Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LEVOBUNOLOL HYDROCHLORIDE (UNII: O90S49LDHH) (LEVOBUNOLOL - UNII:G6317AOI7K)
Allergan, Inc.
levobunolol hydrochloride
levobunolol hydrochloride 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
BETAGAN ® ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension. BETAGAN ® ophthalmic solution is contraindicated in those individuals with bronchial asthma, or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS); sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure (see WARNINGS); cardiogenic shock; or hypersensitivity to any component of these products.
BETAGAN ® (levobunolol hydrochloride ophthalmic solution, USP) is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips, with a yellow high density polystyrene cap, as follows: 5 mL in 10 mL bottle NDC 0023-4385-05 10 mL in 15 mL bottle NDC 0023-4385-10 15 mL in 15 mL bottle NDC 0023-4385-15 Storage : Protect from light. Store at 15°-25°C (59°-77°F). Revised : 09/2021 © 2021 Allergan. All rights reserved. All trademarks are the property of their respective owners. Distributed by: Allergan, USA Inc., Madison NJ 07940
New Drug Application
BETAGAN- LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS ALLERGAN, INC. ---------- BETAGAN (LEVOBUNOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP) STERILE DESCRIPTION BETAGAN (levobunolol hydrochloride ophthalmic solution, USP) sterile is a noncardioselective beta-adrenoceptor blocking agent for ophthalmic use. The solution is colorless to slightly light yellow in appearance with an osmolality range of 250-360 mOsm/kg. The shelf life pH range is 5.5 to 7.5. CHEMICAL NAME: (-)-(_S_)-5-[3-(_tert_-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-1(_2H_)- naphthalenone hydrochloride. STRUCTURAL FORMULA: levobunolol HCl CONTAINS: ACTIVE: levobunolol HCl 0.5%. PRESERVATIVE: benzalkonium chloride 0.004% INACTIVES: edetate disodium; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium chloride; sodium metabisulfite; sodium phosphate, dibasic; and hydrochloric acid or sodium hydroxide to adjust pH. CLINICAL PHARMACOLOGY Levobunolol HCl is a noncardioselective beta-adrenoceptor blocking agent, equipotent at both beta and beta receptors. Levobunolol HCl is greater than 60 times more potent than its dextro isomer in its beta-blocking activity, yet equipotent in its potential for direct myocardial depression. Accordingly, the levo isomer, levobunolol HCl, is used. Levobunolol HCl does not have significant local anesthetic (membrane-stabilizing) 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, ® ® 1 2 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. BETAGAN (levobunolol hydrochloride ophthalmic solution, USP) has Soma hati kamili