A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Testoderm Online, Description, Chemistry, Ingredients - Testosterone (transdermal)
Testoderm Online, Description, Chemistry, Ingredients - Testosterone (transdermal)
DESCRIPTION
TESTODERM®TTS, TESTODERM® and TESTODERM®
WITH ADHESVIE Testosterone Transdermal Systems (referred to collectively
as the TESTODERM® 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®TTS)
or scrotal skin (TESTODERM®
and TESTODERM® WITH ADHESVIE). The TESTODERM®
products are described below.
| Product |
Dose
(mg/day)
|
Size
(cm2)
|
Application Site
|
|
Testoderm® TTS
|
5
|
60
|
Arm, Back, Upper Buttocks
|
| Testoderm®* |
5
|
60
|
Scrotum
|
| Testoderm®* |
4
|
40
|
Scrotum
|
|
Testoderm® with
Adhesive
|
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® 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® 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® 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.
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