Levobunolol Hydrochloride (Page 3 of 3)

OVERDOSAGE

No data are available regarding overdosage in humans. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. If accidentally ingested, efforts to decrease further absorption may be appropriate (gastric lavage). The most common signs and symptoms to be expected with overdosage with administration of a systemic beta-adrenergic blocking agent are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure. Should these symptoms occur, discontinue levobunolol hydrochloride ophthalmic solution therapy and initiate appropriate supportive therapy. The following supportive measures should be considered:

1. Symptomatic bradycardia: Use atropine sulfate intravenously in a dosage of 0.25 mg to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride should be administered cautiously. In refractory cases the use of a transvenous cardiac pacemaker should be considered.

2. Hypotension: Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases the use of glucagon hydrochloride may be useful.

3. Bronchospasm: Use isoproterenol hydrochloride. Additional therapy with aminophylline may be considered.

4. Acute cardiac failure: Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases the use of intravenous aminophylline is suggested. This may be followed, if necessary, by glucagon hydrochloride which may be useful.

5. Heart block (second or third degree): Use isoproterenol hydrochloride or a transvenous cardiac pacemaker.

DOSAGE AND ADMINISTRATION

The recommended starting dose is one to two drops of levobunolol hydrochloride ophthalmic solution, 0.5% in the affected eye(s) once a day. In patients with more severe or uncontrolled glaucoma, levobunolol hydrochloride ophthalmic solution, 0.5% can be administered twice a day. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of levobunolol hydrochloride ophthalmic solution, 0.5% twice a day are not generally more effective. If the patient’s IOP is not at a satisfactory level on this regimen, concomitant therapy with other ophthalmic IOP-lowering agents can be instituted. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.

HOW SUPPLIED

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.

Do not
(click image for full-size original)

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)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-505-05

Levobunolol
Hydrochloride
Ophthalmic
Solution, USP
0.5% (Sterile)

FOR OPHTHALMIC USE ONLY.

Rx only

5 mL

BAUSCH + LOMB

9564501
AB28507

Carton
(click image for full-size original)
LEVOBUNOLOL HYDROCHLORIDE
levobunolol hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-505
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOBUNOLOL HYDROCHLORIDE (LEVOBUNOLOL) LEVOBUNOLOL HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE 0.04 mg in 1 mL
POLYVINYL ALCOHOL, UNSPECIFIED 14 mg in 1 mL
SODIUM CHLORIDE
EDETATE DISODIUM
SODIUM METABISULFITE
MONOBASIC POTASSIUM PHOSPHATE
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-505-05 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-505-05)
2 NDC:24208-505-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-505-10)
3 NDC:24208-505-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
3 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-505-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074326 03/04/1994
Labeler — Bausch & Lomb Incorporated (002207751)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE (24208-505)

Revised: 10/2022 Bausch & Lomb Incorporated

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