Europe — EMA
Montelukast Mylan
GNH USA supplies Montelukast Mylan (Montelukast), a leukotriene receptor antagonist for asthma prophylaxis and allergic rhinitis.
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What is Montelukast?
Montelukast, the active ingredient in Montelukast Mylan, is a leukotriene receptor antagonist presented as an oral tablet for oral use. It is used for asthma prophylaxis and chronic treatment as well as for allergic rhinitis in adults and children.
GNH USA supplies Montelukast Mylan as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Montelukast used for?
Montelukast is a leukotriene receptor antagonist indicated for conditions involving airway inflammation and allergic nasal symptoms.
- Asthma prophylaxis and chronic treatment: reduces the frequency of asthma attacks and improves overall asthma control. - Allergic rhinitis: alleviates nasal congestion, sneezing, itching and rhinorrhea associated with seasonal or perennial allergic rhinitis.
What are the side effects of Montelukast?
Montelukast is generally well tolerated, but adverse reactions can occur.
Common Side Effects: - Headache: mild to moderate headache reported. - Abdominal pain: occasional stomach discomfort. - Cough: transient cough may appear. - Diarrhea: loose stools in some patients. - Upper respiratory tract infection: mild cold‑like symptoms. - Rash: mild skin irritation.
Serious or Rare Side Effects: - Allergic reactions: urticaria, angioedema, or anaphylaxis. - Neuropsychiatric events: agitation, anxiety, depression, or suicidal thoughts. - Hepatotoxicity: elevated liver enzymes or hepatitis. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Blood dyscrasias: eosinophilia or neutropenia. - Cardiovascular events: rare cases of chest pain or palpitations.
What precautions apply to Montelukast?
Before prescribing Montelukast, clinicians should consider several safety aspects.
- Pregnancy: category unknown; use only if the potential benefit justifies the potential risk. - Breastfeeding: unknown safety; weigh benefits against possible infant exposure. - Hepatic impairment: use with caution; monitor liver function in patients with liver disease. - Neuropsychiatric monitoring: observe for mood changes, depression, or suicidal ideation, especially in children and adolescents. - Concomitant severe infections: assess risk as leukotriene inhibition may affect immune response. - Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Montelukast interact with?
Montelukast may interact with other medicines that affect its metabolism or share similar safety concerns.
Major Interactions (Avoid): - Phenobarbital: strong enzyme inducer that can reduce Montelukast plasma levels. - Rifampin: hepatic enzyme inducer leading to decreased efficacy. - St. John's Wort: induces CYP3A4, potentially lowering drug exposure.
Moderate Interactions (Monitor Closely): - Antidepressants (SSRIs, SNRIs): may increase risk of neuropsychiatric side effects. - CYP3A4 inhibitors (ketoconazole, erythromycin): can raise Montelukast concentrations. - Warfarin: monitor INR as occasional alterations in coagulation have been reported.
Frequently asked questions
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Product details
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