البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
LEVOBUNOLOL HYDROCHLORIDE
SANDOZ CANADA INCORPORATED
S01ED03
LEVOBUNOLOL
0.25%
LIQUID
LEVOBUNOLOL HYDROCHLORIDE 0.25%
OPHTHALMIC
5/10/15ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0116868002; AHFS:
CANCELLED POST MARKET
2019-08-01
_ _ _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 اقرأ الوثيقة كاملة