Dutasteride, Oral doo-TAS-teer-ide

What are other names for this medicine?

Type of medicine: 5 alpha-reductase inhibitor (enlarged prostate gland therapy)

Generic and brand names: dutasteride, oral; Avodart

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of an enlarged prostate gland (benign prostatic hyperplasia).

It is also used to:

• reduce the risk of urinary retention (not being able to urinate)
• reduce the chance you will need prostate surgery.

It may also be used for other conditions determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• liver disease
• prostate cancer

Females of childbearing age: Women who are pregnant, may become pregnant, or are breastfeeding should not touch this medicine. It may cause serious harm to the baby. This medicine must not be given to women or children. This medicine is for MEN only.

How do I take it?

This medicine is usually taken once a day. Swallow the capsules whole. Do not break, crush, or chew them. You may take this medicine with or without food. Take it with a full glass of water.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes for as long as prescribed. Do not take more or take it more often than prescribed.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

Caution: This medicine is for men only.

Women and children should not take this medicine or even handle this medicine. If a woman or child touches the medicine, wash the area with soap and water immediately and contact your healthcare provider.

This medicine can affect a blood test called PSA, which is used to screen for prostate cancer. Before you have a PSA test done, be sure the healthcare provider knows you are taking this medicine.

This medicine does not protect you from prostate cancer. Continue to have screening exams as recommended by your healthcare provider.

This medicine may cause impotence (trouble having and keeping an erection), decrease your sex drive, or reduce the amount of semen released during sexual intercourse. These effects are usually mild and temporary when they occur.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Do not donate blood until at least 6 months after taking the last dose of this medicine. This protects pregnant women from receiving a blood transfusion that may contain some of this medicine.

Do not give this medicine to anyone else.

If you need emergency care, surgery, or dental work, tell the healthcare provider you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away): Trouble urinating, blood in urine, pain when urinating.

Other: Temporary and mild impotence, decreased sex drive, breast tenderness or swelling, reduced amount of semen released during sexual intercourse, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), doxycycline (Adoxa, Doryx, Monodox, Vibramycin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, levofloxacin (Levaquin), metronidazole (Flagyl), moxifloxacin (Avelox), pentamidine (NebuPent), norfloxacin (Noroxin), rifampin (Rifadin), telithromycin (Ketek), and tetracycline
• antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (VFEND)
• anti-HIV medicines such as delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• calcium channel blockers such as diltiazem (Cartia XT, Cardizem, Tiazac), nicardipine (Cardene SR), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera HS, Isoptin SR, Verelan)
• heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia XT, Cardizem, Tiazac), dofetilide (Tikosyn), disopyramide (Norpace), flecainide (Tambocor), nicardipine (Cardene SR), procainamide, propafenone (Rythmol), quinidine, sotalol (Betapace), and verapamil (Calan, Covera HS, Isoptin SR, Verelan)
• imatinib (Gleevec)
• natural remedies such as black cohosh, California poppy, golden seal, hawthorn, periwinkle, quinine, saw palmetto, and St. John’s wort
• nefazodone

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.