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Logo TRICHAZOLE INFUSION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

TRICHAZOLE INFUSION

COMPOSITION:
Each 100 mL of the solution contains 500 mg
Metronidazole.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2 (Antimicrobial Agent)

PHARMACOLOGICAL ACTION:
Metronidazole is active against a variety of anaerobic bacteria, particularly Bacteroides fragilis.
Its mechanism of action is reflected in a selective toxicity to anaerobic or microaerophilic micro-organisms and for other, anoxic or hypoxic cells.
In susceptible cells, the nitro group of metronidazole is reduced by electrontransport proteins with low redox potentials (such as ferredoxin in clostridia); these proteins play a much more important role in the metabolism of such cells than they do in aerobes.
Metronidazole thus acts as an electron sink and deprives the cell of required reducing equivalents.

INDICATIONS:
1. The treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of bacteroides and including other species for which metronidazole is bactericidal.
2. For the prevention of post-operative abdominal and pelvic infections due to anaerobic bacteria.
CONTRA-INDICATIONS:
Metronidazole should not be used on patients with blood dyscrasias or with active disease of the central nervous system. Its use should be avoided during pregnancy. If its use is essential during pregnancy the short high dose regiments should not be used.

WARNINGS:

DOSAGE AND DIRECTIONS FOR USE:
Treatment:
Adults and Children over 12 years
100 mL by intravenous infusion eight hourly. The injection should be infused intravenously at the rate of 5 mL per minute, but may be administered alone or concurrently but separately, with other bacteriologically appropriate antibacterial agents in parenteral dosage forms. Oral medication with 400 mg three times daily should be substituted as soon as this becomes feasible. Treatment for seven days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician might decide to prolong treatment, e.g. for the eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.

Children under 12 years
As for adults, but the single intravenous dose is based on 1,5 mL/kg body mass (7,5 mg metronidazole/kg body mass) and the oral dose of 7 mg/kg body mass.

Prevention
Adults and Children over 12 years
100 mL by intravenous infusion immediately before, during or after an operation, followed by the same dose eight hourly until oral medication (200 mg – 400 mg three times daily) can be given to complete a seven-day course.

Children under 12 years
As for adults, but the single intravenous dose is based on 1,5 mL/kg body mass (7,5 mg metronidazole/kg body mass) and the oral dose of 7 mg/kg body mass.

In infants and other patients maintained on intravenous fluids, metronidazole injection may be diluted with appropriate volumes of normal saline, dextrose-saline, dextrose 5% or potassium chloride injections (20 µmol and 40 µmol).

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort, anorexia, nausea, coated tongue, dryness of mouth, unpleasant taste, headache and skin rash.
Vertigo, depression, insomnia, drowsiness, urethral discomfort and darkening of the urine may occur.
There may be a temporary decrease in the total white-cell count. When given in conjunction with alcohol, metronidazole may provoke a disulfiram type reaction in some individuals.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no specific treatment for gross overdosage.
The treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless to pale straw coloured, sterile solution.

PRESENTATION:
100 mL in a flexible PVC bag and 100 mL in a clear-glass infusion bottle sealed with rubber stopper and an aluminium overseal and fitted with a plastic hanger of suitable dimensions for suspending the infusion bottle. Each bottle is individually packed.

STORAGE INSTRUCTIONS:
Protect from light.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Q/20.2/92

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD.
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1982 12-436/11-92
  Tradepak PE

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