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

Montelucaste Mylan

Active Ingredient:
Montelukast
Origin:
EU

Montelucaste Mylan (Montelukast)

Montelukast, the active ingredient in Montelucaste Mylan, is a leukotriene receptor antagonist presented as an oral tablet for oral use. It is indicated for the management of asthma, allergic rhinitis, and exercise‑induced bronchoconstriction in adults and children.

GNH India supplies Montelucaste Mylan as a licensed, GDP‑compliant international pharmaceutical supplier, adhering to EU quality standards and providing the product to hospitals, pharmacies and clinics worldwide. Our global logistics network ensures timely delivery and regulatory support for each market. We maintain validated supply chains where required to preserve product integrity.

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

Montelukast is used to manage conditions mediated by cysteinyl leukotrienes, primarily within the respiratory allergy spectrum.

  • Asthma: reduces frequency of symptoms, improves lung function and decreases exacerbations.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itchy eyes.
  • Exercise‑induced bronchoconstriction: prevents airway narrowing triggered by physical activity.

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, mucus secretion, and vascular permeability, 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 pain often transient.
  • Abdominal pain: discomfort or cramps in the stomach area.
  • Cough: occasional irritation of the throat.
  • Nausea: feeling of queasiness, sometimes with vomiting.
  • Diarrhea: loose stools that may be watery.
  • Sore throat: irritation or scratchy feeling.

Serious or Rare Side Effects

  • Allergic reactions: rash, angioedema, or anaphylaxis.
  • Mood changes: depression, anxiety, or suicidal thoughts.
  • Hepatic enzyme elevation: abnormal liver function tests.
  • Stevens‑Johnson syndrome: severe skin blistering.
  • Blood dyscrasias: neutropenia or eosinophilia.
  • Churg‑Strauss syndrome: rare vasculitis with asthma worsening.

Precautions & Warnings

Before prescribing Montelukast, clinicians should consider several safety aspects.

  • Pregnancy: Category B – use only if clearly needed.
  • Breastfeeding: considered compatible, but monitor infant.
  • Hepatic impairment: use with caution; dose adjustment may be required.
  • Psychiatric history: monitor for mood changes or suicidal ideation.
  • Concomitant leukotriene modifiers: avoid duplicate therapy.
  • Store at ambient temperature: keep below 25°C, retain in original packaging and protect from moisture.

Avoid Interactions

Montelukast may interact with other medicines, requiring attention to the level of risk.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may increase montelukast exposure.
  • Phenobarbital or rifampicin (CYP inducers): can markedly reduce effectiveness.

Moderate Interactions (Monitor Closely)

  • Other leukotriene pathway drugs (e.g., zafirlukast): risk of additive effects.
  • Warfarin: monitor INR as occasional alterations reported.
  • Antidepressants (SSRIs): observe for enhanced mood‑related side effects.

Frequently Asked Questions

Montelucaste Mylan contains montelukast, which is prescribed to treat asthma, allergic rhinitis, and exercise‑induced bronchoconstriction. It works by reducing airway inflammation and preventing bronchospasm, helping patients achieve better symptom control.

Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth muscle and inflammatory cells. This inhibition prevents leukotriene‑driven bronchoconstriction, mucus production, and vascular leakage, thereby easing breathing difficulties and allergic symptoms.

The appropriate dose of Montelucaste Mylan is determined by the prescribing clinician based on the patient’s age, weight, and specific indication. Dosage instructions are provided on the prescription label and should be followed exactly as directed.

Montelucaste Mylan is classified as Pregnancy Category B, indicating no evidence of risk in animal studies but limited human data. It is generally considered compatible with breastfeeding, though mothers should discuss any concerns with their healthcare provider.

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 necessary import documentation.

Montelucaste Mylan 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 with aspirin‑sensitive asthma or those who need additional control beyond inhaled therapy, though it does not replace rescue bronchodilators.

Montelucaste Mylan should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing in bathrooms or other humid environments.

Montelucaste Mylan is taken orally, usually once daily in the evening, with or without food. The tablet should be swallowed whole with a glass of water and not chewed or crushed, unless the prescriber provides an alternative formulation.

Serious risks include rare allergic reactions such as angioedema or anaphylaxis, mood changes including depression or suicidal thoughts, and rare skin conditions like Stevens‑Johnson syndrome. Patients should seek immediate medical attention if they experience any of these symptoms.

Montelucaste Mylan should be avoided in individuals with known hypersensitivity to montelukast or any component of the formulation. It is also not recommended as a sole rescue medication for acute asthma attacks; patients should have a fast‑acting bronchodilator available.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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