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Dutasteride


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

Dutasteride is used for:

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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 prostate surgery.

Dutasteride 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 Dutasteride if:

  • you are allergic to any ingredient in Dutasteride or to other 5 alpha-reductase inhibitors (eg, finasteride)
  • the patient is a woman or a child

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

Before using Dutasteride :

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

  • if you plan 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 liver disease, prostate cancer, urinary tract disease, or problems urinating

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

  • Cimetidine, ciprofloxacin, diltiazem, ketoconazole, ritonavir, troleandomycin, or verapamil because they may increase the risk of Dutasteride 's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dutasteride 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 Dutasteride :

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

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

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

Important safety information:

  • Dutasteride may increase the risk of certain birth defects, including abnormal formation of the genitals in male fetuses. Woman who are pregnant or may become pregnant must NOT handle the capsules. If contact occurs, tell your doctor at once.
  • Dutasteride 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 Dutasteride to prevent exposure through a blood transfusion to a pregnant woman.
  • Dutasteride may decrease your volume of ejaculate. This does not appear to interfere with normal sexual function.
  • Dutasteride may interfere with certain lab tests, including prostate-specific antigen (PSA) for the screening of prostate cancer. Be sure your doctor and lab personnel know you are taking Dutasteride .
  • Lab tests and medical exams, including rectal exams, may be performed while you take Dutasteride . These may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Dutasteride should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Contact with Dutasteride may cause harm to a male fetus. It is not known if Dutasteride is found in breast milk. Dutasteride should not be used in women.

Possible side effects of Dutasteride :

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:

Breast enlargement and/or tenderness; decreased sex drive; decreased volume of ejaculate; inability to have an erection.

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, or tongue; unusual hoarseness).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Dutasteride :

Store Dutasteride at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dutasteride out of the reach of children and away from pets.

General information:

  • If you have any questions about Dutasteride , please talk with your doctor, pharmacist, or other health care provider.
  • Dutasteride 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.

This information is a summary only. It does not contain all information about Dutasteride . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: April 2, 2008
Database Edition 08.2.1.001
Copyright © 2008 Wolters Kluwer Health, Inc.



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