BRINZOLAMIDE Drug Interactions: What You Need to Know

INTERACTIONS

• There is a potential additive effect of the known systemic effects of carbonic anhydrase inhibition in patients receiving both oral and topical carbonic anhydrase inhibitors. ( 7.1 )
• Rare instances of acid-base alterations have occurred with high-dose salicylate therapy. ( 7.2 )

7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide ophthalmic suspension 1%. The concomitant administration of brinzolamide ophthalmic suspension 1% and oral carbonic anhydrase inhibitors is not recommended.

7.2 High-Dose Salicylate Therapy Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations. These alterations were not reported in the clinical trials with brinzolamide. However, in patients treated with oral carbonic anhydrase inhibitors, rare instances of acid-base alterations have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving brinzolamide ophthalmic suspension 1%.

Brinzolamide ophthalmic suspension 1% is contraindicated in patients who are hypersensitive to any component of this product. Hypersensitivity to any component of this product. ( 4 )

AND PRECAUTIONS

• Sulfonamide hypersensitivity reactions. ( 5.1 )
• Corneal edema may occur in patients with low endothelial cell counts. ( 5.2 )

5.1 Sulfonamide Hypersensitivity Reactions Brinzolamide ophthalmic suspension 1% is a sulfonamide and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of brinzolamide ophthalmic suspension 1%. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation immediately.

5.2 Corneal Endothelium Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing brinzolamide ophthalmic suspension 1% to this group of patients.

5.3 Severe Renal Impairment Brinzolamide ophthalmic suspension 1% has not been studied in patients with severe renal impairment [creatinine clearance (CrCl) less than 30 mL/min]. Because brinzolamide ophthalmic suspension 1% and its metabolite are excreted predominantly by the kidney, brinzolamide ophthalmic suspension 1% is not recommended in such patients.

5.4 Acute Angle-Closure Glaucoma The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Brinzolamide ophthalmic suspension 1% has not been studied in patients with acute angle-closure glaucoma.

5.5 Risk of Contamination Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures or other surfaces, since the product can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

5.6 Contact Lens Wear The preservative in brinzolamide ophthalmic suspension 1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of brinzolamide ophthalmic suspension 1%, but may be reinserted 15 minutes after instillation.