Product image of Montelukast Sun Pharma Italia Srl (Montelukast) supplied by GNH India

Montelukast Sun Pharma Italia Srl

Active Ingredient:
Montelukast
Origin:
EU

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

Manufacturer / TM Owner

Sun Pharmaceutical Industries Europe B.V.

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Indications & Clinical Uses

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.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1, preventing leukotrienes D4, C4 and E4 from binding. This inhibition reduces leukotriene‑mediated bronchoconstriction, vascular permeability and inflammatory cell recruitment in the respiratory tract, thereby improving airway patency and decreasing allergic inflammation.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

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.

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.

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.

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.

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 (including any cold‑chain requirements) and necessary import documentation.

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.

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.

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.

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.

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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