Generics: Ketotifen Fumarate.
Dosage Form: Opthalmic solution.
Ketotifen eye drop is indicated for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and eyelids) of allergic conjunctivitis including vernal kerato-conjunctivitis, vernal-keratitis, blepharitis, blepharo-conjunctivitis, and giant papillary conjunctivitis.
Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils.
- Adults and children 3 years and older: 1 drop in the affected eye(s) twice daily, every 8-12 hours, not more than twice per day.
- Children under 3 years of age: Consult with a doctor.
Route of administration: Intraocular.
If Ketotifen eye drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.
Hypersensitivity to Ketotifen or any of the components.
Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug instillation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival haemorrhage.
Pregnancy & Lactation:
There is insufficient information about the usage of ketotifen eye drops in pregnant women. Systemic levels are significantly lower after ocular administration than after oral treatment. Prescriptions for pregnant women should be handled with caution. Although animal research shows excretion into breast milk after oral administration, topical application to humans is unlikely to yield detectable amounts in breast milk. During lactation, ketotifen 0.25 percent eye drops can be utilized.
Precautions & Warnings:
The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.
Ophthalmic Non-Steroid drugs.
Store in a cool and dry place protected from light and moisture. Keep out of reach of children. Do not touch the dropper tip to any surface since this may contaminate the solution. Do not use after 30 days of first opening.
Manufactured by: Square Pharmaceuticals Ltd.