Ketotifen Fumarate (Ophthalmic): Uses, Dosage, Side Effects

Generic Name
Ketotifen Fumarate (Ophthalmic)
Therapeutic Class: Ophthalmic Non-Steroid drugs

Indications:
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, blepharoconjunctivitis, and giant papillary conjunctivitis.

Presentation:
Ketotifen Eye Drops: Each ml Ketomar eye drop contains Ketotifen Fumarate BP equivalent to Ketotifen 0.25mg.

Description:
Ketotifen is a potent anti-allergic substance possessing a powerful and sustained noncompetitive 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.

Dosage & Administration:
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.

Interaction:
If Ketomar eye drops are used concomitantly with other eye medications, there must be at least 5 minutes between the two medications.

Contraindications:
Hypersensitivity to Ketotifen or any of the components

Side Effects:
Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug installation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival hemorrhage.

Pregnancy & Lactation:
There are no adequate data from the use of ketotifen eye drops in pregnant women. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women. Although animal data following oral administration show excretion into breast milk, topical administration to humans is unlikely to produce detectable quantities in breast milk. ketotifen 0.25% eye drops can be used during lactation.

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 these 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.

Overdose:
No case of overdose has been reported. Oral ingestion of a 5 ml bottle contents would be equivalent to 1.25 mg of Ketotifen, which is 60% of a recommended oral daily dose for a 3 years old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of Ketotifen.

Storage:
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 the first opening.
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