Levobunolol

FDA label, Bausch & Lomb Incorporated, ophthalmic, effective 2024-07-24. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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.

Drug interactions

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Label text (3 paragraphs)

Drug Interactions Although levobunolol hydrochloride ophthalmic solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with levobunolol hydrochloride ophthalmic solution and epinephrine may occur. Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

Patients receiving beta-adrenergic blocking agents along with either oral or intravenous calcium antagonists should be monitored for possible atrioventricular conduction disturbances, left ventricular failure and hypotension. In patients with impaired cardiac function, simultaneous use should be avoided altogether. The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects on prolonging atrioventricular conduction time. Phenothiazine-related compounds and beta-adrenergic blocking agents may have additive hypotensive effects due to the inhibition of each other’s metabolism.

Risk of Anaphylactic Reaction While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.

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 (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.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for levobunolol. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Fetotoxicity (as evidenced by a greater number of resorption sites) has been observed in rabbits when doses of levobunolol hydrochloride equivalent to 200 and 700 times the recommended dose for the treatment of glaucoma were given. No fetotoxic effects have been observed in similar studies with rats at up to 1,800 times the human dose for glaucoma. Teratogenic studies with levobunolol in rats at doses up to 25 mg/kg/day (1,800 times the recommended human dose for glaucoma) showed no evidence of fetal malformations. There were no adverse effects on postnatal development of offspring.

It appears when results from studies using rats and studies with other beta-adrenergic blockers are examined, that the rabbit may be a particularly sensitive species. There are no adequate and well-controlled studies in pregnant women. Levobunolol hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

Nursing Mothers It is not known whether this drug is excreted in human milk. Systemic beta-blockers and topical timolol maleate are known to be excreted in human milk. Caution should be exercised when levobunolol hydrochloride ophthalmic solution is administered to a nursing woman.

Breastfeeding (LactMed)

Based on its physicochemical properties and its ophthalmic route of administration, levobunolol appears to present a moderately low risk to the breastfed infant. Some guidelines state that gel formulations are preferred over solutions. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Alternatives LactMed suggests considering:
Source: LactMed: Levobunolol (NICHD, public domain)Revised Oct 15, 2024

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