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In well-controlled clinical studies of brinzolamide, adverse reactions related to brinzolamide were generally mild to moderate and usually did not lead to discontinuation of therapy. Table 1 lists for brinzolamide 1% and placebo reported adverse events possibly, probably or definitely related to therapy occurring at an incidence of 1% or greater.
Table 1: AZOPT
Adverse Events
| |
AZOPT 1%
N=1173
% Incidence
|
Placebo
N=101
% Incidence
|
| Ocular |
| Blurred Vision |
5.0 |
2.0 |
| Discomfort |
2.6 |
3.0 |
| Foreign Body sensation |
1.8 |
0 |
| Dry Eye |
1.2 |
1.0 |
| Hyperemia |
1.1 |
1.0 |
| Pain |
1.0 |
1.0 |
| Nonocular |
| Body as a Whole |
| Headache |
1.5 |
1.0 |
| Special Senses |
| Taste Perversion |
5.6 |
1.0 |
Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. In a 12-month topical ocular primate study, continued administration of brinzolamide ophthalmic suspension resulted in no significant effect on the corneal endothelium as evaluated by specular microscopy.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures or with other surfaces.
If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart.
Although acid-base and electrolyte alterations were not reported in the clinical trials with brinzolamide, these changes have been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e.g., toxicity associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving brinzolamide suspension.
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