Indication: AVODART alone and in combination with the alpha blocker tamsulosin treats urinary symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. AVODART alone also reduces the risk of acute urinary retention (AUR) and prostate surgery. AUR is a condition, possibly requiring surgery, where the prostate is so enlarged that it completely blocks urine coming from the bladder.AVODART is not approved for the prevention of prostate cancer.
Only your doctor can tell if your symptoms are due to BPH. Talk to your doctor about your symptoms and see if AVODART is right for you. AVODART is available by prescription only.
Important Safety Information About AVODART
AVODART is for adult men only. Women, children, and teenagers should not take AVODART. Women should not touch AVODART due to risk of a specific birth defect. If a woman comes in contact with leaking AVODART capsules, she should wash the contact area immediately with soap and water.
Do not take AVODART if you are allergic to dutasteride, finasteride, or any of the ingredients in AVODART.
Before you take AVODART, tell your doctor if you have liver disease.
Some types of medicines should be used with caution when taken with AVODART, such as ritonavir.
You should not donate blood while taking AVODART or for 6 months after you have stopped AVODART. This is important to prevent pregnant women from receiving AVODART through blood transfusions.
AVODART may cause rare and serious allergic reactions, including swelling of your face, tongue, or throat, and serious skin reactions, such as skin peeling. Get medical help right away if you have these serious allergic reactions.
AVODART may cause serious side effects including a higher chance of a more serious form of prostate cancer.
The most common side effects of AVODART include:
‡Some of these events may continue after you stop taking AVODART.
Depressed mood has been reported in patients receiving AVODART.
AVODART has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of AVODART on male fertility is not known.
Your healthcare provider may check you for other prostate problems, including prostate cancer, before you start and while you take AVODART. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. AVODART will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with AVODART (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.
Only your healthcare provider can tell if your symptoms are due to BPH or a more serious condition like prostate cancer. See your doctor for regular exams.
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.
Complete Prescribing Information for AVODART is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader; if you do not have it, follow the link to download a copy.
If you are unable to or do not wish to download Acrobat Reader, but still wish to receive complete Prescribing Information, please click here.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.