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:

Bausch & Lomb Incorporated

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, 0.5% is supplied sterile in a plastic bottle with a controlled drop tip in the following sizes: NDC 24208-505-05 - 5 mL NDC 24208-505-10 - 10 mL NDC 24208-505-15 - 15 mL Storage: Store between 15°C to 25°C (59°F to 77°F). Protect from light. Replace cap immediately after use. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: October 2022 9117404 (Folded) 9117504 (Flat)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOBUNOLOL HYDROCHLORIDE- LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
----------
LEVOBUNOLOL HYDROCHLORIDE
OPHTHALMIC SOLUTION, USP
0.5%
(STERILE)
RX ONLY
FOR USE IN THE EYES ONLY
DESCRIPTION
Levobunolol hydrochloride ophthalmic solution USP, 0.5% is a
noncardioselective beta-
adrenoceptor blocking agent for ophthalmic use.
Levobunolol hydrochloride is represented by the following structural
formula:
Mol. Formula C
H
NO •HCl
Mol. Wt. 327.85
CHEMICAL NAME:
(–)-5-[3-(_tert_-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-1(2_H_)-
naphthalenone hydrochloride.
EACH ML OF 0.5% CONTAINS:
ACTIVE: levobunolol hydrochloride 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: benzalkonium
chloride (0.004%).
CLINICAL PHARMACOLOGY
Levobunolol hydrochloride is a noncardioselective beta-adrenoceptor
blocking agent,
equipotent at both beta and beta receptors. 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
17
25
3
1
2
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 potential