alone.

gradual withdrawal of beta-adrenergic blocking agents prior to general anesthesia because of the reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli. pulmonary: caution should be exercised in the treatment of glaucoma patients with excessive restriction of pulmonary function. there have been reports of asthmatic attacks and pulmonary distress during betaxolol treatment. although rechallenges of some such patients with ophthalmic betaxolol has not adversely affected pulmonary function test results, the possibility of adverse pulmonary effects in patients sensitive to beta-blockers cannot be ruled out. risk from anaphylactic reaction: while taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

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.

alone.

reduction in the forced expiratory volume in one second (fev 1 ) after administration of ophthalmic timolol. betaxolol had no significant effect on pulmonary function as measured by fev 1 , forced vital capacity (fvc) and fev 1 /vc. additionally, the action of isoproterenol, a beta stimulant administered at the end of the study was not inhibited by ophthalmic betaxolol. in contrast, ophthalmic timolol significantly decreased these pulmonary functions. 1 schoene, r. b. et al., am. j. ophthal. 97:86, 1984. a twice the clinical concentration. b inhaled at 240 minutes; measurement at 270 minutes. *timolol statistically different from betaxolol and placebo (p < 0.05). fev 1 - percent change from baseline 1 means betaxolol 1.0% a timolol 0.5% placebo baseline 1.6 1.4 1.4 60 minutes 2.3 -25.7* 5.8 120 minutes 1.6 -27.4* 7.5 240 minutes -6.4 -26.9* 6.9 isoproterenol b 36.1 -12.4* 42.8 no evidence of cardiovascular beta-adrenergic blockade during exercise was observed with betaxolol in a double-masked, three-way crossover study in 24 normal subjects comparing ophthalmic betaxolol, timolol and placebo for effect on blood pressure and heart rate. mean arterial blood pressure was not affected by any treatment; however, ophthalmic timolol produced a significant decrease in the mean heart rate. 1 atkins, j. m. et al. , am. j. oph. 99:173-175, feb., 1985. a twice the clinical concentration. *mean pulse rate significantly lower for timolol than betaxolol or placebo (p < 0.05). mean heart rates 1 bruce stress exercise test treatment minutes betaxolol 1% a timolol 0.5% placebo 0 79.2 79.3 81.2 2 130.2 126.0 130.4 4 133.4 128.0* 134.3 6 136.4 129.2* 137.9 8 139.8 131.8* 139.4 10 140.8 131.8* 141.3 clinical studies: optic nerve head damage and visual field loss are the result of a sustained elevated intraocular pressure and poor ocular perfusion. betaxolol has the action of reducing elevated as well as normal intraocular pressure, and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry. the onset of action with betaxolol hydrochloride ophthalmic solution can generally be noted within 30 minutes and the maximal effect can usually be detected 2 hours after topical administration. a single dose provides a 12-hour reduction in intraocular pressure. clinical observation of glaucoma patients treated with betaxolol ophthalmic solution for up to three years shows that the intraocular pressure lowering effect is well maintained. clinical studies show that topical betaxolol ophthalmic solution reduces mean intraocular pressure 25% from baseline. in trials using 22 mmhg as a generally accepted index of intraocular pressure control, betaxolol ophthalmic solution was effective in more than 94% of the population studied, of which 73% were treated with the beta blocker alone. in controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of ophthalmic betaxolol solution and ophthalmic timolol solution were clinically equivalent. betaxolol ophthalmic solution has also been used successfully in glaucoma patients who have undergone a laser trabeculoplasty and have needed additional long-term ocular hypotensive therapy. betaxolol ophthalmic solution has been well tolerated in glaucoma patients wearing hard or soft contact lenses and in aphakic patients. betaxolol ophthalmic solution does not produce miosis or accommodative spasm which are frequently seen with miotic agents. the blurred vision and night blindness often associated with standard miotic therapy are not associated with betaxolol ophthalmic solution. thus, patients with central lenticular opacities avoid the visual impairment caused by a constricted pupil.

index of intraocular pressure control, betaxolol ophthalmic solution was effective in more than 94% of the population studied, of which 73% were treated with the beta blocker alone. in controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of ophthalmic betaxolol solution and ophthalmic timolol solution were clinically equivalent. betaxolol ophthalmic solution has also been used successfully in glaucoma patients who have undergone a laser trabeculoplasty and have needed additional long-term ocular hypotensive therapy. betaxolol ophthalmic solution has been well tolerated in glaucoma patients wearing hard or soft contact lenses and in aphakic patients. betaxolol ophthalmic solution does not produce miosis or accommodative spasm which are frequently seen with miotic agents. the blurred vision and night blindness often associated with standard miotic therapy are not associated with betaxolol ophthalmic solution. thus, patients with central lenticular opacities avoid the visual impairment caused by a constricted pupil.