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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).
Four strengths of ANDRODERM are available that deliver approximately 2 mg, 2.5 mg, 4 mg, or 5 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 cm? with a 6.0 cm? central drug delivery reservoir containing 9.7 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 2.5 mg/day system has a total contact surface area of 37 cm? with a 7.5 cm? central drug delivery reservoir containing 12.2 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 4 mg/day system has a total contact surface area of 39 cm? with a 12.0 cm? central drug delivery reservoir containing 19.5 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 5 mg/day system has a total contact surface area of 44 cm? with a 15 cm? central drug delivery reservoir containing 24.3 mg testosterone USP, dissolved in an alcohol-based gel. Testosterone USP is a white, or creamy white crystalline powder or crystals chemically described as 17?-hydroxyandrost-4-en-3-one.
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Testosterone C19H28O2
mw 288.42
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 (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
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The active ingredient in the system is testosterone. The remaining components of the system are pharmacologically inactive.
What are the possible side effects of testosterone topical?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using testosterone topical and call your doctor at once if you have any of these serious side effects:
- burn-like blistering of the skin where the transdermal patch is worn;
- skin irritation with patch-wearing that does not get better with time;
- problems with urination;
- swelling of your ankles;
- frequent, prolonged, or...
Read All Potential Side Effects and See Pictures of Androderm »
Androderm Patient Information Including Side Effects
Brand Names: Androderm, AndroGel 2.5 g/packet, AndroGel 5 g/packet, AndroGel Pump 1.25 g/actuation, FIRST-Testosterone, FIRST-Testosterone MC, Testim
Generic Name: testosterone topical (patches and gel) (Pronunciation: tes TOS ter one TOP i kal)
- What is testosterone topical (Androderm)?
- What are the possible side effects of testosterone topical?
- What is the most important information I should know about testosterone topical?
- What should I discuss with my healthcare provider before using testosterone topical?
- How should I use testosterone topical?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using testosterone topical?
- What other drugs will affect testosterone topical?
- Where can I get more information?
What is testosterone topical (Androderm)?
Testosterone is a naturally occurring male hormone necessary for many processes in the body.
Testosterone topical is used to treat conditions in men that result from a lack of natural testosterone.
Testosterone topical may also be used for other purposes not listed in this medication guide.
What are the possible side effects of testosterone topical?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using testosterone topical and call your doctor at once if you have any of these serious side effects:
- burn-like blistering of the skin where the transdermal patch is worn;
- skin irritation with patch-wearing that does not get better with time;
- problems with urination;
- swelling of your ankles;
- frequent, prolonged, or bothersome erections; or
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.
Less serious side effects may include:
- redness, itching, burning, or hardened skin where the skin patch is worn;
- breast swelling or tenderness;
- increased acne or hair growth;
- headache, depressed mood; or
- changes in your sex drive.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about testosterone topical?
This medication should not be used by a woman or a child. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical gel, or with a man's skin areas where a testosterone topical patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away.
Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with the medication. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.
The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.
- Testoderm
- Testim
- AndroGel
- Androderm
Related Drugs Index:
Testosterone, Transdermal, System, Androderm, Buy Androderm