COMBIGAN®

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

BRIMONIDINE TARTRATE; TIMOLOL MALEATE 6.8mg/ml eqv Timolol

Dostupné s:

ABBVIE PTE. LTD.

ATC kód:

S01ED51

Dávkování:

2.0 MG/ML

Léková forma:

SOLUTION, STERILE

Složení:

BRIMONIDINE TARTRATE 2.0 MG/ML; TIMOLOL MALEATE 6.8mg/ml eqv Timolol 5 MG/ML

Podání:

OPHTHALMIC

Druh předpisu:

Prescription Only

Výrobce:

Allergan Pharmaceuticals Ireland

Stav Autorizace:

ACTIVE

Datum autorizace:

2008-01-31

Charakteristika produktu

* ARTWORK IS ACTUAL SIZE
* DROP NOTES AND TEMPLATE BEFORE PROCESSING
* IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER
* PERFORATION REQUIRED: NO
PART NUMBER:
71871SN11
DRAWING NUMBER:
0106901
PAGE:
1 OF 2
DESCRIPTION
Each mL contains: 2.0 mg brimonidine tartrate (equivalent to 1.3 mg of
brimonidine) and 5.0 mg timolol (equivalent to 6.8 mg of timolol
maleate) with benzalkonium chloride, sodium phosphate monobasic
monohydrate, sodium phosphate dibasic heptahydrate , hydrochloric
acid or sodium hydroxide to adjust pH, and purified water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
_Pharmacotherapeutic group:_
Ophthalmological –antiglaucoma preparations and miotics -beta
blocking agents - timolol, combinations
ATC code: SO1ED 51
_Mechanism of action:_
COMBIGAN® consists of two active substances: brimonidine tartrate and
timolol maleate. These two components decrease elevated
intraocular pressure (IOP) by complementary mechanisms of action and
the combined effect results in additional IOP reduction compared to
either compound administered alone.
COMBIGAN® has a rapid onset of action.
Brimonidine tartrate is an alpha-2 adrenergic receptor agonist that is
1000-fold more selective for the alpha-2 adrenoreceptor than the
alpha-1 adrenoreceptor. This selectivity results in no mydriasis and
the absence of vasoconstriction in microvessels associated with human
retinal xenografts.
It is thought that brimonidine tartrate lowers IOP by enhancing
uveoscleral outflow and reducing aqueous humour formation. Timolol is
a
beta
1
and beta
2
non-selective adrenergic receptor blocking agent that does not have
significant intrinsic sympathomimetic, direct myocardial
depressant, or local anaesthetic (membrane-stabilising) activity.
Timolol lowers IOP by reducing aqueous humour formation. The precise
mechanism of action is not clearly established, but inhibition of the
increased cyclic AMP synthesis caused by endogenous beta-adrenergic
stimulation is probable.
_Clinical effects:_
In three controlled, double-mas