Product image of Montelukast Für Pädiatrische Patienten Von 6 Bis 14 Jahren Accord (Montelukast) supplied by GNH India

Montelukast Für Pädiatrische Patienten Von 6 Bis 14 Jahren Accord

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Für Pädiatrische Patienten Von 6 Bis 14 Jahren Accord (Montelukast)

Montelukast, the active ingredient in Montelukast Für Pädiatrische Patienten Von 6 Bis 14 Jahren Accord, is a leukotriene receptor antagonist presented as an oral tablet for oral use. It is indicated for the prophylaxis and chronic treatment of asthma, prevention of exercise‑induced bronchoconstriction, and symptomatic relief of allergic rhinitis in children aged 6 to 14 years.

GNH India supplies Montelukast Für Pädiatrische Patienten Von 6 Bis 14 Jahren Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Accord Healthcare B.V.

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Indications & Clinical Uses

Montelukast acts on the leukotriene pathway to control airway inflammation and allergic symptoms.

  • Asthma: provides prophylaxis and chronic control of bronchial asthma in children.
  • Exercise‑induced bronchoconstriction: prevents bronchospasm triggered by physical activity.
  • Allergic rhinitis: relieves nasal congestion, sneezing and itching associated with seasonal or perennial allergic rhinitis.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth muscle and inflammatory cells. By antagonizing this receptor, it inhibits leukotriene‑mediated bronchoconstriction, vascular permeability, and eosinophil recruitment, thereby reducing airway inflammation and hyper‑responsiveness.

Side Effects

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

Common Side Effects

  • Headache: mild to moderate intensity.
  • Abdominal pain: occasional discomfort.
  • Cough: transient irritation.
  • Nausea: occasional upset stomach.
  • Sore throat: mild irritation.
  • Rash: mild skin redness.

Serious or Rare Side Effects

  • Angioedema: swelling of face, lips or tongue.
  • Stevens‑Johnson syndrome: severe skin reaction.
  • Eosinophilic granulomatosis with polyangiitis: rare vasculitis.
  • Hepatic injury: abnormal liver enzymes.
  • Neuropsychiatric events: mood changes, depression, suicidal thoughts.
  • Anaphylaxis: severe allergic reaction.

Precautions & Warnings

Before initiating therapy, consider the following safety measures.

  • Monitor asthma control: assess symptom frequency and rescue inhaler use.
  • Assess hypersensitivity: avoid if known allergy to montelukast or excipients.
  • Caution in hepatic impairment: adjust use if liver disease is present.
  • Watch for neuropsychiatric symptoms: inform caregivers of mood or behavior changes.
  • Review concomitant medications: check for potential interactions.
  • Store at room temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Montelukast may interact with several drug classes; awareness helps maintain efficacy and safety.

Major Interactions (Avoid)

  • Rifampin: strong CYP3A4 inducer that can lower montelukast levels.
  • Carbamazepine: enzyme inducer reducing therapeutic effect.
  • Phenytoin: may decrease montelukast exposure.
  • Phenobarbital: induces metabolism, potentially reducing efficacy.

Moderate Interactions (Monitor Closely)

  • Fluoxetine or other SSRIs: may increase risk of neuropsychiatric events.
  • Sertraline: similar caution for mood changes.
  • Theophylline: concurrent use may require monitoring of respiratory status.
  • Beta‑agonists: combined bronchodilator effect should be evaluated.

Frequently Asked Questions

The product is prescribed for children aged 6 to 14 years to prevent and control asthma, to avoid exercise‑induced bronchoconstriction, and to relieve symptoms of allergic rhinitis such as nasal congestion, sneezing and itching.

Montelukast blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotrienes from causing bronchial smooth‑muscle contraction, airway swelling, and inflammation. This results in improved breathing and reduced allergic symptoms.

The exact dose is determined by the prescribing clinician based on the child’s age, weight, severity of disease and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for Montelukast in pregnancy and lactation are limited. The medication should only be used if the potential benefit justifies any possible risk to the fetus or infant, and this decision must be made by a qualified health professional.

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 who need additional control of exercise‑induced bronchoconstriction or have allergic rhinitis, but it does not replace rescue bronchodilators.

Store the tablets at room temperature, below 25 °C, in the original packaging. Keep them away from moisture and direct sunlight to maintain product stability.

The medication is taken orally, usually once daily in the evening, with or without food, as directed by the prescriber. Swallow the tablet whole; do not crush or chew unless the formulation specifically allows it.

Serious but rare risks include angioedema, severe skin reactions such as Stevens‑Johnson syndrome, eosinophilic granulomatosis with polyangiitis, hepatic injury, and neuropsychiatric events like mood changes, depression or suicidal thoughts. Any of these symptoms require immediate medical attention.

Children with a known hypersensitivity to montelukast or any of the tablet’s excipients should avoid the product. Caution is also advised for patients with severe liver disease or those taking interacting medications listed under major interactions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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