Avodart

Generic Name: dutasteride (Oral route)

doo-TAS-ter-ide

Commonly used brand name(s):

In the U.S.

• Avodart

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Benign Prostatic Hypertrophy Agent

Pharmacologic Class: 5-Alpha Reductase Inhibitor

Uses For Avodart

Note: Women of childbearing potential should not use or handle dutasteride capsules. Dutasteride can cause birth defects in male fetuses.

Dutasteride is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). This medicine can be used alone or combined with tamsulosin (Flomax®).

Dutasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow. As a result, the size of the prostate is decreased. The effect of dutasteride 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.

Before Using Avodart

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Dutasteride is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dutasteride in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine
• Ciprofloxacin
• Diltiazem
• Ketoconazole
• Ritonavir
• Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer of the prostate—Your doctor will check you for prostate cancer before beginning treatment with this medicine.

• Liver disease—Dutasteride should be used with caution. Effects of this medicine may be increased.

• Problems with urination—Your doctor may want to choose another medicine for you or monitor your kidneys for blockage.

Proper Use of Avodart

You may take this medicine with or without food.

Swallow the capsule whole. Do not crush, open, or chew it because the contents of the capsule may irritate your lips, mouth, or throat.

Remember that this medicine does not cure benign prostatic hyperplasia (BPH), but it does help reduce the size of the prostate. Therefore, you must continue to take it if you expect to keep the size of your prostate down. You may even have to take this medicine for the rest of your life. Do not stop taking this medicine without first discussing it with your doctor.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. 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 using the medicine.

• For oral dosage form (capsules):
  • For benign prostatic hyperplasia (BPH):
    • Adults—0.5 milligram (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Avodart

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 any changes in your medicine. Ask your doctor if you have any questions.

Women and children should not use this medicine. 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 baby. It is very important that pregnant women or women who could become pregnant use caution in handling dutasteride capsules or avoid handling them at all. If a woman does come into contact with this medicine, the affected area should be washed right away with soap and water, especially if the capsule is leaking.

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

Dutasteride may affect the results of certain blood tests, such as the prostate specific antigen (PSA). Your doctor may be testing this regularly. If so, you will need to have new blood tests done 3 to 6 months after you start taking this medicine.

This medicine does not usually affect normal sexual abilities in most men. You may notice that you ejaculate less fluid when you have sex.

Avodart Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

• Blistering, flaking, or peeling of skin
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of skin
• shortness of breath
• skin rash
• swelling of the face, fingers, feet, and/or lower legs
• tightness in the chest
• unusual tiredness or weakness
• wheezing

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• 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
• pain, soreness, swelling, or discharge from the breast or breasts

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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