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Testosterone gel

Pronunciation

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

Children who have been exposed to testosterone 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 testosterone gel.

Closely follow the recommended instructions for use of testosterone gel.


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 an androgen 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 pregnant, 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 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 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, especially soy products or alcohol
  • 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
  • you have a history of blood clots
  • if you are using insulin

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

  • Corticosteroids (eg, prednisone) because they may increase the risk of testosterone gel's side effects
  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased 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.

  • Testosterone gel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get testosterone gel refilled.
  • Apply testosterone gel to clean, dry skin on the shoulders and/or upper arms.
  • Do not apply more than 1 tube/packet to a shoulder or arm at a time. If your dose is 2 tubes or packets, apply the second tube/packet to the other shoulder or arm. If your medicine is in a pump, be sure you know how many pumps you can use on each shoulder or arm.
  • If your medicine is in a pump, prime the pump before the first use. Throw away any medicine that comes out. Check with your pharmacist if you are not sure how to prime the pump.
  • Apply testosterone gel to clean, dry skin.
  • Do not allow another person to apply testosterone gel for you.
  • Do not apply testosterone gel to the scrotum, genitals, or stomach area. Do not apply it over open sores, wounds, or irritated skin.
  • Wash your hands with soap and water immediately after using testosterone gel.
  • Allow testosterone gel to dry for a few minutes before dressing.
  • Cover the application site (eg, with a shirt) to prevent others from coming into contact with testosterone 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 2 hours after applying testosterone gel before showering, swimming, or bathing.
  • If you miss a dose of testosterone 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 testosterone gel.

Important safety information:

  • 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 testosterone gel.
  • Blood clots have happened in patients using testosterone products such as testosterone 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).
  • 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 testosterone 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.
  • Testosterone gel is flammable. Do not store or use near an open flame or while smoking.
  • Tell your doctor or dentist that you use testosterone gel before you receive any medical or dental care, emergency care, or surgery.
  • Testosterone gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using testosterone gel.
  • Diabetes patients - Testosterone 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 testosterone 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), and blood testosterone, may be performed while you use testosterone 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 testosterone gel with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
  • PREGNANCY and BREAST-FEEDING: Testosterone gel may cause harm to the fetus. It is not known if testosterone gel is found in breast milk. Testosterone gel is not approved for use in women.

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; change in sex drive; 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; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast tenderness or enlargement; change in the size or shape of the testicles; excessive daytime sleepiness; frequent, prolonged, or painful erections; interrupted breathing while sleeping; memory problems; mood or mental changes (eg, anxiety, depression, hostility, suicidal thoughts); new or worsening trouble urinating (eg, frequent urination, inability to urinate, weak urine stream); severe or persistent dizziness or headache; swelling of the ankles, feet, or body; symptoms of liver problems (eg, dark urine; pale stools; nausea; loss of appetite; stomach pain; unusual tiredness; yellowing of the skin or eyes); trouble sleeping or other sleep changes; unexplained or unusual weight gain; vomiting.

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.

Proper storage of testosterone gel:

Store testosterone gel between 68 and 77 degrees F (20 and 25 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 testosterone gel, 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take testosterone 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 testosterone gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to testosterone 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 healthcare provider for complete information about the risks and benefits of using testosterone gel.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
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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