General
XALATAN (latanoprost) 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, and growth of eyelashes. Pigmentation is expected to increase as long as XALATAN is administered. After discontinuation of XALATAN, 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 effects of increased pigmentation beyond 5 years are not known. Patients who are expected to receive treatment in only one eye should be informed about the potential for increased pigmentation in the treatment eye and thus, heterochromia between the eyes.
XALATAN may gradually increase the pigmentation of the iris. This effect has predominantly been seen in patients with mixed coloured irides, i.e., blue-brown, grey-brown, green-brown or yellow-brown. The eye colour change is due to increased melanin content in the stromal melanocytes rather than to an increase in the number of melanocytes. This 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 XALATAN can be continued in patients who develop noticeably increased pigmentation, these patients should be examined regularly.
During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant colour change may be permanent.
Hepatic/Biliary/Pancreatic
XALATAN has not been studied in patients with hepatic impairment and should, therefore, be used with caution in such patients.
Ophthalmologic
Macular edema, including cystoid macular edema, has been reported during treatment with XALATAN. These reports have mainly occurred in aphakic patients, in pseudophakic patients with torn posterior lens capsule, or in patients with known risk factors for macular edema. XALATAN should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.
There is no experience with XALATAN in patients with inflammatory ocular conditions, inflammatory glaucoma, neovascular glaucoma or congenital glaucoma, and only limited experience with pseudophakic patients and in patients with pigmentary glaucoma.
XALATAN should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.
XALATAN should be used with caution in patients with a history of herpetic keratitis. XALATAN should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.
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 ocular epithelial surface (see INFORMATION FOR THE CONSUMER).
This product contains benzalkonium chloride as a preservative, which may be absorbed by soft contact lenses. Remove contact lenses before administration of XALATAN. Contact lenses may be reinstalled 15 minutes after administering XALATAN.
Renal
XALATAN has not been studied in patients with renal impairment and should, therefore, be used with caution in such patients.
Respiratory
There is no experience in patients with severe or uncontrolled asthma. Such patients should therefore be treated with caution until there is sufficient experience (see ADVERSE REACTIONS and DETAILED PHARMACOLOGY - Human Pharmacodynamics for experience in patients with mild to moderate asthma).
Sexual Function/Reproduction
Fertility: Latanoprost has not been found to have any effect on male or female fertility in animal studies.
Skin
Eyelid skin darkening, which may be reversible, has been reported in association with the use of XALATAN (see WARNINGS AND PRECAUTIONS).
XALATAN may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Special Populations
Pregnant Women: Reproduction studies have been performed in rats and rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose (see TOXICOLOGY). XALATAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Women: The active substance in XALATAN and its metabolites may pass into breast milk and XALATAN should therefore be used with caution in nursing women (see TOXICOLOGY).
Pediatrics: The safety and efficacy of the use of XALATAN in children has not been established.
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