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Avodart is for the use of men only and should not be taken by women. Avodart can seep through the skin therefore women who are pregnant or may become pregnant should not take Avodart or even touch it in order to keep the future child safe and healthy. Avodart can cause birth defects in a baby so the handling of the product could end up being fatal in some cases. Those with liver disease should talk to their doctor before taking Avodart because it may not be safe for them to take the medicine or the dosage may have to be adjusted. Do not donate blood until it has been at least six months since the last dose was taken as this can be transferred through blood and be harmful to those receiving the blood. BPH is a non-cancerous enlargement of the prostate gland, which is located at the lower portion of the urinary bladder surrounding the urethra (urine carrying tube). In men with BPH, the prostate gland becomes large enough to squeeze the urine tube running through it. If the urine tube is squeezed it narrows, making it more difficult with urination resulting in some or all of the following symptoms: What Avodart does AVODART belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors. AVODART works to lower the production of dihydrotestosterone (DHT) in the body, leading to reduced prostate size, improved urinary flow, reduced risk of acute urinary retention (AUR), and reduced risk of the need for BPH related surgery. While some men have fewer problems and symptoms after 3 months of treatment with AVODART, a treatment period of at least 6 months is usually necessary to see if AVODART will work for you. Nonmedicinal ingredients in your medicine include butylated hydroxytoluene, gelatin, glycerol, iron oxide yellow, lecithin, medium chain triglycerides, monodiglycerides of caprylic/capric acid, purified water, titanium dioxide, and red printing ink containing iron oxide red as the colourant. Your doctor has prescribed AVODART for symptomatic BPH and not for cancer. But a man can have BPH and prostate cancer at the same time. Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks should continue while you take AVODART. About Prostate Specific Antigen (PSA) Your physician may have done a blood test called PSA. AVODART can alter PSA values. AVODART does lower your PSA test result by about 50%. This low PSA Level may give you a false sense of security. Keep a written record of your yearly PSA levels and notify your treating doctors that you have been taking AVODART for the exact number of months you have used. For more information, talk to your physician. Prior to treatment with AVODART, you should have a thorough urological evaluation to determine the severity of your condition, and to exclude the need for immediate surgery or the possibility of prostate cancer. A thorough urological examination generally includes a digital rectal examination (DRE) and an evaluation of urinary symptoms. Your physician may also obtain a blood test for prostate specific antigen (PSA) (see About Prostate Specific Antigen (PSA):). Make sure your doctor knows what other medicines you are taking, or have recently taken. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself. Please inform your doctor about regular consumption of grapefruit juice. This drink is known to increase the blood levels of some drugs in the body. The most common side effects of AVODART are impotence (not able to achieve or maintain an erection), decrease in libido (decreased desire to have sex or a reduced sex drive), changes or problems with ejaculations (including a decrease in amount of semen released during sex) and breast swelling or tenderness. Drug Interactions Dutasteride absorption is not affected by food. The effects of CYP3A4 inhibitors found in foods on dutasteride pharmacokinetics have not been studied. Care should be taken when administering dutasteride to patients who chronically consume CYP3A4 inhibitors found in foods and beverages such as grapefruit juice. In a single sequence, crossover study in healthy volunteers, the administration of tamsulosin or terazosin in combination with AVODART had no effect on the steady state pharmacokinetics of either alpha adrenergic blocker. The percent change in DHT concentrations was similar for AVODART alone compared with the combination treatment. A clinical trial was conducted in which dutasteride and tamsulosin were administered concomitantly for 24 weeks followed by 12 weeks of treatment with either the dutasteride and tamsulosin combination or dutasteride monotherapy. Results from the second phase of the trial revealed no excess of serious adverse events or discontinuations due to adverse events in the combination group compared to the dutasteride monotherapy group. Effects on Prostate Specific Antigen: PSA levels generally decrease in patients treated with AVODART as the prostate volume decreases. In approximately one-half of the subjects, a 20% decrease in PSA is seen within the first month of therapy. After 6 months of therapy, PSA levels stabilize to a new baseline that is approximately 50% of the pre-treatment value. Results of subjects treated with AVODART for up to 2 years indicate this 50% reduction in PSA is maintained. Therefore, a new baseline PSA concentration should be established after 3 to 6 months of treatment with AVODART (see Warnings and Precautions, Effects on PSA and Prostate Cancer Detection).


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