Zidoval

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Metronidazole

Fáanlegur frá:

iNova Pharmaceuticals Australia Pty Ltd

Tegund:

Medicine Registered

Vara einkenni

PRODUCT INFORMATION 
ZIDOVAL
TM
 VAGINAL GEL
_(METRONIDAZOLE 0.75%)_
NAME OF THE DRUG  
Metronidazole. 
Chemically, metronidazole is 2-methyl-5-nitroimidazole-1-ethanol.  It
has a
chemical formula of C
6
H
9
N
3
O
3
, a molecular weight of 171.16, CAS No: 443-48-1;
and has the following structure:
DESCRIPTION
Zidoval Vaginal Gel is an intravaginal dosage form of the synthetic
antibacterial
agent, metronidazole, at a concentration of 0.75%.  Metronidazole is
a member
of the imidazole class of antibacterial agents and is classified
therapeutically as
an anti-bacterial agent. 
Zidoval Vaginal Gel is a non-sterile gelled, purified water solution,
containing
metronidazole at a concentration of 7.5 mg/g (0.75%).  The gel is
formulated at
the normal vaginal pH of 4.0.  The gel also contains carbomer 934P,
disodium
edetate, methylhydroxybenzoate, propylhydroxybenzoate, propylene
glycol.
Each 5 g applicator full of vaginal gel contains approximately 37.5 mg
of
metronidazole.  Zidoval Vaginal Gel does not contain mineral oil.
PHARMACOLOGY
MICROBIOLOGY:  
Metronidazole is a synthetic agent which is effective against a wide
range of
obligate anaerobes.  It is not effective against aerobes or
facultative anaerobes.
Against susceptible organisms, metronidazole is generally bactericidal
at
concentrations equal to or slightly higher than the minimum inhibitory
concentration.  The antibacterial activity results from the
disruption of DNA and
the inhibition of nucleic acid synthesis.  
The aetiology of bacterial vaginosis is unclear and changes in vaginal
flora which
accompany bacterial vaginosis are probably its manifestation rather
than its
cause.  Monitoring changes in vaginal flora by Gram stain slides of
vaginal
discharge smears may supplement diagnosis and assessment of treatment
efficacy by standard clinical criteria.
Metronidazole has been shown to have_ in-vivo_ and clinical activity
against:
-
Obligate anaerobic gram negative bacilli
including _Bacteroides_ species_ (B._
_fragilis, B. distasonis, B. o