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

Montelukast Aristo

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Aristo (Montelukast)

Montelukast, the active ingredient in Montelukast Aristo, is a leukotriene receptor antagonist presented as an oral tablet for oral use. It is prescribed to manage asthma, allergic rhinitis, and exercise‑induced bronchoconstriction in adults and children as directed by a healthcare professional and is used under prescription in the European Union market.

GNH India supplies Montelukast Aristo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable sourcing for regulated markets.

Manufacturer / TM Owner

Aristo Pharma Gmbh (Art 57)

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Indications & Clinical Uses

  • Montelukast is a leukotriene receptor antagonist used to treat conditions involving airway inflammation and allergic symptoms.
  • Asthma: helps decrease airway inflammation and bronchoconstriction, leading to fewer symptoms such as wheezing, coughing and shortness of breath, and reduces the need for rescue inhaler use.
  • Allergic rhinitis: reduces nasal congestion, sneezing, itching and rhinorrhea by blocking leukotriene‑mediated inflammation in the nasal passages, and improves overall nasal airflow.
  • Exercise‑induced bronchoconstriction: prevents the narrowing of airways that can occur during or after physical exertion, improving exercise tolerance, and supports consistent participation in sports or physical activities.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor type 1 (CysLT1) on airway smooth‑muscle cells, inflammatory cells and vascular endothelium. By antagonizing CysLT1, it prevents leukotriene‑D4 and related mediators from binding, thereby inhibiting leukotriene‑induced bronchoconstriction, mucus secretion, vascular permeability and eosinophilic inflammation in the respiratory tract. This action results in a reduction of airway hyper‑responsiveness and improves symptom control over time, and contributes to decreased frequency of asthma exacerbations.

Side Effects

Montelukast may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Headache: mild to moderate head pain that may be intermittent.
  • Abdominal pain: discomfort or cramping in the stomach region.
  • Cough: occasional dry cough without mucus production.
  • Nausea: feeling of queasiness that may precede vomiting.
  • Dizziness: light‑headed sensation, especially when standing quickly.
  • Fatigue: unusual tiredness or lack of energy.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, swelling of face or throat, potentially leading to anaphylaxis.
  • Mood changes: new or worsening depression, anxiety, or thoughts of self‑harm.
  • Liver enzyme elevation: increased ALT/AST indicating possible hepatic injury.
  • Eosinophilic granulomatosis with polyangiitis: rare systemic vasculitis presenting with asthma worsening and eosinophilia.

Precautions & Warnings

Precautions should be observed when prescribing Montelukast.

  • Pregnancy: consult a healthcare provider; safety not established.
  • Breastfeeding: weigh potential benefits against possible risks.
  • Pediatric use: dosage determined by age/weight; monitor for behavioral changes.
  • Elderly: start at lowest effective dose and monitor for adverse effects.
  • Drug interactions: review concomitant medications for potential interactions.
  • Renal impairment: use with caution; monitor renal function.
  • Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture and light.

Avoid Interactions

Montelukast can interact with other medicines, affecting its concentration or therapeutic effect.

Major Interactions (Avoid)

  • Ritonavir: strong CYP3A4 inhibition can raise montelukast levels, increasing risk of adverse effects.
  • Phenobarbital: enzyme induction may lower montelukast exposure, reducing efficacy.
  • Carbamazepine: potent inducer of hepatic enzymes that can markedly decrease montelukast concentrations.

Moderate Interactions (Monitor Closely)

  • Fluconazole: moderate CYP3A4 inhibition may modestly increase montelukast levels; monitor for side effects.
  • Warfarin: possible alteration of anticoagulant effect; check INR regularly when co‑administered.

Frequently Asked Questions

Montelukast Aristo contains the active ingredient montelukast, which is prescribed to manage chronic asthma, relieve symptoms of allergic rhinitis such as nasal congestion and sneezing, and prevent exercise‑induced bronchoconstriction that can limit physical activity.

Montelukast works by selectively blocking the cysteinyl leukotriene receptor type 1 (CysLT1). This prevents leukotrienes from binding to airway cells, thereby reducing bronchoconstriction, mucus production, vascular leakage and eosinophilic inflammation that contribute to asthma and allergic symptoms.

The appropriate dose of Montelukast Aristo is determined by a qualified prescriber based on the patient’s age, weight, clinical condition and response to therapy. Dosing recommendations are provided in the prescribing information and should not be altered without medical guidance.

Safety of montelukast in pregnancy has not been definitively established, and the drug is generally prescribed only if the potential benefit justifies any potential risk. While limited data exist for breastfeeding, it is advisable to discuss risks and benefits with a healthcare professional before use.

To order Montelukast Aristo, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Montelukast belongs to the leukotriene receptor antagonist class, offering an oral alternative to inhaled corticosteroids or long‑acting beta‑agonists for asthma control. Compared with other leukotriene antagonists such as zafirlukast, montelukast has a once‑daily dosing schedule and a similar efficacy profile, but individual response may vary.

Montelukast Aristo tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct sunlight, and ensure the packaging remains tightly closed until use.

Montelukast Aristo is taken orally, usually as a tablet swallowed whole with water. It can be taken with or without food, and the dose is typically administered once daily at the same time each day as directed by the prescriber.

Serious adverse reactions include allergic responses such as rash, swelling or anaphylaxis, mood changes including depression or suicidal thoughts, liver enzyme elevations indicating possible hepatic injury, and the rare occurrence of eosinophilic granulomatosis with polyangiitis. Patients should seek immediate medical attention if any of these symptoms develop.

Montelukast should not be used by individuals with a known hypersensitivity to montelukast or any of the tablet’s excipients. Caution is also advised for patients with severe hepatic impairment, and it is generally avoided in those with a history of serious psychiatric events unless closely monitored.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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