Product image of Ketotifen Stada (Ketotifen Hydrogen Fumarate) supplied by GNH India

Ketotifen Stada

Active Ingredient:
Ketotifen Hydrogen Fumarate
Origin:
EU

Ketotifen Stada (Ketotifen Hydrogen Fumarate)

Ketotifen, the active ingredient in Ketotifen Stada, is an antihistamine (H1 receptor antagonist) presented as an oral tablet for oral use. It is used to treat allergic conditions such as allergic rhinitis, allergic conjunctivitis, and to prevent bronchial asthma attacks.

GNH India supplies Ketotifen Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Stadapharm Gmbh

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Indications & Clinical Uses

  • Ketotifen is an antihistamine that acts on allergic pathways to relieve symptoms.
  • Allergic rhinitis: reduces nasal congestion, itching and sneezing.
  • Allergic conjunctivitis: alleviates eye itching, redness and tearing.
  • Bronchial asthma (prophylaxis): helps prevent bronchospasm and asthma attacks.

How It Works

  • Ketotifen stabilizes mast cells and selectively blocks H1‑histamine receptors. By inhibiting mast‑cell degranulation, it prevents the release of histamine and other inflammatory mediators, reducing the cascade of allergic inflammation. Its H1 antagonism further diminishes the physiological response to any histamine that is released, providing relief from allergic symptoms and contributing to asthma prophylaxis.

Side Effects

Ketotifen may cause adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Drowsiness: mild sedation or sleepiness.
  • Dry mouth: reduced salivation.
  • Headache: transient cranial pain.
  • Nausea: mild gastrointestinal upset.
  • Weight gain: modest increase in body weight.

Serious or Rare Side Effects

  • Severe allergic reaction: anaphylaxis or angioedema.
  • Cardiac arrhythmia: irregular heart rhythm.
  • Hepatotoxicity: liver enzyme elevation.
  • Blood dyscrasias: rare blood cell abnormalities.

Precautions & Warnings

  • When using Ketotifen, consider the following precautions.
  • Pregnancy: consult a healthcare provider before use.
  • Breastfeeding: assess risk versus benefit with a physician.
  • Driving: avoid operating machinery if drowsiness occurs.
  • Drug interactions: review concomitant medications for potential interactions.
  • Elderly: monitor for increased sensitivity to sedative effects.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original packaging.

Avoid Interactions

Ketotifen can interact with other medicines; awareness of the interaction level is important.

Major Interactions (Avoid)

  • MAO inhibitors: risk of hypertensive crisis.
  • CNS depressants: additive sedation.
  • Anticholinergic drugs: increased dry mouth.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors: may increase ketotifen plasma levels.
  • CYP3A4 inducers: may reduce ketotifen efficacy.
  • Other antihistamines: potential additive antihistaminic effects.

Frequently Asked Questions

Ketotifen Stada is used to manage allergic rhinitis, allergic conjunctivitis, and to provide prophylactic treatment for bronchial asthma. It helps relieve nasal and ocular allergy symptoms and reduces the frequency of asthma attacks by stabilizing mast cells and blocking histamine receptors.

Ketotifen works by stabilizing mast cells, preventing them from releasing histamine and other inflammatory mediators. It also selectively blocks H1‑histamine receptors, which reduces the body’s response to any histamine that is present, thereby alleviating allergic symptoms and supporting asthma prevention.

The appropriate dose of Ketotifen Stada is determined by a qualified prescriber based on the patient’s age, condition severity, and response to therapy. Dosage instructions are provided on the prescription label and should be followed exactly as directed by the healthcare professional.

Safety of Ketotifen Stada in pregnancy or while breastfeeding has not been definitively established. Women who are pregnant, planning to become pregnant, or nursing should discuss potential risks and benefits with their healthcare provider before using this medication.

To order Ketotifen Stada, 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.

Ketotifen combines mast‑cell stabilization with H1‑receptor antagonism, offering both preventive and symptomatic relief. Unlike many first‑generation antihistamines, it has a longer duration of action and is also used for asthma prophylaxis, making it a versatile option for patients with both allergic and asthmatic conditions.

Ketotifen Stada should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in their original container, protect them from moisture and direct light, and ensure the packaging remains tightly closed to maintain product stability.

Ketotifen Stada is taken orally, usually with a glass of water. The tablet should be swallowed whole and not chewed or crushed unless otherwise directed by a healthcare professional. Follow the prescribing information for timing relative to meals.

Serious risks, though rare, include severe allergic reactions such as anaphylaxis, cardiac arrhythmias, and significant liver enzyme elevations. Patients should seek immediate medical attention if they experience symptoms like difficulty breathing, swelling of the face or throat, irregular heartbeat, or jaundice.

Ketotifen Stada should be avoided in individuals with known hypersensitivity to ketotifen or any of its excipients. Caution is also advised for patients with severe liver impairment, uncontrolled cardiac conditions, or those taking medications that may cause dangerous interactions, unless supervised by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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