DESCRIPATION:
K-FEN 0.5 is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes. Ketotifen fumarate is a finely crystalline powder with an empirical formula of C23H23NO5S and a molecular weight of 425.50. Each mL of K-FEN 0.5 contains: Active: ketotifen fumarate equivalent to 0.5 mg ketotifen. Preservative: benzalkonium chloride 0.05mg
COMPOSITION:
Label Claim: Each mL Contains :
Ketotifen Fumarate
- Equivalent to Ketotifen
...0.5 mg
- Benzalkonium chloride solution I.P.
0.05 mg (As preservative)
- Aqueous buffered vehicle
q.s.
PACKAGING
Primary packing - 5ml Clear Poly bottles White caps &Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.
SHELF LIFE:
24 months from the date of manufacturing
STORAGE:
Store in Refrigerator after the Container is opened. Keep In Cool & Dark Place
AVAILABILITY:
5ml of solution in Clear poly bottles with white caps & nozzles in properly sealed.
CLINICAL PHARMACOLOGY :
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 has also been demonstrated.
INDICATIONS AND USAGE:
K-FEN 0.5 (ketotifen fumarate ophthalmic solution) is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.
CONTRAINDICATIONS:
K-FEN 0.5 is contraindicated in persons with a known hypersensitivity to any component of this product.
WARNINGS:
For topical ophthalmic use only. Not for injection or oral use.
DOSAGE AND ADMINISTRATION:
The recommended dose is one drop in the affected eye(s) every 8 to 12 hours.
SUPPLY:
K-FEN 0.5 is supplied in one Clear Polethylene Bottle packed with printed labelled & cartons And Such 25 Carton Packed in a Shrink Sleeves & corrugated box.
