DUPHASTON TABLET 10 mg (Film-coated)

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

DYDROGESTERONE

Verfügbar ab:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC-Code:

G03DB01

Dosierung:

10 mg

Darreichungsform:

TABLET, FILM COATED

Zusammensetzung:

DYDROGESTERONE 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

ABBOTT BIOLOGICALS B.V.

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2000-01-10

Fachinformation

Updated 25 Jun 2021
Page 1 of 10
_Duphaston _
_®_
dydrogesterone
1. NAME OF THE MEDICINAL
PRODUCT
Duphaston
®
10 mg film-coated tablets
2. QUALITATIVE AND QUANTITIVE
COMPOSITION
Each film-coated tablet contains 10 mg dydrogesterone.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A round, biconvex, scored, white, film-coated tablet, one side with
inscription ‘155’ on either side of the
score (size 7mm).
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. CLINICAL
PARTICULARS
4.1 THERAPEUTICS
INDICATIONS
-
Symptomatic relief of mild to moderate vasomotor symptoms associated
with menopause.
-
Prevention of postmenopausal osteoporosis, if other treatments are
unsuitable.
PROGESTERONE
DEFICIENCIES
-
Treatment of dysmenorrhoea.
-
Treatment of endometriosis.
-
Treatment of secondary amenorrhoea.
-
Treatment of irregular cycles.
-
Treatment of dysfunction uterine bleeding
-
Treatment of threatened miscarriage
-
Treatment of habitual miscarriage
-
Treatment of infertility due to luteal insufficiency.
-
Luteal support as part of an Assisted Reproductive Technology (ART)
treatment
4.2 POSOLOGY AND METHOD OF
ADMINISTRATION
Dosages, treatment schedule and duration of treatment may be adapted
to the severity of the dysfunction
and the clinical response.
Symptomatic relief of mild to moderate vasomotor symptoms associated
with menopause; prevention of
postmenopausal osteoporosis;
-
Continuous s e q u e n t i a l therapy: An oestrogen is dosed
continuously and one tablet of 10
mg dydrogesterone is added for the last 14 days of every 28 day cycle,
in a sequential manner.
-
Cyclic therapy: When an oestrogen is dosed cyclically with a
treatment-free interval, usually 21 days
on and 7 days off. One tablet of 10 mg dydrogesterone is added for the
last 12 – 14 days of oestrogen
therapy.
Updated 25 Jun 2021
Page 2 of 10
If ultrasound or endometrial biopsies would reveal inadequate
progestational response, 20
mg dydrogesterone should be prescribed.
D