Betaxolol Hydrochloride

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 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 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.

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. Betaxolol Hydrochloride Ophthalmic Solution has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betaxolol Hydrochloride Ophthalmic Solution should be discontinued at the first signs of cardiac failure.

ADVERSE REACTIONS The following adverse reactions have been reported in clinical trials with Betaxolol Hydrochloride Ophthalmic Solution. Ocular Discomfort of short duration was experienced by one in four patients, but none discontinued therapy; occasional tearing has been reported. Rare instances of decreased corneal sensitivity, erythema, itching sensation, corneal punctate staining, keratitis, anisocoria, edema, and photophobia have been reported. Additional medical events reported with other formulations of betaxolol include blurred vision, foreign body sensation, dryness of the eyes, inflammation, discharge, ocular pain, decreased visual acuity, and crusty lashes. Systemic Systemic reactions following administration of Betaxolol Hydrochloride Ophthalmic Solution 0.5% or Betaxolol Hydrochloride Ophthalmic Suspension 0.25% have been rarely reported. These include: Cardiovascular Bradycardia, heart block and congestive failure. Pulmonary Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure. Central Nervous System Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis. Other Hives, toxic epidermal necrolysis, hair loss and glossitis. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.