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Fortesta gel

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

Children who have been exposed to Fortesta 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 Fortesta gel.

Closely follow the recommended instructions for use of Fortesta gel.


Fortesta 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.

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

Do NOT use Fortesta gel if:

  • you are allergic to any ingredient in Fortesta 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 Fortesta gel:

Some medical conditions may interact with Fortesta 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), 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, benign prostatic hypertrophy (BPH), kidney or liver problems, high blood calcium levels, or you are overweight
  • if you are using insulin

Some MEDICINES MAY INTERACT with Fortesta 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 Fortesta gel's side effects
  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Fortesta gel

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

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

  • Fortesta gel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fortesta gel refilled.
  • You will need to prime this product before the first use. To prime it, with the canister in the upright position, depress the pump 8 times and appropriately discard the gel that is pumped out.
  • Apply Fortesta gel with one finger and gently rub it evenly onto clean, dry skin of the front and inner thighs. Make sure that your shorts or pants will be able to cover the application site.
  • Do not apply Fortesta gel to the genitals or other parts of the body. Avoid applying Fortesta gel to the thigh adjacent to the scrotum. Do not apply it over open sores, wounds, or irritated skin.
  • It is best to apply Fortesta gel at the same time every day in the morning after showering or bathing, unless directed otherwise by your doctor.
  • Do not allow another person to apply Fortesta gel for you.
  • Wash your hands with soap and water immediately after using Fortesta gel.
  • Allow Fortesta gel to dry for a few minutes before dressing.
  • After Fortesta gel has dried, cover the application site (eg, with shorts or pants) to prevent others from coming into contact with Fortesta 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 Fortesta gel before you shower or swim. Showering or swimming just 1 hour after applying Fortesta gel may be permitted if done very infrequently.
  • If you miss a dose of Fortesta 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 Fortesta gel.

Important safety information:

  • Fortesta gel may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fortesta 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 or use 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 Fortesta gel.
  • Do not allow others, especially children and women, 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 Fortesta gel, 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.
  • Fortesta gel is flammable. Avoid fire, an open flame, or smoking after application until Fortesta gel has dried.
  • Do not switch between other topical testosterone products and Fortesta gel without talking to your doctor.
  • Tell your doctor or dentist that you take Fortesta gel before you receive any medical or dental care, emergency care, or surgery.
  • Fortesta gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Fortesta gel.
  • Diabetes patients - Fortesta 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 Fortesta gel may lower your sperm count. Discuss any questions or concerns with your doctor.
  • Lab tests, including liver function, hematocrit, blood cholesterol, prostate-specific antigen (PSA), and blood testosterone, may be performed while you use Fortesta 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 Fortesta gel with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
  • Fortesta gel 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: Fortesta gel is not approved for use in women. Fortesta gel may cause harm to the fetus. Do not use Fortesta gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Fortesta gel is found in breast milk. Do not breast-feed while using Fortesta gel.

Possible side effects of Fortesta 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:

Abnormal dreams; acne; change in sex drive; dizziness; headache; skin redness or 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; 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; migraine; mood or mental changes (eg, anxiety, depression, hostility, suicidal thoughts); nausea; new or worsening urination problems (eg, frequent urination, inability to urinate, weak urine stream); pale stools; severe headache; shortness of breath; skin discoloration; stomach pain; swelling of the hands, 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. 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 confusion; one-sided weakness; slurred speech; vision changes.

Proper storage of Fortesta gel:

Store Fortesta gel between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Keep Fortesta gel out of the reach of children and away from pets.

General information:

  • If you have any questions about Fortesta gel, please talk with your doctor, pharmacist, or other health care provider.
  • Fortesta 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 Fortesta 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 Fortesta gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fortesta 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 Fortesta gel.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
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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