资料单张
ANGELIQ
®
1/2 CMI
1
CONSUMER MEDICINE INFORMATION
ANGELIQ 1/2
_oestradiol and drospirenone _
WARNING
The Women’s Health Initiative (WHI) trial examined the health
benefits and risks of combined
_oestrogen plus progestogen_ therapy (n=16,608)
and _oestrogen-alone_ therapy (n=10,739) in
postmenopausal women aged 50 to 79 years.
The _oestrogen plus progestogen_ arm of the WHI trial indicated an
increased risk of
_myocardial infarction (MI), stroke, invasive breast cancer, pulmonary
embolism and deep vein _
_thrombosis _in postmenopausal women receiving treatment with
combined conjugated equine
oestrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA,
2.5 mg/day) for
5.2 years compared to those receiving placebo.
The _oestrogen-alone_ arm of the WHI trial indicated an increased
risk of_ stroke and deep vein _
_thrombosis _in hysterectomised women treated with CEE-alone (0.625
mg/day) for 6.8 years
compared to those receiving placebo.
Other doses of oral conjugated oestrogens with medroxyprogesterone
acetate, and other
combinations and dosage forms of oestrogens and progestogens were not
studied in the WHI
clinical trials and, in the absence of comparable data, these risks
should be assumed to be
similar.
Therefore, the following should be given serious consideration at the
time of prescribing:
•
Oestrogens with or without progestogens should not be prescribed for
primary
or secondary prevention of cardiovascular diseases.
•
Oestrogens with or without progestogens should be prescribed at the
lowest
effective dose for the approved indication.
•
Oestrogens with or without progestogens should be prescribed for the
shortest
period possible for the approved indication.
•
For the prevention of osteoporosis, oestrogen treatment should be
considered
in light of other available therapies.
ANGELIQ
®
1/2 CMI
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产品特点
121206 ANGELIQ 1/2 PI
Page 1 of 20
PRODUCT INFORMATION
ANGELIQ
®
1/2
NAME OF THE MEDICINE
ANGELIQ 1/2 is an HRT preparation containing the oestrogen oestradiol
and the progestogen
drospirenone. Each red film-coated tablet contains: oestradiol 1.0 mg,
drospirenone 2.0 mg.
Oestradiol is oestra-1,3,5(10)-triene-3, 17
-diol, the major estrogenic hormone produced by the
human ovary and has the following chemical structure:
CH
3
OH
O
H
H
H
H
Chemical formula:
C
18
H
24
O
2
Molecular weight:
281.4
CAS No:
50-28-2
Drospirenone is a progestogen. The chemical name for drospirenone
is 6
, 7, 15, 16-
Dimethylene-3-oxo-17
-pregn-4-ene-21, 17-carbolactone and has the following chemical
structure:
O
O
CH
3
H
3
C
O
H
H
H
Chemical formula:
C
24
H
30
O
3
Molecular weight:
366.50
CAS No:
67392-87-4
DESCRIPTION
Oestradiol exists mostly as the hemihydrate, which is a non
hygroscopic, stable solid.
Oestradiol is a white to almost white, crystalline powder and is
practically insoluble in water.
The melting point is between 173 and 180
C.
Drospirenone is a white to off-white crystalline powder. It
is freely soluble in methylene chloride,
soluble in acetone, methanol, sparingly soluble in ethylacetate and
ethanol 96% (v/v) and
121206 ANGELIQ 1/2 PI
Page 2 of 20
practically insoluble in hexane and water.
ANGELIQ 1/2 tablets contain the following excipients: Lactose, maize
starch, pregelatinised
maize starch, povidone 25 000, magnesium stearate, hypromellose,
macrogol 6000, purified
talc, titanium dioxide and iron oxide red.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
ANGELIQ 1/2 contains 17
-oestradiol, which is chemically and biologically identical to
endogenous human oestradiol, and the synthetic progestogen,
drospirenone. 17
-oestradiol
provides hormone replacement during and after the climacteric. The
addition of drospirenon
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