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TRAVATAN (TRAVOPROST): WARNINGS AND PRECAUTIONS

Pigmentation

Travatan (Travoprost) ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes.

Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.

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. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known.

Iris color change may not be noticeable for several months to years. 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. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with Travatan (Travoprost) eye drops can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

Eyelash Changes

Travatan (Travoprost) eye drops may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes.

Eyelash changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation

Travoprost (Travatan) should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Macular Edema

Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. Travatan 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.

Angle-closure, Inflammatory or Neovascular Glaucoma

Travoprost (Travatan) ophthalmic solution has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma.

Bacterial Keratitis

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. 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.

Use with Contact Lenses

Contact lenses should be removed prior to instillation of Travoprost (Travatan) eye drops and may be reinserted 15 minutes following its administration.

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