Testosterone Gel

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Testosterone Gel


Generic Name: Testosterone Gel (tes-TOS-ter-ohn)
Brand Name: AndroGel and Testim

Testosterone Gel is used for:

Treating symptoms of low testosterone in adult men when the body does not make any testosterone or not enough testosterone (hypogonadism). It may also be used for other conditions as determined by your doctor.

Testosterone Gel is a hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.

Do NOT use Testosterone Gel if:

  • you are allergic to any ingredient in Testosterone Gel
  • you are female
  • you are pregnant or breast-feeding
  • you have known or suspected breast or prostate cancer

Contact your doctor or health care provider right away if any of these apply to you.

Before using Testosterone Gel:

Some medical conditions may interact with Testosterone Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you plan to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (especially soy products)
  • if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)
  • if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity

Some MEDICINES MAY INTERACT with Testosterone Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because actions and side effects may be increased by Testosterone Gel
  • Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because side effects, including risk of bleeding, may be increased by Testosterone Gel
  • Propranolol because effectiveness may be decreased by Testosterone Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Testosterone Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Testosterone Gel:

Use Testosterone Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Apply Testosterone Gel to clean, dry skin on the shoulders, upper arms, or stomach.
  • Testosterone Gel comes with an additional patient leaflet. Read it carefully and reread it each time you get Testosterone Gel refilled.
  • Do not apply Testosterone Gel to the scrotum or genitals.
  • Wash your hands immediately after using Testosterone Gel.
  • For best results, wait 5 to 6 hours after applying Testosterone Gel before showering or swimming. Showering or swimming just 1 hour after applying Testosterone Gel may be permitted if done very infrequently.
  • If you miss a dose of Testosterone Gel, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Testosterone Gel.

Important safety information:

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Testosterone Gel.
  • Diabetes patients - Testosterone Gel may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Testosterone Gel is flammable. Do not store or use near an open flame or while smoking.
  • Testosterone Gel can affect the results of certain LAB TESTS. Make sure lab technicians and your doctors know you use Testosterone Gel.
  • LAB TESTS, including liver function, blood cell counts, blood cholesterol, prostatic specific antigen, and blood testosterone, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Testosterone Gel may increase the risk of an enlarged prostate or prostate cancer in ELDERLY patients.
  • This medicine is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Testosterone Gel is not for use in women, especially women who are pregnant, plan to become pregnant, or are breast-feeding. Testosterone Gel has been shown to cause harm to the fetus. It is unknown if Testosterone Gel is excreted in breast milk. Do not breast-feed while using Testosterone Gel.

When used for long periods of time, some people develop a need to continue taking Testosterone Gel. This is known as DEPENDENCE or "addiction." Testosterone Gel has a potential for abuse that may lead to moderate or low physical DEPENDENCE or high psychological DEPENDENCE.

Possible side effects of Testosterone Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; bitter or strange taste in mouth; change in sex drive; dry skin; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache; skin irritation at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; dark urine or light-colored bowel movements; decreased urination; depression or mood changes; dizziness; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; stomach pain; swelling of the ankles or legs; unusual tiredness or weakness; urination problems; weight gain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; one-sided weakness; vision problems.

Proper storage of Testosterone Gel:

Store Testosterone Gel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Testosterone Gel out of the reach of children and away from pets.

General information:

  • If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
  • Testosterone Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Testosterone Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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