Zovex 0.5mg Tablet

Land: Malaysia

Sprog: engelsk

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

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Produktets egenskaber Produktets egenskaber (SPC)
30-08-2017

Aktiv bestanddel:

ALPRAZOLAM

Tilgængelig fra:

Abio Marketing Sdn Bhd

INN (International Name):

ALPRAZOLAM

Enheder i pakken:

100tablet Tablets

Fremstillet af:

CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.

Produktets egenskaber

                                COMPOSITION:
Each tablet contains 0.5 mg Alprazolam
PRODUCT DESCRIPTION:
ZOVEX 0.5mg tablet is a pink oval shaped tablet, with a score on one
side
and "CCP C60" on the other side
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMIc PROPERTIES
Alprazolam,
like
other
benzodiazepines,
has
a
high
affinity
for
the
benzodiazepine
binding
site
in
the
brain.
It
facilitates
the
inhibitory
neurotransmitter action of gamma-aminobutyric acid which mediates both
pre- and post-synaptic inhibition in the central nervous system (CNS).
PHARMACOKINETIC PROPERTIES
Following oral administration, peak plasma concentrations are reached
in
about 1.7 hours. After a single oral dose of 500 micrograms, the
average
maximal
concentration
was
7.1
nanograms/ml.
There
is
a
linear
relationship between the dose and plasma concentration. At least 80%
of
the oral dose is absorbed. About 70% of the absorbed dose is bound to
plasma proteins.
Alprazolam
is
extensively
metabolised
in
the
liver,
primarily
to
hydroxylated
metabolites,
but
about
20%
of
the
dose
is
excreted
as
unchanged alprazolam. Elimination occurs mostly via the kidneys; 80%
of
the dose is excreted into the urine and only 7% into the faeces. The
mean
elimination half-life is 10-12 hours.
INDICATIONS:
Zovex Tablets (alprazolam) are indicated for the treatment of:
ANXIETY STATES (ANXIETY NEUROSES)
Symptoms which occur in such patients include anxiety, tension,
agitation,
insomnia,
apprehension,
irritability
and/or
autonomic
hyperactivity
resulting in a variety of somatic complaints.
MIXED ANXIETY-DEPRESSION
Symptoms of both anxiety and depression occur simultaneously in such
patients.
NEUROTIC OR REACTIVE DEPRESSION
Such patients primarily exhibit a depressed mood or a pervasive loss
of
interest or pleasure. Symptoms of anxiety, psychomotor agitation and
insomnia
are
usually
present.
Other
characteristics
include
appetite
disturbances,
changes
in
weight,
somatic
complaints,
cognitive
disturbances,
decreased
energy,
feeling
of
worthlessness
or
guilt,
or
thoughts of death or suicide.
ANXIETY STATES
                                
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