TRINAZOLE TABLET 200MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METRONIDAZOLE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

METRONIDAZOLE

Unit dalam pakej:

1000 Tablet Tablets; 500 Tablet Tablets; 100 Tablet Tablets; 1000 Tablets

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

TRINAZOLE TABLET
®
_Consumer Medication Information Leaflet (RIMUP)_
Metronidazole 200mg
__________________________________________________________________________________________________________________
Page
1
WHAT IS IN THIS LEAFLET:
1. What Trinazole tablet is used for
2. How Trinazole tablet works
3. Before you use Trinazole tablet
4. How to use Trinazole tablet
5. While you are using it
6. Side effects
7. Storage & Disposal of Trinazole tablet
8. Product Description
9. Manufacturer and Product Registration Holder
10.Date of revision
WHAT TRINAZOLE TABLET IS USED FOR
It is used for the treatment of symptomatic trichomoniasis
in females and males when the presence of trichomanad has
been confirmed by appropriate laboratory procedures.
Metronidazole
is
indicated
in
the
treatment
of
asymptomatic females when organism is associated with
endocervicitis, cervicitis or cervical erosion. T. vaginalis
infection
is
a
veneral
disease.
Therefore,
asymptomatic
sexual
partners
of
treated
patients
should
be
treated
simultaneously
if
the
organism
has
been
found
to
be
present, in order to prevent reinfection of the partner.
Metronidazole
is
indicated
in
the
treatment
of
acute
intestinal amoebiasis (amoebic dysentry) and amoebic liver
abscess. Metronidazole is also indicated in the treatment of
serious infections caused by susceptible anaerobic bacteria.
HOW TRINAZOLE TABLET WORKS
The
active
ingredient
in
the
medicine
is
‘
Metronidazole
’.
It
possesses
direct
trichomonacidal
amebacidal activity against Trichomonas vaginalis and
Entamoeba histolytica. The in vitro minimal inhibitory
concentration for most strains of these organisms is 8
µg/ml or less. Its mechanism of antiprotozoal action is
unknown.
Metronidazole is active in vitro against most
obligate anaerobes but does not appear to possess any
clinically relevant activity against facultative anaerobes
or
obligate
aerobes.
Against
susceptible
organisms,
metronidazole is generally bactericidal at concentrations
equal
to
or
slightly
higher
than
the
inhibitory
concentrat

Ciri produk

TRINAZOLE TABLET
Each tablet contains:-
Metronidazole
200mg
PHARMACODYNAMICS:
Metronidazole possesses direct trichomonacidal amebacidal activity
against Trichomonas vaginalis and Etamoeba histolytica. The in
vitro minimal inhibitory concentration for most strains of these
organisms is 8ug/ml or less. Its mechanism of antiprotozoal action is
unknown.
Metronidazole is active in vitro against most obligate anaerobes but
does not appear to possess any clinically relevant activity against
facultative anaerobes or obligate aerobes. Against susceptable
organisms, metroidazole is generally bactericidal at concentrations
equal
to or slighty higher than the inhibitory concentrations.
Metronidazole has been shown to have in vitro and clinical activity
against the following organisms:
Anaerobic gram negative bacilli, including:
Bacteroides fragilis group _(B. fragilis, B.ovatus,
B.thetaiotaomicion, B.vulgatus)_
_Fusobacterium_ species
Anaerobic gram positive bacilli, including:
_Clostridium_ species and susceptible strains of Eubacterium.
anaerobic gram positive cocci, including:
_Peptococcus species, Peptostreptococcus_ species
PHARMACOLOGY:
Following oral administration, Metronidazole is well absorbed with
peak plasma concentrations occuring between one and two hours
after administration. For oral dosage form, the elimination half-life
in healthy human is eight hours. The major route of elimination of
Metronidazole and its metabolites is via the urine (60-80%) of the
dose), with fecal excretion accounting for 6-15% of the dose. Renal
clearance of Metronidazole is approximately 10ml/mim/1.73m.
Metronidazole appears in cerebrospinal fluid, saliva and breast milk
in concentrations similar to those found in plasma.
Decreased
renal
funtion
does
not
after
the
single-dose
pharmacokinetics
of
Metronidazole.
However,
plasma
clearance
of
metronidazloe is decreased in patients with decreased liver function.
INDICATIONS:
Metronidazole is indicated for the treatment of symptomatic
trichomoniasis in females and males when the presence