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Since Apraclonidine ophthalmic solution will be used with other ocular glaucoma therapies, an approximate 5 minute interval between instillation of each medication should be practiced to prevent washout of the previous dose. Patients were considered to be treatment failures in this study if, in the opinion of the investigators, their IOP was uncontrolled by the masked study medication or there was evidence of further optic nerve damage or visual field loss, and surgery was indicated.
h�b```e``Rf`b`�Z� Ȁ ��,@�q��H���'/600�;���Z��Z����ѐ"P� �4��M@��9�"���v��S�L|̤��,#����H3� @� A] The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation.The following adverse reactions (incidences) were reported in clinical studies of Apraclonidine ophthalmic solution as being possibly, probably, or definitely related to therapy:The following adverse reactions were reported in 5 to 15% of the patients: discomfort, hyperemia, and pruritus.The following adverse reactions were reported in 1 to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema, and tearing.The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, photophobia.Dry mouth occurred in approximately 10% of the patients.The following adverse reactions were reported in less than 3% of the patients: abnormal coordination, asthenia, arrhythmia, asthma, chest pain, constipation, contact dermatitis, depression, dermatitis, dizziness, dry nose, dyspnea, facial edema, headache, insomnia, malaise, myalgia, nausea, nervousness, paresthesia, parosmia, peripheral edema, pharyngitis, rhinitis, somnolence, and taste perversion.The following events have been identified during post-marketing use of Apraclonidine ophthalmic solution in clinical practice.
Ocular blood flow studies have not been conducted in humans.Apraclonidine Ophthalmic Solution, USP 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction.
Repeated dose-response and comparative studies (0.125% - 1.0% apraclonidine) demonstrate that 0.5% apraclonidine is at the top of the dose/response IOP reduction curve. Systemic clonidine may inhibit the production of catecholamines in response to insulin-induced hypoglycemia and mask the signs and symptoms of hypoglycemia.Since Apraclonidine may reduce pulse and blood pressure, caution in using drugs such as beta-blockers (ophthalmic and systemic), antihypertensives, and cardiac glycosides is advised. NOT FOR INJECTION INTO THE EYE. Patients using cardiovascular drugs concurrently with Apraclonidine ophthalmic solution should have pulse and blood pressure frequently monitored. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored.An unpredictable decrease of IOP control in some patients and incidence of ocular allergic responses and systemic side effects may limit the utility of Apraclonidine ophthalmic solution.
Single dose ocular blood flow studies in monkeys, using the microsphere technique, demonstrated a reduced blood flow for the anterior segment; however, no reduction in blood flow was observed in the posterior segment of the eye after a topical dose of Apraclonidine ophthalmic solution. Caution and monitoring of depressed patients are advised since Apraclonidine has been infrequently associated with depression.Apraclonidine can cause dizziness and somnolence.
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