Testosterone Topical gel

What is this medicine?

TESTOSTERONE (tes TOS ter one) is the main male hormone. It supports normal male traits such as muscle growth, facial hair, and deep voice. This gel is used in males to treat low testosterone levels.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• breast cancer
• diabetes
• heart disease
• if a female partner is pregnant or trying to get pregnant
• kidney disease
• liver disease
• lung disease
• prostate cancer, enlargement
• an unusual or allergic reaction to testosterone, soy proteins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is applied at the same time every day (preferably in the morning) to clean, dry, intact skin. If you take a bath or shower in the morning, apply the gel after the bath or shower. Open the packet(s) or tube(s) needed for proper dosage, or, if using the multi-dose pump, pump the dose into the palm of your hand. You can put the entire dose into your palm at once or just a little at a time to apply; however, be sure you use the correct total dose. Apply to the appropriate skin site (see below). Allow the skin to dry a few minutes before putting on clothing. The skin gel is flammable. Avoid fire, flame, or smoking until the gel has dried. Wash your hands after use.

For AndroGel: Apply on the shoulders, upper arm, or abdomen as directed. Do not apply to the scrotum or genitals. It is best to wait for 5 to 6 hours after application of the gel before showering or swimming.

For Testim: Apply on the shoulders or upper arms as directed. Do not apply to the scrotum, genitals, or abdomen. Do not shower or swim for at least 2 hours after application of the gel.

Make sure that you are using your testosterone gel product correctly. You will get an information sheet with each prescription and refill. Read this sheet carefully each time. This sheet may change.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If it is more than 12 hours until your next dose, apply the missed dose as soon as you remember. If your next dose is less than 12 hours away, it is best to wait and then go back to your normal schedule. Do not apply double or extra doses.

What may interact with this medicine?

• medicines for diabetes
• medicines that treat or prevent blood clots like warfarin
• oxyphenbutazone
• propranolol
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. They will need to check the level of testosterone in your blood.

Female partners may absorb some testosterone if they come into direct contact with the skin area to which the gel has been applied. This may include contact during sexual activity. If a partner has contact with the skin treated with the gel, they should wash their skin with soap and water as soon as they can to remove any gel. Check with a health care professional if your female partner has any changes in body hair, voice, or acne. Also, a female partner who is pregnant or trying to get pregnant should avoid contact with the gel or treated skin.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This drug is banned from use in athletes by most athletic organizations.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast enlargement
• breathing problems
• changes in mood, especially anger, depression, or rage
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite, nausea
• nausea, vomiting
• right upper belly pain
• stomach pain
• swelling of ankles
• too frequent or persistent erections
• trouble passing urine or change in the amount of urine
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• change in sex drive or performance
• hair loss
• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 to 30 degrees C (59 to 86 degrees F). Keep closed until use. Protect from heat and light. This medicine is flammable. Avoid exposure to heat, fire, flame, and smoking. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.