Generic Name: testosterone (tes-TOS-ter-one)
Brand Name: Axiron
Children who have been exposed to Axiron solution 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 Axiron solution.
Closely follow the recommended instructions for use of Axiron solution.
Axiron solution is used for:
Replacing 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.
Axiron solution is an androgen hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.
Do NOT use Axiron solution if:
- you are allergic to any ingredient in Axiron solution
- 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.
Before using Axiron solution:
Some medical conditions may interact with Axiron solution. 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), high cholesterol levels, swelling or fluid build-up (edema), or lung or breathing problems (eg, 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 Axiron solution. 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 Axiron solution's side effects
- Anticoagulants (eg, warfarin) because the risk of its side effects may be increased by Axiron solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Axiron solution 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 Axiron solution:
Use Axiron solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Axiron solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Axiron solution refilled.
- Prime this product before the first use. To prime it, depress the pump 3 times and wash any product that is dispensed down the sink.
- Depress the pump once to fill the applicator cup. Holding the applicator upright, wipe Axiron solution steadily up and down onto clean, dry skin in the armpit. If Axiron solution drips or runs, it can be wiped back up with the applicator cup. Do NOT apply Axiron solution to other parts of your body (eg, scrotum, penis, stomach, shoulders, upper arms). Do NOT apply it over open sores, wounds, or irritated skin.
- Do NOT use your fingers or hand to rub the medicine into the skin.
- You may need to alternate between armpits when applying Axiron solution. Be sure you understand how to apply Axiron solution. Contact your doctor or pharmacist if you have questions or concerns about how to apply Axiron solution.
- Wash your hands with soap and water immediately after using Axiron solution.
- Allow Axiron solution to dry completely before dressing.
- After Axiron solution has dried, cover the application site (eg, with a shirt) to prevent others from coming into contact with Axiron solution. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
- After using Axiron solution, rinse the applicator with room temperature water and pat it dry with a tissue. Replace the applicator and cap on the bottle for storage.
- Do NOT get Axiron solution in your eyes. If you do, rinse thoroughly with water. If eye irritation persists, contact your doctor.
- Apply Axiron solution at the same time every morning after showering or bathing, unless your doctor tells you otherwise.
- If you are also using an antiperspirant or deodorant (stick or roll-on), apply it at least 2 minutes before you apply Axiron solution.
- For best results, wait 2 hours after applying Axiron solution before you wash the application site or swim.
- If you miss a dose of Axiron solution, 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 Axiron solution.
Important safety information:
- Do NOT take more than the recommended dose 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 Axiron solution.
- Do not allow others, especially children and women, to come into contact with the medicine, the unclothed or unwashed application site, or any unwashed clothing that may have touched the application site. If someone else comes into contact with Axiron solution, have them wash the area with soap and water right away.
- Contact your doctor right away if a child you are in close contact with develops enlarged genitals, pubic hair, or increased sex drive, or if your female partner develops a change in hair distribution, an increase in acne, or any masculine signs.
- Axiron solution is flammable. Avoid fire, an open flame, or smoking after application until Axiron solution has dried.
- Do not switch between other topical testosterone products and Axiron solution without talking to your doctor.
- Tell your doctor or dentist that you take Axiron solution before you receive any medical or dental care, emergency care, or surgery.
- Blood clots have happened in patients using testosterone products such as Axiron solution. 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).
- Axiron solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Axiron solution.
- Diabetes patients - Axiron solution 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 Axiron solution 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) levels, and blood testosterone, may be performed while you use Axiron solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Axiron solution with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
- Axiron solution should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Axiron solution may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Axiron solution is not approved for use in women.
Possible side effects of Axiron solution:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; breast tenderness or enlargement; change in sex drive; diarrhea; headache; skin irritation or redness at the application site; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems while sleeping; calf or leg pain, swelling, or redness; change in the size or shape of the testicles; chest pain; dark urine; frequent or prolonged erections; loss of appetite; mood or mental changes (eg, anger, anxiety); new or worsening trouble urinating (eg, frequent urination, inability to urinate, weak urine stream); pale stools; severe headache or dizziness; shortness of breath; stomach pain; swelling of the ankles or feet; unexplained or unusual weight gain; unusual tiredness or weakness; 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 Axiron solution:
Store Axiron solution 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, fire, moisture, and light. Do not store in the bathroom. When it is time to throw Axiron solution away, throw away the applicator and cap as well. Keep Axiron solution out of the reach of children and away from pets.
- If you have any questions about Axiron solution, please talk with your doctor, pharmacist, or other health care provider.
- Axiron solution 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 Axiron solution 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 Axiron solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Axiron solution. 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 Axiron solution.
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.