For: Glaucoma (Open Angle), Intraocular Hypertension
Xelpros (latanoprost) is a prostaglandin F2? analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension. XELPROS (latanoprost ophthalmic emulsion) is supplied as an off-white to pale yellow, translucent, isotonic, sterile, buffered emulsion of latanoprost 0.005% (50 mcg/mL). It is supplied as a 2.5 mL emulsion filled in a 5-mL clear low density polyethylene bottle with a clear low density polyethylene dropper tip, and a turquoise high density polyethylene pilfer-proof cap. Each mL contains 50 mcg of latanoprost. These highlights do not include all the information needed to use XERLPROS 0.005% safely and effectively. See full prescribing information for XELPROS� .
XELPROS� (latanoprost ophthalmic emulsion) 0.005%, for topical ophthalmic use
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
XELPROS is a prostaglandin F2? analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic emulsion containing latanoprost 50 mcg/mL (0.005%). (3)
CONTRAINDICATIONS
Known hypersensitivity to latanoprost or any other ingredients in this product. (4)
WARNINGS AND PRECAUTIONS
�
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)
ADVERSE REACTIONS
Most common ocular adverse reactions (incidence ?5%) for XELPROS are: eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Thimerosal: Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least five (5) minutes apart. (7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2018
2.5 mL fill, 0.005% (50 mcg/mL)
Package of 1 bottle NDC 47335-317-90
Multi-Pack of 3 bottles NDC 47335-317-92
Storage: Protect from light. Store at 2�C to 25�C (36�F to 77�F). During shipment to the patient, the bottle may be maintained at temperatures up to 40�C (104�F) for a period not exceeding 8 days. After opening, XELPROS can be used until the expiration date stamped on bottle and then discarded.
