Flutamide is a nonsteroidal antiandrogen (testosterone blocker) medicine.

Flutamide capsules are used to treat prostate cancer.

Flutamide is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

Flutamide can cause serious liver problems. Call your doctor at once if you have upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Take flutamide capsules exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Flutamide is usually taken every 8 hours.

Follow your doctor's dosing instructions very carefully.

Drink plenty of liquids. Your doctor may recommend a special diet to help prevent diarrhea.

You will need frequent medical tests.

It is recommended you get blood tests: before starting treatment with flutamide, every month for the first 4 months of treatment, and periodically after the first 4 months.

Call your doctor if you have severe or ongoing diarrhea. Your doctor may recommend an anti-diarrhea medicine.

You should not stop using flutamide suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Prostate Cancer:

250 mg orally every 8 hours

Comments:
-This drug may be taken with or without food.
-Stage B2-C Prostatic Carcinoma: Treatment with this drug and the goserelin acetate implant starting 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
-Stage D2 Metastatic Carcinoma: This drug should be initiated with the LHRH-agonist and continued until progression.

Use: Locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate

You should not use flutamide if you are allergic to it, or if you have severe liver problems.

Flutamide should never be taken by a woman or a child.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease;

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency;

• hemoglobin M disease;

• if you smoke; or

• if you also take a blood thinner (warfarin, Coumadin, Jantoven).

Although flutamide is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

Unless your doctor tells you otherwise, continue your normal diet.

To help prevent diarrhea, avoid dairy products such as milk, cheese, and yogurt. Do not use laxatives while taking flutamide.

Get emergency medical help if you have signs of an allergic reaction to flutamide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Flutamide can cause serious liver problems. Call your doctor at once if you have:

• nausea, upper stomach pain, loss of appetite;

• itching, tiredness, flu-like symptoms;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Common flutamide side effects may include:

• breast swelling or tenderness;

• hot flashes;

• vomiting, nausea, diarrhea; or

• impotence, loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with flutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to flutamide.

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.