艾弗目眼藥水０．２％

País: Taiwan

Língua: chinês

Origem: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Ingredientes ativos:

BRIMONIDINE TARTRATE

Disponível em:

台灣愛力根藥品股份有限公司 台北市中正區羅斯福路2段102號9樓 (53529261)

Código ATC:

S01EA05

Forma farmacêutica:

點眼液劑

Composição:

BRIMONIDINE TARTRATE (2408005310) MG

Unidades em pacote:

瓶裝

Classe:

製　劑

Tipo de prescrição:

須由醫師處方使用

Fabricado por:

ALLERGAN PHARMACEUTICALS IRELAND CASTLEBAR ROAD, WESTPORT, CO. MAYO, IRELAND IE

Área terapêutica:

brimonidine

Indicações terapêuticas:

開放角隅青光眼或高眼壓。

Resumo do produto:

註銷日期: 2023/04/07; 註銷理由: 自請註銷; 有效日期: 2024/10/18; 英文品名: ALPHAGAN OPHTHALMIC SOLUTION 0.2%

Status de autorização:

已註銷

Data de autorização:

1999-10-18

Folheto informativo - Bula

ALPHAGAN® 0.2%
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® 0.2% 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® 0.2% 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® 0.2% 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® 0.2% is indicated for lowering intraocular pressure in
patients
with open-angle glaucoma or ocular hypertension. The IOP lowering
efficacy of
ALPHAGAN®