XALATAN Safety Information
Important Safety Information
XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in
patients with open-angle glaucoma (OAG) or ocular hypertension (OH).
XALATAN can cause changes to pigmented tissues. Most frequently reported are 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.
Iris pigmentation is likely to be permanent while eyelid skin darkening and eyelash
changes may be reversible. The effects beyond 5 years are unknown.
Most common ocular events/signs and symptoms (5% to 15%) reported with XALATAN in
the three 6-month registration trials included blurred vision, burning and stinging,
conjunctival hyperemia, foreign-body sensation, itching, increased iris pigmentation,
and punctate epithelial keratopathy.
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 aphakic patients, in pseudophakic
patients with a torn posterior lens capsule, or in patients with known risk factors
for macular edema.
The recommended dosage of XALATAN is one drop (1.5 μg) in the affected eye(s) once
daily in the evening. If one dose is missed, treatment should continue with the
next dose as normal. The dosage of XALATAN should not exceed once daily; the combined
use of two or more prostaglandins, or prostaglandin analogs including XALATAN, is
not recommended. It has been shown that administration of these prostaglandin drug
products more than once daily may decrease the intraocular pressure-lowering effect
or cause paradoxical elevations in IOP.
There have been reports of bacterial keratitis associated with the use of multiple-dose
containers of topical ophthalmic products.