GYNPROGEST

Država: Indonezija

Jezik: indonezijski

Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivni sastojci:

PROGESTERONE

Dostupno od:

NUFARINDO - Indonesia

INN (International ime):

PROGESTERONE

Doziranje:

100 Mg

Farmaceutski oblik:

KAPSUL LUNAK

Jedinice u paketu:

DUS, 2 BLISTER @ 15 KAPSUL LUNAK

Proizveden od:

LABORATORIOS LEON FARMA, S.A. - Spain

Datum autorizacije:

2022-03-21

Svojstava lijeka

GYNPROGEST
PROGESTERONE
Soft Capsules
COMPOSITION
Each capsule contains 100 mg micronized Progesterone.
Each capsule contains 200 mg micronized Progesterone.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group (ATC Code: G03DA04: Genito-urinary system
and sex hormones).
Progesterone is a natural progesterone, the main hormone of the corpus
luteum and the placenta.
It acts on the endometrium by converting the proliferating phase to
the secretatory phase.
Gynprogest capsules have all the properties of endogenous progesterone
with induction of a full
secretory endometrium and in particular gestagenic, antiestrogenic,
slightly anti- androgenic and
antialdosterone effects.
PHARMACOKINETICS PROPERTIES
_Absorption _
Micronised progesterone is absorbed by the digestive tract.
Pharmacokinetic studies conducted in
healthy
volunteers
have
shown
that
oral
adminstration
of
2
capsules
(200 mg),
plasma
progesterone levels increased to reach the Cmax of 13.8 ng/ml +/- 2.9
ng/ml in 2.2 +/-1.4 hours. The
elimination half-life observed was 16.8 +/-2.3 hours. Although there
were inter-individual variations, the
individual
pharmacokinetic
characteristics
were
maintained
over
several
months,
indicating
predictable responses to the drug.
_Distribution _
Progesterone is approximately 96%-99% bound to serum proteins,
primarily to serum albumin (50%-
54%) and transcortin (43%-48%).
_Elimination _
Urinary elimination is observed for 95% in the form of
glycuroconjugated metabolites, mainly 3a, 5 B-
pregnadiol (pregnadiol).
_Metabolism _
Progesterone is metabolised primarily by the liver. The main plasma
metabolites are 20 a hydroxy-
4a-prenolone and 5 a-dihydroprogesterone. Some progesterone
metabolites are excreted in the
bile
and
these
may
be
deconjugated
and
further
metabolized
in
the
gut
via
reduction,
dehydroxylation and epimerization. The main plasma and urinary
metabolites are similar to those
found during the physiological secretion of the corpus luteum.
INDICATIONS
Gynprogest is prescribed for disorder r