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