DRUG CLASSIFICATION MECHANISM OF ACTION INDICATIONS CONTRAINDICATIONS ADVERSE EFFECTS NURSING

RESPONSIBILITIES
Duphaston Progestogen; Pharmacotherapeutic group:  Progesterone Known The most commonly reported Check the doctors
Progestin deficiencies: hypersensitivity to the adverse drug reactions of order.
Generic Name: Genito-urinary system active substance or to patients treated with
and sex hormones.  Treatment of any of the excipients. dydrogesterone in clinical Assess if patient is
Dydrogesterone dysmenorrhea. trials of indications without allergic to
ATC code: Known or suspected estrogen treatment are: dydrogesterone
progestogen or other
G03DB01.  Treatment of dependent neoplasms  vaginal hemorrhage, ingredients of
dydrogesterone; endometriosis. (e.g. meningioma). Duphaston tablet.
Belongs to the class of Dydrogesterone Undiagnosed vaginal  migraines/headache, If you have a
pregnadien derivative relieves the bleeding. known or
progestogens used in pain during  nausea, suspected history
progestogenic menstruation Treatment for luteal of tumours like
hormone preparations. due to support as part of an meningioma. If
 vomiting,
endometriosis Assisted Reproductive you have vaginal
Pharmacology: without Technology (ART) bleeding whose
 abdominal pain,
Pharmacodynamics: inhibiting treatment should be cause is not
Mechanism of action: ovulation. discontinued upon determined.
 menstrual disorders
diagnosis of
and
Dydrogesterone is an  Treatment of abortion/miscarriage. Verify patients
orally-active secondary Contraindications for identity.
the use of estrogens  breast
progestogen which amenorrhea. pain/tenderness.
produces a complete when used in Administer the
secretory combination with right frug in the
endometrium in an dydrogesterone. right dose and
 Treatment of
estrogen-primed route at the right
irregular cycles.
uterus thereby time.
providing protection  Treatment of
against the increased Given with or
dysfunctional
risk for endometrium without food but
uterine
hyperplasia and/or it is preferred to
bleeding.
carcinogenesis induced take on an empty
by estrogens. It is stomach. It
indicated in all cases of depends on the
endogenous  Treatment of doctors order.
 progesterone pre-menstrual
deficiency. syndrome. Document and
Dydrogesterone has no record
estrogenic, no  Treatment of
androgenic, no threatened
thermogenic, no miscarriage.
anabolic and no
corticoid activity.
 Treatment of
Pharmacokinetics: habitual
miscarriage.
Absorption:
 Treatment of
Following oral infertility due
administration, to luteal
dydrogesterone is insufficiency.
rapidly absorbed with a
time maximum
between 0.5 and 2.5
 Luteal support
hours. The absolute
as part of an
bioavailability of
Assisted
dydrogesterone (oral
Reproductive
20 mg dose versus 7.8
Technology
mg intravenous
(ART)
infusion) is 28 %. The
treatment.
following table
provides
Hormone replacement
pharmacokinetic
therapy:
parameters of
dydrogesterone (D)
and 20α-  To counteract
dihydrodydrogesterone the effects of
(DHD) after single dose unopposed
administration of 10 estrogen on the
mg dydrogesterone. endometrium
in hormone
replacement
Distribution:
therapy for
 women with
After intravenous disorders due
administration of to natural or
dydrogesterone the surgical
steady-state volume of induced
distribution is menopause
approximately 1400 L. with an intact
Dydrogesterone and uterus.
DHD are more than
90% bound to plasma
proteins.

Metabolism:

Following oral
administration,
dydrogesterone is
rapidly metabolized to
DHD. The levels of the
main active metabolite
DHD peak about 1.5
hours postdose. The
plasma levels of DHD
are substantially higher
as compared to the
parent drug. The AUC
and Cmax ratios of
DHD to
dydrogesterone are in
the order of 40 and 25,
respectively. Mean
terminal half lives of
dydrogesterone and
DHD vary between 5 to
7 and 14 to 17 hours,
respectively. A
common feature of all
 metabolites
characterized is the
retention of the 4,6
diene-3-one
configuration of the
parent compound and
the absence of 17α-
hydroxylation. This
explains the lack of
estrogenic and
androgenic effects of
dydrogesterone.

Elimination:

After oral
administration of
labelled
dydrogesterone, on
average 63% of the
dose is excreted into
the urine. Total plasma
clearance is 6.4 L/min.
Within 72 hours
excretion is complete.
DHD is present in the
urine predominantly as
the glucuronic acid
conjugate.

Dose and time dependencies:

The single and multiple

dose pharmacokinetics
are linear in the oral
dose range 2.5 to 10
mg. Comparison of the
 single and multiple
dose kinetics shows
that the
pharmacokinetics of
dydrogesterone and
DHD are not changed
as a result of repeated
dosing. Steady state
was reached after 3
days of treatment.

References:

MIMS. (2022). Duphaston. Duphaston Dosage & Drug Information | MIMS Philippines. Retrieved April 20, 2022, from
https://www.mims.com/philippines/drug/info/duphaston

Chinnuswamy, D. (2018, January 31). Dydrogesterone drug information - indications, dosage, side effects and precautions. Medindia. Retrieved April 23, 2022,
from https://www.medindia.net/doctors/drug_information/dydrogesterone.htm