全球首个促睫的毛生长处方药Latisse(比马前列素眼科溶液.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION ________________________CONTRAINDICATIONS_______________________ Hypersensitivity. (4.1) These highlights do not include all the information needed to use LATISSE? safely and effectively. See full prescribing _________________WARNINGS AND PRECAUTIONS________________ information for LATISSE?. Concurrent administration of LATISSE? and IOP-lowering prostaglandin analogs in ocular hypertensive patients may LATISSE? (bimatoprost ophthalmic solution) 0.03% decrease the IOP-lowering effect. Patients using these products Initial U.S. Approval: 2001 concomitantly should be closely monitored for changes to their intraocular pressure. (5.1) ____________________INDICATIONS AND USAGE_____________________ LATISSE? is a prostaglandin analog, indicated to treat Pigmentation of the eyelids and iris may occur. Iris pigmentation hypotrichosis of the eyelashes by increasing their growth is likely to be permanent. (5.2, 5.3) including length, thickness and darkness. (1) _______________________ADVERSE REACTIONS________________________ ________________DOSAGE AND ADMINISTRATION________________ Most common adverse events (incidence approximately 3% - 4%) Apply nightly directly to the skin of the upper eyelid margin at are eye pruritus, conjunctival hyperemia, and skin the base of the eyelashes using the accompanying applicators. hyperpigmentation. (6) Blot any excess solution beyond the eyelid margin. Dispose of the applicator after one use. Repeat for the opposite eyelid To report SUSPECTED ADVERSE REACTIONS, contact margin using a new sterile applicator. (2) Allergan at 1-800-433-8871 or the FDA at 1-800-FDA-1088 or