Europe — EMA
Monoketo (Ketotifen Hydrogen Fumarate)
GNH USA supplies Monoketo (Ketotifen), a antihistamine/mast cell stabilizer for allergic conjunctivitis and seasonal eye allergy.
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What is Ketotifen Hydrogen Fumarate?
Ketotifen, the active ingredient in Monoketo, is an antihistamine / mast cell stabilizer presented as an ophthalmic solution for ocular use. It is used to relieve eye itching, redness and swelling caused by allergic conjunctivitis and seasonal allergic eye disease in adults and children.
GNH USA supplies Monoketo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Ketotifen Hydrogen Fumarate used for?
Monoketo, an ophthalmic antihistamine and mast cell stabilizer, is indicated for allergic conditions of the eye. - Allergic conjunctivitis: reduces ocular itching, redness and tearing associated with allergic inflammation. - Seasonal allergic eye disease: alleviates symptoms triggered by pollen or seasonal allergens. - Itching of the eyes: provides rapid relief of eye itch caused by histamine release.
What are the side effects of Ketotifen Hydrogen Fumarate?
Ketotifen eye drops are generally well tolerated, but ocular preparations can cause local reactions.
Common Side Effects: - Stinging or burning sensation upon instillation - Transient blurred vision - Mild eye redness - Temporary itching or irritation - Dry eye sensation - Mild headache
Serious or Rare Side Effects: - Allergic reaction (e.g., swelling of eyelids, rash) - Corneal ulcer or epithelial defect - Severe eye pain or photophobia - Vision loss or significant visual disturbance - Persistent intraocular inflammation
What precautions apply to Ketotifen Hydrogen Fumarate?
When using Monoketo, consider the following safety measures. - Allergy assessment: avoid if known hypersensitivity to ketotifen or any excipients. - Contact lens use: discontinue lenses before and after instillation unless advised by an eye‑care professional. - Persistent symptoms: seek medical advice if irritation continues beyond 7 days. - Contamination risk: keep the dropper tip clean and avoid touching it to any surface. - Storage: Store at room temperature: keep in the original container, protect from light and moisture.
What does Ketotifen Hydrogen Fumarate interact with?
Ketotifen eye drops may interact with other medications affecting ocular or systemic histamine pathways.
Major Interactions (Avoid): - Systemic antihistamines or mast cell stabilizers: may increase cumulative antihistaminic effect. - MAO inhibitors: potential for enhanced central antihistamine activity.
Moderate Interactions (Monitor Closely): - Topical ocular corticosteroids: monitor intra‑ocular pressure when used together. - Alcohol or sedatives: may exacerbate ocular dryness. - Other ophthalmic solutions (e.g., mydriatics): stagger administration to prevent dilution or reduced efficacy.



