LEVOBUNOLOL HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOBUNOLOL HYDROCHLORIDE (UNII: O90S49LDHH) (LEVOBUNOLOL - UNII:G6317AOI7K)

Available from:

Physicians Total Care, Inc.

INN (International Name):

LEVOBUNOLOL HYDROCHLORIDE

Composition:

LEVOBUNOLOL HYDROCHLORIDE 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levobunolol Hydrochloride 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 Hydrochloride 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.

Product summary:

Levobunolol hydrochloride ophthalmic solution USP, is supplied in a plastic bottle with a controlled drop tip in the following sizes: 0.5%      5 mL bottles - NDC 54868-3363-1           

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOBUNOLOL HYDROCHLORIDE - LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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LEVOBUNOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION
DES CRIPTION
Levobunolol Hydrochloride Ophthalmic Solution USP is a
noncardioselective beta-adrenoceptor
blocking agent for ophthalmic use.
Levobunolol hydrochloride is represented by the following structural
formula:
C
H NO •HCl
Mol. Wt. 327.85
CHEMICAL NAME:
(-)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-1(2H)-naphthalenone
hydrochloride.
EACH ML OF 0.25% AND 0.5% CONTAINS:
ACTIVE: Levobunolol Hydrochloride 2.5 mg (0.25%) and 5 mg (0.5%);
INACTIVES: Polyvinyl
Alcohol 1.4%, Sodium Chloride, Dibasic Sodium Phosphate, Edetate
Disodium, Sodium Metabisulfite,
Monobasic Potassium Phosphate, and Purified Water. Hydrochloric Acid
and/or Sodium Hydroxide
may be added to adjust pH (5.5 - 7.5); PRESERVATIVE ADDED:
Benzalkonium Chloride (0.004%).
CLINICAL PHARMACOLOGY
Levobunolol hydrochloride 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 hydrochloride, is used. Levobunolol hydrochloride
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 has been shown to be an active agent in lowering elevated
as well as normal intraocular
pressure (IOP) whether or not accompanied by glaucoma. Eleva