Testosterone Topical (patient information)

Why is this medication prescribed

Testosterone topical gel is 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 is needed for the growth and functioning of the male sexual organs and for the development of typical male characteristics. Symptoms of low testosterone include decreased sexual desire and ability, extreme tiredness, low energy, depression, brittle bones that may break easily, and loss of certain male characteristics such as muscular build and deep voice. Testosterone gel works by supplying testosterone to replace the testosterone that is normally produced in the body.

How should this medicine be used

Topical testosterone comes as a gel to apply to the skin. It is usually applied once a day. It is best to apply testosterone gel in the morning. To help you remember to use testosterone gel, use it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use testosterone gel exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.

AndroGel ® and Testim® brand gels both contain testosterone, but they are manufactured differently and are used in slightly different ways. Be sure that you know which brand of gel you are using and how and where you should apply it. Read the manufacturer's patient information that came with your gel carefully.

You can apply AndroGel® anywhere on your shoulders, upper arms, or abdomen (area between your chest and your waist). You can apply Testim® anywhere on your shoulders or upper arms, but you should not apply it to your abdomen. You should not apply either gel to your penis or scrotum or to skin that has sores, cuts, or irritation.

Be careful not to get testosterone gel in your eyes. If you do get testosterone gel in your eyes, wash them right away with warm, clean water. Call a doctor if your eyes become irritated.

You should not shower, bathe, swim, or wash the place where you applied the medication for at least 2 hours after you apply Testim® gel or at least 5-6 hours after you apply AndroGel ®. Once in while, you may shower, bathe or swim as soon as 1 hour after you apply AndroGel ®, but you should usually wait the full 5-6 hours. If you usually take a bath or shower in the morning, be sure to take your bath or shower before you apply either brand of testosterone gel.

Testosterone gel comes in single use tubes and packets and a multiple use pump. The pump releases a specific amount of testosterone gel each time the top is pressed. You will probably need to press the top of the pump four to eight times to get your full dose of testosterone gel. Your doctor or pharmacist will tell you how many times to press the pump for each dose, and how many doses your pump contains. Throw away the pump after you have used that number of doses even if it is not empty.

Testosterone gel may catch fire. Stay away from open flames and do not smoke while you are applying testosterone gel and until the gel has dried completely.

Your doctor may start you on a low dose of testosterone gel and gradually increase your dose, not more than once every two weeks.

Testosterone gel may control your condition but will not cure it. Continue to use testosterone gel even if you feel well. Do not stop using testosterone gel without talking to your doctor. If you stop using testosterone gel, your symptoms may return.

To use testosterone gel, follow these steps:

• Be sure that the skin in the place where you plan to apply testosterone gel is completely dry.
• Open your container of testosterone gel. If you are using a packet, fold the top edge at the perforation and tear across the packet along the perforation. If you are using a tube, unscrew the cap. If you are using a pump for the first time, press down on the top of the pump three times and discard the medication that comes out down a drain or in a trash can that is safe from children and pets.
• Squeeze the packet or tube or press down on the top of the pump the right number of times to place the medication on the palm of your hand. It may be easier to apply testosterone gel if you squeeze the medication onto your palm and apply it to your skin in small portions.
• Apply the medication to the area you have chosen.
• Throw away the empty packet or tube in a trash can that is safe from children and pets.
• Wash your hands with soap and water right away.
• Allow the medication to dry for a few minutes before you cover the area with clothing.

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 gel

• tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or soy.
• 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: inhaled steroids such as beclomethasone (QVAR), budesonide (Pulmicort), flunisolide (AeroBid), fluticasone (Flovent), and triamcinolone (Azmacort); insulin (Humalin, Humalog, Novolin, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); propranolol (Inderal); and steroid creams, lotions, or ointments such as alclometasone (Aclovate), betamethasone (Diprolene, Diprosone, Valisone), clobetasol (Temovate), desonide (DesOwen), desoximetasone (Topicort), diflorasone (Psorcon, Florone), fluocinolone (Derma-Smoothe, Flurosyn, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), hydrocortisone (Cortizone, Westcort, others), mometasone (Elocon), and triamcinolone (Aristocort). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or anyone in your family has or has ever had prostate cancer or if a doctor has told you that you might have prostate cancer if you smoke or work with heavy metals such as cadmium and if you have or have ever had breast cancer, diabetes, or heart, kidney, liver, or lung disease.
• you should know that testosterone gel 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 testosterone gel can harm people who touch the skin where you applied it. It is most harmful to women, especially if they are pregnant, and children. Cover the place where you applied testosterone gel with a shirt to prevent others from touching it. If you expect direct skin contact with someone else, you should wash the place where you applied testosterone gel with soap and water first. However, it is best to wait several hours after you apply the medication before you wash the area. If someone else touches the testosterone gel in your container or the place where you applied testosterone gel, that person should wash the area with soap and water as soon as possible. Tell your doctor if your female partner or anyone who has touched testosterone gel develops acne or grows hair in new places on his or her body.

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

If your next scheduled dose is not due for 12 hours or longer, apply the missed dose as soon as you remember it. However, if your next dose is due in less than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Side Effects

Mild Side Effects

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

• breast enlargement and/or pain
• decreased sexual desire
• acne
• hair loss
• hot flushes
• depression
• mood changes
• nervousness
• headache
• difficulty falling asleep or staying asleep
• teary eyes
• changes in ability to smell or taste

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:

• swelling of the hands, feet, ankles, or lower legs
• breathing problems, especially during sleep
• erections that happen too often or that last too long
• difficulty urinating
• frequent urination, especially at night
• upset stomach
• vomiting
• yellow or darkened skin

Medications similar to testosterone that are taken by mouth for a long time may cause serious damage to the liver or liver cancer. Testosterone gel 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 gel 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). 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

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 gel.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using testosterone gel.

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

Brand names

• Androgel®
• Testim®