XALATAN® (latanoprost ophthalmic solution) 0.005% (50 µg/ml) Description

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Prescribing Information

XALATAN^® (latanoprost ophthalmic solution)
0.005% (50 µg/ml)
Description


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Latanoprost is a prostaglandin F_2α analogue. Its chemical name is isopropyl-(Z)-
7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C₂₆H₄₀O₅ and its chemical structure is:

Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol and octanol. It is practically insoluble in water.

XALATAN Sterile Ophthalmic Solution (latanoprost ophthalmic solution) is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of XALATAN contains 50 micrograms of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous and water for injection. One drop contains approximately 1.5 µg of latanoprost.

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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)