Product image of Montelukast supplied by GNH India

Montelukast

Active Ingredient:
Montelukast
Origin:
EU

Montelukast

Montelukast, the active ingredient in this product, is a leukotriene receptor antagonist presented as an oral tablet for oral use. It treats asthma, exercise‑induced bronchoconstriction and allergic rhinitis in adults and children as prescribed by a healthcare professional to manage symptoms.

GNH India supplies this product as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Krka, D.D., Novo Mesto

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Indications & Clinical Uses

Montelukast is indicated for conditions involving leukotriene‑mediated airway inflammation and allergic responses.

  • Asthma: improves control of persistent asthma and reduces frequency of exacerbations.
  • Exercise‑induced bronchoconstriction: prevents bronchospasm triggered by physical activity.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itching associated with seasonal allergies.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1. By antagonizing this receptor, it prevents leukotriene D4 from binding, which inhibits bronchoconstriction, vascular permeability, mucus secretion and eosinophilic inflammation in the airways. This action reduces airway narrowing and inflammatory responses that underlie asthma and allergic rhinitis. The blockade is competitive and long‑lasting, allowing once‑daily dosing and contributing to improved symptom control over time.

Side Effects

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

Common Side Effects

  • Headache: mild to moderate intensity, often transient.
  • Upper respiratory tract infection: symptoms such as sore throat, nasal congestion or mild fever.
  • Abdominal pain: discomfort in the stomach area, may be intermittent.
  • Diarrhea: loose stools, usually self‑limiting.
  • Cough: occasional dry cough without fever.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, swelling, or anaphylaxis requiring immediate medical attention.
  • Mood changes: depression, anxiety, or suicidal thoughts reported in rare cases.
  • Hepatotoxicity: elevated liver enzymes or hepatitis, monitored by liver function tests.
  • Angioedema: rapid swelling of face, lips or tongue, potentially airway‑obstructing.
  • Blood disorders: eosinophilia or neutropenia, identified through blood counts.

Precautions & Warnings

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

  • Assess asthma control: confirm that the patient’s asthma is not well‑controlled with inhaled therapy alone.
  • Monitor for neuropsychiatric events: watch for mood changes, depression or suicidal thoughts.
  • Evaluate liver function: consider baseline liver enzymes in patients with hepatic disease.
  • Use caution in children: pediatric dosing requires careful adjustment and monitoring.
  • Review concomitant medications: check for potential interactions that may alter efficacy.
  • Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.

Avoid Interactions

Montelukast can interact with other medicines, affecting its effectiveness or safety.

Major Interactions (Avoid)

  • Rifampin: a potent CYP3A4 inducer that can markedly lower montelukast plasma concentrations, reducing clinical efficacy.
  • Phenobarbital: hepatic enzyme inducer that may decrease montelukast levels, potentially compromising asthma control.

Moderate Interactions (Monitor Closely)

  • Ketoconazole: strong CYP3A4 inhibitor that can increase montelukast exposure, requiring observation for enhanced effects.
  • Fluconazole: moderate inhibitor of CYP3A4 that may raise montelukast levels slightly; monitor for side effects.
  • Warfarin: occasional reports of altered International Normalized Ratio; check coagulation status when initiating or stopping montelukast.
  • Antidepressants (SSRIs): possible additive neuropsychiatric effects; observe patients for mood changes or suicidal ideation.

Frequently Asked Questions

Montelukast is prescribed to manage chronic asthma, prevent exercise‑induced bronchoconstriction, and relieve symptoms of allergic rhinitis such as nasal congestion, sneezing and itching. It is used in both adult and pediatric patients when a leukotriene‑mediated component of airway disease is identified.

Montelukast works by selectively blocking the cysteinyl leukotriene receptor CysLT1. This prevents leukotriene D4 from binding, thereby reducing bronchoconstriction, airway edema, mucus secretion and inflammatory cell recruitment that contribute to asthma and allergic rhinitis.

The appropriate dose of Montelukast is set by the prescribing healthcare professional based on the patient’s age, weight, indication and overall clinical status. Dosage forms and strengths are selected to match the individual treatment plan, and patients should follow the prescriber’s instructions exactly.

Safety data for Montelukast in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any potential risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the risks and alternatives with their physician.

To request Montelukast, 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 (including any cold‑chain requirements) and the necessary import documentation.

The primary alternative to Montelukast is inhaled corticosteroid therapy, which directly reduces airway inflammation. Montelukast offers an oral, once‑daily option that targets leukotriene pathways, making it useful as add‑on therapy or for patients who cannot tolerate inhaled steroids. Compared with other leukotriene antagonists such as zafirlukast, Montelukast has a similar efficacy profile but a more convenient once‑daily dosing schedule.

Montelukast tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and avoid storing in bathrooms or other humid environments.

Montelukast is taken orally, usually as a tablet that is swallowed whole with a glass of water. It can be taken with or without food, and the dose is typically administered once daily at the same time each day as directed by the prescriber.

Serious risks include neuropsychiatric events such as depression, anxiety, or suicidal thoughts, as well as severe allergic reactions like anaphylaxis or angioedema. Hepatotoxicity, manifested by elevated liver enzymes or hepatitis, may also occur. Patients should seek immediate medical attention if any of these symptoms develop.

Montelukast should be avoided in individuals with known hypersensitivity to the drug or any of its excipients. Caution is advised for patients with a history of severe psychiatric disorders, liver disease, or those taking medications that strongly induce CYP3A4 enzymes, as efficacy may be reduced.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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