Testosterone, Transdermal

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KEY POINTS

• This medicine is a patch put on the skin to increase levels of testosterone. Use it exactly as directed.
• Pregnant women and children must avoid skin contact with this medicine. To protect others from skin to skin contact with this medicine, cover the area where you apply it with clothing.
• This medicine may raise cholesterol, increase the risk of blood clots, or cause other serious side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: androgen; male hormone

Generic and brand names: testosterone, transdermal; Androderm

What is this medicine used for?

This medicine is a patch used on the skin to replace testosterone (male hormone) in men whose bodies do not have enough of the hormone. This medicine is absorbed through the skin into the body.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or hormone
• A stroke or transient ischemic attack (TIA)
• Blood clots in your legs, lungs, brain, or eyes
• Diabetes
• Heart disease or heart attack
• High cholesterol
• Kidney or liver disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Male breast cancer
• Prostate cancer
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: This medicine MUST NOT be used by women who are pregnant, or may become pregnant, or by those who are breast-feeding. This medicine is has been reported to cause birth defects. Contact your healthcare provider immediately if a woman has contact with this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Follow your healthcare provider's directions carefully. These patches must be attached to clean, dry skin that is not oily. Do not place patches over skin areas that will receive a lot of pressure during sleep or sitting such as the buttocks or over a bony area. Carefully follow the instructions included in the medicine package for proper use of this medicine. Be sure you know where you are to apply this medicine and how to apply it. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18 years.

What if I miss a dose?

If you forget to apply a patch, apply it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and apply the next one as directed. Do not apply double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine should not be used by women, especially women who are pregnant or breast-feeding. Serious harm can be done to the unborn baby or to a child who is breast-feeding.

This medicine may:

• Raise your cholesterol.
• Increase your risk for prostate cancer or worsen an enlarged prostate.
• Cause enlarged or painful breasts.
• Worsen heart failure symptoms by causing you to retain fluid.
• Cause sleep apnea.
• Increase your risk of blood clots.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

The patch adhesive can cause mild skin irritation. Talk to your healthcare provider about using a steroid cream (not ointment) if this becomes bothersome. Do not use lotion or ointments on your skin before putting on a patch.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

This medicine may lower the sperm count in men. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. The patch may need to be removed before certain tests or procedures such as MRIs.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Trouble urinating; increased or decreased urination; swelling in feet, legs, hands, or arms, or any unexplained swelling; erections that happen too often or last longer than 4 hours; painful ejaculation; yellowing of the skin or eyes; dark urine; light-colored bowel movements; unexplained nausea or vomiting; weakness or numbness in arm or leg; unusual bruising or bleeding; redness, warmth, or swelling in your lower legs, ankles, or feet; sudden shortness of breath; chest pain; breathing problems, especially while sleeping; extreme drowsiness; tender or enlarged breasts; unusual mood changes.

Other: Headache; itching, burning, or redness of the skin where the patch was applied; acne.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Saw palmetto
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the patch in the original pouch until you use it. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.