Pronunciation:

tes-TOS-ter-one

Brand Names:

• Androderm
• Androplex

Dosage Forms:

• Patch, Extended Release

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Androgen

Uses of This Medicine:

Testosterone transdermal patch is used for the treatment of males whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of testosterone transdermal patch in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of testosterone transdermal patch in the geriatric population. However, elderly patients may be at an increased risk for developing prostate problems, including prostate cancer, which may require caution in patients receiving testosterone transdermal patch.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Bupropion
• Dicumarol
• Levoketoconazole
• Methotrexate
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Diabetes or
• Drug abuse or dependence, history of or
• Enlarged prostate or
• Heart attack, history of or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Problems in passing urine or
• Sleep apnea (breathing problem) or
• Stroke, history of—Use with caution. May make these conditions worse.

• Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases.

• Breast cancer (males) or
• Prostate cancer, known or suspected—Should not be used in patients with these conditions.

• Heart disease (eg, congestive heart failure) or
• Kidney disease or
• Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

• Lung disease or
• Obesity—May increase risk for sleep apnea.

Proper Use of This Medicine:

Your doctor will test the testosterone levels in your blood before you start and while you are using this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Testosterone skin patch comes in two different doses and different patch sizes. Ask your doctor which is the right one for you.

Make sure that you wash your hands with soap and water before and after applying the patch.

For patients using the patch:

• After opening the pouch that contains the patch, apply the patch immediately.
• Apply the patch to a clean, dry area of the skin on your back, abdomen or stomach, thighs, or upper arm. Do not put the patch over burns, cuts, or irritated skin. Avoid putting the patch on oily or sweaty skin, or on areas covered with hair, since the patch may not stick tightly to these areas.
• Do not apply the patch to your scrotum or genital area. Avoid applying this medicine to a bony area (such as your shoulder) or to an area that might be under pressure for a long time (such as the back of your leg when you are sitting).
• The patch can be worn during sexual intercourse, or while taking a shower or bath. Wait for at least 3 hours after applying the medicine before you shower, swim, or wash the application site. However, heavy exercise and sweating may cause the patch to fall off.
• When replacing an old patch, make sure that you apply the new patch on a different spot. Do not put another patch back on the same spot for at least 7 days.
• Do not apply any type of ointment product on your skin before you put on the patch.
• If a patch comes off, just put it back on the same spot. If the patch will not stick and you have been wearing it for fewer than 12 hours, put on a new patch. Then stay on your regular schedule and replace it with a fresh patch at your next regular time. If you have already been wearing the patch for more than 12 hours, do not put on a new patch. Wait to put on a new patch at your next regular time. Do not use extra patches to make up for the one that came off.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (patch):
  • For hormone replacement:
    • Adults—At first, one 4-milligram (mg) patch applied nightly for 24 hours. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage—

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms.

Precautions While Using This Medicine:

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 this medicine. Blood tests will be needed to check for unwanted effects.

This medicine 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 this medicine, 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.

This medicine 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.

This medicine 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.

This medicine 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.

This medicine 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, this medicine 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 this medicine.

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.

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

This medicine 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.

This medicine 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Skin itching, blistering, or redness at the application site

Less common

Blistering, burning, crusting, dryness, or flaking of the skin

bloody or black, tarry stools

burning feeling at the application site

constipation

difficult urination

hardening or thickening of the skin under patch

itching, scaling, severe redness, soreness, or swelling of the skin

pelvic pain

severe stomach pain

vomiting of blood or material that looks like coffee grounds

Rare

Bladder pain

bloody or cloudy urine

blurred vision

difficult, burning, or painful urination

dizziness

frequent urge to urinate

headache

lower back or side pain

nervousness

pounding in the ears

slow or fast heartbeat

testicular problems

Incidence not known

Pain, redness, or swelling in the arm or leg

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

rash

tiredness

trouble concentrating

trouble sleeping

Rare

Accelerated growth

blemishes on the skin

body pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

cold hands and feet

contamination of the application site

decreased interest in sexual intercourse

fear

feeling of constant movement of self or surroundings

inability to have or keep an erection

increased appetite

lightheadedness

loss in sexual ability, desire, drive, or performance

loss of bladder control

mood or mental changes

pimples

sensation of spinning

thinking abnormalities

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.