Product image of Montelucaste Tetrafarma (Montelukast) supplied by GNH India

Montelucaste Tetrafarma

Active Ingredient:
Montelukast
Origin:
EU

Montelucaste Tetrafarma (Montelukast)

Montelukast, the active ingredient in Montelucaste Tetrafarma, 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 patients requiring control of leukotriene‑mediated airway inflammation.

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

Manufacturer / TM Owner

Tetrafarma- Produtos Farmacêuticos, Lda.

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Indications & Clinical Uses

Montelukast acts on the leukotriene pathway to reduce airway inflammation and bronchoconstriction.

  • Asthma: improves long‑term control and reduces the frequency of asthma attacks in adults and children.
  • Exercise‑induced bronchoconstriction: prevents narrowing of the airways that occurs during or after physical activity.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itching caused by seasonal or perennial allergens.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth muscle and inflammatory cells. By preventing leukotriene binding, it inhibits leukotriene‑mediated bronchoconstriction, mucus secretion, vascular permeability, and eosinophil recruitment, thereby reducing 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: mild to moderate pain often reported during early treatment.
  • Abdominal pain: discomfort or cramps in the stomach region.
  • Nausea: feeling of queasiness without vomiting.
  • Dizziness: transient sense of light‑headedness.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, swelling, or difficulty breathing.
  • Neuropsychiatric events: mood changes, agitation, or suicidal thoughts.
  • Hepatic injury: abnormal liver function tests or jaundice.
  • Angioedema: rapid swelling of the face, lips, or tongue.
  • Stevens‑Johnson syndrome: severe skin blistering and mucosal involvement.

Precautions & Warnings

Before prescribing Montelukast, clinicians should consider several safety aspects.

  • Assess asthma control: ensure baseline control before adding therapy.
  • Monitor neuropsychiatric symptoms: watch for mood changes or suicidal ideation.
  • Use caution in hepatic impairment: adjust use if liver disease is present.
  • Avoid in known hypersensitivity: discontinue if allergic reaction occurs.
  • Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Montelukast may interact with other medicines, requiring attention to dosage and monitoring.

Major Interactions (Avoid)

  • Ritonavir: can increase montelukast plasma concentrations, raising risk of side effects.
  • Phenobarbital: may reduce montelukast effectiveness by enhancing metabolism.

Moderate Interactions (Monitor Closely)

  • Fluconazole: may modestly raise montelukast levels.
  • Carbamazepine: can lower montelukast exposure.
  • Warfarin: monitor INR as montelukast may affect anticoagulation control.

Frequently Asked Questions

Montelucaste Tetrafarma contains montelukast, which is indicated for the long‑term management of asthma, prevention of exercise‑induced bronchoconstriction, and relief of symptoms associated with allergic rhinitis such as nasal congestion, sneezing, and itching.

Montelukast blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth muscle and inflammatory cells. This inhibition prevents leukotrienes from causing bronchoconstriction, mucus production, and inflammation, thereby improving airway patency and reducing allergic symptoms.

The specific dose of Montelucaste Tetrafarma is determined by the prescribing healthcare professional based on the patient’s age, weight, severity of disease, and other clinical factors. 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. Healthcare providers should weigh the potential benefits against any possible risks and discuss these considerations with the patient before prescribing. Breastfeeding mothers should consult their physician regarding continuation of therapy.

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 particularly useful for patients who need additional control of leukotriene‑mediated inflammation or who experience exercise‑induced bronchoconstriction, complementing other inhaled therapies.

Montelucaste Tetrafarma should be stored at room temperature, below 25 °C. 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 once daily, with or without food, as directed by the prescriber. Swallow the tablet whole with water; do not crush, chew, or split the tablet unless specifically instructed.

Serious adverse events, though rare, include severe allergic reactions such as anaphylaxis, neuropsychiatric effects like mood changes or suicidal thoughts, and hepatic injury. Patients should seek immediate medical attention if they experience rash, swelling, difficulty breathing, or significant changes in mood.

Montelucaste Tetrafarma is contraindicated in individuals with known hypersensitivity to montelukast or any of the tablet’s excipients. It should also be avoided in patients who have experienced severe allergic reactions to leukotriene receptor antagonists.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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