ASOLAN TABLET 0.5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ALPRAZOLAM

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

ALPRAZOLAM

Unit dalam pakej:

500 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA (M) SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
1
ASOLAN TABLET 0.5 MG
Alprazolam 0.5mg
WHAT IS IN THE LEAFLET?
1.
What ASOLAN is used for
2.
How ASOLAN works
3.
Before you use ASOLAN
4.
How to use ASOLAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ASOLAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ASOLAN IS USED FOR
ASOLAN is used for the short-
term treatment of anxiety.
ASOLAN is used for treatment
of depression for examples:
•
Anxiety
with
depressive
symptoms
•
Mixed
anxiety-depression
(both
anxiety
and
depression
occur
simultaneously)
•
Neurotic
or
reactive
depression
(depressed
mood or a pervasive loss of
interest or pleasure)
ASOLAN is also used to treat
panic attacks.
Your
doctor
may
have
prescribed
ASOLAN
for
another
reason.
Ask
your
doctor
if
you
have
any
questions about why ASOLAN
has been prescribed for you.
HOW ASOLAN WORKS
ASOLAN belongs to a group
of
medicines
called
benzodiazepines.
These medicines are thought to
work by their action on brain
chemicals.
BEFORE YOU USE ASOLAN
-
_When you must not take it_
_ _
ASOLAN
is
contraindicated
in
the following conditions:
•
myasthenia gravis (a
condition where muscles
become easily tired and
weak)
•
chronic obstructive airways
disease (lung disease)
Do not take ASOLAN if you
have an allergy to:
•
Medicines
containing
alprazolam
•
Any other benzodiazepine
medicine
Do not take ASOLAN if you
are
breastfeeding.
ASOLAN
passes into the breast milk and
may
cause
drowsiness
and
feeding
difficulties
in
the
infant.
Do not take ASOLAN if
the
packaging
is
torn
or
shows
signs of tampering.
-
_Before you start to use it_
_ _
Tell your doctor if you have
allergies
to
any
other
medicines, foods, preservatives
or dyes.
Tell
your
doctor
if
you
are
pregnant
or
plan
to
become
pregnant.
ASOLAN
may
affect your unborn baby if you
take it during pregnancy. Your
doctor
will
discuss
the
risks
and
benefits
of
taking
ASOLAN during pregnancy.
Elderly
or
debilitated
(weak)
person
may
be
particu

Ciri produk

Page 1 of 3
[REVISION DATE: 03.02.2023]
[DUOPHARMA (M) SDN BHD]
ASOLAN TABLET 0.5MG
DESCRIPTION:
A round pink, 7 mm diameter tablet with marking “DUOMA/DUOMA” and
“DUO 2”
COMPOSITION:
Each tablet contains Alprazolam 0.5 mg
PHARMACODYNAMICS:
In general, benzodiazepines act as depressants of the central nervous
system (CNS), producing all levels of CNS depression from mild
sedation to hypnosis to coma depending on dose. The precise sites
and mechanisms of action have not been completely established.
Although various mechanisms of action have been proposed, it is
believed that benzodiazepines enhance or facilitate the inhibitory
neurotransmitter action of gamma-aminobutyric acid (GABA), which is
one of the major inhibitory neurotransmitters in the brain and
mediates both pre- and post-synaptic inhibition in all regions of the
CNS,
following interaction between the benzodiazepine and a specific
neuronal membrane receptor.
Pharmacological properties of alprazolam in animals appear similar to
those of other benzodiazepines, that is, it produces significant
anxiolytic, muscle relaxant, sleep promoting and anticonvulsant
effects in
appropriate animal models.
PHARMACOKINETICS:
Following oral administration to fasting subjects, alprazolam is
rapidly absorbed with nearly complete bioavailability. Alprazolam
exhibits linear kinetics; after single dose administration of 0.5 –
3.0 mg plasma
levels of 8.0 p 40 mg/mL were observed; during multiple dose
administration of 1.5 – 10 mg/day in divided doses, steady state
plasma levels of 18.3 – 100 mg/mL were observed. Peak plasma levels
showed
a two- to three-fold variation within individual treatment groups. The
plasma half life of alprazolam after single doses in health subjects
has ranged from 6 to 25 hours. The mean half life of individual
treatment
groups ranged only from 10 to 14 hours. Alprazolam and its metabolites
are excreted primarily in the urine. About 50 percent of the dose is
excreted within 24 hours, and 94 percent after 72 hours. With
chronic dosing, t