STESOLID RECTAL TUBE 5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DIAZEPAM

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DIAZEPAM

Unit dalam pakej:

5 x 2.5ml mL

Dikeluarkan oleh:

PT Actavis Indonesia

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
STESOLID RECTAL TUBE 5MG
Diazepam (5mg)
__________________________________________________________________________________________
__________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Stesolid is used for
2.
How Stesolid works
3.
Before you use Stesolid
4.
How to take Stesolid
5.
While you are using Stesolid
6.
Side Effects
7.
Storage
and
Disposal
of
Stesolid
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT STESOLID IS USED FOR
Stesolid rectal tubes are enemas
containing the active ingredient
diazepam. Diazepam is a type
of
medicine
called
a
benzodiazepine.
Benzodiazepines
are
used
for
their sedative, anxiety-relieving
and muscle-relaxing effects.
Stesolid is used in controlling
convulsions,
or
seizures
associated with fever in children
(febrile convulsions).
HOW STESOLID WORK
Diazepam works by acting on
receptors
in
the
brain
called
GABA
receptors.
This
causes
the release of a neurotransmitter
called GABA in the brain.
Neurotransmitters are chemicals
that are stored in nerve cells in
the brain and nervous system.
Diazepam
helps
control
convulsions
because
the
increased activity of GABA that
it causes in the brain helps to
calm excessive electrical nerve
activity that is responsible for
causing seizures.
As
diazepam
increases
the
activity of GABA in the brain, it
increases its calming effect and
results in sleepiness, a decrease
in
anxiety
and
relaxation
of
muscles.
Stesolid
rectal
tubes
are
administered
into
the
rectum.
The
diazepam
is
absorbed
rapidly
into
the
bloodstream
from the rich supply of blood
vessels
in
this
area.
Rectal
administration is used when a
rapid effect is needed, but an
injection
is
impractical
or
undesirable.
BEFORE YOU USE STESOLID
_-When you must not take it _
Do not use Stesolid if you are:
-allergic
(hypersensitive)
to
diazepam, other benzodiazepine
medicines or to any of the other
ingredients in Stesolid
-have severe b

Ciri produk

THERAPEUTIC GROUP
Anxiolyticum and anticonvulsant.
PRODUCT DESCRIPTION
Clear, colourless to yellowish liquid in a yellow low-density
polyethylene tube.
COMPOSITION
Rectal tubes of 2.5 ml containing 5 mg of diazepam in solution.
Also contains benzoic acid, sodium benzoate, ethanol, propylene
glycol,
benzyl alcohol.
PHARMACOLOGY
Diazepam has an anxiolytic, sedative, amnestic, hypnotic,
anticonvulsant,
and muscle-relaxing activity. Diazepam is easily absorbed from the
rectal
mucosa. The e ffects is already seen within 5-10 minutes. Maximal
plasma
concentration is attained within 10-20 minutes. Diazepam is
metabolised in
the liver and its major metabolite, desmethyldiazepam, is
pharmacologically
active. The half-life of diazepam is within a range of 20 hours to a
few days;
that of desmethyldiazepam is longer. Diazepam is distributed
throughout the
body and passes quickly the blood-brain barrier. In the blood, 96-98
per cent
of diazepam is bound to plasma proteins.
INDICATIONS
Epileptic and febrile convulsions; to relieve muscle spasm caused by
tetanus;
as a sedative in minor surgical and dental procedures, initial use in
anxiety
and agitation, when the disorder is severe, disabling or subjecting
the
individual to extreme distress. Diazepam Rectal Tube may be used in
these
indications when a rapid e ffect is required but where intravenous
injection is
impracticable or undesirable. Diazepam Rectal Tube may be of
particular value
for the immediate treatment of convulsions in children.
CONTRAINDICATIONS
-
Known hypersensitivity to diazepam, benzodiazepines or any of the
excipients.
-
Phobic or obsessional states; chronic psychosis, hyperkinesis
(paradoxical
reactions may occur).
-
Acute pulmonary insufficiency; respiratory depression, acute or
chronic
severe respiratory insufficiency (ventilatory failure may be
exacerbated).
-
Myasthenia gravis (condition may be exacerbated).
-
Sleep apnoea (condition may be exacerbated).
-
Severe hepatic insufficiency (elimination half-life of diazepam may be
prolonged).
-
Acute porphyr