Testosterone GelGeneric Name:
Testosterone (tes-TOS-ter-one)Brand Name:
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 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 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
- if you have heart problems (eg, congestive heart failure), coronary artery disease, angina (chest pain), high cholesterol levels, swelling or fluid build-up (edema), lung problems, or sleep apnea (long pauses in breathing while you sleep)
- if you have cancer, diabetes, an enlarged prostate, kidney or liver problems, or high blood calcium levels, or you are overweight
- 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) or corticotropin (ACTH) because they may increase the risk of Testosterone Gel's side effects
- Anticoagulants (eg, warfarin), carbamazepine, or oxyphenbutazone because the risk of their side effects may be increased by Testosterone Gel
- Propranolol because its 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.
- 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 allow another person to apply Testosterone Gel for you.
- Do not apply Testosterone Gel to the scrotum or genitals. 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 5 to 6 hours after applying Testosterone Gel before you shower or swim. 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, 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:
- Testosterone Gel may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Testosterone Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- 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.
- 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 take 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, prostatic 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.
- Testosterone 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: Testosterone Gel may cause harm to the fetus. It is not known if Testosterone Gel is found in breast milk. Testosterone Gel should not be used by 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; breast tenderness or enlargement; 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); calf pain, swelling, or redness; change in the size or shape of the testicles; dark urine; excessive daytime sleepiness; frequent, prolonged, or painful erections; interrupted breathing while sleeping; 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 headache; skin discoloration; stomach pain; swelling of the ankles 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include blurred vision or other vision changes; one-sided weakness; slurred speech.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.
- 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.
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.
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