IOPIDINE- apraclonidine hydrochloride solution/ drops

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 10 mg in 1 mL

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy. IOPIDINE 1% Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Produktbesonderheiten:

IOPIDINE 1% Ophthalmic Solution as base is a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied as follows: 0.1 mL in plastic ophthalmic dispensers, packaged two per pouch. These dispensers are enclosed in a foil overwrap as an added barrier to evaporation. 0.1 mL (packaged two per pouch) NDC 0065-0660-10 Storage: Store at 2°C to 25°C (36°F-77°F). Protect from light. Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Alcon® a Novartis company * a trademark of Novartis © Novartis T2018-17 March 2018

Berechtigungsstatus:

New Drug Application

Fachinformation

IOPIDINE - APRACLONIDINE HYDROCHLORIDE SOLUTION/ DROPS
ALCON LABORATORIES, INC.
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IOPIDINE* 1%
(APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 1% AS BASE
STERILE
DESCRIPTION
IOPIDINE 1% Ophthalmic Solution 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
281.6.
The chemical structure of apraclonidine hydrochloride is:
Each mL of IOPIDINE 1% Ophthalmic Solution contains: ACTIVES:
apraclonidine
hydrochloride 11.5 mg equivalent to apraclonidine base 10 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).
Osmolality is 260-320
mOsm.
CLINICAL PHARMACOLOGY
Apraclonidine is a relatively selective, alpha adrenergic agonist and
does not have
significant membrane stabilizing (local anesthetic) activity. When
instilled into the eye,
IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution) has the
action of
reducing intraocular pressure (IOP). Ophthalmic apraclonidine has
minimal effect on
cardiovascular parameters.
Optic nerve head damage and visual field loss may result from an acute
elevation in IOP
that can occur after argon or Nd:YAG laser surgical procedures.
Elevated IOP, whether
acute or chronic in duration, is a major risk factor in the
pathogenesis of visual field loss.
The higher the peak or spike of IOP, the greater the likelihood of
visual field loss and
optic nerve damage especially in patients with previously compromised
optic nerves. The
onset of action with IOPIDINE 1% Ophthalmic Solution can usually be
noted within one
hour and the maximum IOP reduction usually occurs three to five hours
after application
9
11
3
4
of a single dose. The precise mechanism o