국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Allergan
BETAGAN 0,5% Liquifilm Sterile Ophthalmic Solution SCHEDULING STATUS: Schedule 3 PROPRIETARY NAME (and dosage form): BETAGAN 0,5% Liquifilm Sterile Ophthalmic Solution COMPOSITION BETAGAN 0,5% Liquifilm Sterile Ophthalmic solution contains: Levobunolol hydrochloride 5 mg/mL Liquifilm (polyvinyl alcohol) 14 mg/mL Sodium metabisulphite (antioxidant) 2 mg/mL Benzalkonium chloride (preservative) 0,004% m/v. PHARMACOLOGICAL CLASSIFICATION A 15.4. Ophthalmic preparations. Other PHARMACOLOGICAL ACTION Levobunolol is a non-cardioselective beta-adrenoreceptor blocking agent, equipotent at both beta 1 , and beta 2 receptors. Levobunolol is 60 times more potent than its dextro isomer in its beta-blocking activity. In order to obtain the highest degree of beta-blocking potential without increasing the potential for direct myocardial depression, the levo isomer, levobunolol, is used. Levobunolol does not have significant local anaesthetic (membrane stabilising) or intrinsic sympathomimetic activity. BETAGAN, when instilled in the eye, will lower elevated intraocular pressure as well as normal intraocular pressure, whether or not accompanied by glaucoma. The onset of action with one drop of BETAGAN can be detected within one hour after treatment, with maximum effect seen between two and six hours. A significant decrease can be maintained for up to 24 hours following a single dose. The exact mechanism of action of levobunolol in reducing intraocular pressure is not known. BETAGAN reduces intraocular pressure with little or no effect on pupil size in contrast to the miosis which cholinergic agents are known to produce. INDICATIONS BETAGAN is indicated for the control of intraocular pressure in chronic open angle glaucoma and ocular hypertension. CONTRA-INDICATIONS BETAGAN is contraindicated in patients wi 전체 문서 읽기