Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
APRACLONIDINE HYDROCHLORIDE (UNII: D2VW67N38H) (APRACLONIDINE - UNII:843CEN85DI)
Alcon Laboratories, Inc.
APRACLONIDINE HYDROCHLORIDE
APRACLONIDINE 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
IOPIDINE® (apraclonidine ophthalmic solution) 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with IOPIDINE® (apraclonidine ophthalmic solution) 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of IOPIDINE® (apraclonidine ophthalmic solution) 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because IOPIDINE® (apraclonidine ophthalmic solution) 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of IOPIDINE® (apraclonidine ophthalmic solution) 0.5% diminishes over time in some patients. This loss of
IOPIDINE® (apraclonidine ophthalmic solution) 0.5% as base in a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied in plastic ophthalmic DROP-TAINER® dispenser as follows: 5 mL NDC 0065-0665-05 10 mL NDC 0065-0665-10 Storage: Store between 2°C to 27°C (36°F-80°F). Protect from freezing and light. © 2018 Novartis Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 ALCON® A Novartis company Revised: June 2018 T2018-87
New Drug Application
IOPIDINE- APRACLONIDINE SOLUTION ALCON LABORATORIES, INC. ---------- IOPIDINE (APRACLONIDINE OPHTHALMIC SOLUTION) 0.5% AS BASE DESCRIPTION IOPIDINE (apraclonidine ophthalmic solution) 0.5% contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off-white powder and is highly soluble in water. Its chemical name is 2-[(4- amino-2,6 dichlorophenyl) imino]imidazolidine monohydrochloride with an empirical formula of C H Cl N and a molecular weight of 281.57 g/mol. The chemical structure of apraclonidine hydrochloride is: EACH ML OF IOPIDINE (APRACLONIDINE OPHTHALMIC SOLUTION) 0.5% CONTAINS: ACTIVE: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg. INACTIVES: sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4-7.8), purified water and benzalkonium chloride 0.01% (preservative). CLINICAL PHARMACOLOGY Apraclonidine hydrochloride is a relatively selective alpha-2-adrenergic agonist. When instilled in the eye, IOPIDINE (apraclonidine ophthalmic solution) 0.5%, has the action of reducing elevated, as well as normal, intraocular pressure (IOP), whether or not accompanied by glaucoma. Ophthalmic apraclonidine has minimal effect on cardiovascular parameters. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. IOPIDINE (apraclonidine ophthalmic solution) 0.5% has the action of reducing IOP. The onset of action of apraclonidine can usually be noted within one hour, and maximum IOP reduction occurs about three hours after instillation. Aqueous fluorophotometry studies demonstrate that apraclonidine's predominant mechanism of action is reduction of aqueous flow via stimulation of the alpha-adrenergic system. Repeated dose-response and comparative studies (0.125%-1.0% apraclonidine) demonstrate that 0.5% apraclonidine is at the top of the dos Leggi il documento completo