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:

Pacific Pharma, Inc.

INN (International Name):

levobunolol hydrochloride

Composition:

levobunolol hydrochloride 2.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LEVOBUNOLOL HYDROCHLORIDE- LEVOBUNOLOL HYDROCHLORIDE SOLUTION/ DROPS
PACIFIC PHARMA, INC.
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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