AndroGel (Testosterone)

Testosterone Transdermal Patch (tes tos' ter one) Androderm® Testoderm®¶

Testosterone topical is used to treat the symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain tests to check your testosterone levels to see if they are low before you begin to use testosterone topical. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone topical works by replacing the testosterone that is normally produced by the body.

Topical testosterone comes as a gel and solution to apply to the skin. It is usually applied once a day. It is best to apply testosterone gel or solution in the morning. To help you remember to apply testosterone topical, apply 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 topical exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor. Testosterone topical products are manufactured differently and are used in slightly different ways. Be sure that you know which topical brand you are using and how and where you should apply it. Read the manufacturer's patient information that came with your topical testosterone product carefully. If you usually take a bath or shower in the morning, be sure to take your bath or shower before you apply testosterone topical products. Read the manufacturer's patient information about your topical testosterone product for information about when you can wash, shower, bath, or swim after you apply the medication. You should not apply any testosterone topical products to your penis or scrotum or to skin that has sores, cuts, or irritation. Be careful not to get testosterone topical in your eyes. If you do get testosterone topical in your eyes, wash them right away with warm, clean water. Call a doctor if your eyes become irritated. Testosterone topical comes in single use tubes, packets, and a multiple-use pump. The pump releases a specific amount of testosterone each time the top is pressed. Your doctor or pharmacist will tell you how many times to press the pump for each dose, and how many doses your pump contains. Dispose of the pump after you have used that number of doses even if it is not empty. Testosterone gel and solution may catch fire. Stay away from open flames and do not smoke while you are applying testosterone topical and until the gel or solution has dried completely. Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment. Testosterone topical may control your symptoms but will not cure your condition. Continue to use testosterone topical even if you feel well. Do not stop using testosterone topical without talking to your doctor. If you stop using testosterone topical, your symptoms may return. To use testosterone topical products, follow these steps: Be sure that the skin in the place where you plan to apply testosterone topical is clean and completely dry. Open your testosterone topical container. 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 an Androgel®, Axiron®, or Volgelxo® pump for the first time, press down on the top of the pump three times. If you are using a Fortesta® pump for the first time, press down on the top of the pump eight times. Always discard the extra medication that comes out after priming the pump 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. However, if using the Axiron® pump, use the provided applicator to apply the medication; do not use your fingers or hands to apply the medication. Apply the medication to the area you have chosen. Dispose of the empty packet or tube in a trash can safely, out of the reach of 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.

Before using testosterone gel, tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in topical testosterone products. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); insulin (Apridra, Humalog, Humulin, others); and oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not use testosterone topical. tell your doctor if you have or have ever had sleep apnea (breathing stops for short periods of time during sleep), benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; diabetes; or heart, kidney, liver, or lung disease. you should know that there have been reports of serious side effects in people who use testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone topical. Be sure to use testosterone topical exactly as directed by your doctor.

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

Apply the missed dose 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 a double dose to make up for a missed dose.

Transdermal testosterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: burn-like blisters, pain, redness, hardness, burning, or itching in the place you applied the patches enlarged or tender breasts acne depression headache Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: lower leg pain, swelling, warmth, or redness shortness of breath slow or difficult speech dizziness or faintness weakness or numbness of an arm or leg chest pain erections that happen more than usual or that do not go away swelling of the hands, feet, and ankles difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away nausea vomiting yellowing of the skin or eyes rash hives itching difficulty breathing, especially at night Testosterone patches may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children. Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of using this medication. Testosterone may cause other side effects. Call your doctor if you have any unusual problems while using 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). Testosterone patches may burst if exposed to extreme heat or pressure. Store testosterone transdermal patches in a safe place so that no one else can use it accidentally or on purpose. Keep track of how many patches are left so you will know if any are missing. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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 using testosterone patches. Do not let anyone else use your medication. Testosterone transdermal patches are a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. ¶ This branded product is no longer on the market. Generic alternatives may be available.