Europe — EMA
Ketotifeno Dermogen (Ketotifen Hydrogen Fumarate)
GNH USA supplies Ketotifeno Dermogen (Ketotifen), a antihistamine (mast cell stabilizer) for allergic conjunctivitis and ocular itching.
Request sourcing
What is Ketotifen Hydrogen Fumarate?
Ketotifen Hydrogen Fumarate, the active ingredient in Ketotifeno Dermogen, is an antihistamine (mast cell stabilizer) presented as an ophthalmic solution for ocular use. It is indicated for the relief of allergic conjunctivitis symptoms such as itching, redness, and tearing in adults and children. The formulation is designed for topical administration directly onto the eye surface, providing rapid symptom control.
GNH USA supplies Ketotifeno Dermogen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance, and reliable logistics for global healthcare providers.
What is Ketotifen Hydrogen Fumarate used for?
Ketotifeno Dermogen, an ocular antihistamine, is used to manage allergic eye conditions.
- Allergic conjunctivitis: reduces itching, redness, and tearing caused by allergic inflammation of the conjunctiva. - Seasonal allergic conjunctivitis: provides symptom relief during pollen or allergen seasons. - Ocular itching due to allergy: alleviates persistent eye itch associated with environmental allergens.
What are the side effects of Ketotifen Hydrogen Fumarate?
Ketotifeno Dermogen may cause local or systemic adverse reactions.
Common Side Effects: - Transient eye irritation or burning sensation. - Blurred vision shortly after instillation. - Mild headache or ocular dryness.
Serious or Rare Side Effects: - Severe allergic reaction (e.g., angio‑edema, anaphylaxis). - Persistent eye pain, swelling, or vision loss. - Corneal ulceration or infection requiring medical attention.
What precautions apply to Ketotifen Hydrogen Fumarate?
Before using Ketotifeno Dermogen, consider the following safety measures.
- Hypersensitivity: discontinue if signs of allergy to ketotifen or excipients appear. - Infected eyes: avoid use without physician guidance to prevent worsening infection. - Contact lens wearers: remove lenses before instillation and wait before reinserting. - Pregnancy and breastfeeding: safety not established; use only if clearly needed. - Concurrent ocular medications: administer at least 5 minutes apart to avoid dilution. - Store at room temperature: keep in the original container, protect from light and moisture.
What does Ketotifen Hydrogen Fumarate interact with?
Ketotifeno Dermogen may interact with other ocular or systemic agents.
Major Interactions (Avoid): - Use with ocular anesthetics containing preservatives that can increase irritation. - Concurrent systemic antihistamines that may cause additive sedation (monitor if systemic effects are noted).
Moderate Interactions (Monitor Closely): - Topical corticosteroids: may mask infection signs; monitor ocular health. - Other mast‑cell stabilizers: additive effect on ocular tissues; observe for excessive dryness. - Contact lens solutions with preservatives: may increase irritation when used together.



