Product image of Montelukast Stada (Montelukast) supplied by GNH India

Montelukast Stada

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Stada (Montelukast)

Montelukast, the active ingredient in Montelukast Stada, is a leukotriene receptor antagonist presented as an oral tablet for oral use. It is used to manage asthma, allergic rhinitis, and exercise‑induced bronchoconstriction in adults and children as part of maintenance therapy. It is indicated for long‑term control of symptoms and reduction of exacerbations, and may be prescribed for patients with intermittent or persistent disease patterns.

GNH India supplies Montelukast Stada as a licensed, GDP‑compliant international pharmaceutical supplier, providing regulated, quality‑assured batches to hospitals, pharmacies, and clinics worldwide, with support for import documentation and logistics across multiple markets.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

  • Montelukast is a leukotriene receptor antagonist used in the management of respiratory and allergic conditions.
  • Asthma: Provides maintenance therapy that improves symptom control, decreases nighttime awakenings, and significantly reduces the need for rescue inhalers in patients with persistent asthma.
  • Allergic rhinitis: Alleviates nasal congestion, rhinorrhea, sneezing and itchy eyes in seasonal or perennial allergic rhinitis, supporting better daily functioning.
  • Exercise‑induced bronchoconstriction: Prevents airway narrowing that occurs during or after vigorous physical activity, allowing patients to exercise with fewer respiratory symptoms.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor type 1 (CysLT1) on airway smooth‑muscle cells, sub‑mucosal glands and inflammatory cells. By antagonizing CysLT1, it prevents leukotriene‑D4, -E4 and related mediators from binding, thereby inhibiting bronchoconstriction, mucus secretion, vascular permeability and eosinophilic inflammation that contribute to asthma and allergic rhinitis. The blockade is competitive and reversible, leading to sustained reduction of airway hyper‑responsiveness over the dosing interval.

Side Effects

Montelukast is generally well tolerated, but a range of adverse reactions have been reported.

Common Side Effects

  • Headache: mild to moderate head pain.
  • Upper respiratory tract infection: symptoms of cold or flu.
  • Abdominal pain: discomfort in the stomach area.
  • Diarrhea: loose stools.
  • Cough: occasional dry cough.
  • Rash: mild skin irritation.

Serious or Rare Side Effects

  • Allergic reactions (angioedema, anaphylaxis): swelling of face, throat or severe hypersensitivity.
  • Mood changes (depression, suicidal thoughts): new or worsening mental health symptoms.
  • Hepatotoxicity (elevated liver enzymes): signs of liver injury.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis: severe skin blistering.
  • Churg‑Strauss syndrome (eosinophilic granulomatosis with polyangiitis): systemic vasculitis with eosinophilia.

Precautions & Warnings

When prescribing Montelukast, clinicians should consider several precautionary measures to ensure safe use.

  • Assess asthma control: confirm patient is on appropriate inhaled therapy before adding Montelukast.
  • Monitor for neuropsychiatric events: watch for depression, agitation or suicidal ideation.
  • Evaluate liver function: consider baseline tests in patients with hepatic disease.
  • Use in pediatric patients: follow age‑specific safety data and dosing recommendations.
  • Avoid in patients with known hypersensitivity to Montelukast or any tablet excipients.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and keep in original packaging.

Avoid Interactions

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

Major Interactions (Avoid)

  • Phenobarbital, carbamazepine, phenytoin: enzyme inducers that can reduce Montelukast plasma levels.
  • Ritonavir: strong CYP3A4 inhibitor that may increase Montelukast exposure.

Moderate Interactions (Monitor Closely)

  • Warfarin: potential alteration of anticoagulant effect; monitor INR.
  • Fluconazole: moderate CYP3A4 inhibition may raise Montelukast levels.
  • Antidepressants (e.g., fluoxetine): possible additive neuropsychiatric effects.
  • Theophylline: may increase risk of side effects; monitor levels.

Frequently Asked Questions

Montelukast Stada is indicated for the long‑term management of asthma, for relief of symptoms of allergic rhinitis, and for prevention of exercise‑induced bronchoconstriction. It is prescribed as part of a maintenance regimen to improve control of airway inflammation and reduce the frequency of exacerbations in both adult and pediatric patients.

Montelukast selectively blocks the cysteinyl leukotriene receptor type 1 (CysLT1) on airway smooth‑muscle cells and inflammatory cells. By preventing leukotrienes such as LTC4, LTD4 and LTE4 from binding, it inhibits bronchoconstriction, mucus secretion, vascular leakage and eosinophilic inflammation that contribute to asthma and allergic symptoms.

The dosage of Montelukast Stada is determined by the prescribing clinician based on the patient’s age, weight, indication and overall treatment plan. The prescriber selects the appropriate strength and administration schedule in accordance with local labeling and clinical guidelines; patients should follow the exact instructions provided on the prescription label.

Safety data for Montelukast in pregnancy are limited, and the product is classified as pregnancy category unknown. It should only be used if the potential benefit justifies any potential risk to the fetus. Regarding lactation, small amounts may be excreted in breast milk; a healthcare professional should evaluate the risk‑benefit before continuing therapy while nursing.

To place an order, visit the product page on gnhindia.com, submit an enquiry with the required quantity, and provide institutional or trade credentials. GNH India works with hospitals, pharmacies and procurement teams worldwide, confirming eligibility, then replies with pricing, availability, shipping terms (including any required temperature control) and assistance with import documentation.

Montelukast belongs to the leukotriene receptor antagonist class, offering an oral alternative to inhaled corticosteroids or long‑acting β‑agonists. It is particularly useful for patients with aspirin‑exacerbated respiratory disease or those who prefer a tablet form. While it provides modest improvement in lung function, it is generally less potent than inhaled steroids for severe asthma, and is often used as add‑on therapy.

Montelukast Stada tablets should be stored at ambient temperature, preferably below 25 °C (77 °F). Keep the product in its original container, protect it from moisture, heat and direct sunlight. Do not refrigerate or freeze the tablets, and ensure they are kept out of reach of children.

Montelukast Stada is taken orally, usually once daily in the evening with or without food, as directed by the prescriber. The tablet should be swallowed whole with a glass of water; it should not be chewed, crushed or split unless the specific formulation permits. Consistent timing helps maintain steady drug levels.

Serious adverse events, although rare, include severe allergic reactions such as angioedema or anaphylaxis, neuropsychiatric effects like depression or suicidal thoughts, and rare skin disorders such as Stevens‑Johnson syndrome. Clinicians should monitor patients for any new or worsening mood changes, hypersensitivity signs, or severe skin eruptions, and discontinue the drug promptly if such events occur.

Montelukast Stada is contraindicated in individuals with known hypersensitivity to montelukast sodium or any of the tablet excipients. It should also be avoided in patients who have experienced severe allergic reactions to leukotriene‑modifying agents. Caution is advised in patients with active liver disease, uncontrolled psychiatric conditions, or those taking interacting enzyme‑inducing medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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