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). 1) Anaerobic infections: Treatment for 7 days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician may decide to prolong treatment, eg 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.

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 (frequency 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, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug; drowsiness, dizziness, convulsions, headaches Nervous system disorders Not known During intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported.

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 in patients with epilepsy or those who have had seizures as high doses of Metronidazole can induce seizures.

• 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.

• Patients should be warned that metronidazole may darken urine. 2. 3), the use of metronidazole for longer treatment than usually required should be carefully considered. • Neuropathy (central and peripheral): Regular clinical and laboratory monitoring (especially leukocyte count) are advised if administration of metronidazole 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.

If symptoms or signs of SJS, TEN or AGEP are present, metronidazole treatment must be immediately discontinued. Interference with laboratory tests Metronidazole may interfere with certain types of blood test determinations in blood (aminotransferase [ALT], aspartate aminotransferase [AST], lactate dehydrogenase [LDH], triglycerides, glucose), which may lead to false negative or an abnormally low result.

These analytical determinations are based on a decrease in ultraviolet absorbance, a fact that occurs when nicotinamide adenine dinucleotide hydrogen (NADH) is oxidised to nicotinamide adenine dinucleotide (NAD). The interference is due to the similarity in the absorption peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.

Information on sodium content This medicine contains less than 1 mmol sodium (23 mg) per each tablet, that is to say essentially ‘sodium-free’.

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