País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
apraclonidine hydrochloride (UNII: D2VW67N38H) (apraclonidine - UNII:843CEN85DI)
Akorn
apraclonidine hydrochloride
apraclonidine 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
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. Patients on maximally tolerated medical therapy who are treated with Apraclonidine Ophthalmic Solution, USP 0.5% as base to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly. The addition of Apraclonidine Ophthalmic Solution, USP 0.5% as base 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 Apraclonidine Ophthalmic Solution, USP 0.5% as base is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of Apraclonidine Ophthalmic Solution, USP 0.5% as base diminishes over time in some patients.
Apraclonidine Ophthalmic Solution, USP 0.5% as base in a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied in a white plastic LDPE ophthalmic bottle with a natural LDPE controlled dropper tip and a purple polypropylene cap as follows: Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and light. Retain in carton until time of use. Rx Only AKORN Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 AC00N Rev. 01/22
Abbreviated New Drug Application
APRACLONIDINE OPHTHALMIC- APRACLONIDINE HYDROCHLORIDE SOLUTION/ DROPS AKORN ---------- APRACLONIDINE OPHTHALMIC SOLUTION, USP 0.5% AS BASE RX ONLY DESCRIPTION Apraclonidine Ophthalmic Solution, USP 0.5% as base 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. The chemical structure of apraclonidine hydrochloride is: EACH ML OF APRACLONIDINE OPHTHALMIC SOLUTION, USP 0.5% AS BASE CONTAINS: ACTIVE: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg; INACTIVES: sodium acetate, sodium chloride, sodium hydroxide and/or hydrochloric acid may be added to adjust pH (4.4 to 7.8) and water for injection; PRESERVATIVE: benzalkonium chloride 0.01%. CLINICAL PHARMACOLOGY Apraclonidine hydrochloride is a relatively selective alpha-2-adrenergic agonist. When instilled in the eye, apraclonidine ophthalmic solution 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. Apraclonidine ophthalmic solution 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% to 1.0% apraclonidine) demonstrate that 0.5% apraclonidine is at t Leer el documento completo