Product image of Montelucaste Generis (Montelukast Sodium) supplied by GNH India

Montelucaste Generis

Active Ingredient:
Montelukast Sodium
Origin:
EU

Montelucaste Generis (Montelukast Sodium)

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

GNH India supplies Montelucaste Generis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution networks across Europe, Asia, Africa and the Americas. Our quality‑assured manufacturing adheres to EU GMP standards, ensuring consistent product integrity.

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

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

  • Asthma (maintenance therapy): reduces frequency of daytime and nighttime symptoms, lowers need for rescue inhalers, and decreases risk of severe exacerbations, thereby improving overall lung function.
  • Allergic rhinitis (seasonal or perennial): alleviates nasal congestion, sneezing, itching, watery eyes and rhinorrhea, contributing to better sleep quality and daily comfort.
  • Exercise‑induced bronchoconstriction: prevents bronchospasm triggered by physical activity, allowing patients to engage in sports or exercise with improved tolerance and reduced coughing.

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 inhibits the actions of leukotriene D4 and related mediators that cause bronchoconstriction, mucus secretion, vascular permeability and inflammatory cell recruitment, thereby reducing airway inflammation and hyper‑responsiveness. The effect is dose‑dependent and contributes to long‑term control of asthma symptoms in patients.

Side Effects

Montelukast may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Headache
  • Abdominal pain
  • Cough
  • Nausea

Serious or Rare Side Effects

  • Allergic reactions such as angioedema or anaphylaxis
  • Mood changes including depression or suicidal thoughts
  • Hepatic enzyme elevation or hepatitis
  • Severe skin reactions like Stevens‑Johnson syndrome

Precautions & Warnings

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

  • Assess asthma control before initiating: confirm patient is on appropriate inhaled therapy.
  • Monitor for neuropsychiatric events: watch for mood changes, depression or suicidal ideation.
  • Use caution in hepatic impairment: consider dose adjustment or close monitoring.
  • Avoid use in patients with known hypersensitivity to montelukast or any component of the formulation.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Montelukast can interact with other medicines, affecting its plasma concentration or clinical effect.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ritonavir): may increase montelukast levels and risk of side effects.
  • CYP inducers (e.g., phenobarbital, carbamazepine): may reduce drug exposure and diminish efficacy.

Moderate Interactions (Monitor Closely)

  • Aspirin or NSAIDs in aspirin‑sensitive patients: may exacerbate bronchospasm.
  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise montelukast concentrations.
  • Co‑administration with another leukotriene antagonist (e.g., zafirlukast): may increase risk of adverse reactions.

Frequently Asked Questions

Montelucaste Generis contains montelukast, which is prescribed to help control chronic asthma, relieve symptoms of seasonal or perennial allergic rhinitis, and prevent exercise‑induced bronchoconstriction. It works as a maintenance therapy, reducing airway inflammation and the frequency of asthma attacks or allergy‑related nasal symptoms.

Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on cells in the respiratory tract. By antagonising this receptor, it prevents leukotriene D4 and related mediators from causing bronchoconstriction, mucus production, vascular leakage and inflammatory cell recruitment, thereby helping to keep the airways open and less reactive.

The specific dose of Montelucaste Generis is determined by the prescribing clinician based on the patient’s age, weight, severity of disease and response to therapy. Standard dosing regimens exist for different indications, but the exact amount and frequency should always follow the individual prescriber’s order.

Safety data for Montelucaste Generis in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Healthcare providers should weigh potential benefits against possible risks and discuss any concerns with the patient before prescribing it to pregnant or nursing women.

To place an order, submit an enquiry on the Montelucaste Generis 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 (including any cold‑chain needs) 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 and is especially useful for patients who cannot tolerate steroids or need additional control for exercise‑induced bronchoconstriction. Compared with other leukotriene antagonists such as zafirlukast, montelukast has a similar efficacy profile but a more convenient dosing schedule.

Montelucaste Generis should be stored at ambient temperature below 25 °C, protected from moisture and light. Keep the product in its original packaging until use, and avoid exposing it to excessive heat or humidity to maintain its stability and potency.

The medication is taken orally, usually once daily in the evening, with or without food. Tablets should be swallowed whole with a glass of water and not crushed or chewed, unless the specific formulation advises otherwise.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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