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Glossary
AndroGel
– a hormone, like testosterone, that causes the body to develop masculine characteristics.

Bone mineral density (BMD)
– a measurement of how thick and strong the bones in the body are.

Corticosteroids
– medicines used to provide relief for inflamed areas of the body. They lessen swelling, redness, itching, and allergic reactions. They are often used as part of the treatment for a number of different diseases, such as severe allergies or skin problems, asthma, or arthritis. Corticosteroids may also be used for other conditions as determined by your doctor.

Diabetes
– a condition characterized by too much blood glucose in the body. In type 1 diabetes, the pancreas no longer makes the hormone, insulin. When this happens, blood glucose cannot enter the cells to be used for energy. In type 2 diabetes, either the pancreas does not make enough insulin or the body is unable to use insulin correctly.

Drug interaction
– certain medicines taken together may make your medicine less effective, cause unexpected side effects, or increase the action of one or more of the medicines. Be sure to tell your doctor about all of the medicines you are taking.

Erectile dysfunction (ED)
– the inability to achieve an erection all or some of the time, or the inability to sustain an erection.

Gynecomastia
– enlarged breasts in men.

HDL
– also known as high-density lipoprotein, this so-called good cholesterol is thought to protect against heart attack by carrying away buildup of cholesterol on artery walls.

Hormone
– a chemical substance made in one part of the body that travels through the bloodstream and affects cells and tissues in another part of the body.

Hyperlipidemia
– a higher than normal amount of fats or lipids in the blood. Hyperlipidemia is linked to high cholesterol and heart disease.

Hypertension
– high blood pressure, usually defined as at least 140 mm Hg systolic pressure over 90 mm Hg diastolic pressure (140 over 90).

Hypogonadism
– the medical term for low testosterone (Low T), which means the body doesn't make enough testosterone; Low T may affect mood, muscle mass, bone mineral density, and sexual function.

Insulin
– a hormone that helps the body use glucose for energy.

LDL
– also known as low density lipoprotein, this is the so-called bad cholesterol that can clog those arteries that lead to the heart and the brain.

Low T
– also known as low testosterone or hypogonadism, which means the body doesn't make enough testosterone; Low T may affect mood, muscle mass, bone mineral density, and sexual function.

Obesity
– defined as a BMI (body mass index) over 30 kg/m2. An adult male is considered obese when his weight is 20% or more over the maximum desirable for their height.

Osteoporosis
– a condition marked by less than normal bone density. Low bone density can make bones brittle and increase the risk of breaking a bone.

Oxyphenbutazone
– a medicine used to treat arthritis, gout, and similar conditions.

Pituitary gland
– an endocrine gland suspended beneath the brain, supplying numerous hormones that control many vital processes. Some of the hormones it supplies that influence sexual function include follicle stimulating hormone and lutenizing hormone.

Propranolol
– a medicine (beta-blocker) mostly used to treat high blood pressure.

Prostate specific antigen (PSA)
– a protein made by the cells of the prostate gland that can signal increased growth of the prostate. Doctors perform a PSA test to check for prostate disease.

Rheumatoid arthritis
–a chronic (long-term) disease that is characterized by inflammation of the joints and surrounding tissues.

Testosterone
– a hormone that helps some of the body's organs work the way they should. It's one of the most important male sex hormones. Testosterone increases body and facial hair, deepens the voice, maintains sperm cell production, and controls sexual desire and function. Testosterone can also affect energy and mood.

Triglycerides
– the chemical form in which most fat exists in food as well as in the body. Calories eaten and not used immediately for energy are converted to triglycerides and stored in cells for energy between meals.

USE

AndroGel® (testosterone gel) is a prescription medicine used to treat adult males who have low or no testosterone.

IMPORTANT SAFETY INFORMATION

Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel.

AndroGel can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel was applied to your skin.
  • Women and children should avoid contact with the unwashed or unclothed application area where AndroGel has been applied.
  • To lower the risk of transfer of AndroGel, you should apply AndroGel only to areas that will be covered by a short sleeve T-shirt. These areas include shoulders, upper arms, and stomach area. Do not apply AndroGel to your penis or scrotum. Wash your hands right away with soap and water after applying AndroGel. After the gel has dried, cover the application area with clothing. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child makes contact with the AndroGel application area, that area on the woman or child should be washed well with soap and water right away.
Stop using AndroGel and call your healthcare provider right away if you see any signs or symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel.

Do not use AndroGel if you: have breast cancer; have or might have prostate cancer; or are allergic to any of the ingredients in AndroGel, including soy.

AndroGel is not meant for use in women and must not be used in women who are pregnant, may become pregnant, or are breast-feeding. AndroGel may harm the unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the skin area where AndroGel has been applied.

Other serious side effects include the following:
  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination)
  • Possible increased risk of prostate cancer
  • In large doses, AndroGel may lower your sperm count
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease
  • Enlarged or painful male breasts
  • Having problems breathing while you sleep (sleep apnea)
  • Blood clots in the legs. This can include pain, swelling, or redness of your legs
Tell your healthcare provider about all the medicines you take, especially if you take insulin, corticosteroids, or medicines that decrease blood clotting.

The most common side effects reported with use of AndroGel are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.

For further information, talk with your healthcare provider.

Please see full Prescribing Information including the Medication Guide, for AndroGel.

If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, visit www.pparx.org or call the toll-free number (1-888-4PPA-NOW) for assistance.

This information is intended for residents of the United States.
For international product information please visit us at http://www.solvay.com.
© 2010 Solvay Pharmaceuticals, Inc.
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