Europe — EMA
Montelucaste Generis (Montelukast Sodium)
GNH USA supplies Montelucaste Generis (Montelukast), a leukotriene receptor antagonist for asthma maintenance and allergic rhinitis. Request a quote.
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What is 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 USA 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.
What is Montelukast Sodium used for?
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.
What are the side effects of Montelukast Sodium?
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
What precautions apply to Montelukast Sodium?
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.
What does Montelukast Sodium interact with?
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.
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