Megex-I Suspension 800mg20ml

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

MEGESTROL ACETATE

Tilgængelig fra:

IMEKS PHARMA SDN. BHD.

INN (International Name):

MEGESTROL ACETATE

Enheder i pakken:

20 pouches x 20 ml

Fremstillet af:

DAEWON PHARM CO LTD

Indlægsseddel

_CONSUMER _
_MEDICATION _
_INFORMATION _
_LEAFLET _
_(RIMUP)_
MEGEX-I SUSPENSION
® 800MG/20ML
Megestrol Acetate (800mg/20ml)
_ _
1
WHAT IS IN THE LEAFLET
1.
What Megex-I Suspension is used for
2.
How Megex-I Suspension works
3.
Before you use Megex-I Suspension
4.
How to use Megex-I Suspension
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Megex-I
Suspension
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT MEGEX-I SUSPENSION IS USED FOR
Megex-I
Suspension
helps
to
increase
appetite and/or to overcome loss of weight
which
often
occurs
in
patients
who
are
suffering from cancer or AIDS.
HOW MEGEX-I SUSPENSION WORKS
Megex-I
Suspension
contains
the
active
ingredient megestrol acetate. It belongs to a
group
of
medicines
called
progestogens.
Megestrol acetate has a unique characteristic
to boost up appetite in patients. However, the
exact mechanism of how it functions remain
unknown.
BEFORE YOU USE MEGEX-I SUSPENSION
-
_When you must not use it_
Do not take Megex-I Suspension:
•
If
you
have
known
hypersensitivity
to
megestrol acetate or any ingredients listed at
the end of this leaflet.
• If you are pregnant or think that you may
be pregnant.
• If you are breastfeeding.
_If you are not sure whether you should start _
_taking this product, consult your doctor. _
-
_Before you start to use it _
• Tell your doctor if you are pregnant or
intent to become pregnant. This medication
must not be used during pregnancy as it may
cause harm to your unborn baby. Women of
child-bearing
age
should
use
an
effective
form
of
birth
control
while
taking
this
medication.
• Breastfeeding is not recommended while
using this product as megestrol may pass into
breast
milk
and
could
have
undesirable
effects on nursing infant. If it is necessary for
you
to
take
this
medicine,
breastfeeding
should be discontinued.
Tell your doctor if you:
• have severe liver problems.
• have a history of suffering from blood clots
(thrombophlebitis).
• have diabetes, as Megex-I

Produktets egenskaber

MEGEX-I SUSPENSION 800MG/20ML
DESCRIPTION
White to cream coloured suspension with orange fragrant
and taste.
CONTENTS
Each
20ml
of
suspension
contains
megestrol
acetate
800mg.
Preservative: Sodium Benzoate 0.1% w/v
PHARMACODYNAMICS
Megestrol acetate exhibits classical progestational activity.
It possesses little or no estrogenic, androgenic or adreno-
corticoid
action.
The
anti-tumour
action
of
megestrol
acetate on carcinoma of the breast is unclear. However, it
is known to compete for progesterone, androgen and
glucocorticoid receptors, and affect pituitary functions.
Megestrol acetate is even used to enhance appetite in
patients with cachexia and anorexia. The precise mecha-
nism of this is unknown but the efficacy of megestrol
acetate in cachexia and anorexia has been established
with statistically significant improvement in appetite. The
gain in weight while taking megestrol acetate, particularly
at high doses, is usually not associated with water reten-
tion, but is associated with an increased appetite/food
intake and an increase in fat and body cell mass.
PHARMACOKINETICS
Mechanism of Action
The appetite enhancing property of megestrol acetate and
its possible use in cachexia have been recorded. However,
the exact mechanism on how megestrol acetate produces
effects in anorexia and cachexia remain unknown.
Absorption and Distribution
The oral absorption of megestrol acetate appeared to be
variable. Estimates of the plasma concentrations of mege-
strol acetate are dependent, not only on the measurement
method used, but also on intestinal and hepatic inactiva-
tion of the drug, which may be affected by intestinal tract
motility, intestinal bacteria, antibiotics administered, body
weight, diet, and hepatic function.
There is no difference in safety following administration of
megestrol acetate under fasting and fed conditions, there-
fore megestrol acetate could be taken without regard to
meals.
Metabolism and Excretion
Metabolites have accounted for only 5% to 8% of an
administered dose of megestrol acetate.