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warnings
WARNINGS Latanoprost Ophthalmic Solution, 0.005% has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes. Pigmentation is expected to increase as long as Latanoprost Ophthalmic Solution, 0.005% is administered. After discontinuation of Latanoprost Ophthalmic Solution, 0.005%, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible In some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known.
ADVERSE REACTIONS Adverse events referred to In other sections of this insert: Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema (see WARNINGS and PRECAUTIONS ). Controlled Clinical Trials: The ocular adverse events and ocular signs and symptoms reported In 5 to 15% of the patients on Latanoprost Ophthalmic Solution, 0.005% in the three 6-month, multi-center, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctuate epithelial keratopathy. Local conjunctival hyperemia was observed; however, less than 1 % of the patients treated with Latanoprost Ophthalmic Solution, 0.005% required discontinuation of therapy because of intolerance to conjunctival hyperemia. In addition to the above listed ocular events/signs and symptoms, the following were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain, lid crusting, lid discomfort/pain, lid edema, lid erythema, and photophobia. The following events were reported in less than 1 % of the patients: conjunctivitis, diplopia and discharge from the eye. During clinical studies, there were extremely rare reports of the following: retinal artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy. The most common systemic adverse events seen with Latanoprost Ophthalmic Solution, 0.005% were upper respiratory tract infection/cold/flu, which occurred at a rate of approximately 4%. Chest pain/angina pectoris, muscle/joint/back pain, and rash/ allergic skin reaction each occurred at a rate of 1 to 2%. Clinical Practice: The following events have been Identified during postmerketlng use of Latanoprost Ophthalmic Solution, 0.005% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Latanoprost Ophthalmic Solution, 0.005%, or a combination of these factors, include: asthma and exacerbation of asthma; corneal edema and erosions; dyspnea; eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); eyelid skin darkening; herpes keratitis; intraocular inflammation (iritis/uveitis); keratitis; macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; dizziness, headache, and toxic epidermal necrolysis.