IOPIDINE- apraclonidine solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

APRACLONIDINE HYDROCHLORIDE (UNII: D2VW67N38H) (APRACLONIDINE - UNII:843CEN85DI)

Verfügbar ab:

Alcon Laboratories, Inc.

INN (Internationale Bezeichnung):

APRACLONIDINE HYDROCHLORIDE

Zusammensetzung:

APRACLONIDINE 5 mg in 1 mL

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

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

Berechtigungsstatus:

New Drug Application

Fachinformation

IOPIDINE- APRACLONIDINE SOLUTION
ALCON LABORATORIES, INC.
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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