ANPROMIDE TABLET 2MG

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

LOPERAMIDE HYDROCHLORIDE

متاح من:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (الاسم الدولي):

LOPERAMIDE HYDROCHLORIDE

الوحدات في الحزمة:

1000 Tablets

المصنعة من قبل:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ANPROMIDE TABLETS 2MG
Loperamide Hydrochloride (2mg)
WHAT IS IN THIS LEAFLET:
1.
What Anpromide Tablets is used for
2.
How Anpromide Tablets works
3.
Before you use Anpromide Tablets
4.
How to use Anpromide Tablets
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Anpromide
Tablets
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ANPROMIDE TABLETS IS USED FOR
Loperamide is indicated for the control
and symptomatic relief of acute diarrhoea
and of chronic diarrhoea, and to reduce
the volume of discharge from ileostomies
(an opening in the abdominal wall where
the small intestine is diverted that’s made
during surgery).
HOW ANPROMIDE TABLETS WORKS
Loperamide
hydrochoride
is
the
active
ingredient
of
Anpromide
Tablets.
Loperamide
belongs
to
the
group
of
medicine called Antidiarrheal, which act
to relieve symptoms of diarrhea. It works
by prolongs the transit time of intestinal
contents
and
making
the
stools
more
dense.
BEFORE YOU USE ANPROMIDE TABLETS
-
_When you must not use it _

If
you
are
allergic
(hypersensitive)
to
Loperamide
hydrochloride or any of the other
ingredients of Anpromide Tablets
2mg.

If
you
have
toxic
megacolon
(expansion
of
colon
caused
by
complication
of
inflammatory
large
intestine
disease
or
infection)._ _

If
you
have
dysentry
or
if
constipation
must
be
avoided
because
it
may
result
in
fluid
retention in the intestine, which
may
aggravate
and
mask
dehydration
and
depletion
of
electrolytes,
especially
in
children.

If
you
have
severe
colitis
(inflammation of the lining of
the large intestine).

For children under 6 years old.
-
_Before you start to use it_
You must tell your doctor if:

You
have
allergies
to
any
medicine which you have taken
previously to treat your current
condition.

You
are
pregnant,
trying
to
become
pregnant
or
breast-
feeding. The medicines should be
used
during
pregnancy
and
lactation
only
when
clearly
indicated.
_Pregnancy and br

خصائص المنتج

7012-03
ANPROMIDE TABLET 2MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Each tablet contains:
Loperamide
hydrochloride………………………………………………2mg
PRODUCT DESCRIPTION:
A pink, scored, flat of diameter 7mm tablets with ‘MPI’ logo.
PHARMACODYNAMICS
:
Loperamide is a synthetic derivative of pethidine that inhibits gut
motility and may also reduce gastrointestinal secretions.
Loperamide binds to the opiate receptor in the gut wall. Consequently,
it inhibits the release of acetylcholine and
prostaglandins, thereby reducing propulsive peristalsis, and
increasing intestinal transit time.
Loperamide increases viscosity, increases bulk density, reduces daily
fecal volume, and diminishes loss of fluids and
electrolytes. Loperamide increases the tone of the anal sphincter,
thereby reducing incontinence and urgency. Additionally,
loperamide will prolong mouth-to-cecum transit time without affecting
gastric emptying.
PHARMACOKINETICS:
_Absorption: _ Most ingested loperamide is absorbed from the gut, but
as a result of significant first pass metabolism,
systemic bioavailability is only approximately 0.3%.
_Distribution: _
Little intact drug reaches the systemic circulation
Gastrointestinal tract: 85%
Liver: 5%
Tissues: 0.04 to 0.2%
The plasma protein binding of loperamide is 95%, mainly to albumin.
_Metabolism: _
Loperamide undergoes significant first pass metabolism in the liver.
Oxidative N-demethylation is the main metabolic
pathway for loperamide, and is mediated mainly through CYP3A4 and
CYP2C8. Oxidative n-dealkylation may be another
pathway. Due to this very high first pass effect; plasma
concentrations of unchanged drug remain extremely low.
_Elimination: _
The half-life of loperamide in man is 10.8 hours with a range of 9-14
hours. Approximately 50% of an orally administered
dose is excreted unchanged, primarily in the faeces; there is slight
urinary excretion
INDICATION:
Loperamide HCl is indicated for the symptomatic control of acute and
chronic diarrhea. In patients with an ileostom