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Apraclonidine
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  • FDA PI

Apraclonidine

Generic name: Apraclonidine hydrochloride
Dosage form: ophthalmic solution
Drug class:Ophthalmic glaucoma agents

Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.

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 C9H11Cl3N4 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 do...