TEVA-LATANOPROST/TIMOLOL SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

S01ED51

INN (Mezinárodní Name):

TIMOLOL, COMBINATIONS

Dávkování:

5MG; 50MCG

Léková forma:

SOLUTION

Složení:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

Podání:

OPHTHALMIC

Jednotky v balení:

2.5ML

Druh předpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0248501002; AHFS:

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2015-10-16

Charakteristika produktu

PRODUCT MONOGRAPH
PR
TEVA-LATANOPROST/TIMOLOL
_(FIXED COMBINATION OF LATANOPROST 50 _MCG/ML _AND TIMOLOL 5 MG/ML AS
TIMOLOL MALEATE) _
STERILE OPHTHALMIC SOLUTION
ELEVATED INTRAOCULAR PRESSURE THERAPY
PROSTAGLANDIN F
2Α
ANALOGUE AND BETA-ADRENERGIC RECEPTOR BLOCKER
Control No. : 141333
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
September 26, 2012
2
PRODUCT MONOGRAPH
PR
TEVA-LATANOPROST/TIMOLOL
_ (FIXED COMBINATION OF LATANOPROST 50 _MCG/ML _AND TIMOLOL 5 MG/ML AS
TIMOLOL MALEATE) _
STERILE OPHTHALMIC SOLUTION
THERAPEUTIC CLASSIFICATION
ELEVATED INTRAOCULAR PRESSURE THERAPY
PROSTAGLANDIN F
2Α ANALOGUE AND BETA-ADRENERGIC RECEPTOR BLOCKER
ACTION_S _AND CLINICAL PHARMACOLOGY
TEVA-LATANOPROST/TIMOLOL consists of two components
_: _
latanoprost and timolol
maleate. Each mL of TEVA-LATANOPROST/TIMOLOL contains latanoprost 50
micrograms
and timolol maleate 6.8 mg equivalent to 5 mg timolol. These two
components decrease elevated
intraocular pressure (IOP) by different mechanisms of action.
LATANOPROST
is a prostanoid selective FP receptor agonist which reduces the IOP by
increasing
the outflow of aqueous humor. The main mechanism of action is
increased uveoscleral outflow.
In addition, some increase in outflow facility (decrease in trabecular
outflow resistance) has been
reported in man.
TIMOLOL MALEATE
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 anesthetic (membrane-stabilizing) activity.
Timolol lowers the IOP by
decreasing the formation of aqueous humor in the ciliary epithelium.
The precise mechanism of
action is not clearly established. The combined effect of these two
agents administered as
TEVA-LATANOPROST/TIMOLOL once daily results in additional intraocular
pressure
reduction compared to either component administered alone separately.
For details of
information obtained from Clinical Trials with latanoprost and timolol
maleate ophthalmic
soluti