Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
LEVOBUNOLOL HYDROCHLORIDE
TEVA CANADA LIMITED
S01ED03
LEVOBUNOLOL
0.25%
SOLUTION
LEVOBUNOLOL HYDROCHLORIDE 0.25%
OPHTHALMIC
10ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0116868002; AHFS:
CANCELLED POST MARKET
2018-05-02
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 Izlasiet visu dokumentu