APRACLONIDINE OPHTHALMIC- apraclonidine hydrochloride solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

apraclonidine hydrochloride (UNII: D2VW67N38H) (apraclonidine - UNII:843CEN85DI)

Available from:

Akorn

INN (International Name):

apraclonidine hydrochloride

Composition:

apraclonidine 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

APRACLONIDINE OPHTHALMIC- APRACLONIDINE HYDROCHLORIDE SOLUTION/ DROPS
AKORN
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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