FLAGYL

Posology 1.

Prophylaxis against anaerobic infection:

Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery. Adults: 400 mg 8 hourly during 24 hours immediately preceding operation followed by postoperative intravenous or rectal administration until the patient is able to take tablets.

Paediatric population Children < 12 years: 20 – 30 mg/kg as a single dose given 1 – 2 hours before surgery Newborns with a gestation age < 40 weeks: 10 mg/kg body weight as a single dose before operation. 2.

Anaerobic infections:

The duration of a course of Flagyl treatment is about 7 days but it will depend upon the seriousness of the patient’s condition as assessed clinically and bacteriologically.

Treatment of established anaerobic infection:

Adults: 800 mg followed by 400 mg 8 hourly. 5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days. 5 mg/kg every 12 hours. 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.

3.

Protozoal and other infections:

Dosage is given in terms of metronidazole or metronidazole equivalent ChildrenDuration of dosage in days Adults and children over 10 years 7 – 10 years 3 – 7 years 1 – 3 years Urogenital trichomoniasis (Where re-infection is likely, in adults the consort should receive a similar course of treatment concurrently) 7 Or 5 – 7 2000 mg as a single dose Or 200 mg three times daily or 400 mg twice daily 40 mg/kg orally as a single dose Or 15 – 30 mg/kg/day divided in 2 – 3 doses; not to exceed 2000 mg/kg dose 40 mg/kg orally as a single dose Or 15 – 30 mg/kg/day divided in 2 – 3 doses; not to exceed 2000 mg/kg 40 mg/kg orally as a single dose Or 15 – 30 mg/kg/day divided in 2 – 3 doses; not to exceed 2000 mg/kg dose dose Bacterial vaginosis 5 – 7 Or 1 400 mg twice daily Or 2000 mg as a single dose N/A Amoebiasis (a) Invasive intestinal disease in susceptible subjects 5 800 mg three times daily 400 mg three times daily 200 mg four times daily 200 mg three times daily (b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis 5 – 10 (c) Amoebic liver abscess also other forms of extra- intestinal amoebiasis 5 400 mg three times daily 200 mg three times daily 100 mg four times daily 100 mg three times daily 5 – 10 400 – 800 mg three times daily 200 – 400 mg three times daily 100 – 200 mg four times daily 100 – 200 mg three times daily(d) Symptomless cyst passers Alternatively, doses may be expressed by body weight: 35 to 50 mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400 mg/day Giardiasis 3 2000 mg once daily 1000 mg once daily 600 – 800 mg once daily 500 mg once daily Or 5 Or 7 – 10 Or 400 mg three times daily Or 500 mg twice daily 4.

The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

Serious adverse reactions occur rarely with standard recommended regimens. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.

g. g. ataxia, dysarthria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug • drowsiness, dizziness, convulsions, headaches Not known: • during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported.

In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced. 4).

Skin and subcutaneous tissue disorders:

Very rare: skin rashes, pustular eruptions, acute generalised exanthematous pustulosis (AGEP), pruritis, flushing Not known: erythema multiforme, Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), fixed drug eruption Musculoskeletal, connective tissue and bone disorders: Very rare: myalgia, arthralgia Renal and urinary disorders: Very rare: darkening of urine (due to metronidazole metabolite) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. Patients should be warned that metronidazole may darken urine. 2. 3), the use of Flagyl for longer treatment than usually required should be carefully considered.

Neuropathy (central and peripheral) Alternatively, as expressed in mg per kg of body weight: 15 – 40 mg/kg/day divided in 2 – 3 doses. Acute ulcerative gingivitis 3 200 mg three times daily 100 mg three times daily 100 mg twice daily 50 mg three times daily Acute dental infections 3 – 7 200 mg three times daily N/A Leg ulcers and pressure sores 7 400 mg three times daily N/A Children and infants weighing less than 10 kg should receive proportionally smaller dosages.

Elderly:

Flagyl is well tolerated by the elderly but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group. Regular clinical and laboratory monitoring (especially leucocyte count) are advised if administration of Flagyl for more than 10 days is considered to be necessary and patients should be monitored for adverse reactions, such as peripheral or central neuropathy (such as paraesthesia, ataxia, dizziness, vertigo, convulsive seizures).

Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation. Hepatotoxicity in patients with Cockayne Syndrome Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne Syndrome have been reported with products containing metronidazole for systemic use.

In this population, metronidazole should not be used unless the benefit is considered to outweigh the risk and if no alternative treatment is available. Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached.

1.