LEVOBUNOLOL HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

LEVOBUNOLOL HYDROCHLORIDE

Composition:

LEVOBUNOLOL HYDROCHLORIDE 5 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOBUNOLOL HYDROCHLORIDE- LEVOBUNOLOL HYDROCHLORIDE SOLUTION
SANDOZ INC
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LEVOBUNOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP
STERILE
DESCRIPTION
Levobunolol Hydrochloride Ophthalmic Solution is a sterile,
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.
Structural Formula: levobunolol HCl
CHEMICAL NAME:
(-)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-1(2H)-naphthalenone
hydrochloride.
EACH ML OF 0.5% CONTAINS:
ACTIVE: levobunolol HCl 0.5%. PRESERVATIVE: benzalkonium chloride
0.004%. INACTIVES: polyvinyl
alcohol 1.4%; edetate disodium; sodium metabisulfite; sodium
phosphate, dibasic; potassium phosphate,
monobasic; sodium chloride; hydrochloric acid or sodium hydroxide to
adjust pH; and purified water.
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.
1
2
Beta-adrenergic receptor blockade in the bronchi and bronchioles
results in increased airway resistance
from unopposed para-sympathetic activity. Such an effect in patients
with asthma or other
bronchospastic conditions is potentially dangerous. Levobunolol
Hydrochloride Ophthalmic Solution,
USP has been shown to be an acti