Winthrop Pharmaceuticals UK Ltd

section 4.8 (undeisrable effect)

addition of aseptic meningitis and optic neuropathy/neuritis

Change to section 4.1 to add the following wording: Flagyl is indicated in adults and children for the following instructions. Licensed indications remain unchanged.

Also following text added under this section: Considerations should be given to official guidance on the appropriate use of antibacterial agents.

Section 4.2: there are changes to the information included for dosage and administeration in children.

For prophylaxis against anaerobic infection the following guidance is provided or children:
Children < 12 years: 20-30mg/kg as a single dose given 1-2 hours before surgery. Newborns with a gestation age < 40 weeks: 10mg/kg body weight as a single dose before operation.

Previously the SPC just advised a 7.5mg/kg 8 hourly dose.

For the treatment of established anaerobic infection- where previsouly the SPC just advised a 7.5mg/kg 8 hourly dose, guidance has been ammended to;

Children > 8 weeks to 12 years of age: The usual daily dose is 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours. The daily dose may be increased to 40mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.

Children < 8 weeks of age: 15mg/kg as a single dose daily or divided into 7.5mg/kg every 12 hours. In newborns with a gestation age < 40 weeks, accumulation of metronidazole can occur during the first week of life, therefore the concentrations of  metronidazole in serum should preferable be monitored after a few days therapy.

information for use in urogenital trichomoniasis has been updated to:

Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.