UTROGESTAN CAPSULE 100MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PROGESTERONE

Boleh didapati daripada:

SYARIKAT WELLCHEM SDN. BHD.

INN (Nama Antarabangsa):

PROGESTERONE

Unit dalam pakej:

30Capsule Capsules

Dikeluarkan oleh:

Capsugel

Risalah maklumat

UTROGESTAN ORAL CAPSULE

Progesterone (100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Utrogestan is used for
2.
How Utrogestan works
3.
Before you use Utrogestan
4.
How to use Utrogestan
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Utrogestan
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UTROGESTAN IS USED FOR
Utrogestan is used for disorders
related to progesterone insufficiency
in women:
-
Menstrual disorder (irregular or
absence of menses)
-
Benign mastopathy (a type of
breast disease)
-
Premenstrual syndrome (PMS)
- Menopausal symptoms (used
together with estrogen hormone)
HOW DOES UTROGESTAN WORK
Utrogestan contains natural female
hormone progesterone. It is identical
to the hormone naturally produced in
your body.
As you approach menopause, the
amount of female hormones (estrogen
and progesterone) in the body drops.
Utrogestan when used as prescribed
through oral route, restores the level
of progesterone in your body and
relieves menopausal symptoms.
BEFORE YOU USE UTROGESTAN
_- When you must not use it _
Do not use Utrogestan if you are
allergic to progesterone or any of the
inactive ingredients of this medicine,
listed at the end of the leaflet. Signs
and symptoms of allergic includes:
-
Itchy skin, red rashes
-
Swollen lips, tongue, eyes or face
-
Feeling tight at your chest, trouble
of breathing.
Do not use Utrogestan if you have
severe liver problem.
If any of the above conditions appear
for the first time while taking
Utrogestan, stop taking it at once and
consult your doctor immediately.
_- Before you start to use it _
Talk to your doctor or pharmacist
before using Utrogestan.
_- Taking other medicines _
Please inform your doctor or
pharmacist if you are taking or have
recently taken or might take any other
medicine. This includes medicines
obtained without a prescription (from
pharmacy, supermarket, convenient
shop etc) and any herbal medicines.
HOW TO USE UTROGESTAN
_- How to u

Ciri produk

UTROGESTAN CAPSULE 100MG
DESCRIPTION : Utrogestan 100 mg, round and slightly yellow soft
capsules, containing whitish oily suspension.
CONTENT :
Utrogestan contains natural physiological progesterone identical to
that secreted by the human ovary. Each capsule, contains 100mg natural
micronized progesterone.
PHARMACOLOGY :
The mechanism of actions are similar to those of natural progesterone
in particular : anti – estrogen, anti-androgen, antialdosterone and
gestagen.
ORAL ROUTE :
Micronised progesterone is absorbed by the gut. The increase in
progesterone plasma levels starts within the first hour and peak
plasma
progesterone levels are observed 1 to 3 hours following
administration.
Pharmacokinetic studies conducted in volunteers showed that after
simultaneous ingestion of two capsules, plasma progesterone levels
increased
from a mean of 0.13ng/ml to 4.25ng/ml after 1 hour, to 11,75ng/ml
after 2 hours, to 8.37ng/ml after 4 hours, to 2.00ng/ml after 6 hours
and to
1.64ng/ml after 8 hours.
In view of the retention time of the hormone in the tissue, it appears
necessary, in order to obtain in impregnation throughout the 24 hours
period, to
divide the dose into two separate administrations with a 12 hours
interval. Individual variations exist, however the same individual
should maintain
the same pharmacokinetic characteristics at several month distance, to
allow for good individual adaptation of the dose.
METABOLIZATION :
In the plasma, the principal metabolites are 20 α- Hydroxy – 4 α
pregnanolone and 5 α dihydroprogesterone. 95% of urinary elimination
occurs in
the form of glycuroconjugated metabolites the principle being 3 α 5
β pregnanediol (pregnandiol). These plasma and urinary metabolites
are
identical to those found during the physiological secretion of the
ovarian corpus luteum.
VAGINAL ROUTE :
ABSORPTION :
Progesterone administered vaginally has an optimal therapeutic effect
since it induces rapid high plasma levels of progesterone after one
hour.
The optimal plasma concentration of progesterone i