In men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL taking dutasteride in the 4-year Reduction by dutasteride of Prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (dutasteride 1.0% versus placebo 0.5%) [see Indications … Available for Android and iOS devices. Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration. Reduction of fetal adrenal weights, reduction in fetal prostate weights, and increases in fetal ovarian and testis weights were observed at the highest dose tested in monkeys. The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters has not been evaluated. Atorvastatin, 10 mg, fluvastatin, 80 mg, lovastatin, 40-80 mg, and simvastatin, 20 mg can reduce LDL-C by 30-40%; fluvastatin, 40 mg, lovastatin, 10.20 mg, and simvastatin, 10 mg can decrease LDL-C by 20-30% [ 14 ]. In men with prostate volumes <40 cc, the mean decrease was -3.7 units for dutasteride and -2.2 units for placebo, with a mean difference between the 2 treatment groups of -1.5 at Month 24.Statistically significant differences (dutasteride versus placebo) were noted at the earliest post-treatment prostate volume measurement in each trial (Month 1, Month 3, or Month 6) and continued through Month 24. found this review helpful.Reviewer: WIlliamE, 45-54 on Treatment for 1 to less than 2 years (Patient) 18
More than 90% of the trial population was Caucasian. To interpret serial PSAs in men taking dutasteride, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. The average steady-state serum dutasteride concentration was 40 ng/mL following 0.5 mg/day for 1 year.
At tumorigenic doses, luteinizing hormone levels in rats were increased by 167%. people
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.From clinical trials with dutasteride as monotherapy or in combination with tamsulosin:• The most common adverse reactions reported in subjects receiving dutasteride were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. Dutasteride is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Although not all of these side effects may occur, if they do occur they may need medical attention. statin+ASA+dutasteride, statin+ASA, dutasteride+statin, dutasteride+ASA). Dutasteride is contraindicated for use in women of childbearing potential, including nursing women. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. Although not all of these side effects may occur, if they do occur they may need medical attention. The clinical significance of dutasteride’s effect on semen characteristics for an individual patient’s fertility is not known. Histological evaluation of the genital papilla of fetuses revealed evidence of feminization of the male fetus at all doses.
The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).No clinical benefit has been demonstrated in patients with prostate cancer treated with dutasteride.The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.The following adverse reactions have been identified during post-approval use of dutasteride. Therefore, dutasteride may cause fetal harm when administered to a pregnant woman. WebMD does not endorse any specific product, service, or treatment.Do not consider WebMD User-generated content as medical advice. Trial entry criteria were similar to the double-blind, placebo-controlled monotherapy efficacy trials described above in section 14.1. people Adverse Reactions Reported Over a 48-Month Period in1% of Subjects and More Frequently in the Coadministration Therapy Group Than the Groups Receiving Monotherapy With DEffect on 5 Alpha-Dihydrotestosterone and Testosterone:[see Contraindications (4), Warnings and Precautions (5.1)]Effect on Acute Urinary Retention and the Need for BPH-Related Surgery:Figure 2. Some of these opinions may contain information about treatment or uses of drug products that have not been approved by the U.S. Food and Drug Administration. Therefore, on average, the dose unaccounted for approximated 55% (range: 5% to 97%).The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state.
Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. As a percent of dose, there was approximately 5% unchanged dutasteride (~1% to ~15%) and 40% as dutasteride-related metabolites (~2% to ~90%).
Although not all of these side effects may occur, if they do occur they may need medical attention. statin+ASA+dutasteride, statin+ASA, dutasteride+statin, dutasteride+ASA). Dutasteride is contraindicated for use in women of childbearing potential, including nursing women. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. Although not all of these side effects may occur, if they do occur they may need medical attention. The clinical significance of dutasteride’s effect on semen characteristics for an individual patient’s fertility is not known. Histological evaluation of the genital papilla of fetuses revealed evidence of feminization of the male fetus at all doses.
The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).No clinical benefit has been demonstrated in patients with prostate cancer treated with dutasteride.The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.The following adverse reactions have been identified during post-approval use of dutasteride. Therefore, dutasteride may cause fetal harm when administered to a pregnant woman. WebMD does not endorse any specific product, service, or treatment.Do not consider WebMD User-generated content as medical advice. Trial entry criteria were similar to the double-blind, placebo-controlled monotherapy efficacy trials described above in section 14.1. people Adverse Reactions Reported Over a 48-Month Period in1% of Subjects and More Frequently in the Coadministration Therapy Group Than the Groups Receiving Monotherapy With DEffect on 5 Alpha-Dihydrotestosterone and Testosterone:[see Contraindications (4), Warnings and Precautions (5.1)]Effect on Acute Urinary Retention and the Need for BPH-Related Surgery:Figure 2. Some of these opinions may contain information about treatment or uses of drug products that have not been approved by the U.S. Food and Drug Administration. Therefore, on average, the dose unaccounted for approximated 55% (range: 5% to 97%).The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state.
Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. As a percent of dose, there was approximately 5% unchanged dutasteride (~1% to ~15%) and 40% as dutasteride-related metabolites (~2% to ~90%).