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Molecule

Levobunolol

Also known as levobunolol hydrochloride
Available on requestOphthalmology
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Levobunolol is a beta-adrenergic blocker. It is available as eye drops for ophthalmic use. MedsAcross supplies Levobunolol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Beta-Adrenergic Blocker, Adrenergic beta-Antagonists
ATC classification
S01ED03 Levobunolol · Eye medicines, subgroup S01E, subgroup S01ED
US FDA first approval
19 December 1985
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops
Identifiers
UNII G6317AOI7KRxCUI 1813CAS 47141-42-4DrugBank DB01210Q408556

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

Dosing overview

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.

Source: US FDA prescribing information

Contraindications

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, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure, cardiogenic shock, or hypersensitivity to any component of these products.

Source: US FDA prescribing information

Warnings and precautions

As with other topically applied ophthalmic drugs, levobunolol hydrochloride ophthalmic solution may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents. Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension. Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.

Source: US FDA prescribing information

Side effects

In clinical trials the use of levobunolol hydrochloride ophthalmic solution has been associated with transient ocular burning and stinging in up to 1 in 3 patients, and with blepharoconjunctivitis in up to 1 in 20 patients. Decreases in heart rate and blood pressure have been reported. The following adverse reactions have been reported rarely with the use of levobunolol hydrochloride ophthalmic solution: iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus. Decreased corneal sensitivity has been noted in a small number of patients. Although levobunolol has minimal membrane-stabilizing activity, there remains a possibility of decreased corneal sensitivity after prolonged use.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Levobunolol, sorted by availability.

MedicineManufacturerRegisterAvailability
Levobunolol 5 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 19 December 1985Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Levobunolol in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Levobunolol available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Levobunolol and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Levobunolol approved by the US FDA?

Yes. The US FDA first approved Levobunolol on 19 December 1985, according to Drugs@FDA.

Does Levobunolol need cold chain shipping?

No listed presentation of Levobunolol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Levobunolol in?

Levobunolol is classified under ATC code S01ED03 (Levobunolol).

References

  1. Levobunolol Hydrochloride prescribing information (Bausch & Lomb). U.S. National Library of Medicine, DailyMed. Retrieved 24 July 2024

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