Product image of Montelukast Sodium Sandoz (Montelukast) supplied by GNH India

Montelukast Sodium Sandoz

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Sodium Sandoz (Montelukast)

Montelukast, the active ingredient in Montelukast Sodium Sandoz, is a leukotriene receptor antagonist presented as an oral tablet for systemic use. It is used to manage chronic asthma and allergic rhinitis in adults and children as part of a maintenance therapy regimen.

GNH India supplies Montelukast Sodium Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable global distribution.

Manufacturer / TM Owner

Sandoz Ltd

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Indications & Clinical Uses

Montelukast is indicated for conditions involving leukotriene‑mediated inflammation, primarily within the respiratory tract.

  • Asthma: Improves long‑term control and reduces the frequency of asthma attacks when used as maintenance therapy.
  • Allergic rhinitis: Relieves nasal congestion, sneezing and itching associated with seasonal or perennial allergic rhinitis.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth muscle, mucosal cells and inflammatory cells. By antagonising this receptor, it prevents leukotriene D4, E4 and related cysteinyl leukotrienes from binding, thereby reducing bronchoconstriction, mucus secretion, vascular permeability and eosinophilic inflammation that contribute to asthma and allergic rhinitis symptoms.

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.

Serious or Rare Side Effects

  • Allergic reactions: rash, angioedema, or anaphylaxis.
  • Neuropsychiatric events: mood changes, depression, or suicidal thoughts.
  • Hepatic enzyme elevation: abnormal liver function tests.

Precautions & Warnings

Before initiating therapy, consider the following safety measures.

  • Neuropsychiatric monitoring: Observe patients for mood changes or suicidal ideation.
  • Hepatic function: Use cautiously in patients with liver impairment and monitor liver enzymes.
  • Hypersensitivity: Avoid in individuals with known allergy to montelukast or any excipients.
  • Pregnancy counseling: Discuss potential risks with pregnant or planning‑to‑be‑pregnant patients.
  • Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Montelukast may interact with other medicines; review patient medication lists.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase montelukast plasma levels.
  • Rifampin: induces metabolism, potentially reducing efficacy.
  • Phenobarbital: enzyme inducer that can lower drug exposure.

Moderate Interactions (Monitor Closely)

  • Antidepressants: may augment neuropsychiatric side‑effects.
  • NSAIDs: concurrent use may increase risk of gastrointestinal discomfort.

Frequently Asked Questions

Montelukast Sodium Sandoz is used as a maintenance therapy for chronic asthma and to relieve symptoms of allergic rhinitis, such as nasal congestion, sneezing and itching. It helps reduce the frequency of asthma attacks and improves overall respiratory control when taken regularly as prescribed.

Montelukast works by selectively blocking the cysteinyl leukotriene receptor CysLT1. This inhibition prevents leukotrienes D4, E4 and related molecules from triggering bronchoconstriction, mucus production and inflammation in the airways, thereby improving breathing and reducing allergic nasal symptoms.

The appropriate dose of Montelukast is determined by the prescribing healthcare professional based on the patient’s age, condition and response to therapy. Patients should follow the exact dosing instructions provided by their prescriber and not adjust the dose on their own.

Safety data for Montelukast during pregnancy and lactation are limited, and the pregnancy category is not definitively established. Women who are pregnant, planning pregnancy, or breastfeeding should discuss potential risks and benefits with their healthcare provider before using the medication.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The sales team then responds with pricing, availability, shipping details and any necessary import documentation.

Montelukast and inhaled corticosteroids target different pathways. Montelukast blocks leukotriene receptors, while inhaled corticosteroids reduce broad airway inflammation. Montelukast is often used as an add‑on therapy or alternative for patients who cannot tolerate steroids, but it is not a substitute for inhaled corticosteroids in severe asthma where steroids remain first‑line.

Montelukast tablets should be stored at room temperature, below 25 °C, in the original packaging to protect them from moisture and direct sunlight. Keep the product out of reach of children and do not use if the packaging is damaged or the tablets appear discoloured.

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 specific timing and administration instructions given by their prescriber.

Serious risks include allergic reactions such as rash, angioedema or anaphylaxis, and neuropsychiatric events like depression, mood swings, or suicidal thoughts. Patients should seek immediate medical attention if they experience any signs of severe allergic response or significant changes in mood or behavior.

Montelukast should not be used by individuals with a known hypersensitivity to montelukast or any of its excipients. Caution is advised for patients with severe liver impairment, and it is generally avoided in patients who have experienced serious neuropsychiatric reactions to the drug.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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