IDAMAN PHARMA DIAZEPAM TABLET 10MG

국가: 말레이시아

언어: 영어

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

지금 구매하세요

환자 정보 전단 환자 정보 전단 (PIL)
24-09-2020
제품 특성 요약 제품 특성 요약 (SPC)
12-11-2020

유효 성분:

DIAZEPAM

제공처:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (International Name):

DIAZEPAM

패키지 단위:

30 Tablets; 1000 Tablets

Manufactured by:

IDAMAN PHARMA MANUFACTURING SDN BHD

환자 정보 전단

                                IDAMAN PHARMA DIAZEPAM TABLET 10MG
Diazepam 10mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
Idaman
Pharma
Diazepam
Tablet 10mg is used for
2.
How Idaman Pharma Diazepam Tablet
10mg works
3.
Before
you
use
Idaman
Pharma
Diazepam Tablet 10mg
4.
How to use Idaman Pharma Diazepam
Tablet 10mg
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Idaman
Pharma Diazepam Tablet 10mg
8.
Product Description
9.
Product
Registration
Holder
&
Manufacturer
10.
Date of Revision
WHAT
IDAMAN
PHARMA
DIAZEPAM
TABLET 10MG IS USED FOR
Idaman Pharma Diazepam Tablet 10mg
is used to:
•
Relieve anxiety in short - term (2-4
weeks).
•
Help to relax muscles during muscle
spasm.
•
An adjunct to certain seizures.
•
Treat
acute
alcohol
withdrawal
symptoms.
•
Relieve
anxiety
and
tension
before
operative procedures.
•
As
oral
premedication
for
the
nervous dental patient.
HOW
IDAMAN
PHARMA
DIAZEPAM
TABLET 10MG WORKS
Idaman Pharma Diazepam Tablet 10mg
belongs to a group of medicines called
benzodiazepines. It is thought to work by
acting on chemicals in the brain as a
tranquilizer.
BEFORE
YOU
USE
IDAMAN
PHARMA
DIAZEPAM TABLET 10MG
_- When you must not use it _
Do not take Idaman Pharma Diazepam
Tablet 10mg and tell your doctor if:
•
You
are
allergic
to
diazepam
or
to
other benzodiazepine medicines or to
any of the other ingredients in your
tablets
(see
section
PRODUCT
DESCRIPTION
).
•
You have acute-close angle glaucoma
(high pressure in the eye)
•
You
have
myasthenia
gravis
(a
condition
which
causes
muscles
to
weaken and tire easily)
•
You have severe breathing
problems
(severe obstructive disease)
•
You have severe liver dysfunction
•
You have sleep apnea syndrome.
_ _
_- Before you start to use Idaman Pharma _
_Diazepam Tablet 10mg _
Get
advice
from
your
doctor
or
pharmacist if:
•
You
are
elderly
or
suffer
severe
weakness
•
You have arteriosclerosis (thickening
or hardening of blood vessels)
•
You have liver or kidney problems
•
You have breathing difficulty
                                
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제품 특성 요약

                                IDAMAN PHARMA MANUFACTURING
IDAMAN PHARMA DIAZEPAM TABLET 10MG
PRODUCT DESCRIPTION
Clean, dry, uniform, round, flat, bevel edged tablets and scored
on one side. Colour: Blue.
Each tablet contains Diazepam 10mg
Source of lactose: Bovine
ROUTE OF ADMINISTRATION
Oral
PHARMACODYNAMICS
Diazepam is a benzodiazepine tranquilliser with anticonvulsant,
sedative,
muscle
relaxant
and
amnesic
properties.
Benzodiazepines, such as diazepam, bind to receptors in various
regions of the brain and spinal cord. This binding increases the
inhibitory effects of gamma-aminobutyric acid (GABA). GABAs
functions
include
CNS
involvement
in
sleep
induction.
Also
involved in the control of hypnosis, memory, anxiety, epilepsy
and neuronal excitability.
PHARMACOKINETICS
ABSORPTION
Diazepam is readily and completely absorbed from the GI tract.
Peak
plasma
concentrations
occurring
within
about
30-90
minutes of oral administration, a steady plasma concentration is
reached after 5-6 days and is directly related to dose.
DISTRIBUTION
Diazepam crosses the blood-brain barrier and is highly lipid
soluble, this causes the initial effects to decrease rapidly as it is
redistributed into fat deposits and tissues Diazepam is very
extensively bound to plasma proteins (98-99%). Diazepam and
its metabolites also enters breast milk and crosses the placenta
freely, this may lead to accumulation in the infant or foetus.
BIOTRANSFORMATION
Diazepam is extensively metabolised in the liver and, in addition
to desmethyldiazepam, its active metabolites include oxazepam
and temazepam. Diazepam has a biphasic half-life with an initial
rapid
distribution
phase
followed
by
a
prolonged
terminal
elimination phase of 1 or 2 days; its action is further prolonged
by the even longer half-life of 2-5 days of its principle active
metabolite,
desmethyldiazepam
(nordiazepam),
the
relative
proportion
of
which
increases
in
the
body
on
long-term
administration. The plasma half-life of diazepam is prolonged in
neonates, in the elderly, and in patients with kidney or liver
disease.
ELI
                                
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