TRUSOPT has not been studied in patients with severe renal impairment (CrCl < 30 mL/min). Because TRUSOPT 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.
TRUSOPT 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, including severe reactions such as Stevens- Johnson syndrome and toxic epidermal and toxic epidermal necrolysis. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
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 (e.g., dorzolamide) after filtration procedures.
TRUSOPT Ophthalmic Solution 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 minutes after use.
There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Precautions should be used when prescribing TRUSOPT to this group of patient.
Mutagenesis, Carcinogenesis and Impairment of Fertility: In a 2 year study of dorzolamide administered orally to male and female rats, urinary bladder papillomas were seen in male rats in the highest dosage group of 20mg/kg/day. No treatment related tumors were seen in a 21-months study in male and female mice given oral doses up to 75 and 37.5mg/kg/day, respectively.
The increased incidence of urinary bladder papillomas seen in the high-dose male rats appears to be class effect of carbonic anhydrase inhibitors in rats. Rats are particularly prone to developing papillomas in response to foreign bodies, compounds causing crystalluria and diverse sodium salts.
No changes in bladder urothelium were seen in dogs given oral dorzolamide hydrochloride for 1 year at doses of 2mg/kg/day or in monkeys given 20μL of 3% dorzolamide hydrochloride topically to the eye bid of 1 year.
Dorzolamide showed no mutagenic potential in a series of standard assays for gene mutations, chromosomal damage and DNA damage.
In reproduction studies of dorzolamide hydrochloride in rats, there were no adverse effects on the reproductive capacity of males or females at oral doses up to 15 and 7.5mg/kg/day.
Use in Children: Safety and effectiveness have not been established.
Use in Elderly: Of the total number of patients in clinical studies of TRUSOPT, 44% were 65 years of age and over, while 10% were 75 years of age and over. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals to the product cannot be ruled out.