Flutamide

What is Flutamide?

• Flutamide (Eulexin) an acetanilid, nonsteroidal, orally active antiandrogen used to treat prostate cancer.

Flutamide Structure

Flutamide ball-and-stick

What are the uses of this medicine?

• Flutamide (Eulexin) is used in combination with other therapies, is a treatment option for men with some types of prostate cancer.

Prostate cancer:

• Prostate cancer results from the abnormal growth of prostate cells.
• Medical scientists do not know exactly what causes the abnormal cells, but age, environment and genetics are important factors.
• Male hormones ("androgens") cause the cancer to grow.
• The cancer growth can be slowed down by blocking the effect of androgens.

How does this medicine work?

• Flutamide demonstrates potent antiandrogenic effects.
• It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both.
• The flutamide product is used together with an injection called "LHRH agonist," as a combined treatment called "total androgen blockade."
• The goal of this treatment is to reduce androgen levels and to block the effect of androgen on the tumor.
• The LHRH agonist reduces androgen levels.
• Flutamide therapy blocks the effect of androgen on the tumor.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have liver problems
• are allergic to it

What drug interactions can this medicine cause?

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 anticoagulants (blood thinners) such as warfarin (Coumadin).

Is this medicine FDA approved?

• Flutamide was first described in 1967 and was first introduced for medical use in 1983.
• It became available in the United States in 1989.

How should this medicine be used?

Recommended dosage:

• The recommended dosage is 2 capsules 3 times a day at 8 hour intervals for a total daily dose of 750 mg.

Administration:

• Flutamide comes as a capsule to take by mouth.
• It is usually taken with or without food every 8 hours (three times a day.)
• Take flutamide at around the same times every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Flutamide capsules, USP, 125 mg

This medicine is available in fallowing brand namesː

• Eulexin

What side effects can this medication cause?

The most common side effects of this medicine include:

• Diarrhea
• Cystitis
• Proctitis
• Hematuria
• Hot flashes
• Loss of libido
• Impotence
• Diarrhea
• Nausea/vomiting
• Gynecomastia
• Hypertension
• drowsiness/confusion/depression/anxiety/nervousness
• Anorexia
• Anemia
• Hepatitis and jaundice
• Irritation at the injection site
• Edema
• elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine

What special precautions should I follow?

• Flutamide capsules are for use only in men. This product has no indication for women and should not be used in this population.
• There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking flutamide. Serum transaminase levels should be measured prior to starting treatment with flutamide. Flutamide is not recommended in patients whose ALT values exceed twice the upper limit of normal. Serum transaminase levels should then be measured monthly for the first 4 months of therapy, and periodically thereafter.
• Flutamide may cause fetal harm when administered to a pregnant woman.
• Patients should be informed that flutamide capsules and the drug used for medical castration should be administered concomitantly.
• Close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when flutamide capsules are administered concomitantly with warfarin.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Flutamide may cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• FLUTAMIDE

Inactive ingredient:

• FERROSOFERRIC OXIDE
• STARCH, CORN
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• FD&C BLUE NO. 2
• FD&C RED NO. 40
• ALUMINUM OXIDE
• GELATIN
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• FERRIC OXIDE RED
• SODIUM LAURYL SULFATE
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

Manufactured by:

• CIPLA Verna.
• Goa, India

Manufactured for:

• Cipla USA, Inc.
• Sawgrass Corporate Parkway.
• Suite 130 Miami, FL

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

• Dailymed label info on Flutamide
• FDA Flutamide

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