Generic Name: dutasteride (doo-TAS-ter-ide)
Brand Name: Avodart

Avodart is used for:

Treating symptoms of benign prostatic hyperplasia (BPH) or enlargement of the prostate gland. It also helps to reduce the risk of urinary blockage and the need for surgery to treat BPH. It may be used alone or along with another medicine (tamsulosin).

Avodart is a 5 alpha-reductase enzyme inhibitor. It works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland.

Do NOT use Avodart if:

  • you are allergic to any ingredient in Avodart or to another 5 alpha-reductase inhibitor (eg, finasteride)
  • the patient is a woman who is pregnant or may become pregnant
  • the patient is a child

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Avodart:

Some medical conditions may interact with Avodart. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart failure, urinary tract problems, or problems urinating
  • if you have a history of abnormal liver function tests, prostate cancer, increased serum prostate-specific antigen (PSA) levels, or liver problems

Some MEDICINES MAY INTERACT with Avodart. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Ritonavir because it may increase the risk of Avodart's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Avodart may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Avodart:

Use Avodart as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Avodart. Talk to your pharmacist if you have questions about this information.
  • Take Avodart by mouth with or without food.
  • Swallow Avodart whole. Do not break, crush, chew, or open before swallowing. Do not take capsules that are cracked, deformed, discolored, or leaking. Avodart can irritate your lips, mouth, and throat.
  • Take Avodart on a regular schedule to get the most benefit from it. Taking Avodart at the same time each day will help you remember to take it.
  • Continue to take Avodart even if you feel well. Do not miss any doses.
  • If you miss a dose of Avodart, take it as soon as possible if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Avodart.

Important safety information:

  • Avodart may increase the risk of certain birth defects, including abnormal formation of the genitals in male fetuses. Women who are pregnant or may become pregnant must NOT handle the capsules. Avodart is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or who may become pregnant comes in contact with leaking capsules, the contact area should be washed immediately with soap and water. If contact occurs, tell your doctor at once.
  • Avodart stays in the blood stream for 4 to 6 months after you stop taking it. Do not donate blood for at least 6 months after your last dose of Avodart to prevent exposure through a blood transfusion to a pregnant woman.
  • Avodart may increase the risk of a certain type of prostate cancer. Discuss any questions or concerns with your doctor.
  • Avodart may cause decreased sexual desire or ability (eg, decrease in sex drive, problems with ejaculation, difficulty in achieving or keeping an erection). If you develop decreased sexual desire or ability that continues or becomes bothersome, check with your doctor. If this effect continues after you stop Avodart, contact your doctor.
  • Avodart may decrease the amount of semen released during sex. However, the effect of Avodart on fertility is not known. Discuss any questions or concerns with your doctor.
  • Rarely, there have been cases of male breast cancer reported in patients taking Avodart. Discuss any questions or concerns with your doctor. Tell your doctor right away if you develop breast changes, such as lumps, pain, or nipple discharge.
  • Check with your doctor about whether you should use a barrier method of birth control (eg, condoms) if you have sex with a pregnant woman while taking Avodart.
  • Avodart may interfere with certain lab tests, including PSA tests for the screening of prostate cancer. Be sure your doctor and lab personnel know you are taking Avodart.
  • Lab tests and medical exams may be performed while you take Avodart. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Avodart should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Avodart may cause harm to the fetus. It is not known if Avodart is found in breast milk. Avodart is not approved for use in women.

Possible side effects of Avodart:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased sexual desire or ability; decreased amount of semen released during ejaculation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); breast enlargement, lumps, pain, or tenderness; depression; nipple discharge; red, swollen, blistered, or peeling skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Avodart:

Store Avodart at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Avodart out of the reach of children and away from pets.

General information:

  • If you have any questions about Avodart, please talk with your doctor, pharmacist, or other health care provider.
  • Avodart is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Avodart or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Avodart. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Avodart. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Avodart.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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