Product image of Montelukast Accord (Montelukast Sodium) supplied by GNH India

Montelukast Accord

Active Ingredient:
Montelukast Sodium
Origin:
EU

Montelukast Accord (Montelukast Sodium)

Montelukast, the active ingredient in Montelukast Accord, is a leukotriene receptor antagonist presented as an oral dosage form for oral use. It is used to manage asthma, exercise‑induced bronchoconstriction and allergic rhinitis in adults and children.

GNH India supplies Montelukast Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company follows EU GMP standards, provides full regulatory dossiers and offers reliable logistics for global distribution.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

  • Montelukast acts on the leukotriene pathway to control airway inflammation and bronchoconstriction.
  • Asthma: reduces frequency of wheezing episodes and improves lung function.
  • Exercise‑induced bronchoconstriction: prevents narrowing of airways during physical activity.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itching.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth‑muscle cells, mast cells and eosinophils. By antagonising this receptor, it prevents leukotriene D4, E4 and related mediators from binding, thereby inhibiting inflammatory cell recruitment, mucus secretion and bronchial smooth‑muscle contraction, which reduces airway edema and hyper‑responsiveness.

Side Effects

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

Common Side Effects

  • Headache
  • Abdominal pain
  • Cough
  • Nausea
  • Dizziness

Serious or Rare Side Effects

  • Angioedema
  • Stevens‑Johnson syndrome
  • Hepatic injury
  • Neuropsychiatric events such as agitation or suicidal thoughts

Precautions & Warnings

When prescribing Montelukast, consider specific safety aspects.

  • Pregnancy: Category B; use only if benefit outweighs risk.
  • Lactation: Small amounts excreted in breast milk; evaluate infant risk.
  • Pediatric use: Safety established in children ≥6 months; follow prescriber guidance.
  • Hepatic impairment: Use with caution; monitor liver enzymes.
  • Hypersensitivity: Discontinue if allergic reaction occurs.
  • Store below 25°C: keep in original packaging, protect from moisture.

Avoid Interactions

Montelukast can interact with several medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Rifampin, phenobarbital, carbamazepine: strong CYP3A4 inducers that lower montelukast exposure.
  • St. John’s wort: herbal CYP3A4 inducer may reduce effectiveness.
  • Concurrent use with other leukotriene pathway inhibitors (e.g., zafirlukast) may increase adverse‑effect risk.

Moderate Interactions (Monitor Closely)

  • Warfarin: montelukast may enhance anticoagulant effect; monitor INR.
  • Theophylline: possible increase in plasma levels; observe for toxicity.
  • Oral contraceptives: may slightly raise hormone levels; monitor for menstrual changes.

Frequently Asked Questions

Montelukast Accord contains the leukotriene receptor antagonist montelukast sodium and is indicated for the long‑term management of asthma, the prevention of exercise‑induced bronchoconstriction, and the relief of symptoms associated with allergic rhinitis such as nasal congestion, sneezing and itching.

Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth‑muscle cells, mast cells and eosinophils. This inhibition prevents leukotrienes D4, E4 and related mediators from triggering inflammation, mucus production and bronchial smooth‑muscle contraction, thereby helping keep the airways open.

The appropriate dose of Montelukast Accord is determined by the prescribing healthcare professional based on the patient’s age, clinical condition and response to therapy. Dosage recommendations are provided in the product labeling, but the final regimen is set by the prescriber.

Montelukast is classified as Pregnancy Category B, indicating that animal studies have not shown risk to the fetus and there are no adequate human studies. It should be used during pregnancy only if the potential benefit justifies the potential risk. Small amounts are excreted in breast milk, so a risk‑benefit assessment is required for nursing mothers.

To order Montelukast Accord, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials. After confirmation, the team provides pricing, availability, shipping details and any necessary import documentation.

Montelukast belongs to the leukotriene receptor antagonist class, which works by blocking leukotriene‑mediated inflammation, whereas inhaled corticosteroids reduce airway inflammation through a different pathway and short‑acting bronchodilators provide rapid relief of bronchospasm. Montelukast is taken orally once daily and is often used as an add‑on therapy or for patients who prefer a non‑inhaled option.

Montelukast Accord should be stored below 25 °C in a dry place. Keep the tablets in the original container, protect them from moisture and direct sunlight, and ensure the packaging is tightly closed to maintain product stability.

Montelukast Accord is administered orally, usually as a tablet taken with or without food. The exact timing (e.g., in the evening) and whether it should be taken with a meal are determined by the prescribing clinician based on the individual’s therapeutic plan.

Serious adverse reactions, although rare, include angioedema, severe skin reactions such as Stevens‑Johnson syndrome, hepatic injury and neuropsychiatric events like agitation, depression or suicidal thoughts. Patients should seek immediate medical attention if they experience swelling of the face or throat, rash with blistering, persistent abdominal pain, or any sudden change in mood.

Montelukast Accord should be avoided in individuals with known hypersensitivity to montelukast sodium or any component of the formulation. Caution is advised for patients with severe hepatic impairment, and it is not recommended for use in children under six months of age unless specifically directed by a specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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