GNH USA

Europe — EMA

Montelukast Sun Pharma Italia Srl

GNH USA supplies Montelukast Sun Pharma Italia Srl (Montelukast), a leukotriene receptor antagonist for asthma, exercise‑induced bronchoconstriction

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What is Montelukast?

Montelukast, the active ingredient in Montelukast Sun Pharma Italia Srl, is a leukotriene receptor antagonist presented as an oral dosage form for oral use. It is indicated for the management of asthma, exercise‑induced bronchoconstriction and allergic rhinitis in adults and children.

GNH USA supplies Montelukast Sun Pharma Italia Srl as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Montelukast used for?

Montelukast acts on the leukotriene pathway to control airway inflammation and bronchoconstriction. - Asthma: improves control of persistent asthma and reduces exacerbations. - Exercise‑induced bronchoconstriction: prevents narrowing of airways during physical activity. - Allergic rhinitis: alleviates nasal congestion, sneezing and itching caused by seasonal or perennial allergens.

What are the side effects of Montelukast?

Montelukast is generally well tolerated, but adverse reactions can occur.

Common Side Effects: - Headache: mild to moderate intensity. - Abdominal pain: occasional discomfort. - Cough: transient irritation. - Nausea: occasional upset stomach. - Diarrhoea: loose stools. - Fatigue: feeling of tiredness.

Serious or Rare Side Effects: - Angioedema: swelling of face, lips or tongue. - Stevens‑Johnson syndrome: severe skin reaction. - Eosinophilic granulomatosis with polyangiitis: rare vasculitis. - Hepatic injury: abnormal liver enzymes. - Anaphylaxis: life‑threatening allergic response. - Neuropsychiatric events: mood changes, including suicidal thoughts.

What precautions apply to Montelukast?

Before prescribing Montelukast, clinicians should consider several safety aspects. - Liver function monitoring: assess hepatic status in patients with existing liver disease. - Neuropsychiatric vigilance: watch for mood alterations, depression or suicidal ideation. - Caution in severe hepatic impairment: dose adjustment may be required. - Hypersensitivity avoidance: discontinue if signs of allergic reaction appear. - Pregnancy risk assessment: category B, discuss benefits versus potential risks. - Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

What does Montelukast interact with?

Montelukast may interact with other medicines, influencing its efficacy or safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase montelukast plasma levels. - Phenobarbital or rifampicin: may reduce therapeutic effect by inducing metabolism. - Ritonavir (HIV protease inhibitor): can raise exposure and risk of adverse events.

Moderate Interactions (Monitor Closely): - Selective serotonin reuptake inhibitors: may heighten neuropsychiatric risk. - β2‑agonists: additive bronchodilator effect may require dose adjustment. - Non‑steroidal anti‑inflammatory drugs: possible increase in rash or hypersensitivity reactions.

Frequently asked questions

What conditions is Montelukast Sun Pharma Italia Srl used for?+
Montelukast Sun Pharma Italia Srl is prescribed to manage persistent asthma, prevent exercise‑induced bronchoconstriction, and relieve symptoms of allergic rhinitis such as nasal congestion, sneezing and itching. It works by targeting leukotriene pathways that contribute to airway inflammation and narrowing.
How does Montelukast work in the body?+
Montelukast blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotrienes D4, C4 and E4 from binding. This inhibition reduces bronchoconstriction, vascular leakage and inflammatory cell recruitment in the airways, leading to improved breathing and reduced allergic symptoms.
What is the usual dose of Montelukast Sun Pharma Italia Srl?+
The appropriate dose of Montelukast is determined by the prescribing healthcare professional based on the patient’s age, condition and clinical response. Dosage instructions are provided on the prescription label and should be followed exactly as directed.
Is Montelukast safe to use during pregnancy or breastfeeding?+
Montelukast is classified as pregnancy category B, indicating that animal studies have not shown risk but there are limited human data. It may be used during pregnancy only if the potential benefit justifies the potential risk. Limited data are available for breastfeeding; a decision should be made in consultation with a physician.
How do I order Montelukast Sun Pharma Italia Srl from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.
How does Montelukast compare with other asthma treatments?+
Montelukast belongs to the leukotriene receptor antagonist class, offering an oral alternative to inhaled corticosteroids and long‑acting β2‑agonists. It is particularly useful for patients who experience exercise‑induced bronchoconstriction or have allergic rhinitis, but it may be less potent than inhaled steroids for severe asthma control.
What are the recommended storage conditions for Montelukast Sun Pharma Italia Srl?+
Montelukast tablets should be stored at room temperature, below 25 °C, in the original blister pack or container. Protect the product from moisture, excessive heat and direct sunlight to maintain its stability and potency.
How is Montelukast administered?+
Montelukast is taken orally, usually once daily in the evening, with or without food. The tablet should be swallowed whole with a glass of water. Patients should follow the dosing schedule prescribed by their healthcare provider.
What are the most serious risks associated with Montelukast?+
Serious risks include neuropsychiatric events such as mood changes, depression or suicidal thoughts, as well as rare allergic reactions like angioedema, Stevens‑Johnson syndrome and eosinophilic granulomatosis with polyangiitis. Any sudden or severe symptoms should prompt immediate medical attention.
Who should not use Montelukast Sun Pharma Italia Srl?+
Montelukast should be avoided in individuals with known hypersensitivity to the drug or any of its excipients. Caution is advised for patients with severe hepatic impairment, and it is not recommended for use in children under the approved age for the specific indication without physician guidance.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Montelukast
Route
Oral Use
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Origin
EU

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