![]() Use In Specific Populations Pregnancy Pregnancy Category C These effects were not observed at 3 mcg/kg/day (75 times the MRHOD). At 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg/kg/day (250 times the MRHOD of 0.04 mcg/kg/day on a mcg/kg basis). A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes. Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels. However, at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day did not show any evidence of carcinogenic potential. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Use With Contact LensesĬontact lenses should be removed prior to instillation of Avatan Z ® and may be reinserted 15 minutes following its administration. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. Angle-Closure, Inflammatory Or Neovascular GlaucomaĪvatan Z ® has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma. Avatan Z ® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. Intraocular InflammationĪvatan Z ® should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. ![]() Eyelash changes are usually reversible upon discontinuation of treatment. These changes include increased length, thickness, and number of lashes. Eyelash ChangesĪvatan Z ® may gradually change eyelashes and vellus hair in the treated eye. While treatment with Avatan Z ® (travoprost ophthalmic solution) 0.004% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Neither nevi nor freckles of the iris appear to be affected by treatment. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Iris color change may not be noticeable for several months to years. The long-term effects of increased pigmentation are not known. Patients who receive treatment should be informed of the possibility of increased pigmentation. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. ![]() The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. Pigmentation is expected to increase as long as travoprost is administered. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. Included as part of the "PRECAUTIONS" Section PRECAUTIONS Pigmentation
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