RATIO-LEVOBUNOLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LEVOBUNOLOL HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

S01ED03

INN (International Name):

LEVOBUNOLOL

Dosage:

0.25%

Pharmaceutical form:

SOLUTION

Composition:

LEVOBUNOLOL HYDROCHLORIDE 0.25%

Administration route:

OPHTHALMIC

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0116868002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-05-02

Summary of Product characteristics

PRODUCT MONOGRAPH
RATIO-LEVOBUNOLOL
LEVOBUNOLOL HYDROCHLORIDE
OPHTHALMIC SOLUTION
0.25% AND 0.5%
GLAUCOMA THERAPY
NONCARDIOSELECTIVE BETA-ADRENOCEPTOR BLOCKING AGENT
TEVA CANADA LIMITED
DATE OF PREPARATION:
30 NOVOPHARM COURT
APRIL 16, 2013
TORONTO, ONTARIO
CANADA M1B 2K9
WWW.TEVACANADA.COM
CONTROL #: 163603
Page 2
PRODUCT MONOGRAPH
RATIO-LEVOBUNOLOL
LEVOBUNOLOL HYDROCHLORIDE
OPHTHALMIC SOLUTION
0.25% AND 0.5%
GLAUCOMA THERAPY
NONCARDIOSELECTIVE BETA-ADRENOCEPTOR BLOCKING AGENT
ACTIONS AND CLINICAL PHARMACOLOGY
Levobunolol HCl is a noncardioselective beta-adrenoceptor antagonist,
equipotent at
both beta
1
and beta
2
receptors. Levobunolol HCl is approximately 60 times more potent
than the dextro isomer of levobunolol in its beta-blocking activity,
yet equipotent in its
potential for direct myocardial depression. Accordingly, the levo
isomer, levobunolol, is
used.
Levobunolol
HCl
does
not
have
a
significant
local
anesthetic
(membrane
stabilizing) effect or intrinsic sympathomimetic activity.
Beta-adrenergic receptor blockade reduces cardiac output in both
healthy subjects and
patients with heart disease. In patients with severe impairment of
myocardial function,
beta-adrenergic receptor blockade may inhibit the stimulatory effect
of the sympathetic
nervous system necessary to maintain adequate cardiac function.
Beta-adrenergic receptor blockade in the bronchi and bronchioles
results in increased
airway resistance from unopposed parasympathetic activity. Such an
effect in patients
with
asthma
or
other
bronchospastic
conditions
is
potentially
dangerous.
Page 3
RATIO-LEVOBUNOLOL (levobunolol HCl), when instilled into the eye, will
lower elevated
intraocular pressure (IOP) as well as normal (IOP), whether or not
accompanied by
glaucoma. Elevated IOP is a major risk factor in the pathogenesis of
glaucomatous
visual field loss. The higher the level of intraocular pressure, the
greater the likelihood
of optic nerve damage and visual field loss.
The onset of action with one drop of RATIO-LEVOBUNOLOL can be detected
within