Ketotifen Fumarate

DESCRIPTION

ZADITOR^TM 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.

Established Name: Ketotifen Fumarate Ophthalmic Solution

Chemical Name: 4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b] thiophen-10(9H)-one hydrogen fumarate

Each mL of ZADITOR^TM contains:

Active: 0.345 mg ketotifen fumarate equivalent to 0.25 mg ketotifen.

Inactives: glycerol, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water.

Preservative: benzalkonium chloride 0.01%. It has a pH of 4.4 to 5.8 and an osmolality of 210-300 mOsm/kg.

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