SANDOZ LEVOBUNOLOL LIQUID

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LEVOBUNOLOL HYDROCHLORIDE

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

S01ED03

INN (International Name):

LEVOBUNOLOL

복용량:

0.25%

약제 형태:

LIQUID

구성:

LEVOBUNOLOL HYDROCHLORIDE 0.25%

관리 경로:

OPHTHALMIC

패키지 단위:

5/10/15ML

처방전 유형:

Prescription

치료 영역:

BETA-ADRENERGIC AGENTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2019-08-01

제품 특성 요약

_ _
_Sandoz Levobunolol _
_Page 1 of 18_
PRODUCT MONOGRAPH
PR
SANDOZ LEVOBUNOLOL
LEVOBUNOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP
0.25% and 0.5%
Glaucoma Therapy
Sandoz Canada Inc.
145 Jules-Leger
Boucherville, QC
J4B 7K8
Date of Preparation:
June 7, 2012
Submission Control No: 155888
_ _
_Sandoz Levobunolol _
_Page 2 of 18_
PRODUCT MONOGRAPH
PR
SANDOZ LEVOBUNOLOL
LEVOBUNOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP
THERAPEUTIC CLASSIFICATION
Glaucoma Therapy
ACTIONS AND CLINICAL PHARMACOLOGY
Levobunolol HCl is a noncardioselective beta-adrenoceptor antagonist,
equipotent at both beta
1
and beta
2
receptors. Levobunolol is approximately 60 times more potent than the
dextro isomer
of bunolol in its beta-blocking activity, yet equipotent in its
potential for direct myocardial
depression. Accordingly, the levo isomer, levobunolol, is used.
Levobunolol does not have a
significant local anesthetic (membrane stabilizing) effect or
intrinsic sympathomimimetic
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.
Levobunolol, when instilled into the eye, will lower elevated
intraocular pressure as well as
normal IOP, whether or not accompanied by glaucoma. Elevated
intraocular pressure 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 levobunolol can be detected
within one hour after treatment,
with maximum effect seen betwe