Europe — EMA
Montelucaste Mylan (Montelukast)
GNH USA supplies Montelucaste Mylan (Montelukast), a leukotriene receptor antagonist for asthma, allergic rhinitis and exercise‑induced bronchoconstriction.
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What is 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 USA 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.
What is Montelukast used for?
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.
What are the side effects of Montelukast?
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.
What precautions apply to Montelukast?
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.
What does Montelukast interact with?
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
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Product details
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