XALATAN® (latanoprost ophthalmic solution) How Supplied

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Prescribing Information

XALATAN^® (latanoprost ophthalmic solution)
How Supplied


	Return to the XALATAN Product Center

XALATAN Sterile Ophthalmic Solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 µg/mL). It is supplied as a 2.5 mL solution in a 5 mL clear low density polyethylene bottle with a clear low density polyethylene dropper tip, a turquoise high density polyethylene screw cap, and a tamper-evident clear low density polyethylene overcap.

2.5 mL fill, 0.005% (50 µg/mL)
Package of 1 bottle	NDC 0013-8303-04

Storage: Protect from light. Store unopened bottle(s) under refrigeration at 2º to 8ºC (36º to 46ºF). During shipment to the patient, the bottle may be maintained at temperatures up to 40ºC (104ºF) for a period not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25ºC (77ºF) for 6 weeks.

Rx only

Pfizer

Manufactured By:
Catalent Pharma Solutions
Woodstock, IL 60098, USA

Pfizer Manufacturing Belgium NV
Puurs, Belgium

LAB-0135-8.0
Revised January 2009

PRINTER-FRIENDLY

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.

Please see full prescribing information.

XALATAN^® (latanoprost ophthalmic solution)