제품 특성 요약
Each
ELAGOX
Pack contains 28 Tablets, among these 21 tablets are light
yellow color tablet film coated which contains Drospirenone USP 3.0 mg
&
Ethinylestradiol USP 0.03 mg and remaining 7 white colored round
tablets are
without API.
DESCRIPTIONS
ELAGOX
contains two active ingredients, Ethinylestradiol and Drospirenone.
Ethinylestradiol is a synthetic version of oestrogen and Drospirenone
is a synthetic
form of progesterone. The hormonal components of
ELAGOX
inhibit ovulation
by
suppressing
gonadotropin
release.
Secondary
mechanisms,
which
may
contribute to the effectiveness of
ELAGOX
as a contraceptive, include changes
in the cervical mucus (which increase the difficulty of sperm
penetration) and
changes
in
the
endometrium
(which
reduce
the
likelihood
of
implantation).
Drospirenone has antimineralocorticoid activity, counteracting
oestrogen related
sodium retention. In combination with Ethinylestradiol, Drospirenone
displays a
favourable
lipid
profile
with
an
increase
in
high-density
lipoprotein
HDL.
Drospirenone
exerts
antiandrogenic
activity
and
does
not
counteract
the
Ethinylestradiol-related sex hormone binding globulin (SHBG) increase
which is
useful for binding and inactivating the endogenous androgens.
PHARMACOKINETICS
ABSORPTION
The absolute bioavailability of DRSP is about 76%. The absolute
bioavailability of
EE is approximately 40%. The absolute bioavailability of
ELAGOX
tablet, has not
been evaluated. Serum concentrations of DRSP and EE reached peak
levels
within 1-2 hours after administration of Drospirenone & ethinyl
estradiol tablets.
FOOD EFFECT
The rate of absorption of DRSP and EE following single administration
of a
formulation slower under fed (high fat meal).
DISTRIBUTION
DRSP and EE serum concentrations decline in two phases. The apparent
volume
of distribution of DRSP does not bind to sex hormone binding globulin
(SHBG) or
corticosteroid binding globulin (CBG) but binds about 97% to other
serum proteins.
EE is reported to be highly but non-specifically bound to serum
albumin (approxi-
matel
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