Ketotifen is a relatively selective, non-competitive histamine antagonist (H1 receptor) and mast cell stabilizer. Ketotifen inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils have also been demonstrated.
Stafen Sterile Eye Drops: Each ml contains Ketotifen Fumarate BP equivalent to Ketotifen 0.25 mg.
Preservative: Benzalkonium Chloride
Stafen is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.
1 drop in the affected eye (s) every 8-12 hours.
Stafen is contraindicated in-patients with known hypersensitivity to any component of this product.
Stafen should not be used to treat contact lens related irritation. Stafen should not be administered while wearing contact lenses. Lenses may be inserted 10 minutes following administration of Stafen.
Ocular allergic reactions, burning or stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, keratitis, lacrimation, disorder, mydriasis, photophobia, rash, headache, rhinitis may be reported.
Pregnancy: Pregnancy category C.
Nursing Mother: It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Stafen is administered to a nursing woman.
Paediatric Use: Safety & effectiveness in paediatric patients below the age of 3 years have not been established.
Stafen Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.
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