DYNIDAZOL TABLET 400MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METRONIDAZOLE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

METRONIDAZOLE

Unit dalam pakej:

1000 Tablet Tablets

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
DYNIDAZOL TABLET
Metronidazole (200mg, 400mg)
Page 1 of 2
What is in this leaflet
1.
What DYNIDAZOL TABLET is
used for
2.
How DYNIDAZOL TABLET works
3.
Before you use DYNIDAZOL
TABLET
4.
How to use DYNIDAZOL TABLET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DYNIDAZOL TABLET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What DYNIDAZOL TABLET is used
for
Metronidazole is used in the treatment
and prevention of certain bacterial
infections.
How DYNIDAZOL TABLET works
This medicine works by killing or
stopping the growth of protozoa and
bacteria. It also has a radiosensitising
effect on hypoxic tumour cells.
Before you use DYNIDAZOL
TABLET
- When you must not use it
Do not take DYNIDAZOL TABLET if
you have hypersensitivity to
Metronidazole.
Pregnancy and lactation
Do not take DYNIDAZOL TABLET if
you are pregnant, trying to get pregnant
or think you may be pregnant.
Do not take DYNIDAZOL TABLET if
you are breast-feeding. Ask your doctor
or pharmacist for advice before taking
any medicine.
-
Before you start use it
Tell your doctor or pharmacist if:
-
Blood disorder
-
Active disease of the central nervous
system
-
Severely impaired liver function
-
Taking other medicines
Tell your doctor if you are under:
-
Alcohol usage
-
Warfarin-type oral anticoagulants
treatment
-
Lithium treatment (for depressive
disorders)
-
Phenobarbitone treatment (to control
seizures)
-
Phenytoin treatment (to control
seizures)
-
Cimetidine treatment (relieve
heartburn)
Inform your doctor if you are affected
by Cockayne syndrome.
Cases of severe liver toxicity or acute
liver failure in patients with Cockayne
syndrome have been reported with
product containing Metronidazole.
Stop taking Dynidazol Tablet and tell
your doctor immediately if you develop:
stomach pain, decreased appetite,
nausea, vomiting, fever, unusual
tiredness, yellowing of the skin & whites
of the eyes, dark-coloured urine, light or
clay-coloured stools or it

Ciri produk

DYNIDAZOL
DESCRIPTION
CONTENT
Dynidazol Tablet 200mg
MAL19987009AZ
TABLET
Colour
:
White
Shape
:
Round & Biconvex
Each tablet contains:
Metronidazole ........................ 200 mg
Dynidazol Tablet 400mg
MAL19973017AZ
TABLET
Colour
:
White
Shape
:
Round, Flat & Scored
Each tablet contains:
Metronidazole ........................ 400 mg
PHARMACODYNAMICS:
Metronidazole is a 5-nitroimidazole derivative with activity against
anaerobic protozoa and anaerobic bacteria; it also has
a radiosensitising effect on hypoxic tumour cells. Its mechanism of
action is thought to involve interference with DNA by
a metabolite in which the nitro group of Metronidazole has been
reduced.
PHARMACOKINETICS:
Metronidazole is readily absorbed following administration by mouth
and bioavailability approaches 100%. Peak plasma
concentrations of approximately 5 and 10 µg per mL are achieved an
average of one hour after single doses of 250 and
500 mg respectively. Absorption may be delayed, but is not reduced
overall by administration with food. Metronidazole is
widely distributed. It appears in most body tissues and fluids
including biles, bone, breast milk, cerebral abscesses,
cerebrospinal fluid, liver and liver abscesses, saliva, seminal fluid,
and vaginal secretions, and achieves concentrations
similar to those in plasma. It also crosses the placenta and rapidly
enters the foetal circulation. No more than 20% is
bound to plasma proteins. Metronidazole is metabolised in the liver by
side-chain oxidation and glucuronide formation.
The plasma elimination half-life of Metronidazole is about 8 hours;
that of the hydroxy metabolite is slightly longer. The
half-life of Metronidazole is reported to be longer in neonates and in
patients with severe liver disease; that of the
hydroxy metabolite is prolonged in patients with renal failure. The
majority of a dose of Metronidazole is excreted in the
urine, mainly as metabolites; a small amount appears in the faeces.
Depending on the assay method used, up to 80% of
a dose has been recovered in the uri