testosterone 10 mg/0.5 gram/actuation transdermal gel pump

Generic name:
Testosterone gel pump 2% - transdermal

Pronunciation
(tes-TOS-ter-one)

Brand name(s)
Fortesta

Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with any unwashed or unclothed area where the medication has been applied. Tell both of your doctors right away if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals (penis or clitoris), early development of pubic hair, increased erections (in boys) or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.

This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.

Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.

This drug should not be used by women.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using testosterone gel and each time you get a refill. Learn how to use the pump and how to apply the gel correctly. If you have any questions, ask your doctor or pharmacist.

There are many testosterone products available for use on the skin. They may have different amounts of testosterone and may not have the same effects. Read the dosing instructions carefully for each product. Do not change products without asking your doctor or pharmacist.

Follow the instructions for priming the pump if you are using it for the first time.

Apply the medication to clean, dry skin on the front and inner thigh(s) as directed by your doctor, usually once daily in the morning. Pump this medication directly onto the thigh(s). Use one finger to rub the gel in evenly. Apply only to areas that would be fully covered by clothing (shorts or pants). Avoid applying this medication to broken, irritated skin. Do not apply this medication to other areas of the body including to the genitals (penis or scrotum) or to the area of the thighs next to the genitals. Do not let others apply this medication to your body.

The dosage is based on your medical condition, lab tests, and response to treatment. Follow your doctor's instructions carefully on the exact number of pumps for each dose.

After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Wait a few minutes for the application site to dry completely before dressing. Be sure to always wear clothing (such as shorts or pants) to cover the application site until you wash the areas well with soap and water. To get the best effect, wait at least 2 hours before showering/swimming to allow the drug to be absorbed through the skin.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.

This medication is flammable until dry. Let the gel dry before smoking or going near an open flame.

Tell your doctor if your condition does not get better or if it gets worse.

Redness/irritation at the application site and acne may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• nausea/vomiting that doesn't stop
• severe stomach/abdominal pain
• dark urine
• yellowing eyes/skin
• swelling hands/ankles/feet
• breast pain/enlargement
• very slow/shallow/difficult breathing (possibly while sleeping)
• difficulty urinating
• increased urination (especially at night)
• mental/mood changes (such as depression, agitation, hostility)
• testicle pain/tenderness
• fast/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breast cancer (males)
• prostate problems (such as cancer, enlarged prostate or BPH)
• difficulty breathing during sleep (apnea)
• high cholesterol level
• bone cancer
• diabetes
• heart problems (such as heart failure, heart attack)
• stroke
• blood clots (such as in the leg, lungs)

Direct contact with the application site can expose others to this medication. Women and children should avoid contact with any unwashed or unclothed area where the medication has been applied. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child makes contact with the application area, that area on the woman or child should be washed well with soap and water right away.

If this medication accidentally gets into your eyes, rinse the eyes right away with clean, warm water. Get medical help right away if necessary.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.

Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Monitor your child's height periodically.

This medication can affect fertility in males. Ask your doctor for more details.

This medication should not be used by women. Women accidentally exposed to this medication may have side effects due to testosterone gel. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. Women who are pregnant or breastfeeding must avoid contact with this medication. This medication may harm an unborn or breastfeeding baby. Consult your doctor for more details.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• "blood thinners" (such as warfarin)

This medication may interfere with certain lab tests (such as thyroid function tests, creatinine level), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as PSA, cholesterol, hemoglobin/hematocrit, testosterone blood levels, prostate exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another problem unless your doctor directs you to do so. A different medication may be necessary in that case.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Do not store near an open flame. Do not freeze. Discard used pumps in a secure trash can. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.