Dutasteride (By mouth)

Introduction

Dutasteride (doo-TAS-ter-ide)

Treats problems with urination caused by an enlarged prostate (benign prostatic hyperplasia or BPH). This medicine is used alone or may be combined with tamsulosin (Flomax®).

When This Medicine Should Not Be Used

How to Use This Medicine

Liquid Filled Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Swallow the capsule whole. Do not crush, chew, or open it. The contents of the capsule may irritate your lips, mouth, or throat.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), ciprofloxacin (Cipro®), diltiazem (Cardizem®), ketoconazole (Nizoral®), ritonavir (Norvir®), troleandomycin (Tao®), or verapamil (Calan®).

Warnings While Using This Medicine

• Women who are pregnant or may become pregnant should avoid touching or handling this medicine. This medicine can get into the body through the skin and may harm an unborn male baby. If any of this medicine gets on the skin of a pregnant woman, wash the area immediately with soap and water, especially if the capsule is broken.
• Make sure your doctor knows if you have liver disease.
• Do not donate blood for at least 6 months after you stop taking this medicine. The medicine can remain in your blood for a long time and be passed on to a pregnant woman who receives a blood transfusion.
• This medicine may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.
• This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.
• This medicine does not usually affect normal sexual abilities for most men. You may notice that you ejaculate less fluid when you have sex.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Brand Name(s)

Avodart

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Decrease in how much or how often you urinate.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Swelling in your hands, ankles, or feet.

If you notice these less serious side effects, talk with your doctor:

• Breasts feeling tender or getting bigger.
• Decrease or change in your sexual desire.
• Dizziness.
• Mild skin rash or itching.
• Problems with ejaculation.
• Trouble having or keeping an erection.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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