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10Cohen JLong-term efficacy and safety of terazosin alone and in combination with other antihypertensive agentsAm Heart J 1221991919-25.

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.

Hytrinadministered in the feed to rats at doses of 840and 250 mg/kg/day70350and 2100 mg/M 2dayfor two yearswas associated with a statistically significant increase in benign adrenal medullary tumors of male rats exposed to the 250 mg/kg doseThis dose is 175 times the maximum recommended human dose of 20 mg12 mg/M 2Female rats were unaffectedHytrin was not oncogenic in mice when administered in feed for 2 years at a maximum tolerated dose of 32 mg/kg/day110 mg/M 29 times the maximum recommended human doseThe absence of mutagenicity in a battery of testsof tumorigenicity of any cell type in the mouse carcinogenicity assayof increased total tumor incidence in either speciesand of proliferative adrenal lesions in female ratssuggests a male rat species-specific eventNumerous other diverse pharmaceutical and chemical compounds have also been associated with benign adrenal medullary tumors in male rats without supporting evidence for carcinogenicity in man.

Figure 3Mean Change in Peak Flow Rate from Baseline Long-termOpen-labelNon-placebo Controlled StudyN494)

Figure 3Mean Change in Peak Flow Rate from Baseline Long-termOpen-labelNon-placebo Controlled StudyN494)

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