Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh
Inc. nor any other party involved in the preparation of this program shall be
liable for any special, consequential, or exemplary damages resulting in whole
or part from any user's use of or reliance upon this material. PLEASE READ THE
DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING
THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE
DISCLAIMER. [ Read the disclaimer
| <<Back |
New drug index
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZYMAXID™ safely and effectively. See full prescribing information for
ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5%
ZYMAXID™ sterile ophthalmic solution is an 8-methoxyfluoroquinolone
anti-infective for the treatment of bacterial conjunctivitis. Its
chemical name is
ZYMAXID™ is a clear, pale yellow, sterile, preserved aqueous solution
with an osmolality of 260-330 mOsm/kg and a pH of 5.1-5.7.
ZYMAXID™ contains Active: gatifloxacin 0.5% (5 mg/mL); Inactives:
benzalkonium chloride 0.005%; edetate disodium; purified water; and
sodium chloride. May contain hydrochloric acid and/or sodium hydroxide
to adjust pH.
Mechanism of Action
Gatifloxacin is a fluoroquinolone antibacterial.
Gatifloxacin ophthalmic solution 0.3% or 0.5% was administered to one
eye of 6 healthy male subjects each in an escalated dosing regimen
starting with a single 2 drop dose, then 2 drops 4 times daily for 7
days, and finally 2 drops 8 times daily for 3 days. At all time points,
serum gatifloxacin levels were below the lower limit of quantification
(5 ng/mL) in all subjects.
Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl
substituent at C7. The antibacterial action of gatifloxacin results from
inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an
essential enzyme that is involved in the replication, transcription, and
repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a
key role in the partitioning of the chromosomal DNA during bacterial
cell division. The mechanism of action of fluoroquinolones including
gatifloxacin is different from that of aminoglycoside, macrolide, and
tetracycline antibiotics. Therefore, gatifloxacin may be active against
pathogens that are resistant to these antibiotics and these antibiotics
may be active against pathogens that are resistant to gatifloxacin.
There is no cross-resistance between gatifloxacin and the aforementioned
classes of antibiotics. Cross resistance has been observed between
systemic gatifloxacin and some other fluoroquinolones.
Resistance to gatifloxacin in vitro develops via multiple-step
mutations. Resistance to gatifloxacin in vitro occurs at a general
frequency of 1 x 10-7 to 10-10.
Gatifloxacin has been shown to be active against most isolates of the
following organisms both microbiologically and clinically, in
conjunctival infections as described in the INDICATIONS AND USAGE.
Patients 1 year of age or older: Instill one drop every two
hours in the affected eye(s) while awake, up to 8 times on Day
1. Instill one drop two to four times daily in the affected
eye(s) while awake on Days 2 through 7.