BETAGAN- 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:

Allergan, Inc.

INN (International Name):

levobunolol hydrochloride

Composition:

levobunolol hydrochloride 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

BETAGAN- LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS
ALLERGAN, INC.
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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