Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
levobunolol hydrochloride (UNII: O90S49LDHH) (levobunolol - UNII:G6317AOI7K)
Pacific Pharma, Inc.
levobunolol hydrochloride
levobunolol hydrochloride 2.5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Levobunolol HCl 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. Levobunolol HCl 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.
Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25% 10 mL in 15 mL bottle NDC 60758-063-10 Levobunolol HCl 0.5% 5 mL in 10 mL bottle NDC 60758-060-05 10 mL in 15 mL bottle NDC 60758-060-10 15 mL in 15 mL bottle NDC 60758-060-15 Storage : Protect from light. Store at 15°-25°C (59°-77°F). Revised : 12/2018 For more information, contact: Allergan at 1-800-678-1605 Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All trademarks are the property of their respective owners. v1.0USPI060
New Drug Application Authorized Generic
LEVOBUNOLOL HYDROCHLORIDE- LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS PACIFIC PHARMA, INC. ---------- LEVOBUNOLOL HCL OPHTHALMIC SOLUTION, USP 0.25% AND 0.5% STERILE DESCRIPTION Levobunolol HCl ophthalmic solution, USP 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(2_H_)-naphthalenone hydrochloride. STRUCTURAL FORMULA: levobunolol HCl CONTAINS: ACTIVE: Levobunolol HCl 0.25% or 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, 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 HCl ophthalmic solution, USP has been shown to be an active a Прочитайте повний документ