Androderm

Name: Androderm

Description

ANDRODERM (testosterone transdermal system) is designed to deliver testosterone continuously for 24 hours following application to intact, non-scrotal skin (e.g., back, abdomen, thighs, upper arms).

Two strengths of ANDRODERM are available that deliver approximately 2 mg or 4 mg of testosterone per day.

ANDRODERM has a central drug delivery reservoir surrounded by a peripheral adhesive area. The ANDRODERM 2 mg/day system has a total contact surface area of 32 cm² with a 6.0 cm² central drug delivery reservoir containing 9.7 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 4 mg/day system has a total contact surface area of 39 cm² with a 12.0 cm² central drug delivery reservoir containing 19.5 mg testosterone USP, dissolved in an alcohol-based gel. Testosterone USP is a white, or creamy white crystalline powder or crystals chemically described as 17ß-hydroxyandrost-4-en-3-one.

The ANDRODERM systems have six components as shown in Figure 1. Proceeding from the top toward the surface attached to the skin, the system is composed of (1) metallized polyester/Surlyn® (ethylene-methacrylic acid copolymer)/ethylene vinyl acetate backing film with alcohol resistant ink, (2) a drug reservoir of testosterone USP, alcohol USP, glycerin USP, glycerol monooleate, methyl laurate, sodium hydroxide NF, to adjust pH, and purified water USP, gelled with carbomer copolymer Type B NF, (3) a permeable polyethylene microporous membrane, and (4) a peripheral layer of acrylic adhesive surrounding the central, active drug delivery area of the system. Prior to opening of the system and application to the skin, the central delivery surface of the system is sealed with a peelable laminate disc (5) composed of a five-layer laminate containing polyester/polyesterurethane adhesive/aluminum foil/polyester-urethane adhesive/polyethylene. The disc is attached to and removed with the release liner (6), a silicone-coated polyester film, which is removed before the system can be used.

Figure 1: System Schematic

The active ingredient in the system is testosterone. The remaining components of the system are pharmacologically inactive.

Androderm Overview

Testosterone is a prescription medication used to treat low testosterone levels (hypogonadism) in men who do not produce enough natural testosterone. It may also be used to treat delayed puberty in adolescent males. Testosterone may also be administered to women to treat certain types of cancer.

Testosterone is a hormone that is usually produced by the body. It controls the growth, development, and function of male sexual organs and characteristics.

This medication comes in several topical forms for the skin, nose, and mouth that are applied to the body one to three times daily, depending on the dosage form.

This medication is also available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

Common side effects of testosterone include irritation and redness at the site of application, headache, acne, stomach pain, nervousness, hair loss, changes in mood and behavior, and changes in the ability to taste or smell.

Androderm Drug Class

Androderm is part of the drug class:

  • 3 oxoandrosten 4 derivatives

Inform MD

Before taking testosterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to testosterone or to any of its ingredients
  • have or have had prostate cancer or an enlarged prostate
  • have or have had breast cancer
  • have sleep apnea
  • have heart problems
  • have diabetes
  • have kidney disease
  • have lung disease
  • have liver disease
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Androderm and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if testosterone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using testosterone.

What should I avoid while using Androderm (testosterone topical)?

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for 2 to 5 hours after applying testosterone gel. Follow the directions provided with your specific brand.

Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.

Testosterone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a testosterone skin patch, avoid using an ointment form of the steroid.

What do I need to tell my doctor BEFORE I take Androderm?

  • If you have an allergy to testosterone or any other part of Androderm (testosterone transdermal patch).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are male and have breast or prostate cancer.
  • If you have any of these health problems: Heart disease, kidney disease, or liver disease.
  • If you are a woman. This medicine is not approved for use in women. If you are a woman using this medicine, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
  • If the patient is a child. Do not give Androderm to a child.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Androderm with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Androderm?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • There may be a higher chance of prostate cancer. Talk with the doctor.
  • If you have an enlarged prostate, your signs can get worse while you use Androderm. Call your doctor if this happens to you.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Treatment with this medicine may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
  • This medicine is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
  • The patch may have metal. Take off the patch before an MRI.
  • If you are 65 or older, use Androderm with care. You could have more side effects.
  • This medicine is not approved for treating low testosterone levels caused by getting older. Talk with your doctor.
  • This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Androderm (testosterone transdermal patch), please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Androderm. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Androderm.

Review Date: October 4, 2017

Patient Counseling Information

See "FDA-approved patient labeling (Patient Information)."

Patients should be informed of the following information:

  • Use in Men with Known or Suspected Prostate or Breast Cancer

Men with known or suspected prostate or breast cancer should not use Androderm [see Contraindications (4) and Warnings and Precautions (5.1)].

