Ophthalmic Solution, 0.025%
ZADITOR™ 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
4-(1-Methyl-4-piperidylidene)-4 H -benzo[4,5]cyclohepta[1,2- b ] thiophen-10(9 H)-one hydrogen fumarate
Each mL of ZADITOR™ 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.