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

Ketof

Active Ingredient:
Ketotifen Hydrogen Fumarate
Origin:
EU

Ketof (Ketotifen Hydrogen Fumarate)

Ketotifen, the active ingredient in Ketof, is an antihistamine (H1 receptor antagonist) presented as an oral tablet for oral use. It is employed to manage allergic conditions such as rhinitis, conjunctivitis, and to aid in asthma prophylaxis in patients requiring mast‑cell stabilization.

GNH India supplies Ketof as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution aligned to EU regulatory standards. The product meets stringent quality specifications and is available for bulk procurement across multiple regions.

Manufacturer / TM Owner

Hexal Ag

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Indications & Clinical Uses

  • Ketotifen is used in the management of allergic disorders by targeting histamine‑mediated pathways.
  • Allergic rhinitis: relief of nasal congestion, sneezing and itching.
  • Allergic conjunctivitis: reduction of eye redness, itching and tearing.
  • Asthma prophylaxis: prevention of bronchial hyper‑responsiveness and mast‑cell mediated attacks.

How It Works

  • Ketotifen acts as a selective antagonist of histamine H1 receptors, preventing histamine from binding and triggering allergic responses. In parallel, it stabilizes mast cells, inhibiting the release of inflammatory mediators such as leukotrienes, prostaglandins and cytokines, thereby reducing tissue inflammation and bronchial hyper‑reactivity.

Side Effects

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

Common Side Effects

  • Drowsiness or somnolence.
  • Dry mouth or throat.
  • Weight gain.
  • Headache.
  • Nausea.
  • Mild gastrointestinal discomfort.

Serious or Rare Side Effects

  • Severe skin reactions, including Stevens‑Johnson syndrome.
  • Anaphylactic or anaphylactoid reactions.
  • Hepatotoxicity manifested by elevated liver enzymes.
  • Cardiac arrhythmias or palpitations.
  • Hematologic abnormalities such as neutropenia.
  • Visual disturbances or blurred vision.

Precautions & Warnings

  • Ketotifen should be used with consideration of individual health status and potential risks.
  • Pregnancy: consult a healthcare professional before use.
  • Breastfeeding: weigh potential benefits against possible infant exposure.
  • Elderly patients: monitor for increased sedation.
  • Renal or hepatic impairment: dose adjustment may be required.
  • Concomitant CNS depressants: avoid additive drowsiness.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Ketotifen can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of exaggerated antihistaminic effects.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole): may increase plasma concentrations.
  • CNS depressants (e.g., benzodiazepines): additive sedation.

Moderate Interactions (Monitor Closely):\n- Alcohol: may enhance drowsiness.

  • Anticholinergic agents: increase dry‑mouth risk.
  • Other antihistamines: potential for cumulative antihistaminic activity.

Frequently Asked Questions

Ketof contains ketotifen, which is indicated for the treatment of allergic rhinitis, allergic conjunctivitis, and as a prophylactic agent in asthma. It helps relieve nasal and ocular symptoms caused by histamine release and reduces the frequency of asthma attacks by stabilizing mast cells.

Ketotifen works by blocking histamine H1 receptors, preventing histamine from triggering allergic symptoms. At the same time, it stabilizes mast cells, limiting the release of inflammatory mediators such as leukotrienes and cytokines, which contributes to reduced airway hyper‑responsiveness and ocular irritation.

The dosage of Ketof is determined by the prescribing clinician based on the patient’s age, severity of symptoms, and overall health status. Healthcare providers set the appropriate strength and frequency to achieve optimal therapeutic effect while minimizing adverse reactions.

Safety data for ketotifen in pregnancy and lactation are limited. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare professional before starting Ketof.

To request Ketof, 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 and any necessary import documentation.

Ketof combines H1‑receptor antagonism with mast‑cell stabilization, offering both symptom relief and preventive benefits. Unlike many first‑generation antihistamines, it has a longer duration of action and is also used for asthma prophylaxis, making it a broader‑spectrum option for patients with multiple allergic manifestations.

Ketof should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in the original packaging, protect them from moisture, excessive heat and direct sunlight to maintain potency throughout the shelf life.

Ketof is supplied as oral tablets intended for swallowing with water. The medication is taken as directed by a healthcare professional, usually once or twice daily, depending on the clinical indication and individual response.

Serious adverse events, although rare, can include severe skin reactions such as Stevens‑Johnson syndrome, anaphylaxis, liver toxicity, and cardiac arrhythmias. Patients should seek immediate medical attention if they notice rash, breathing difficulty, jaundice, or irregular heartbeats.

Ketof is contraindicated in individuals with known hypersensitivity to ketotifen or any excipients in the tablet. Caution is advised for patients with severe hepatic impairment, uncontrolled asthma, or those taking medications that may cause dangerous interactions, such as MAO inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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