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TR Carpenter, C Vangyi, C Zerouala, M Carrier, B Short, B Brar; Safety and Systemic Exposure of Gatifloxacin 0.5% Ophthalmic Solution in Dogs . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1581.
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Purpose:Gatifloxacin is a novel, broad spectrum, 4th generation fluoroquinolone antibiotic being developed for the treatment of ocular bacterial infections. We assessed ocular and systemic toxicity following topical ophthalmic administration of gatifloxacin in beagle dogs. Methods:Beagle dogs (n = 48) received 2 drops of ophthalmic gatifloxacin 0.5% or placebo in the right eye either 10 times daily for 1 month, or on a variable dose schedule of 32 times daily for 2 days, then 16 times daily for 5 days, then 4 times daily for the remainder of 3 months. 8 dogs/group were analyzed at the end of treatment; the remaining animals were analyzed after a 1 month recovery period. Results:There was no evidence of toxicity on ocular clinical signs, slit lamp biomicroscopy, indirect ophthalmoscopy, pupillary reflex, nor on intraocular pressure. There were no drug-related systemic effects as assessed by clinical signs, body weight, hematology, clinical chemistry, urinalysis, organ weight, or histopathology. Plasma Cmax values following the final daily dose among dogs treated 10 times/day on day 7 (73.7 ng/mL) and day 28 (65.0 ng/mL) were comparable. Conclusion:Topical ophthalmic gatifloxacin 0.5% administered to dogs for up to 3 months with as many as 32 applications daily did not produce ocular or systemic toxicity.
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