Iris pigment changes: Latanoprost has been associated with an increase in brown pigmentation of the iris in some patients, especially those with mixed colored irides that contain the color brown at baseline, due to increased melanin content in the stromal melanocytes of the iris, rather than to an increase in the number of melanocytes. Typically, brown pigmentation around the pupil gradually spreads concentrically toward the periphery and the entire iris or parts of the iris also may become brownish in color. The change in iris color is mild in most cases and may not be detected clinically. The increase in iris pigmentation in one or both eyes has been documented. Iris freckles or nevi do not appear to be affected by Latanoprost therapy. No accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has been observed.
There was no evidence of adverse consequences due to increased pigmentation even when administration of Latanoprost continued. IOP reduction was similar in patients regardless of the development of increased iris pigmentation. Latanoprost therapy can be continued in patients who develop increased iris pigmentation. These patients should be examined regularly and, depending on the clinical situation, treatment may be discontinued.
Onset of increased iris pigmentation generally occurred within the first year of treatment, rarely during the second or third year, and has not been after the fourth year of treatment. The rate of progression of iris pigmentation decreases with time and is stable by five years. The increase in brown pigment generally does not progress further if Latanoprost is discontinued, but the change in iris color is likely to be permanent. Unilateral treatment can result in permanent heterochromia.
Eyelid and eyelash changes: Pigmentation of the eyelid and eyelash changes associated Latanoprost treatment may be reversible. Latanoprost may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.
Macular oedema: Macular edema, including cystoid macular edema, has been reported during treatment with Latanoprost in aphakic patients, in pseudophakic patients with torn posterior lens capsule, or in patients with known risk factors for macular edema. Latanoprost should be used with caution in these patients.
Glaucoma: There is limited experience in inflammatory neovascular glaucoma with Latanoprost treatment. Latanoprost should be used with caution in these conditions.
Herpetic keratitis: Latanoprost should be used with caution in patients with a history of herpetic keratitis and 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.
Contact lenses: This product contains benzalkonium chloride, which may be absorbed by contact lenses.
Effects on ability to drive and use machines: Instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.
Use in children: Efficacy and safety data in the age group <1 year are very limited. No data are available for preterm infants (less than 36 weeks gestational age).
In children from 0 to <3 years old that mainly suffer from primary congenital glaucoma (PCG), surgery (e.g., trabeculotomy/goniotomy) remains the first line treatment.
Long-term safety in children has not yet been established.
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