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

Ketoftil

Active Ingredient:
Ketotifen Hydrogen Fumarate
Origin:
EU

Ketoftil (Ketotifen Hydrogen Fumarate)

Ketotifen hydrogen fumarate, the active ingredient in Ketoftil, is an antihistamine (mast cell stabilizer) presented as an ophthalmic solution for ocular use. It is employed to relieve symptoms of allergic eye conditions such as conjunctivitis, seasonal allergic eye disease, and ocular itching in patients of all ages.
GNH India supplies Ketoftil as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Polifarma S.P.A

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Indications & Clinical Uses

  • Ketoftil acts on allergic ocular inflammation and provides symptomatic relief for several eye conditions.
  • Allergic conjunctivitis: reduces itching, redness and watery discharge caused by allergens.
  • Seasonal allergic eye disease: stabilises mast cells to prevent flare‑ups during pollen seasons.
  • Ocular itching: alleviates persistent itch associated with allergic reactions.

How It Works

  • Ketotifen hydrogen fumarate stabilises mast cells and blocks H1 histamine receptors on ocular tissues. By preventing degranulation, it reduces the release of inflammatory mediators such as histamine, leukotrienes and prostaglandins, thereby limiting ocular redness, swelling and itching associated with allergic reactions.

Side Effects

Ketoftil may cause local and systemic adverse reactions.

Common Side Effects

  • Stinging or burning sensation upon instillation.
  • Transient blurred vision.
  • Mild eye irritation or redness.
  • Temporary headache.
  • Dry eye sensation.
  • Mild eyelid swelling.

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis) with swelling of the face or throat.
  • Corneal ulceration or persistent epithelial defect.
  • Significant visual loss or sudden decrease in vision.
  • Persistent eye pain unresponsive to treatment.
  • Secondary ocular infection.

Precautions & Warnings

Before using Ketoftil, consider the following precautions.

  • Hypersensitivity: avoid if the patient has known allergy to ketotifen or formulation excipients.
  • Contact lens wear: discontinue use while wearing lenses and wait at least 15 minutes after instillation before reinserting.
  • Ocular infection: monitor for signs of infection; discontinue if infection develops.
  • Dry eye syndrome: use with caution in patients with severe dry eye, as irritation may worsen.
  • Store at room temperature: keep in the original container, protect from light and moisture.

Avoid Interactions

Ketoftil may interact with other ophthalmic or systemic agents.

Major Interactions (Avoid)

  • Concurrent use of multiple ocular antihistamines may increase local irritation.
  • Combination with topical corticosteroids may mask signs of infection.

Moderate Interactions (Monitor Closely)

  • Systemic antihistamines may enhance sedative effects.
  • Co‑administration with beta‑blocker eye drops may affect intra‑ocular pressure control.
  • Preservative‑containing contact lens solutions may exacerbate ocular irritation.

Frequently Asked Questions

Ketoftil is an ophthalmic solution containing ketotifen hydrogen fumarate. It is used to treat allergic eye conditions such as allergic conjunctivitis, seasonal allergic eye disease, and ocular itching by reducing inflammation and relieving symptoms like redness, swelling, and itch.

Ketotifen hydrogen fumarate works by stabilising mast cells and blocking H1 histamine receptors on the ocular surface. This dual action prevents the release of histamine and other inflammatory mediators, thereby decreasing the allergic response that causes eye irritation and itching.

The specific dosing regimen for Ketoftil is determined by the prescribing clinician. Typically, one drop is instilled in the affected eye(s) as directed, and the frequency is adjusted based on the severity of symptoms and patient response.

Safety data for ketotifen hydrogen fumarate in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To order Ketoftil, 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.

Ketoftil (ketotifen) offers both H1‑receptor blockade and mast‑cell stabilisation, whereas many alternatives such as olopatadine primarily provide H1 antagonism. This dual mechanism can give longer‑lasting relief for some patients, though individual response varies and choice should be guided by clinical judgement.

Ketoftil should be stored at room temperature, below 25 °C, in its original container. Protect the bottle from direct light and moisture. Do not freeze the solution, and keep the cap tightly closed when not in use.

Ketoftil is administered as an eye drop. The patient should wash hands, tilt the head back, pull down the lower eyelid to create a pocket, and place the prescribed number of drops into the conjunctival sac. Close the eye gently and avoid blinking excessively for a few seconds.

Serious risks, though rare, include severe allergic reactions such as anaphylaxis, corneal ulceration, persistent visual loss, and secondary ocular infections. Patients should seek immediate medical attention if they experience sudden vision changes, intense eye pain, swelling of the face or throat, or signs of infection.

Ketoftil should not be used by individuals with a known hypersensitivity to ketotifen hydrogen fumarate or any excipients in the formulation. It is also contraindicated in patients with active ocular infections until the infection is resolved, and caution is advised for contact‑lens wearers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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