IOPIDINE 1%- apraclonidine hydrochloride ophthalmic solution solution/ drops

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Harrow Eye, LLC

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

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 82667‑200-01 Storage: Store at 2°C to 25°C (36°F‑77°F). Protect from light. Manufactured for: Harrow Eye, LLC™ Nashville, TN 37205 USA Revised: February 2023

Status autorizacije:

New Drug Application

Svojstava lijeka

IOPIDINE 1%- APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION SOLUTION/
DROPS
HARROW EYE, LLC
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IOPIDINE 1% (APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 1% AS
BASE
STERILE
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.
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
of a single dose. The precise mechanism of the ocular hypotensiv