This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.

Testosterone helps the body to produce sperm and to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.

This drug should not be used by women.

Read the Patient Information Leaflet provided by your pharmacist before you start using testosterone and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Apply the medication as directed to the clean, dry skin of the shoulders/upper arms, once daily in the morning or as directed by your doctor. Certain brands of this medication may also be applied to the lower stomach (abdomen). Check your Patient Information Leaflet or ask your pharmacist if your brand may be applied to the lower abdomen. Dosage is based on your medical condition and response to therapy.

Avoid applying gel to skin with open sores or to broken, irritated skin. Do not apply this medication to the genitals (penis or scrotum).

After applying this medication, wash your hands thoroughly with soap and water to reduce the possibility of spreading the medicine from your hands to other people.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Allow this medication to dry completely on the skin before getting dressed. Make sure to cover the application site with clothing.

After applying the gel, wait several hours before showering or swimming (2 to 6 hours depending on brand) to make sure all the drug is absorbed. If you are unsure how long you must wait, check the manufacturer's Patient Information Leaflet or ask your pharmacist.

This medication is flammable. Avoid smoking and open flame until the gel has dried.

Inform your doctor if your condition persists or worsens.

Nausea, vomiting, headache, dizziness, hair loss, trouble sleeping, change in sexual desire, redness/swelling of the skin, change in skin color, or acne may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: breast pain/enlargement, swelling of the feet/ankles (edema), weight gain, very slow/shallow/difficult breathing (possibly while sleeping), weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: trouble urinating, mental/mood changes (e.g., depression, agitation, hostility), change in size/shape of the testicles, testicle pain/tenderness, stomach/abdominal pain, dark urine, yellowing of eyes/skin, change in the amount of urine, calf tenderness/swelling/pain.

In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, rapid pulse, and sweating. If you are experiencing these symptoms, consult your doctor.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Avoid spreading this medication to others (see How to Use and Precautions sections). If your female partner or your children develop any changes in hair location, an increase in acne, unusual increase in size of genitals (penis or clitoris), or other signs of the effects of testosterone, tell both of your doctors immediately.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or to soy; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer (males), prostate cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or BPH), heart problems, kidney problems, diabetes, high cholesterol level, lung disease, obesity, difficulty breathing during sleep (apnea), high blood pressure, bone cancer.

Direct contact with the application site can spread this medication to others. Protect others from direct skin contact with the application site. This is especially important for women (especially pregnant women) and children. You can use clothing (e.g., long-sleeved shirt) to cover the area, but if you expect to have direct contact with someone else, you should wash the application site with soap and water in advance. Should anyone's skin directly contact the application site, their skin should be washed immediately with soap and water.

If this medication accidentally gets into your eyes, rinse the eyes immediately with clean, warm water. Seek medical attention if necessary.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Some men, particularly the elderly, are at a higher risk for developing enlarged prostates or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.

Extreme caution is advised if using this drug in children because it might stunt the growth of the child. Monitor the child's growth rate carefully.

This medication should not be used in women.

Women must avoid direct skin contact with a male's testosterone application site if the woman is pregnant, may be pregnant, or breast-feeding. Testosterone may be absorbed into her bloodstream and cause harm to the unborn/breast-feeding baby. Discuss the risks with your doctor.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: beta blockers (e.g., propranolol), "blood thinners" (e.g., warfarin), corticosteroids (e.g., prednisone), oral diabetes medication (e.g., glyburide, metformin), insulin, oxyphenbutazone.

This medication may interfere with certain laboratory tests (including thyroid function tests, creatinine level), possibly causing false test results. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed. Symptoms of an overdose may include weakness on one side of the body, slurred speech, vision problems, or confusion.

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (e.g., PSA, cholesterol, hemoglobin, hematocrit, testosterone blood levels, prostate exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another problem unless told to do so by your doctor. A different medication may be necessary in those cases.

Inform all your doctors that you are using or have used this medication.

If you miss a dose, use it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom or near an open flame. Keep all medicines away from children and pets, and throw out used gel packets in a secure trash can.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.