RENESE (polythiazide) is contraindicated in patients with anuria, and in patients known to be sensitive to thiazides or to other sulfonamide derivatives.
Drug/Laboratory Test Interactions
In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary VMA of 17%. Therefore, false positive results may occur in screening tests for pheochromocytoma in patients who are being treated with prazosin. If an elevated VMA is found, prazosin should be discontinued and the patient retested after a month.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenic or mutagenic studies have been conducted with Minizide. However, no carcinogenic potential was demonstrated in 18 month studies in rats with either MINIPRESS or RENESE at dose levels more than 100 times the usual maximum human doses. MINIPRESS was not mutagenic in in vivo genetic toxicology studies.
Minizide produced no impairment of fertility in male or female rats at 50 and 25 mg/kg/day of MINIPRESS and RENESE respectively. In chronic studies (one year or more) of MINIPRESS in rats and dogs, testicular changes consisting of atrophy and necrosis occurred at 25 mg/kg/day (60 times the usual maximum recommended human dose). No testicular changes were seen in rats or dogs at 10 mg/kg/day (24 times the usual maximum recommended human dose). In view of the testicular changes observed in animals, 105 patients on long term MINIPRESS therapy were monitored for 17-ketosteroid excretion and no changes indicating a drug effect were observed. In addition, 27 males on MINIPRESS alone for up to 51 months did not have changes in sperm morphology suggestive of drug effect.
Use in Pregnancy
Pregnancy Category C. Minizide was not teratogenic in either rats or rabbits when administered in oral doses more than 100 times the usual maximum human dose. Studies in rats indicated that the combination of RENESE (40 times the usual maximum recommended human dose) and MINIPRESS (8 times the usual maximum recommended human dose) caused a greater number of stillbirths, a more prolonged gestation, and a decreased survival of pups to weaning than that caused by MINIPRESS alone. There are no adequate and well controlled studies in pregnant women. Therefore, Minizide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether MINIPRESS or RENESE is excreted in human milk. Thiazides appear in breast milk. Thus, if use of the drug is deemed essential the patient should stop nursing.
Safety and effectiveness in children has not been established.