AndroGel gel

Pronunciation

Generic Name: testosterone (tes-TOS-ter-one)
Brand Name: AndroGel

Children who have been exposed to AndroGel gel have developed symptoms such as enlarged genitals; increased pubic hair, erections, or sex drive; aggressive behavior; and increased bone age. Contact the child's doctor right away if any of these symptoms occur. Children should avoid contact with unwashed or unclothed application sites in men who use AndroGel gel.

Closely follow the recommended instructions for use of AndroGel gel.


AndroGel 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.

AndroGel gel is an androgen hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.

Do NOT use AndroGel gel if:

  • you are allergic to any ingredient in AndroGel gel, including alcohol
  • you are female
  • you are or may become pregnant, or are 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.

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Before using AndroGel gel:

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

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart problems (eg, congestive heart failure), coronary artery disease, angina (chest pain), high cholesterol levels, swelling or fluid buildup (edema), lung problems, or sleep apnea (long pauses in breathing while you sleep)
  • if you have cancer, diabetes, an enlarged prostate or benign prostatic hypertrophy (BPH), kidney or liver problems, or high blood calcium levels, or you are overweight
  • if you are using insulin
  • if you have a history of blood clots

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

  • Corticosteroids (eg, prednisone) or corticotropin (ACTH) because they may increase the risk of AndroGel gel's side effects
  • Anticoagulants (eg, warfarin), carbamazepine, or oxyphenbutazone because the risk of their side effects may be increased by AndroGel gel
  • Propranolol because its effectiveness may be decreased by AndroGel gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if AndroGel 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 AndroGel gel:

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

  • AndroGel gel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get AndroGel gel refilled.
  • Tear the medicine packet(s) open at the dotted line. Squeeze the contents of the medicine packet(s) into the palm of your hand or directly onto the application site. Apply AndroGel gel right away to clean, dry skin on the shoulders and upper arms as directed by your doctor. It should be applied at the same time each morning after showering or bathing, unless your doctor directs you otherwise. The area to which you apply AndroGel gel should be able to be covered by a short sleeve T-shirt.
  • Do not allow another person to apply AndroGel gel for you.
  • Do not apply AndroGel gel to the stomach, scrotum, or genitals. Do not apply it over open sores, wounds, or irritated or broken skin.
  • Wash your hands with soap and water immediately after using AndroGel gel.
  • Allow AndroGel gel to dry completely before dressing.
  • Cover the application site (eg, with a shirt) to prevent others from coming into contact with AndroGel gel. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
  • For best results, wait at least 2 hours after applying AndroGel gel before you shower or swim.
  • Discard used or unused medicine packets appropriately in the trash out of the reach of children and away from pets.
  • If you miss a dose of AndroGel gel, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use AndroGel gel.

Important safety information:

  • AndroGel gel may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use AndroGel gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not change your dose of AndroGel gel without checking with your doctor.
  • Patients who use androgens (such as testosterone) may have an increased risk of prostate cancer. Check with your doctor if you have questions about your risk of prostate cancer while you use AndroGel gel.
  • Do not allow others to come into contact with the medicine, the application site, or any unwashed clothing that may have touched the application site. If someone else comes into contact with AndroGel gel, have them wash the area with soap and water right away.
  • Contact your doctor right away if your female partner develops a change in hair distribution, an increase in acne, or any masculine signs.
  • AndroGel gel is flammable. Allow AndroGel gel to dry after applying it before you smoke or go near an open flame.
  • Do not switch between AndroGel gel and other testosterone products without first talking with your doctor. The application site and/or dose may not be the same as other testosterone products.
  • Tell your doctor or dentist that you use AndroGel gel before you receive any medical or dental care, emergency care, or surgery.
  • Blood clots have happened in patients using testosterone products such as AndroGel gel. Tell your doctor if you have ever had a blood clot. Call your doctor right away if you have symptoms of a blood clot (eg, swelling, warmth, numbness, change of color, or pain in a leg or arm; chest pain; shortness of breath; coughing up blood).
  • AndroGel gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using AndroGel gel.
  • Diabetes patients - AndroGel gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Large doses of AndroGel gel may lower your sperm count. Discuss any questions or concerns with your doctor.
  • Lab tests, including liver function, complete blood cell counts, blood cholesterol, prostate-specific antigen (PSA), blood calcium levels, and blood testosterone, may be performed while you use AndroGel gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use AndroGel gel with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
  • AndroGel gel should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: AndroGel gel may cause harm to the fetus. It is not known if AndroGel gel is found in breast milk. AndroGel gel should not be used by women.

Possible side effects of AndroGel 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:

Skin irritation at the application site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast tenderness or enlargement; breathing problems while sleeping; calf or leg pain, swelling, or redness; changes in skin color; change in the size or shape of the testicles; dark urine; excessive daytime sleepiness; frequent, prolonged, or painful erections; loss of appetite; memory problems; mood or mental changes (eg, anxiety, depression, hostility, suicidal thoughts); nausea; new or worsening trouble urinating (eg, frequent urination, inability to urinate, weak urine stream); pale stools; severe or persistent headache, dizziness, or blurred vision; shortness of breath; stomach pain; swelling of the ankles, feet, or legs; trouble sleeping or other sleep changes; unexplained or unusual weight gain; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision or other vision changes; confusion; one-sided weakness; slurred speech.

Proper storage of AndroGel gel:

Store AndroGel gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, fire, moisture, and light. Do not store in the bathroom. Keep AndroGel gel out of the reach of children and away from pets.

General information:

  • If you have any questions about AndroGel gel, please talk with your doctor, pharmacist, or other health care provider.
  • AndroGel 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take AndroGel gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about AndroGel gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to AndroGel gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using AndroGel gel.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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