Testosterone-transdermal

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

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 (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: male breast cancer, prostate cancer.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or BPH), heart problems, kidney problems, diabetes, high cholesterol level, difficulty breathing during sleep (apnea), high blood pressure, bone cancer.If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.Extreme caution is advised if using this drug in children because it might stunt the growth of the child. Monitor the child's growth rate carefully.Elderly men may be at greater risk for developing an enlarged prostate or prostate cancer while using this drug. Consult your doctor or pharmacist for more details.This medication should not be used by women (see Side Effects section for a list of effects that may occur if a woman is exposed to testosterone.) Also, testosterone can cause harm to an unborn or breast-feeding baby.

Do not share this medication with others. It is against the law.Laboratory and/or medical tests (e.g., PSA, cholesterol, hemoglobin, hematocrit, testosterone blood levels, prostate exams) should be performed from time to time to monitor your progress or check for side effects. 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 told to do so by your doctor. A different medication may be necessary in those cases.Inform all your doctors that you are using or have used this medication.

In the U.S.

• Androderm

In Canada

• Androplex

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check for any problems or unwanted effects that may be caused by testosterone. Blood tests will be needed to check for unwanted effects.

testosterone should not be used by women who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the patch or medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using testosterone, tell your doctor right away.

If a woman comes in contact with the patch, wash the skin area right away with soap and water to remove all the medicine. If the patch sticks to a woman, remove the patch right away and wash her skin thoroughly with soap and water.

If your female partner starts to have male-like changes such as unusual hair growth or increased acne, check with your doctor.

testosterone may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

testosterone may increase the risk of prostate cancer, especially in older men. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.

testosterone may cause blood clotting problems. Tell your doctor right away if you have pain, redness, or swelling in the arm or leg, shortness of breath, sharp pains in the chest, or trouble breathing.

testosterone may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

In some cases, testosterone may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using testosterone.

Tell your doctor if you experience too frequent erection of the penis, nausea, vomiting, yellowing of your skin or the whites of your eyes, or swelling of the ankle.

testosterone may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

testosterone may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.

testosterone contains aluminum that may cause skin burns at the patch site if you have a procedure called a magnetic resonance imaging (MRI) scan while you are wearing the patch. You must remove the patch before your MRI to prevent skin burns.

Check with your doctor immediately if mild, burn-like skin blisters, redness, itching, or swelling occurs at the site of application during or after treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Remember that your doctor has prescribed this medication because he or she 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: persistent nausea/vomiting, 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.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

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.

List Testosterone 10 Mg/0.5 Gram/Actuation Transdermal Gel Pump side effects by likelihood and severity.