| Flagyl Injection:
Section 4.1- wording changed to Flagyl is indicated in adults and children for the following indications…. No indications have changed.
Section 4.2.
Prophylaxis against anaerobic infection
Following text added- 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
Treatment of established anaerobic infections:
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.
Following guidance and information is new;
Bacterial vaginosis:
Adolescents: 400mg twice daily for 5-7 days or 2000mg as a single dose.
Urogenital trichomoniasis:
Adults and adolescents: 2000mg as a single dose or 200mg 3 times daily for 7 days or 400mg twice daily for 5-7 days
Children < 10 years: 40mg/kg orally as a single dose or 15-30 mg/kg/day divided in 2-3 doses for 7 days; not to exceed 2000mg/dose
Giardiasis:
> 10 years: 2000mg once daily for 3 days, or 400mg three times daily for 5 days, or 500mg twice daily for 7 to 10 days
Children 7 to 10 years: 1000mg once daily for 3 days
Children 3 to 7 years: 600 to 800mg once daily for 3 days
Children 1 to 3 years: 500mg once daily for 3 days
Alternatively, as expressed in mg per kg of body weight: 15-40mg/kg/day divided in 2-3 doses.
Amoebiasis:
> 10 years: 400 to 800mg 3 times daily for 5-10 days
Children 7 to 10 years: 200 to 400mg 3 times daily for 5-10 days
Children 3 to 7 years: 100 to 200mg 4 times daily for 5-10 days
Children 1 to 3 years: 100 to 200mg 3 times daily for 5-10 days
Alternatively, doses may be expressed by body weight: 35 to 50mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400mg/day
Eradication of Helicobacter pylori in paediatric patients: As a part of a combination therapy, 20mg/kg/day not to exceed 500mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy
Section 4.5- following text added- Psychotic reactions have been reported in patients who are using metronidazole and disulfiram concurrently.
Section 4.9: following text added;
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.
Section 10- date changed to 04.11.2011
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