Betaxolol

Indications

INDICATIONS AND USAGE Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION The recommended dose is one to two drops of Betaxolol Hydrochloride Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol Hydrochloride Ophthalmic Solution may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.

Contraindications

CONTRAINDICATIONS Hypersensitivity to any component of this product. Betaxolol Hydrochloride Ophthalmic Solution is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.

Warnings and precautions

WARNING Topically applied beta-adrenergic blocking agents 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.

Pregnancy

Pregnancy Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively.

Storage and supply

HOW SUPPLIED Betaxolol Hydrochloride Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 5, 10 and 15 mL in plastic ophthalmic dispensers. 5 mL: NDC 61314-245-01 15 mL: NDC 61314-245-02 10 mL: NDC 61314-245-03 STORAGE: Store at 20° to 25°C (68° to 77°F) . Rev.

Source: Betaxolol Hydrochloride (Betaxolol Hydrochloride) — US FDA prescribing information, 2023-10-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.