In the U.S.—

• Benign prostatic hyperplasia therapy agent

Dutasteride (du-TAS-tur-ide) is used to treat men who have symptoms of an enlarged prostate gland.

Dutasteride blocks an enzyme called 5-alpha-reductase, which is necessary to change testosterone to another hormone that causes the prostate to grow. As a result, the size of the prostate is decreased. The effect of dutasteride on the prostate lasts only as long as the medicine is taken. If it is stopped, the prostate begins to grow again

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (U.S.)

In deciding to use a medicine, the risks of taking dutasteride must be weighed against the good it will do. This is a decision you and your doctor will make. For dutasteride, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dutasteride or any other medicine that blocks 5-alpha-reductase, such as finasteride. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Women who are or may become pregnant should not take dutasteride or touch dutasteride capsules, because it can cause changes in the genitals (sex organs) of male fetuses.

Breast-feeding—It is not known whether dutasteride passes into breast milk. Dutasteride is not recommended for use in women or women who are breast feeding.

Children—Dutasteride is not recommended for use in children.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or non-prescription (over-the-counter [OTC]) medicine.

• Cancer of the prostate or
• Liver disease or
• Problems with urination

Dosing—

Follow your doctor's orders or the directions on the label. If your dose is different, do not change it unless your doctor tells you to do so.

Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking dutasteride.

• For oral dosage form (capsules):
  • For benign prostatic hyperplasia:
    • Adults—0.5 milligram (mg) once daily. May take with or without food. Capsules should be swallowed whole. Dutasteride is not for use in women.
    • Children—Dutasteride is not for use in children.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine longer than needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visits for any problems that may be caused by this medicine.

Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause a risk to the developing male fetus. A female should use caution if she has to handle the capsules. If a female comes into contact with dutasteride, wash the area immediately with soap and water, especially if the capsule is leaking.

Men who have taken dutasteride should not donate blood until 6 months has passed since their last dose. Dutasteride can remain in your blood for a long time, and can be transmitted to a pregnant female receiving a blood transfusion.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• Less common
  • Abnormal ejaculation;  decreased interest in sexual intercourse;  decreased sexual performance or desire;  impotence;  inability to have or keep an erection;  loss in sexual ability, desire, drive, or performance;  swelling of the breasts or breast soreness 
  
  

Amount of semen in ejaculate may be decreased in some patients. This decrease does not interfere with normal sexual function.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.