FDA label 4D3F099E-7F56-EE86-9507-018C8533A874

WARNINGS NOT FOR INJECTION OR ORAL ADMINISTRATION. FOR TOPICAL OPHTHALMIC USE ONLY. COMBINE PARTS I AND II PRIOR TO DISPENSING AND LABEL WITH A TWO (2) WEEK EXPIRATION DATE 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 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. Betoptic ® Pilo Ophthalmic Suspension should be discontinued at the first signs of cardiac failure.

ADVERSE REACTIONS In multi-center controlled clinical trials of Betoptic ® Pilo Ophthalmic Suspension the adverse events reported in an approximately 5 to 20% incidence of patients were: headaches, blurred vision, dim vision, abnormal vision, and vitreous disorder. In the 3-month controlled clinical trials, 12% of patients enrolled on Betoptic ® Pilo treatment discontinued the therapy within the first two weeks of treatment because of intolerance due to adverse reactions. In a 24-month long-term safety study, by Month-12, 20% of patients had discontinued and by the Month-24 endpoint, 55% of patients had discontinued Betoptic ® Pilo therapy. The following adverse events were reported at an incidence of 1 to 4% of patients: bronchitis, browache, constipation, dizziness, hyperemia, ocular discomfort, nausea, and pain. The following adverse events were reported in less than 1% of the patients: abnormal dreams, asthenia, asthma, blepharitis, conjunctival edema, lid erythema, lid margin crusting, lid spasm, palpitation, periorbital edema, photophobia, scotoma, synechiae, and tearing. In addition, the following adverse events have been associated with ophthalmic formulations containing betaxolol or pilocarpine: Ocular : Discomfort characterized by burning and stinging upon instillation, ciliary spasm, conjunctival vascular congestion, myopia (especially in younger individuals who have recently started therapy), and reduced visual acuity in poor illumination (frequently experienced by older individuals and individuals with lens opacity), corneal punctate keratitis, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes. Retinal detachments have been reported with the use of miotics such as pilocarpine and cataracts may occur with prolonged use of pilocarpine. Additional ocular events reported with other formulations of betaxolol or pilocarpine include allergic reactions, decreased corneal sensitivity, edema, anisocoria, lacrimation, and superficial keratitis (corneal granularity). Systemic : Cardiovascular ; Bradycardia, heart block, and congestive heart failure; Pulmonary ; Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma, and respiratory failure; Nervous System ; Insomnia, dizziness, vertigo, temporal or supraorbital headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis; Other : Hives, toxic epidermal necrolysis, hair loss and glossitis.