediatric Aurobindo Pharma (Malta) (Montelukast)

Montelukast, the active ingredient in Montelukast Paediatric Aurobindo Pharma (Malta), is a leukotriene receptor antagonist presented as a pediatric oral formulation for oral use. It is employed to manage asthma, exercise‑induced bronchoconstriction and allergic rhinitis in children.
GNH India supplies Montelukast Paediatric Aurobindo Pharma (Malta) as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aurobindo Pharma (Malta) Limited

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Indications & Clinical Uses

Montelukast acts on the leukotriene pathway to control inflammatory airway diseases.

  • Asthma: reduces frequency and severity of bronchospasm episodes in pediatric patients.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itchy eyes caused by seasonal allergens.
  • Exercise‑induced bronchoconstriction: prevents airway narrowing during physical activity in children.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotriene D4 and related mediators from binding. This inhibition reduces bronchial smooth‑muscle contraction, vascular permeability, and eosinophil recruitment, thereby diminishing airway inflammation and hyper‑responsiveness associated with asthma and allergic rhinitis.

Side Effects

Montelukast is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Headache
  • Abdominal pain
  • Cough
  • Sore throat
  • Nausea
  • Diarrhoea

Serious or Rare Side Effects

  • Allergic reactions such as rash, angioedema or anaphylaxis
  • Neuropsychiatric events including mood changes or suicidal thoughts
  • Hepatic enzyme elevation
  • Severe skin reactions like Stevens‑Johnson syndrome
  • Bronchospasm paradoxically worsening
  • Hematologic abnormalities

Precautions & Warnings

When prescribing Montelukast, clinicians should consider several safety measures.

  • Monitor liver function: obtain baseline hepatic enzymes and repeat if clinically indicated.
  • Assess neuropsychiatric status: watch for mood swings, anxiety or suicidal ideation.
  • Use caution in severe hepatic impairment: dose adjustment may be required.
  • Avoid in patients with known hypersensitivity to montelukast or any formulation component.
  • Adjust in renal impairment: limited data, monitor renal function.
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Montelukast may interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Phenobarbital: strong enzyme inducer that can lower montelukast plasma levels.
  • Rifampin: reduces exposure by inducing hepatic metabolism.
  • Ketoconazole: potent CYP3A4 inhibitor that may increase montelukast concentrations.

Moderate Interactions (Monitor Closely)

  • Warfarin: possible alteration of INR, monitor coagulation parameters.
  • Beta‑agonists: additive bronchodilatory effect, observe for excessive tachycardia.
  • NSAIDs: may increase risk of hepatic enzyme elevation, check liver function periodically.

Frequently Asked Questions

Montelukast Paediatric is indicated for the preventive treatment of asthma, control of exercise‑induced bronchoconstriction, and relief of symptoms associated with allergic rhinitis in children. It helps reduce airway inflammation and allergic responses that trigger breathing difficulties.

Montelukast blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotrienes such as LTC4, LTD4, and LTE4 from binding. By inhibiting these inflammatory mediators, it reduces bronchial smooth‑muscle contraction, mucus secretion, and vascular leakage that contribute to asthma and allergic rhinitis.

The appropriate dose of Montelukast Paediatric is determined by the prescribing clinician based on the child’s age, weight, and specific condition. Healthcare professionals follow local prescribing guidelines and adjust the regimen as needed for optimal control.

Safety data for Montelukast in pregnancy and lactation are limited. The prescriber should weigh potential benefits against risks and consider alternative therapies when possible. Women who are pregnant, planning pregnancy, or breastfeeding should discuss use with their healthcare provider.

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

Montelukast belongs to the leukotriene receptor antagonist class, offering an oral alternative to inhaled corticosteroids or long‑acting beta‑agonists. It is especially useful for patients with allergic components or those who experience exercise‑induced bronchoconstriction, but it is generally used as an add‑on rather than a sole replacement for inhaled steroids.

Montelukast Paediatric should be stored below 25 °C in a dry place. 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 chewable tablet or oral suspension, as directed by the prescriber. It is typically given once daily in the evening, but the exact timing and method are determined by the treating clinician.

Serious risks include rare allergic reactions such as rash, angioedema or anaphylaxis, and neuropsychiatric events like mood changes, depression, or suicidal thoughts. Patients and caregivers should seek immediate medical attention if any severe or unexpected symptoms develop.

Montelukast Paediatric is contraindicated in individuals with known hypersensitivity to montelukast or any of its excipients. Caution is advised for children with severe hepatic impairment, and the drug should be avoided in patients who have experienced serious allergic reactions to leukotriene‑modifying agents.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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