AZOPT^® Suspension

AZOPT^® (brinzolamide ophthalmic suspension) is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

The recommended dose is one drop of AZOPT^® Suspension in the affected eye(s) three times daily.

AZOPT^® Suspension may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten (10) minutes apart.

AZOPT^® Suspension is contraindicated in patients who are hypersensitive to any component of this product.

Sulfonamide Hypersensitivity Reactions -AZOPT^® Suspension 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 AZOPT^® Suspension. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is re-administered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation

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 AZOPT^® Suspension to this group of patients.

Severe Renal Impairment -AZOPT^® Suspension has not been studied in patients with severe renal impairment (CrCl < 30 mL/min). Because AZOPT^® Suspension and its metabolite are excreted predominantly by the kidney, AZOPT^® Suspension is not recommended in such patients.

Acute Angle-Closure Glaucoma -The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.
AZOPT^® Suspension has not been studied in patients with acute angle-closure glaucoma.

Contact Lens Wear - - The preservative in AZOPT^® Suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation, but may be reinserted 15 minutes after instillation.

In clinical studies of AZOPT^® Suspension, the most frequently reported adverse events reported in 5-10% of patients were blurred vision and bitter, sour or unusual taste. Adverse events occurring in 1-5% of patients were blepharitis,dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.

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 AZOPT^® Suspension. The concomitant administration of AZOPT^® Suspension and oral carbonic anhydrase inhibitors is not recommended.

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 AZOPT^® Suspension.

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