Levobunolol Hydrochloride Ophthalmic Solution USP, 0.5%, 5mL

NDC: 24208-505-05

Levobunolol Hydrochloride Ophthalmic Solution, USP 0.5%, 5 mL — Bausch & Lomb

Active ingredient	Levobunolol hydrochloride 0.5% (5 mg per mL)
Dosage form	Ophthalmic solution
Route	Topical ophthalmic
Size	5 mL
Manufacturer	Bausch & Lomb
NDC	24208-505-05

Indications and Usage

Lowers intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Dosage and Administration

Instill one to two drops of the 0.5% solution in the affected eye(s) once daily; may be increased to twice daily in patients with more severe or uncontrolled glaucoma. Dosages above one drop twice daily are not generally more effective.

Warnings and Precautions

• Systemically absorbed; may cause the same cardiac and respiratory adverse reactions as systemic beta-blockers, including bronchospasm and cardiac failure
• May mask signs of hypoglycemia in diabetics and symptoms of hyperthyroidism
• Consider gradual withdrawal before elective major surgery; discontinue at the first sign of cardiac failure
• May potentiate muscle weakness in myasthenic patients and potentiate vascular insufficiency syndromes (e.g., Raynaud's phenomenon); contains sodium metabisulfite, which may cause allergic-type reactions in susceptible individuals

Contraindications

Contraindicated in bronchial asthma or history of asthma, severe COPD, sinus bradycardia, second- or third-degree AV block, overt cardiac failure, cardiogenic shock, or hypersensitivity to any component.

Adverse Reactions

Transient ocular burning and stinging occur in up to 1 in 3 patients, and blepharoconjunctivitis in up to 1 in 20. Less frequent effects include headache, bradycardia, hypotension, and other cardiovascular events.

Storage and Handling

Store between 15°C to 25°C (59°F to 77°F). Protect from light. Replace cap immediately after use.

How Supplied

Sterile 0.5% ophthalmic solution in a plastic dropper bottle with controlled drop tip, including 5 mL size.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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