METROLEX INJECTION

Country: Malaysia

Language: English

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

Active ingredient:

METRONIDAZOLE

Available from:

SPG PHARMA (MALAYSIA) SDN BHD

INN (International Name):

METRONIDAZOLE

Units in package:

100ml mL

Manufactured by:

SIAM BHEASACH CO LTD

Summary of Product characteristics

Drawing No. METR-INJ-500-03-L-ENG-MY-A0004
Sent date 31/05/2019
METR-INJ-500-03-L-ENG-MY-A0004
©
Copyrighted Siam Bheasach 2019. All rights reserved.
PRODUCT NAME
Metrolex Injection
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each 100 mL contains 500 mg metronidazole
PRODUCT DESCRIPTION
Clear, colourless sterile solution
PHARMACODYNAMICS
Pharmacotherapeutic group: antibacterials for systemic use: imidazole
derivatives &
antiprotozoals : nitroimidazole derivatives
Mechanism of Action
Metronidazole is an anti-infectious drug belonging to the
pharmacotherapeutic group of
nitroimidazole derivatives, which have effect mainly on strict
anaerobes. This effect is
probably caused by interaction with DNS and different metabolites.
Metronidazole has antibacterial and antiprotozoal actions and is
effective against
anaerobic bacteria and against Trichomonas vaginalis and other
protozoa including
Entamoeba histolytica and Giardia lamblia.
Microbiological Susceptibility
The prevalence of acquired resistance may vary geographically and with
time for
selected species and local information is desirable, particularly when
treating severe
infections.
Metronidazole is usually active against the following microorganisms
(just an
approximate guidance):-
SUSCEPTIBLE
Gram-Negative Aerobes:
Helicobacter pylori
Anaerobes:
Bacteroides fragilis
Clostridium difficile
Peptostreptococcus
Bifidobacterium>>resistant (70%)
Clostridium perfringens
Prevotella
Bilophila
Eubacterium
Porphyromonas
Clostridium
Fusobacterium
Veillonella
RESISTANT
Gram-Positive Aerobes:
Actinomyces
Anaerobes:
Mobiluncus
Propionibacterium acnes
ANTIPARASITIC ACTIVITY
Entamoeba histolytica
Giardia intestinalis
Trichomonas vaginalis
PHARMACOKINETICS
Distribution
After administration of a single 500 mg dose, mean peak plasma
concentrations of
metronidazole (C
max
= 14 - 18
μ
g/mL) are reached at the end of a 20 minute infusion.
Steady state plasma concentrations (C
ss
= 17 and 13
μ
g/mL) are reached after
administration of metronidazole every 8 or 12 hours respectively.
Plasma p