Europe — EMA
Oftallen (Ketotifen Hydrogen Fumarate)
GNH USA supplies Oftallen (Ketotifen Hydrogen Fumarate), a mast cell stabilizer for allergic conjunctivitis. Request a quote for global supply.
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What is Ketotifen Hydrogen Fumarate?
Ketotifen Hydrogen Fumarate, the active ingredient in Oftallen, is a mast cell stabilizer presented as a tablet for oral use. It is used to manage allergic eye conditions such as seasonal allergic conjunctivitis in adults and children. GNH USA supplies Oftallen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Oftallen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Ketotifen Hydrogen Fumarate used for?
Ketotifen Hydrogen Fumarate is a mast‑cell stabilizer that acts on allergic pathways in the eye.
- Seasonal allergic conjunctivitis: reduces itching, redness and watery discharge. - Vernal keratoconjunctivitis: helps control chronic inflammation and photophobia. - Atopic keratoconjunctivitis: alleviates discomfort and prevents flare‑ups.
What are the side effects of Ketotifen Hydrogen Fumarate?
Side effects are generally mild and related to local ocular exposure.
Common Side Effects: - Transient stinging or burning sensation. - Temporary blurred vision. - Mild ocular irritation. - Slight headache. - Dry eye sensation.
Serious or Rare Side Effects: - Persistent eye irritation or inflammation. - Allergic contact dermatitis around the eye. - Vision changes not resolving within 24 hours. - Severe headache or neurological symptoms. - Systemic hypersensitivity reactions.
What precautions apply to Ketotifen Hydrogen Fumarate?
Patients should be aware of specific safety considerations when using Oftallen.
- Avoid contact with lenses: remove contact lenses before application and wait before reinserting. - Concomitant eye medications: inform the clinician of any other ocular drops being used. - Pregnancy and lactation: discuss with a healthcare professional before use. - Pediatric use: dosage and safety in children under 2 years have not been established. - Storage: Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Ketotifen Hydrogen Fumarate interact with?
Oftallen may interact with other ophthalmic agents, requiring monitoring.
Major Interactions (Avoid): - Concurrent use with other mast‑cell stabilizers may increase local irritation.
Moderate Interactions (Monitor Closely): - Combination with non‑steroidal anti‑inflammatory eye drops can heighten risk of corneal toxicity. - Use with topical antihistamines may amplify sedative effects if systemic absorption occurs. - Interaction with systemic antihistamines may alter overall antihistaminic load. - Caution with preservative‑containing drops, as cumulative preservative exposure can irritate the ocular surface.



