FLAGYL

Posology 1.

Treatment of Anaerobic Infections:

Adults and children over 10 years: 1 g suppository inserted into the rectum eight hourly for three days. Oral medication with 400 mg three times daily should be substituted as soon as this becomes feasible. If rectal medication must be continued for more than three days, the suppositories should be inserted at 12 hourly intervals.

5 mg/kg bodyweight three times daily.

Infants and children under 5 years:

As for children of 5 – 10 years but with appropriate reduction in dosage of suppositories (one half of a 500 mg suppository for 1 – 5 years and one quarter of a 500 mg suppository for under 1 year). 2.

Prevention of Anaerobic Infections:

In appendectomy and post-operative medication for elective colonic surgery. Adults and children over 10 years: 1 g suppository inserted into the rectum two hours before surgery and repeated at eight hourly intervals until oral medication (200 – 400 mg three times daily) can be given to complete a seven day course.

If rectal medication is necessary after the third post-operative day, the frequency of administration should be reduced to 12 hourly. 5 mg/kg bodyweight three times daily) becomes possible. Method of administration Rectal

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) Metronidazole has no direct activity against aerobic or facultative anaerobic bacteria. 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.

If the liver function tests become markedly elevated during treatment, the drug should be discontinued. 8). Skin and subcutaneous tissue disorders Cases of severe bullous skin reactions such as Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or acute generalised exanthematous pustulosis (AGEP) have been reported with metronidazole.

1.