ALPHAGAN OPHTHALMIC SOLUTION 0.2%

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

BRIMONIDINE TARTRATE

Disponible desde:

ABBVIE PTE. LTD.

Código ATC:

S01EA05

Dosis:

0.20%

formulario farmacéutico:

SOLUTION

Composición:

BRIMONIDINE TARTRATE 0.2%

Vía de administración:

OPHTHALMIC

tipo de receta:

Prescription Only

Fabricado por:

ALLERGAN PHARMACEUTICALS IRELAND

Estado de Autorización:

ACTIVE

Fecha de autorización:

1998-05-27

Ficha técnica

ALPHAGAN
®
BRIMONIDINE TARTRATE
OPHTHALMIC SOLUTION 0.2%
DESCRIPTION
EACH ML CONTAINS: brimonidine tartrate 2 mg (equivalent to 1.32 mg as
brimonidine free base) with:
benzalkonium chloride 0.05 mg, polyvinyl alcohol 14 mg; sodium
chloride; sodium citrate; citric acid and
purified water.
CLINICAL PHARMACOLOGY
ALPHAGAN
®
is a relatively selective alpha-2 adrenergic agonist. It has a peak
ocular hypotensive effect
occurring at two hours post-dosing. Fluorophotometric studies in
animals and humans suggest that
brimonidine tartrate has a dual mechanism of action by reducing
aqueous humor production and increasing
uveoscleral outflow.
After ocular administration of a 0.2% solution, plasma concentrations
peaked within 1 to 4 hours and
declined with a systemic half-life of approximately 3 hours.
In humans, systemic metabolism of brimonidine is extensive. It is
metabolized primarily by the liver. Urinary
excretion is the major route of elimination of the drug and its
metabolites. Approximately 87% of an orally-
administered radioactive dose was eliminated within 120 hours, with
74% found in the urine.
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. ALPHAGAN
®
has the action of lowering
intraocular pressure with minimal effect on cardiovascular and
pulmonary parameters.
In comparative clinical studies with timolol 0.5%, lasting up to one
year, the IOP lowering effect of
ALPHAGAN
®
was approximately 4-6 mm Hg compared with approximately 6 mm Hg for
timolol. Eight
percent of subjects were discontinued from studies due to inadequately
controlled intraocular pressure,
which in 30% of these patients occurred during the first month of
therapy. Approximately 20% were
discontinued due to adverse experiences.
INDICATIONS AND USAGE
ALPHAGAN
®
is indicated for lowering intraocular pressure in patients with
open-angle glaucoma or ocular
hypertension. The IOP lowering efficacy of ALPHAGAN
®
ophthalmic soluti