Conmy Special Precautions

General: Prostatic Cancer: Carcinoma of the prostate and BPH cause many of the same symptoms. These two diseases frequently co-exist. Therefore, patients thought to have BPH should be examined prior to starting terazosin hydrochloride therapy to rule out the presence of carcinoma of the prostate.
Orthostatic Hypotension: While syncope is the most severe orthostatic effect of terazosin, other symptoms of lowered blood pressure, such as dizziness. lightheadedness and palpitations, were more common and occurred in some 28% of patients in clinical trials for hypertension. In BPH clinical trials, 21% of the patients experienced one or more of the following: dizziness, hypotension, postural hypotension, syncope and vertigo. Patients with occupations in which such events represent potential problems, should be treated with particular caution.
Use in Pregnancy: Teratogenic Effects: Terazosin was not teratogenic in either rats or rabbits when administered oral doses up to 280 to 60 times; respectively, the maximum recommended human dose. Fetal resorptions occurred in rats with 480 mg/kg/day, approximately 280 times to maximum recommended human dose. Increased fetal resorptions, decrease fetal weight and an increased number of supernumerary ribs were observed in offspring of rabbits dosed with 60 times the maximum recommended human dose. The finding (in both species) were most likely secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women and the safety of terazosin in pregnancy has not been established. Terazosin hydrochloride is not recommended during pregnancy unless the potential benefit justifies the potential risk to the mother and fetus.
Non-teratogenic Effects: In a peri- and post-natal development study in rats, significantly more pups died in the group dosed with 120 mg/kg/day (>75 times the maximum recommended human dose) then in the control group during the three week postpartum period.
Use in Lactation: It is not known whether terazosin is excreted in breast milk. Because many drugs are excreted in milk, caution should exercised when terazosin is administered to a nursing woman.
Use in children: Safety and effectiveness in children have not been determined.