GNH USA

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.

Frequently asked questions

What is Oftallen used for?+
Oftallen contains ketotifen hydrogen fumarate and is indicated for the relief of symptoms associated with allergic eye conditions such as seasonal allergic conjunctivitis, vernal keratoconjunctivitis and atopic keratoconjunctivitis. It helps reduce itching, redness and watery discharge.
How does ketotifen hydrogen fumarate work?+
Ketotifen hydrogen fumarate acts as a mast‑cell stabiliser and H1‑histamine receptor antagonist. By preventing mast‑cell degranulation it limits the release of histamine and other inflammatory mediators, thereby decreasing ocular surface inflammation and allergy‑related symptoms.
What is the usual dose of Oftallen?+
The dose of Oftallen is determined by the prescribing clinician based on the patient’s age, severity of symptoms and response to therapy. The prescriber will provide specific instructions on how many drops or tablets to use and how often.
Is Oftallen safe during pregnancy or breastfeeding?+
Safety data for ketotifen hydrogen fumarate in pregnancy and lactation are limited. Women who are pregnant, planning pregnancy or breastfeeding should discuss potential risks and benefits with their healthcare provider before using Oftallen.
How do I order Oftallen from GNH USA?+
To order, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.
How does Oftallen compare with other allergic eye treatments?+
Oftallen provides both antihistamine and mast‑cell stabilising actions in a single agent, whereas many eye drops offer only antihistamine activity. This dual mechanism can give longer‑lasting symptom control compared with agents that act solely on histamine receptors.
How should Oftallen be stored and handled?+
Store the product at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. Keep out of reach of children and do not use if the seal is broken or the product appears discoloured.
How is Oftallen administered?+
Oftallen is supplied as an oral tablet that is taken by mouth with water. The prescriber will advise the appropriate dosing schedule, typically once or twice daily, and whether it should be taken with food.
What are the most serious risks associated with Oftallen?+
Serious adverse reactions are rare but may include persistent eye irritation, allergic contact dermatitis around the eye, or systemic hypersensitivity reactions. Patients should seek medical attention if symptoms worsen or do not improve within 24 hours.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ketotifen Hydrogen Fumarate
Route
Ocular Use
Manufacturer
Horus Pharma
Origin
EU

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