Europe — EMA
Ketotifeno Farmalider (Ketotifen Hydrogen Fumarate)
GNH USA supplies Ketotifeno Farmalider (Ketotifen), a antihistamine and mast cell stabilizer for allergic conjunctivitis and ocular itching.
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What is Ketotifen Hydrogen Fumarate?
Ketotifen hydrogen fumarate, the active ingredient in Ketotifeno Farmalider, is an antihistamine and mast cell stabilizer presented as an ophthalmic solution for ocular use. It relieves symptoms of allergic conjunctivitis such as itching, redness and swelling in patients with seasonal or perennial eye allergies.
GNH USA supplies Ketotifeno Farmalider as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Ketotifen Hydrogen Fumarate used for?
Ketotifeno Farmalider is used to manage ocular allergic conditions by targeting histamine‑mediated inflammation.
Allergic conjunctivitis: reduces itching, redness and swelling of the eye. Ocular itching due to allergy: provides rapid relief of itch sensation. Redness from eye allergy: diminishes vascular congestion and visible redness.
What are the side effects of Ketotifen Hydrogen Fumarate?
Ketotifeno Farmalider may cause local ocular reactions and, rarely, systemic effects.
Common Side Effects: - Transient burning or stinging sensation after instillation. - Mild blurred vision lasting a few minutes. - Dry eye or foreign‑body feeling. - Mild headache. - Temporary increased tearing.
Serious or Rare Side Effects: - Severe allergic reaction (e.g., angio‑edema of the eyelid). - Persistent eye irritation or corneal ulceration. - Vision loss. - Significant intra‑ocular pressure rise. - Systemic hypersensitivity (rash, urticaria).
What precautions apply to Ketotifen Hydrogen Fumarate?
Before using Ketotifeno Farmalider, consider the following precautions.
Avoid use in patients with known hypersensitivity to ketotifen or any excipients. Do not apply to infected or inflamed eyes without medical advice. Monitor for worsening ocular symptoms; discontinue if severe irritation occurs. Use with caution in patients taking other ocular antihistamines or steroids. Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.
What does Ketotifen Hydrogen Fumarate interact with?
Ketotifeno Farmalider may interact with other medications affecting ocular or systemic histamine pathways.
Major Interactions (Avoid): - Concurrent use of systemic antihistamines that cause additive sedation. - Co‑administration with ocular vasoconstrictors that may increase intra‑ocular pressure.
Moderate Interactions (Monitor Closely): - Use with other mast cell stabilisers may enhance local effects. - Systemic MAO inhibitors may potentiate antihistaminic activity. - Topical corticosteroids may mask signs of infection when used together.