  • Potential Adverse Reactions with Androgens

Patients should be informed that treatment with androgens may lead to adverse reactions that include:

  • Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing 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 and having a weak urine flow
  • Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness
  • Too frequent or persistent erections of the penis
  • Nausea, vomiting, changes in skin color, or ankle swelling
  • Patients Should be Advised of these Application Instructions
  • Androderm should not be applied to the scrotum.
  • Androderm should not be applied over a bony prominence or on a part of the body that could be subject to prolonged pressure during sleep or sitting. Application to these sites has been associated with burn-like blister reactions.
  • Androderm does not have to be removed during sexual intercourse, nor while taking a shower or bath.
  • Androderm systems should be applied nightly.  The site of application should be rotated, with an interval of 7 days between applications to the same site.
  • If the Androderm system becomes loose, smooth it down again by rubbing your finger firmly around the edges. If a patch falls off before noon, replace it with a fresh patch and wear it until you apply a fresh patch(es) that evening. If it falls off later in the day, do not replace it until you apply a fresh patch(es) that evening. If it falls off do not tape Androderm to skin.
  • If patients or caregivers experience difficulty separating the patch from the release liner or observe transfer of adhesive to the liner, tearing and/or other damage to the patch during removal from the liner, the patch should be discarded, and a new patch should be applied.
  • Androderm should be applied immediately after opening the individual pouch and removing the protective liner. Do not use if the individual pouch seal is broken or if the patch appears to be damaged. Do not cut patches. Only intact patches should be applied.
  • Strenuous exercise or excessive perspiration may loosen a patch or cause it to fall off.
  • Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because Androderm contains aluminum, it is recommended to remove the system before undergoing an MRI.
  • Avoid swimming or showering until 3 hours following application of Androderm [see Dosage and Administration (2)  and Clinical Pharmacology (12.3)].

For all medical inquiries contact:
Allergan
Medical Communications
Irvine, CA 92612
1-800-678-1605

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

PATIENT INFORMATION
Androderm® (an-dro-derm) CIII
(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 due to certain medical conditions.

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 or effective to treat men who have low testosterone due to aging.

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:

  • insulin
  • medicines that decrease blood clotting
  • corticosteroids

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.

Applying Androderm:

  • 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 pull off easily from the protective plastic liner. Do not use the Androderm patch if the liner is hard to pull off. Throw away the Androderm patch and get a new one.
 3. Check the protective plastic liner. You should not see any glue (adhesive) sticking to the liner. Do not use the Androderm patch if you see any adhesive sticking to the liner. Throw away the Androderm patch and get a new one.
Throw away the clear plastic liner and silver disc.
4. 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.
  • Possible increased risk of heart attack or stroke.
  • 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
  • depression
  • headache
  • 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 1-800-678-1605. 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

Inactive ingredients:

  • 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

For all medical inquiries contact:
Allergan
Medical Communications
Irvine, CA 92612
1-800-678-1605

Distributed By:
Allergan USA, Inc.
Irvine, CA 92612

This Patient Information has been approved by the U.S. Food and Drug Administration

Content Updated: 10/2016

PRINCIPAL DISPLAY PANEL

Androderm (testosterone transdermal system) CIII
NDC 0023-5990-60
Carton x 60 systems, 2 mg/day

PRINCIPAL DISPLAY PANEL

Androderm (testosterone transdermal system) CIII
NDC 0023-5992-30
Carton x 30 systems, 4 mg/day

Androderm 
testosterone patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-5990
Route of Administration TRANSDERMAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE (TESTOSTERONE) TESTOSTERONE 2 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
GLYCERIN  
GLYCERYL OLEATE  
METHYL LAURATE  
WATER  
CARBOMER 1342  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0023-5990-60 60 POUCH in 1 CARTON
1 1 PATCH in 1 POUCH
1 1 d in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020489 09/29/1995
Androderm 
testosterone patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-5992
Route of Administration TRANSDERMAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE (TESTOSTERONE) TESTOSTERONE 4 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
GLYCERIN  
GLYCERYL OLEATE  
METHYL LAURATE  
WATER  
CARBOMER 1342  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0023-5992-30 30 POUCH in 1 CARTON
1 1 PATCH in 1 POUCH
1 1 d in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020489 09/29/1995
Labeler - Allergan, Inc. (144796497)
Revised: 10/2016   Allergan, Inc.

Testosterone Identification

Substance Name

Testosterone

CAS Registry Number

58-22-0

Drug Class

Androgens

Hormones

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