"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
(testosterone) Transdermal System for Topical Use
Read this Patient Information before you start taking ANDRODERM and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is ANDRODERM?
ANDRODERM is a prescription medicine that contains testosterone. ANDRODERM is used to treat adult males who have low or no testosterone.
Your healthcare provider will test your blood for testosterone before you start and while you are taking ANDRODERM.
It is not known if ANDRODERM is safe and effective in children younger than 18 years old. Improper use of ANDRODERM may affect bone growth in children.
ANDRODERM is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your ANDRODERM in a safe place to protect it. Never give your ANDRODERM to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.
ANDRODERM is not meant for use by women.
Who should not use ANDRODERM?
Do not use ANDRODERM if you:
- are a man who has breast cancer
- have or might have prostate cancer
- are pregnant or may become pregnant or are breastfeeding. ANDRODERM may harm your unborn or breastfeeding baby.
Talk to your healthcare provider before taking this medicine if you have any of the above conditions.
What should I tell my healthcare provider before using ANDRODERM?
Before you use ANDRODERM, tell your healthcare provider if you:
- have breast cancer
- have or might have prostate cancer
- have urinary problems due to an enlarged prostate
- have heart problems
- have kidney or liver problems
- have problems breathing while you sleep (sleep apnea)
- have diabetes
- have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using ANDRODERM with other medicines can affect each other. Especially, tell your healthcare provider if you take:
- medicines that decrease blood clotting
Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all your medicines if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use ANDRODERM?
- It is important that you apply ANDRODERM exactly as your healthcare provider tells you to.
- ANDRODERM patches come in 2 different doses and different patch sizes.
- Your healthcare provider will tell you how many ANDRODERM patches to apply and when to apply them.
- Your healthcare provider may change your ANDRODERM dose. Do not change your ANDRODERM dose without talking with your healthcare provider.
- Apply ANDRODERM at about the same time each night.
- Wait 3 hours before showering, bathing, or swimming. This will ensure that the greatest amount of ANDRODERM is absorbed into your system.
- ANDRODERM does not need to be removed during sex or while you take a shower or bath.
- Strenuous exercise or excessive perspiration may loosen your ANDRODERM patch or cause it to fall off.
- If your ANDRODERM patch becomes loose, smooth it down
again by rubbing your finger firmly around the edges. Do not tape
ANDRODERM patches to your skin.
- If your ANDRODERM patch falls off before noon, put on a new ANDRODERM patch and wear it until you put on a new ANDRODERM patch at your regular time.
- If your ANDRODERM patch falls off after noon, do not put on a new one. Wait and apply your ANDRODERM patch at your regular time.
- You should change your ANDRODERM patch every 24 hours. You should remove the old patch before applying the new one.
- You should change (rotate) your ANDRODERM application site every day. Do not use a site that you have used before for at least 7 days.
- Skin redness may happen on the skin where your ANDRODERM patch was removed. If your skin redness does not go away, talk to your healthcare provider. Your healthcare provider may tell you to use an over-the-counter hydrocortisone cream on your red skin.
- Patches that have aluminum in them can cause skin burns at the patch site during a magnetic resonance imaging scan (MRI). Because ANDRODERM contains aluminum, you should take off your ANDRODERM patch before you have an MRI.
- Do not use an ANDRODERM patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way. Throw it away and get a new one.
- Before applying ANDRODERM, make sure that the application area is clean, dry, and there is no broken skin.
- Avoid areas of skin that are oily, perspire heavily, or are covered with hair, since ANDRODERM may not stick well to these areas.
- ANDRODERM is to be applied to your back, stomach area (abdomen), upper arms, or thighs only (See Figure A and Figure B). Do not apply ANDRODERM to any other parts of your body such as your scrotum, buttocks or over a bony area.
1. Open the foil pouch. Tear along the edge and remove the patch from the pouch (See Figure C).
Do not cut the ANDRODERM protective pouch.
2. Remove the protective plastic liner and silver disc from the patch. Hold on to the tabs on the patch and the protective plastic liner and gently pull the two apart to remove the plastic liner and silver disc from the patch (See Figure D).
This will expose the adhesive and central reservoir area on the patch (See Figure E).
The patch should separate easily from the protective liner. Throw away the patch if the liner is hard to remove. There should not be any adhesive (glue) sticking to the liner.
Throw away the clear plastic liner and silver disc.
3. Apply the patch. Apply the patch right away after you remove the patch from the protective pouch and remove the plastic liner.
Place the patch flat on the skin with the sticky side down and firmly press around the edges. Make sure that the patch sticks well to the skin.
What are the possible side effects of ANDRODERM?
ANDRODERM can cause serious side effects including:
- If you already have an
enlargement of your prostate gland your signs and symptoms may get worse while
using ANDRODERM. This can include:
- increased urination at night
- trouble starting your urine stream
- having to pass urine many times during the day
- having an urge that you have to go to the bathroom right away
- having a urine accident
- being unable to pass urine or weak urine flow
- Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use ANDRODERM.
- Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. This can include pain, swelling or redness of your legs.
- In large doses ANDRODERM may lower your sperm count.
- Swelling of your ankles, feet, or body, with or without heart failure.
- Enlarged or painful breasts.
- Problems breathing while you sleep (sleep apnea).
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of ANDRODERM include:
- skin redness, irritation, burning, or blisters where ANDRODERM is applied
- back pain
- prostate abnormalities
Other side effects include more erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ANDRODERM. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ANDRODERM?
- Keep ANDRODERM at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ANDRODERM in its sealed protective foil pouch until you are ready to use it. Do not remove an ANDRODERM patch from the pouch until you are ready to use it.
- Safely throw away your used ANDRODERM patch. Fold your used ANDRODERM patch in half so that the sticky sides stick together. Throw away your used ANDRODERM patch in the household trash.
- Be careful to prevent accidental exposure of ANDRODERM to children or pets.
General information about the safe and effective use of ANDRODERM
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ANDRODERM for a condition for which it was not prescribed. Do not give ANDRODERM to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about ANDRODERM. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ANDRODERM that is written for health professionals.
For more information, go to www.androderm.com or call 1-800-272-5525. If you have questions or concerns about your ANDRODERM treatment, ask your healthcare provider or pharmacist.
What are the ingredients in ANDRODERM?
Active ingredient: testosterone
- Backing Film: Metallized polyester/Surlyn® (ethylene-methacrylic acid copolymer)/ethylene vinyl acetate backing film with alcohol resistant ink
- Drug Reservoir: Testosterone USP, alcohol USP, glycerin USP, glycerol monooleate, methyl laurate, sodium hydroxide NF, purified water USP, gelled with carbomer copolymer Type B NF
- Microporous Membrane: a permeable polyethylene microporous membrane
- Adhesive: a peripheral layer of acrylic adhesive surrounding the central, active drug delivery area of the system.
- Disc: a five-layer laminate containing polyester/polyesturethane adhesive/aluminum foil/polyester-urethane adhesive/polyethylene
- Release Liner: a silicone-coated polyester film, which is removed before the system can be used
Last reviewed on RxList: 11/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Androderm Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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