Prasterone, Dehydroepiandrosterone, DHEA oral dosage forms

What is prasterone, dehydroepiandrosterone, DHEA?

PRASTERONE (Prestara™), is also known as DHEA. DHEA products are similar to a hormone produced naturally in the body. DHEA is sometimes called the 'mother hormone' because many of the female and male sex hormones are produced from DHEA. Prestara™ will only be available with a prescription and is used to treat systemic lupus erythematosus (SLE or 'lupus'). DHEA is also available as a nutritional supplement. While dietary supplements of DHEA are promoted as a way to prevent aging or to treat female or male complaints, there is no medical evidence for these claims, and the FDA does not support these uses. Because many of the effects of DHEA, either positive or harmful, are not known, it is recommended that you talk with your health care professional about the use of this hormone prior to taking it.

What should my health care professional know before I take DHEA?

It is important for you to tell your prescriber or health care professional or other health care professional that you are using DHEA.

Talk to your health care provider BEFORE taking DHEA supplements if you have any of the following conditions:

• breast cancer (men or women)

• cancer of the lining of the uterus (endometrial cancer)

• diabetes mellitus or high blood sugar levels

• an immune deficiency disorder, such as AIDS or HIV virus infection

• infertility

• liver disease, including hepatitis or liver cancer

• menstrual problems

• post-menopause

• prostate cancer or an enlarged prostate gland

• rheumatoid arthritis

• systemic lupus erythematosus (SLE or "lupus")

• unusual vaginal bleeding

• uterine cancer

• vaginal cancer

• an unusual or allergic reaction to DHEA or other hormones, soy, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take DHEA tablets or capsules by mouth. Follow the directions on the label, or talk to your health care professional about directions for use. Swallow the tablets or capsules with a drink of water. If the tablets upset your stomach, take them with food or milk.

Do not take more often than directed on the package or by your health care professional.

• For all uses of this medicine:

Before taking DHEA, read the product label and discuss the use of this hormone with your health care prescriber. Make certain you understand the possible risks or benefits.

Supplements of DHEA should not be given to teenagers, children, or infants. The use of this hormone is often not recommended in healthy young adults below the age of 30 years.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with DHEA?

Drug interactions with DHEA are not well known. DHEA may interact with:

• alprazolam, triazolam, or other medications for sleep or for anxiety

• aspirin, ASA

• cilostazol

• clopidogrel

• male hormones (such as methyltestosterone or testosterone)

• female hormones (such as estrogens or progestins)

• birth control hormones (such as birth control pills, implants or injections)

• corticosteroids (such as prednisone)

• fertility treatments (such as clomiphene, leuprolide, or other hormone injections)

• medications for the treatment of diabetes

• saw palmetto

• ticlopidine

• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking DHEA?

Visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6—12 months. You should also discuss the need for any regular tests or exams while on DHEA with your health care professional, and follow his or her guidelines for these tests. If you have any unusual changes in your health, contact your prescriber or health care professional for advice.

If you have any reason to think you are pregnant; stop taking DHEA at once and contact your prescriber or health care professional. You should not try to get pregnant while taking DHEA.

DHEA use is banned in competitive sports. Both college (NCAA) and olympic (USOC) committees do not allow DHEA use among athletes.

If you are going to have elective surgery, you may need to stop taking your DHEA beforehand. Consult your health care professional for advice prior to scheduling the surgery, and tell them you are taking this supplement.

What side effects may I notice from taking DHEA?

Very little is known about the potential adverse effects that may occur with DHEA use. You are encouraged to report any side effects promptly to your health care professional.

Side effects that you should report to your prescriber or health care professional as soon as possible:

Symptoms of potential liver problems:

• abdominal pain

• dark or brown colored urine

• loss of appetite

• nausea and vomiting

• unusual tiredness

• weakness

• yellowing of the skin or eyes

Examples of other side effects to report to your prescriber or health care professional:

• acne

• breast pain, swelling, or change in breast appearance

• hair growth in unusual places

• headache

• hoarseness of the voice

• menstrual changes

• need for frequent urination or bladder pressure, especially at night

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

GENERAL INFORMATION REGARDING DIETARY SUPPLEMENTS:

Dietary supplements include amino acids, hormones, vitamins, minerals, herbs, botanicals and other plant-derived substances, and extracts of these substances. These products are easy to identify as they must state "Dietary Supplement" on the label. A "Supplement Facts" panel is provided on the label for most products. Supplements are not drugs and are not regulated like drugs. You should note that rigid quality control standards are not required for dietary supplements. Big differences in potency and purity of these products can occur. Scientific data to support the use of a dietary supplement for a certain disease or ailment may not be available. This product is not intended to diagnose, treat, cure or prevent any disease.

The Food and Drug Administration suggests the following to help consumers protect themselves:

• Always read product labels and follow directions.

• "Natural" doesn't mean a product is safe for humans to take.

• Look for products containing ingredients with the "USP" notation. This indicates the manufacturer followed the standards of the US Pharmacopoeia.

• Supplements produced or distributed by a nationally known food or drug company are more likely to be made under tight controls as these companies have standards in place for their other products. You can write to the company for more information about how the product was made.