METRONIDAZOLE

Posology Metronidazole Tablets should be taken during or after meals, swallowed with water and NOT CHEWED.

Elderly:

Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of dosage.

Hepatic impairment:

Caution is advised in patients with hepatic encephalopathy. 4). g. for eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.

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. In newborns with a gestation age <40 weeks, accumulation of metronidazole can occur during the first week of life, why the concentrations of metronidazole in serum should preferable be monitored after a few days therapy.

Children under 10 years:

A more suitable dosage form should be used for this age group. Prophylaxis against anaerobic infection - chiefly in the context of abdominal (especially colorectal) and gynaecological surgery. Adults: 1g stat dose 24 hours pre-operatively, followed by 400mg at 8 hourly intervals during the 24 hours preceding operation followed by post-operative iv or rectal administration until the patient is able to take tablets.

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.

Children under 10 years:

A more suitable dosage form should be used for this age group. 2) Treatment of established infections: Adults and children over 10 years: 800mg followed by 400mg 8 hourly.

Children under 10 years:

A more suitable dosage form should be used for this age group. 3) Urogenital trichomoniasis: Where reinfection is likely, sexual partners should be treated concomitantly. Adults and adolescents: 2000 mg as a single dose or 200 mg 3 times daily for 7 days or 400 mg twice daily for 5-7 days.

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.

Children under 10 years:

A more suitable dosage form should be used for this age group. 4) Bacterial vaginosis Adults: 400mg twice daily for 7 days, or 2g as a single dose for one day only. Adolescents: 400 mg twice daily for 5-7 days or 2000 mg as a single dose.

5) Amoebiasis Adults> 10 years: 400 to 800 mg 3 times daily for 5-10 days. Children 7 to 10 years: 200 to 400 mg 3 times daily for 5-10 days. Children 3 to 7 years: 100 to 200 mg 4 times daily for 5-10 days. Children 1 to 3 years: 100 to 200 mg 3 times daily for 5-10 days.

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.

Children under 7 years:

A more suitable dosage form should be used for this age group. 6) Giardiasis: Adults > 10 years: 2000 mg once daily for 3 days, or 400 mg. three times daily for 5 days, or 500 mg twice daily for 7 to 10 days. Children 7 to 10 years: 1000 mg once daily for 3 days.

Children 3 to 7 years: 600 to 800 mg once daily for 3 days. Children 1 to 3 years: 500 mg once daily for 3 days. Alternatively, as expressed in mg per kg of body weight: 15-40 mg/kg/day divided in 2-3 doses.

Children under 7 years:

A more suitable dosage form should be used for this age group. 7) Acute ulcerative gingivitis (for 3 day duration): Adults and children over 10 years: 200mg three times daily.

Children under 10 years:

A more suitable dosage form should be used for this age. 8) Acute dental infections (for 3-7 day duration): Adults and children over 10 years: 200mg three times daily. 9) Leg ulcers and pressure sores (for 7 day duration): Adults and children over 10 years: 400mg three times daily.

10) Treatment of Helicobacter pylori in infected patients As a part of a combination therapy, 20 mg/kg/day not to exceed 500 mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy. Method of Administration For oral administration.

Frequency type and severity of adverse reactions in children are the same as in adults 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 in discontinuation of the drug, drowsiness, dizziness, convulsions, headaches Not known Depression, paraesthesia, 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). 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.

• Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. 5). • Caution is advised in patients with porphyria. • Metronidazole tablets should not be used in patients with blood dyscrasias or with active non-infectious disease of the central nervous system.

High doses of metronidazole may mask the presence of syphilis. • Caution in patients with epilepsy or those who have had seizures as high doses of metronidazole can induce seizures. 6). • Regular clinical and laboratory surveillance are advised if treatment continues for more than 10 days.

• Consideration of the therapeutic benefit against the risk of peripheral neuropathy is advised with continuous therapy for chronic conditions. • There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist.

• The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients, however, retain the metabolites of metronidazole. The clinical significance of this is not known at present.

• In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight-hour period of dialysis. Metronidazole should, therefore, be readministered immediately after haemodialysis. • No routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IPD) or continuous ambulatory peritoneal dialysis (CAPD).

• Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to symptoms of the encephalopathy.

Therefore, metronidazole should be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. • 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). • Patients should be warned that metronidazole may darken urine. 3), the use of metronidazole for longer treatment than usually required should be carefully considered.

Excipients • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine, as this product contains lactose • This medicine contains less than 1 mmol (23mg) sodium per tablet, that is to say essentially ‘sodium-free’.

1. 6). g. 6)