AndroGel Packets

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Testosterone topical (for the skin) is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone will not enhance athletic performance and should not be used for that purpose.

Testosterone topical may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or
• male breast cancer.

Tell your doctor if you have ever had:

• breast cancer or prostate cancer;
• enlarged prostate, urination problems;
• heart problems;
• a heart attack, stroke, or blood clot;
• sleep apnea (breathing stops during sleep); or
• liver or kidney disease.

The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Using testosterone may increase your risk of developing prostate cancer. Ask your doctor about this risk.

Testosterone can lower your sperm count and may affect fertility (your ability to have children).

This medicine should not be used by a woman. Testosterone may harm an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical patches or gels, or with a man's skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away.

Do not use testosterone topical on anyone younger than 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Never use testosterone topical in larger amounts, or for longer than prescribed.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

Different brands of testosterone topical have different instructions for use. Not every brand of this medicine is used on the same skin areas. Some brands are applied to the shoulder, upper arm, or stomach. Other brands are applied to the thighs or to the underarms. Carefully follow the patient instructions provided with your medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not apply testosterone topical to your penis or scrotum. Some brands of this medicine should also not be applied to the back, chest, or stomach areas. Apply this medicine only to the skin areas recommended for your specific brand of testosterone topical.

Wash your hands with soap and water before and after applying testosterone transdermal.

Apply testosterone gel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress.

Testosterone gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged.

Apply the transdermal skin patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Choose a different skin area each time you put on a new patch. Do not use the same skin area twice in a 7-day period.

You may need frequent blood tests.

Store at room temperature. Do not freeze. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

After removing a skin patch, fold it closed with the sticky side in, and throw it away. Place used patches and empty testosterone tubes in a trash container that pets and children cannot get to.

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

If a skin patch falls off in the morning, reapply it. If it does not stick well, apply a new patch. If the patch falls off in the afternoon and cannot be reapplied, wait until your regular patch replacement time in the evening before putting on a new patch.

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

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for at least 2 hours after applying testosterone gel. Follow the directions provided with your specific brand.

Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.

Avoid using an ointment form of any steroid skin medicine your doctor recommends to treat skin irritation caused by wearing a testosterone skin patch. This includes over-the-counter hydrocortisone.

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

Stop using testosterone topical and call your doctor at once if you have:

• increased urination (many times per day), loss of bladder control;
• painful or difficult urination;
• breast pain or swelling;
• painful or bothersome erections;
• swelling, rapid weight gain, shortness of breath during sleep;
• chest pain or pressure, pain spreading to your jaw or shoulder;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Common side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;
• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
• increased prostate-specific antigen;
• increased blood pressure;
• mood changes, strange dreams;
• frequent or prolonged erections;
• nausea, vomiting; or
• swelling in your lower legs.

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.

Tell your doctor about all your other medicines, especially:

• insulin;
• a blood thinner (warfarin, Coumadin, Jantoven); or
• steroid medicine (methylprednisolone, prednisone, and others.)

This list is not complete. Other drugs may affect testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your pharmacist can provide more information about testosterone topical.