Zophtal Special Precautions

General: Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. The effect of continued administration of ZOPHTAL on the corneal endothelium has not been fully evaluated. The management of patients with acute-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. ZOPHTAL has not been studied in patients with acute angle-closure glaucoma. ZOPHTAL has not been studied in patients with severe renal impairment (CrCl < 30 mL/min). Because ZOPHTAL and its metabolite are excreted predominantly by the kidney. ZOPHTAL is not recommended in such patients.
ZOPHTAL has not been studied in patients with hepatic impairment and should be used with caution in such patients.
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 ZOPHTAL. The concomitant administration of ZOPHTAL and oral carbonic anhydrase inhibitors is not recommended.
Information for Patients: ZOPHTAL (Brinzolamide ophthalmic suspension) 1% is a sulfonamide and although administered topically, it is absorbed systemically; therefore, the same types of adverse reactions attributable to sulfonamides may occur with topical administration.
Patients should be advised that if serious or unusual ocular or systemic reactions or signs of hypersensitivity occur, they should discontinue the use of the product and consult their physician (see Warnings).
Vision may be temporarily blurred following dosing with ZOPHTAL (Brinzolamide ophthalmic suspension) 1%. Care should be exercised in operating machinery or driving a motor vehicle.
Patient should be instructed to 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.
Patient should also be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g. trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. The preservative in ZOPHTAL (Brinzolamide ophthalmic suspension) 1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of ZOPHTAL (Brinzolamide ophthalmic suspension) 1%, but may be reinserted 15 minutes after instillation.
Pediatric Use: A three-month controlled clinical study was conducted in which ZOPHTAL (Brinzolamide ophthalmic suspension) 1% was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. Patients were not required to discontinue their IOP-lowering medication(s) until initiation of monotherapy with ZOPHTAL. IOP lowering efficacy was not demonstrated in this study in which the mean decrease in elevated IOP was between 0 and 2 mmHg. Five out of 32 patients demonstrated an increase in corneal diameter of one millimeter.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.