VAGINYL

Metronidazole tablets should be swallowed, without chewing, with half a glassful of water during or after meals. 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: 20-30mg/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 2.

Anaerobic infections:

The duration of a course of metronidazole 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: • Urogenital trichomoniasis:

Adults and adolescents: 200 mg, 3 times daily for 7 days; or 400 mg, twice daily for 5-7 days; or 2000mg as a single dose for 7 days To prevent re-infection, the consort should receive the same course of treatment concurrently. Children: <10 years: 40 mg/kg orally as a single dose; or 15-30 mg/kg/day divided in 2-3 doses for 7 days; not to exceed 2000 mg/dose • Bacterial vaginosis: Adults and adolescents: 400 mg, twice daily for 5-7 days; or 2000 mg as a single dose • Amoebiasis: Adults and children over 10 years: a) Invasive intestinal disease in susceptible subjects, 800 mg three times daily for 5 days, or 2000 mg once daily for three days.

b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis, 400 mg three times daily for 5-10 days or 2000 mg once daily for 2 days. c) Amoebic liver abscess, also forms of extra-intestinal amoebiasis, 400 mg three times daily for 5 days or 2000 mg once daily for two days.

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.

Blood and lymphatic system disorders:

Very rare: agranulocytosis, neutropenia, thrombocytopenia, and pancytopenia Not known: leucopenia.

Immune system disorders:

Rare: anaphylaxis Not known: angiodema, urticaria, fever.

Metabolism and nutrition disorders:

Not known: anorexia.

Psychiatric disorders:

Very rare: psychotic disorders, including confusion and hallucinations. g. g. ataxia, dysathria, 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. • aseptic meningitis • vertigo Eye disorders: Very rare: vision disorders such as diplopia and myopia, which in most cases is transient.

Not known: optic neuropathy/neuritis Ear and labyrinth disorders:

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. 3), the use of Vaginyl for longer treatment than usually required should be carefully considered.

Neuropathy (central and peripheral) Regular clinical and laboratory monitoring (especially leucocyte count) are advised if administration of Vaginyl 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. Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.

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