IOBRIM EYE DROPS ( Brimonidine Tartrate 0.2% wv )

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

BRIMONIDINE TARTRATE

제공처:

UNIMED SDN BHD

INN (국제 이름):

BRIMONIDINE TARTRATE

패키지 단위:

5ml mL

Manufactured by:

FDC LIMITED

제품 특성 요약

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
I
OBRIM EYE DROPS
(Brimonidine Tartrate 0.2% w/v)
COMPOSITION
Brominodine Tartrate ….. 0.2% w/v (2 mg/ml)
Benzalkonium Chloride Ph Eur
………0.005% w/v (0.05 mg/ml)
(as preservative)
DESCRIPTION
Clear, greenish yellow solution.
PHARMACODYNAMICS
MECHANISM OF ACTION
Brimonidine tartrate ophthalmic solution is an 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.
PHARMACOKINETICS
After ocular administration of either a 0.1% or 0.2% solution, plasma
concentrations peaked within 0.5
to 2.5 hours and declined with a systemic half-life of approximately 2
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.
INDICATION
Brimonidine Eye Drops are effective for lowering intraocular pressure
in patients with chronic open-
angle glaucoma or ocular hypertension. Brimonidine Eye Drops may also
be used as adjunctive
therapy when intraocular pressure (IOP) is not adequately controlled
by a topical beta-blocking agent.
There is no known cure for glaucoma. Treatment with Brimonidine Eye
Drops (as with any other
therapy) aims to preserve visual field through decrease of IOP.
RECOMMENDED DOSE
The recommended dose is one drop of Brimonidine tartrate ophthalmic
solution 0.2% in the affected
eye(s) two times daily. For those patients whose IOP peaks in the
afternoon or need additional IOP
control, an additional drop of brimonidine in the afternoon can be
added.
ROUTE OF ADMINISTRATION
For Ocular use only.
CONTRAINDICATIONS
Brimonidine
is
contraindicated
in