XALATAN

AbsorptionLatanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active.

DistributionThe distribution volume in humans is 0.16±0.02 L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration. Studies in man indicate that the peak concentration in the aqueous humor is reached about 2 hours after topical administration. Elim...

14.1 Elevated Baseline IOP Patients with mean baseline IOP of 24-25 mmHg who were treated for 6 months in multi-center, randomized, controlled trials demonstrated 6-8 mmHg reductions in IOP. This IOP reduction with XALATAN 0.005% dosed once daily was equivalent to the effect of timolol 0.5% dosed twice daily. 14.2 Progression of Increased Iris Pigmentation A 3-year open-label, prospective safety study with a 2-year extension phase was conducted to evaluate the progression of increased iris pigmentation with continuous use of XALATAN once-daily as adjunctive therapy in 519 patients with open-an...

The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:

• Iris pigmentation changes [see Warnings and Precautions (5.1) ]
• Eyelid skin darkening [see Warnings and Precautions (5.1) ]
• Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ]
• Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ]
• Macular edema, including...

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. ( 4 )

• Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 )
• Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation XALATAN 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. Pigmentatio...