(doo tas' teer ide)
WHY is this medicine prescribed?
Dutasteride is used alone or with another medication (tamsulosin [Flomax]) to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). Dutasteride is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). Dutasteride may also decrease the chance that prostate surgery will be needed. Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate.
HOW should this medicine be used?
Dutasteride comes as a capsule to take by mouth. It is usually taken once a day with or without food. Take dutasteride at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dutasteride exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not open chew, or crush them.
Your symptoms may improve after you have taken dutasteride for 3 months, but it may take 6 months or longer for you to see the full benefit of dutasteride. Talk to your doctor about how you are feeling during your treatment.
Dutasteride may control your symptoms but will not cure your condition. Continue to take dutasteride even if you feel well. Do not stop taking dutasteride without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking dutasteride,
- tell your doctor and pharmacist if you are allergic to dutasteride, finasteride (Propecia, Proscar), any other medications, or any of the ingredients in dutasteride capsules. Ask your doctor or check the manufacturer's patient information for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antifungals such as ketoconazole (Nizoral); cimetidine (Tagamet); ciprofloxacin (Cipro); diltiazem (Cardizem, Dilacor, Tiazac); ritonavir, (Norvir), troleandomycin (TAO); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had liver disease or prostate cancer.
- you should know that dutasteride is for use only in men. Women, especially those who are or may become pregnant, should not handle dutasteride capsules. Touching the contents of the capsules may harm the fetus. If a woman who is pregnant or who could become pregnant accidentally touches leaking capsules, she should wash the area with soap and water immediately and call her doctor.
- you should know that you should not donate blood while you are taking dutasteride and for 6 months after you stop taking this medication.
What SPECIAL DIETARY instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.
What should I do IF I FORGET to take a dose?
If you remember the missed dose that same day, take the missed dose as soon as you remember it. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take two doses in one day or take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Dutasteride may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- inability to have or maintain an erection
- decrease in sex drive
- problems with ejaculation
Some side effects may be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical help:
- changes in the breasts such as increased size, lumps, pain, or nipple discharge
- swelling of the face, tongue, or throat
- difficulty breathing or swallowing
- peeling skin
Taking dutasteride may increase the risk that you will develop high-grade prostate cancer (a type of prostate cancer that spreads and grows more quickly than other types of prostate cancer). Talk to your doctor about the risks of taking dutasteride.
Dutasteride may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dutasteride capsules that are stored at high temperatures may become deformed or discolored. Dispose of any capsules that are deformed, discolored, or leaky.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to dutasteride.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dutasteride.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
®(as a combination product containing Dutasteride, Tamsulosin)
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