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
Climara Online, Description, Chemistry, Ingredients - Estradiol transdermal
Climara Online, Description, Chemistry, Ingredients - Estradiol transdermal
PRESCRIBING INFORMATION Climara® estradiol transdermal
system
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1. ESTROGENS INCREASE THE RISK OF ENDOMETRIAL
CANCER. Close clinical surveillance of all women taking estrogens is important.
Adequate diagnostic measures, including endometrial sampling when indicated,
should be undertaken to rule out malignancy in all cases of undiagnosed
persistent or recurring abnormal vaginal bleeding. There is currently
no evidence that the use of natural estrogens results in a different endometrial
risk profile than synthetic estrogens of equivalent estrogen doses.
2. There is no indication for estrogen therapy during
pregnancy or during the immediate postpartum period. Estrogens are ineffective
for the prevention or treatment of threatened or habitual abortion. Estrogens
are not indicated for the prevention of postpartum breast engorgement.
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DESCRIPTION
Climara®, estradiol transdermal system, is designed
to release 17b-estradiol continuously upon application
to intact skin. Six (6.5, 9.375, 12.5, 15.0, 18.75 and 25.0 cm2)
systems are available to provide nominal in vivo delivery of 0.025, 0.0375,
0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of
use is 7 days. Each system has a contact surface area of either 6.5, 9.375,
12.5, 15.0, 18.75 or 25.0 cm2, and contains 2.0, 2.85, 3.8, 4.55,
5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems
per unit area is identical.
Estradiol USP (17b-estradiol) is
a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17b-diol.
It has an empirical formula of C18H24O2 and
molecular weight of 272.37.
The Climara® system comprises two layers. Proceeding
from the visible surface toward the surface attached to the skin, these layers
are (1) a translucent polyethylene film, and (2) an acrylate adhesive matrix
containing estra-diol USP. A protective liner (3) of siliconized or fluoropolymer-coated
polyester film is attached to the adhesive surface and must be removed before
the system can be used.
The active component of the system is 17b-estradiol.
The remaining components of the system (acrylate copolymer adhesive, fatty acid
esters, and polyethylene backing) are pharmacologically inactive.
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