Testosterone Transdermal (patient information)

Why is this medication prescribed

Testosterone transdermal patches are used to treat the symptoms of low testosterone in men who do not produce enough natural testosterone. Testosterone is a hormone that is usually produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Symptoms of low testosterone include decreased sexual desire and ability, extreme tiredness, low energy, depression, and loss of certain male characteristics such as muscular build and deep voice. Testosterone patches work by supplying synthetic testosterone to replace testosterone that is normally produced naturally.

How should this medicine be used

Transdermal testosterone comes as a patch to apply to the skin. It is usually applied once daily, and the schedule depends on the type of patch. Androderm patches are applied each night between 8 pm and midnight and left on for 24 hours. Testoderm patches are applied at the same time every morning (or any other regular time of day or night if the morning is inconvenient) and left on for 22-24 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use testosterone patches exactly as directed. Do not apply more or fewer patches or apply the patches more often than prescribed by your doctor.

Androderm and Testoderm brand patches both contain testosterone, but they are manufactured differently and are intended for use on different parts of the body. Be sure you know which type of patch you are using and where, when, and how you are to apply your patches. Carefully read the manufacturer's patient information that comes with your patches.

If you are using Androderm patches, you should choose a spot on your back, stomach, thighs, or upper arms to apply your patch(es). Be sure that the spot you have chosen is not oily, hairy, likely to perspire heavily, over a bone such as a shoulder or hip, or likely to be under pressure from sitting or sleeping. Do not apply to the scrotum or a skin area with open sores or irritation. Also be sure that the patch will stay flat against the skin and will not be pulled or stretched during normal activity. Choose a different spot each night and wait at least 7 days before applying another patch to a spot you have used.

If you are using Testoderm patches, you should apply them to your scrotum. Before you begin treatment, you should shave the hair from the area. Stretch your scrotal skin and shave with short gentle strokes of a disposable razor. Do not use soap, water, lotions, creams, or chemical hair removers. You should shave the area whenever hair has grown back, usually once or twice a week.

Androderm patches may be worn while swimming, bathing, or showering. However, Testoderm patches should be removed before water activities and placed on a clean, dry surface with the shiny side facing up. After water activities, dry your body and reapply the patch using the regular procedure.

If a patch becomes loose, smooth it down with your fingers. If it falls off, try to reapply the same patch. If the patch cannot be reapplied, apply a new one. However, if an Androderm patch falls off after twelve noon or if a Testoderm patch falls off after you have worn it for 12 hours, do not apply a new patch until your next scheduled application time.

Testosterone patches may control your condition but will not cure it. It may take up to 8 weeks before you feel the full benefit of testosterone. Continue to use testosterone patches even if you feel well. Do not stop using testosterone patches without talking to your doctor. If you stop using testosterone, your symptoms may return.

To use Androderm patches, follow these steps:

• Clean and dry the spot where you will apply the patch.
• Tear the foil pouch along the edge and remove the patch.
• Peel the protective liner and silver disc off the patch and throw them away.
• Place the patch on your skin with the sticky side down and press down firmly with your palm for 10 seconds. Be sure it is completely stuck to your skin, especially around the edges.
• When you are ready to remove the patch, pull it off the skin and throw it away in a trash can that is out of the reach of children and pets. Children and pets can be harmed if they chew on or play with used patches.
• Apply a new patch immediately by following steps 1-4.

To use Testoderm patches, follow these steps:

• Be sure that your scrotum and your hands are warm and dry.
• Tear the pouch along the top edge and remove the patch.
• Peel the clear plastic liner off the patch and throw it away.
• Warm the patch by holding it a few inches away from a mild heat source such as a light bulb or blowdryer.
• Sit or stand in a comfortable position. Stretch the skin of your scrotum to smooth out the folds.
• Press the shiny side of the patch onto your scrotum. Cup your hand over the patch and hold it in place for 10 seconds.
• Be sure that the edges of the patch are pressed firmly against your skin. If the patch falls off, repeat steps 4-6. Be sure to warm the patch again and try holding it in place for longer than 10 seconds.
• Put on close fitting underwear to hold the patch in place. If the patch still falls off, wearing an athletic supporter may help.
• When you are ready to remove the patch, gently peel it off the skin and throw it away in a trash can that is out of the reach of children and pets. Children and pets can be harmed if they chew on or play with used patches.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before using testosterone patches

• tell your doctor and pharmacist if you are allergic to testosterone, ethanol, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); insulin (Humalin, Humalog, Novolin, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); and propranolol (Inderal). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have a family history of prostate cancer, if you smoke or work with heavy metals such as cadmium and if you have or have ever had a blood disorder, breast or prostate cancer, diabetes, or heart, kidney, liver, or lung disease.
• you should know that transdermal testosterone is only for use in men. Women should not use this medication, especially if they are or may become pregnant or are breastfeeding. Testosterone may harm the fetus.
• you should know that Androderm and Testoderm patches may be worn during sexual activity. It is very unlikely that your partner will be exposed to more than slight amounts of testosterone. However, there is a slight possiblity that the patch may be transferred to the partner's skin. If this happens, remove the patch and wash the area well. Call a doctor immediately if your female partner develops bad acne or grows hair in new places on her body.
• if you are using Androderm patches, your skin may become irritated in the place where you apply the patch(es). If this happens, you may apply a small amount of hydrocortisone cream to the area after removing your patch(es). Only use hydrocortisone cream; do not use an ointment. If your skin remains irritated after this treatment, call your doctor.

What special dietary instructions should I follow

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

What should I do if I forget a dose

Apply the missed patch(es) as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra patches to make up for a missed dose.

Side Effects

Mild Side Effects

Transdermal testosterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching, pain, or irritation of scrotum if you are using Testoderm patches
• burn-like blisters, pain, redness, hardness, or itching in the place you applied Androderm patches
• enlarged or tender breasts
• acne
• depression
• headache
• dizziness
• pain anywhere in the body, especially the back

Severe Side Effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• erections that happen too often or that do not go away
• upset stomach
• vomiting
• yellowing of skin or eyes
• ankle swelling
• changes in skin color
• difficulty breathing while awake or asleep
• pain in pelvis (area between hips)
• difficult, frequent, or painful urination
• painful ejaculation
• fever or chills
• black and tarry stools
• red blood in stools
• bloody vomit
• vomiting material that looks like coffee grounds
• slow or difficult speech
• faintness
• weakness or numbness of an arm or leg
• rash

Medications similar to testosterone that are taken by mouth for a long time may cause serious damage to the liver or liver cancer. Transdermal testosterone has not been shown to cause this damage. Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of taking this medication.

Testosterone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

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). Use patches immediately after opening the protective pouch. Androderm patches may burst if exposed to extreme heat or pressure. Do not use damaged patches. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

If you wear too many patches, or wear patches for too long, too much testosterone may be absorbed into your bloodstream. In that case, you may experience symptoms of an overdose.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• slow or difficult speech
• faintness
• weakness or numbness of an arm or leg

What other information should I know?

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

Testosterone can interfere with the results of certain laboratory tests. Before having any tests, tell your doctor and the laboratory personnel that you are taking testosterone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Androderm®
• AndroGel®
• Delatestryl®
• Depo®-Testosterone
• Testim®
• Testoderm®
• Testoderm® TTS
• Testopel® Pellets
• Virilon® IM

Brand names of combination products

• Depo-Testadiol® containing Testosterone Cypionate and Estradiol Cypionate