*Some of these events may continue after you stop taking AVODART.Depressed mood has been reported in patients receiving AVODART.Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects with AVODART. Avodart is a prescription medicine used to treat the symptoms of an enlarged prostate (Avodart belongs to a class of drugs called 5-Alpha-Reductase Inhibitors.It is not known if Avodart is safe and effective in children.Get medical help right away, if you have any of the symptoms listed above.Tell the doctor if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of Avodart. In men with prostate volumes ≥40 cc, the mean decrease was -3.8 units for dutasteride and -1.6 units for placebo, with a mean difference between the 2 treatment groups of -2.2 at Month 24. See Figure 7.The additional improvement in Qmax of combination therapy over monotherapy with AVODART was no longer statistically significant at Month 48.The mean prostate volume at trial entry was approximately 55 cc. Do not use
The clinical significance of the effect of dutasteride on semen characteristics for an individual patient’s fertility is not known [see Advise the patient to read the FDA-approved patient labeling (Inform patients that AVODART reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. In a clinical trial, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg.There is no specific antidote for dutasteride. If you miss a dose, skip the missed dose and continue on with your regular schedule. Tell your doctor if you become pregnant during treatment. Both of these isoenzymes produced the 4'-hydroxydutasteride, 6-hydroxydutasteride, and the 6,4'-dihydroxydutasteride metabolites. There was no change in bone mineral density as measured by dual energy x-ray absorptiometry compared with either placebo or baseline. At Month 12, the mean increase in Qmax across the 3 trials pooled was 1.6 mL/sec for AVODART and 0.7 mL/sec for placebo; the mean difference (dutasteride minus placebo) was 0.8 mL/sec (range: 0.7 to 1.0 mL/sec in each of the 3 trials, P <0.001). Eighty-eight percent (88%) of the enrolled trial population was white. Noncompliance with AVODART may also affect PSA test results.To interpret an isolated PSA value in a man treated with AVODART for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men. To interpret serial PSAs in men taking AVODART, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. symptoms of Tell your healthcare provider about all the medicines you take, including prescription and nonprescription
No dose adjustment is recommended.Administration of a single 5-mg dose of AVODART followed 1 hour later by 12 g cholestyramine did not affect the relative bioavailability of dutasteride in 12 normal volunteers.In a trial of 20 healthy volunteers, AVODART did not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.In a trial of 23 healthy volunteers, 3 weeks of treatment with AVODART 0.5 mg/day did not alter the steady-state pharmacokinetics of the S-or R-warfarin isomers or alter the effect of warfarin on prothrombin time when administered with warfarin.Although specific interaction trials were not performed with other compounds, approximately 90% of the subjects in the 3 randomized, double-blind, placebo-controlled safety and efficacy trials receiving AVODART were taking other medications concomitantly.