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

Ketofall

Active Ingredient:
Ketotifen Hydrogen Fumarate
Origin:
EU

Ketofall (Ketotifen Hydrogen Fumarate)

Ketotifen hydrogen fumarate, the active ingredient in Ketofall, is an antihistamine (mast cell stabilizer) presented as an ophthalmic solution for ocular use. It treats allergic eye conditions such as allergic conjunctivitis, seasonal allergic eye disease, and associated itching and redness in patients of all ages.

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

Manufacturer / TM Owner

Pharma Stulln Gmbh

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Indications & Clinical Uses

  • Ketofall, an antihistamine eye drop, is used to manage allergic eye disease by stabilizing mast cells and blocking histamine.
  • Allergic conjunctivitis: reduces itching, redness and tearing caused by allergic inflammation.
  • Seasonal allergic eye disease: alleviates symptoms triggered by pollen or seasonal allergens.
  • Eye itching and redness due to allergy: provides rapid relief of discomfort and visual disturbance.

How It Works

  • Ketotifen hydrogen fumarate acts by stabilizing mast cells, preventing the release of inflammatory mediators such as histamine, leukotrienes and prostaglandins. It also competitively blocks histamine H1 receptors on ocular tissues, thereby diminishing the vascular and neural responses that produce itching, redness and swelling in allergic eye disease.

Side Effects

Ketofall may cause ocular and systemic reactions, most of which are mild and transient.

Common Side Effects

  • Stinging or burning sensation on instillation.
  • Temporary blurred vision.
  • Mild eye irritation or foreign‑body sensation.
  • Transient redness of the conjunctiva.
  • Headache.
  • Dryness of the ocular surface.

Serious or Rare Side Effects

  • Severe allergic reaction (angio‑edema, anaphylaxis).
  • Persistent eye pain or swelling.
  • Vision loss or sudden decrease in visual acuity.
  • Corneal ulcer or keratitis.
  • Persistent photophobia.
  • Intra‑ocular pressure elevation.

Precautions & Warnings

  • Before using Ketofall, consider the following safety measures.
  • Assess hypersensitivity: confirm no known allergy to ketotifen or related antihistamines.
  • Evaluate ocular infection: avoid use if active bacterial, viral or fungal eye infection is present.
  • Monitor contact lens wearers: advise removal of lenses before instillation and for a short period after.
  • Pregnancy and lactation: use only if the prescriber deems benefits outweigh potential risks.
  • Avoid driving or operating machinery if transient visual blur occurs.
  • Store at room temperature: keep in the original container, protect from light and moisture.

Avoid Interactions

Ketofall may interact with other agents that affect ocular or systemic histamine pathways.

Major Interactions (Avoid)

  • Systemic antihistamines (e.g., diphenhydramine): may increase cumulative antihistaminic effect.
  • MAO inhibitors: potential for enhanced central nervous system sedation.
  • Other mast cell stabilizers: additive ocular irritation.

Moderate Interactions (Monitor Closely)

  • Topical ophthalmic non‑steroidal anti‑inflammatory drugs (NSAIDs): monitor for increased irritation.
  • Preservative‑containing eye drops: assess for cumulative preservative toxicity.
  • Contact lens solutions with high acidity or preservatives: may exacerbate discomfort.

Frequently Asked Questions

Ketofall is an ophthalmic solution containing ketotifen hydrogen fumarate and is indicated for the treatment of allergic conjunctivitis, seasonal allergic eye disease, and eye itching or redness caused by allergic reactions. It helps relieve discomfort and reduces inflammation in the eyes.

Ketotifen hydrogen fumarate stabilizes mast cells, preventing the release of histamine and other inflammatory mediators. It also blocks histamine H1 receptors on ocular tissues, which together reduce itching, redness, swelling, and tear production associated with allergic eye conditions.

The dosing regimen for Ketofall is determined by the prescribing clinician based on the severity of the allergic eye condition and patient factors. Typically, one to two drops are instilled in the affected eye(s) as directed by the healthcare professional.

Safety data for ketotifen hydrogen fumarate in pregnancy and lactation are limited. It should only be used if the prescriber judges that the potential benefit outweighs any possible risk to the fetus or infant. Consultation with a healthcare provider is essential.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Ketofall. 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.

Ketofall combines antihistamine activity with mast‑cell stabilization, offering both immediate symptom relief and longer‑term reduction of allergic inflammation. Compared with pure H1‑blocking eye drops, ketotifen may provide more sustained control of allergic eye disease, though individual response can vary.

Ketofall should be stored at room temperature, below 25 °C, in its original container. Protect the bottle from direct light and moisture, and keep it out of reach of children. Do not freeze the solution.

Ketofall is applied as an ophthalmic solution. The patient should wash hands, tilt the head back, pull down the lower eyelid, and instill the prescribed number of drops into the conjunctival sac. Close the eye gently and avoid blinking excessively for a few seconds.

Serious adverse reactions, although rare, include severe allergic responses such as anaphylaxis, persistent eye pain, sudden loss of vision, corneal ulceration, and significant intra‑ocular pressure increase. Any of these symptoms require immediate medical attention.

Ketofall should be avoided in individuals with a known hypersensitivity to ketotifen, other antihistamines, or any component of the formulation. It is also contraindicated in eyes with active infection until the infection is resolved, and in patients where the prescriber determines the risks outweigh benefits.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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