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TESTODERM (testosterone transdermal) ®TTS, TESTODERM (testosterone transdermal) ® and TESTODERM (testosterone transdermal) ® WITH ADHESVIE Testosterone Transdermal Systems (referred to collectively as the TESTODERM (testosterone transdermal) ® products) are designed to release controlled amounts of testosterone, the primary circulating endogenous androgen, continuously upon application to the arm, back or upper buttocks (TESTODERM (testosterone transdermal) ®TTS) or scrotal skin (TESTODERM (testosterone transdermal) ® and TESTODERM (testosterone transdermal) ® WITH ADHESVIE). The TESTODERM (testosterone transdermal) ® products are described below.
| Product | Dose | Size | Application Site |
| Testoderm (testosterone transdermal) ® TTS | 5 | 60 | Arm, Back, Upper Buttocks |
| Testoderm®* | 5 | 60 | |
| Testoderm®* | 4 | 40 | Scrotum |
| Testoderm (testosterone transdermal) ® with | 6 | 60 | Scrotum |
* The composition of the two sizes per unit area is identical.
The active component of each of the systems is testosterone. Testosterone USP is a white or creamy-white crystalline powder or crystals chemically described as 17-beta hydroxyandrost-4-en-3-one. The remaining components of the systems are pharmacologically inactive.
TESTODERM (testosterone transdermal) ® TTS is composed of the following layers: a flexible backing of polyester/ethylene-vinyl acetate copolymer film, a drug reservoir of testosterone USP and 1.2 mL alcohol USP gelled with hydroxypropyl cellulose, and an ethylene-vinyl acetate copolymer membrane coated with a layer of a polyisobutylene adhesive formulation that controls the rate of release of testosterone from the system. A protective liner of silicone-coated polyester covers the adhesive surface. The liner must be removed before application.
TESTODERM (testosterone transdermal) ® is composed of two layers: a soft flexible backing of polyester and a testosterone-containing film of ethylene-vinyl acetate copolymer that contacts the skin surface and modulates the availability of the steroid. A protective liner of fluorocarbon diacrylate or silicone-coated polyester covers the drug film. The liner must be removed before application.
TESTODERM (testosterone transdermal) ® WITH ADHESVIE is composed of three layers: a soft flexible backing of polyester and a testosterone-containing film of ethylene-vinyl acetate copolymer. The surface of the drug film is partially covered by the third layer: thin and narrow adhesive stripes composed of polyisobutylene and colloidal silicon dioxide. A protective liner of fluorocarbon diacrylate covers the adhesive stripes and the adhesive-free area of the drug film. The liner must be removed before application.
The active component of the systems is testosterone. The remaining components of the systems are pharmacologically inactive.
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:
Read All Potential Side Effects and See Pictures of Testoderm »
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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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