Trusopt has not been studied in patients with severe renal impairment (CrCl <30 mL/min). Because dorzolamide HCl and its metabolite are excreted predominantly by the kidney, Trusopt is not recommended in such patients.
The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Trusopt has not been studied in patients with acute angle-closure glaucoma.
Trusopt has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.
Dorzolamide HCl is a sulfonamide and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of Trusopt.
In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of Trusopt. Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. If such reactions are observed, discontinuation of treatment with Trusopt should be considered.
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 Trusopt. The concomitant administration of Trusopt and oral carbonic anhydrase inhibitors has not been studied and is not recommended.
Choroidal detachment has been reported with administration of aqueous suppressant therapy (eg, dorzolamide) after filtration procedures.
Trusopt contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Therefore, Trusopt should not be administered while wearing soft contact lenses. The contact lenses should be removed before application of the drops and not be reinserted earlier than 15 min after use.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Trusopt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Trusopt is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in children have not been established.