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
CombiPatch Online, Description, Chemistry, Ingredients - Estradiol/norethindrone Acetate
CombiPatch Online, Description, Chemistry, Ingredients - Estradiol/norethindrone Acetate
WARNING
Estrogens and progestins should not be used for the prevention
of cardiovascular disease.
The Women’s Health Initiative (WHI) study reported increased
risks of myocardial infarction, stroke, invasive breast cancer, pulmonary
emboli, and deep vein thrombosis in postmenopausal women during 5 years
of treatment with conjugated equine estrogens (CE 0.625 mg) combined with
medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL
PHARMACOLOGY, Clinical Studies). Other doses of conjugated estrogens
with medroxyprogesterone, and other combinations of estrogens and progestins
were not studied in the WHI and, in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, estrogens
with or without progestins should be prescribed at the lowest effective
doses and for the shortest duration consistent with treatment goals and
risks for the individual woman.
|
DESCRIPTION
CombiPatch® (estradiol/norethindrone acetate
transdermal system) is an adhesive-based matrix transdermal patch designed to
release both estradiol and norethindrone acetate (NETA), a progestational agent,
continuously upon application to intact skin.
Two systems are available, providing the following delivery
rates of estradiol and norethindrone acetate.
|
System Size
|
Estradiol (mg)
|
NETA1 (mg)
|
Nominal Delivery Rate2 (mg per day) Estradiol
/ NETA
|
|
9 sq cm round
|
0.62
|
2.7
|
0.05 / 0.14
|
|
16 sq cm round
|
0.51
|
4.8
|
0.05 / 0.25
|
|
1 NETA = norethindrone acetate
|
|
2 Based on in vivo/in vitro flux data,
delivery of both components per day via skin of average permeability (interindividual
variation in skin permeability is approximately 20%).
|
Estradiol USP (estradiol) is a white to creamy white, odorless,
crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol.
The molecular weight of estradiol is 272.39 and the molecular formula is C18H24O2.
Norethindrone acetate USP is a white to creamy white, odorless,
crystalline powder, chemically described as 17-hydroxy-19-nor-17a-pregn-4-en-20-yn-3-one
acetate. The molecular weight of norethindrone acetate is 340.47 and the molecular
formula is C22H28O3.
CombiPatch transdermal systems are comprised of three layers.
Proceeding from the visible surface toward the surface attached to the skin,
these layers are (1) a translucent polyolefin film backing, 2) an adhesive layer
containing estradiol, norethindrone acetate, acrylic adhesive, silicone adhesive,
oleyl alcohol, oleic acid NF, povidone USP and dipropylene glycol, and (3) a
polyester release protective liner, which is attached to the adhesive surface
and must be removed before the system can be used.
The active components of the system are estradiol USP and norethindrone
acetate USP. The remaining components of the system are pharmacologically inactive.
top
