Loading…
METRONIDAZOLE is a brand name for Metronidazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Metronidazole is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause. Metronidazole is active against a wide range of pathogenic micro- organisms, notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, Anaerobic cocci…
Verbatim from this product's MHRA label. Tap a section to expand.
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 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.
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 Bacterial vaginosis 5-7 or 1 400 mg twice daily 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 5-10 400 mg three times daily 200 mg three times daily 100 mg four times daily 100 mg three times daily c) Amoebic liver abscess also other forms of extraintestinal 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.
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: angioedema, urticaria, fever.
Metabolism and nutrition disorders:
Not known: anorexia.
Psychiatric disorders:
Very rare: psychotic disorders, including confusion and hallucinations. 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. -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. 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 leucocyte 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Metronidazole in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
35 to 50 mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400 mg/day. 3 or 2000 mg once daily Or 1000 mg once daily 600-800 mg once daily 500 mg once daily Giardiasis 5 or 400 mg three times daily or 7-10 500 mg twice daily 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:
Metronidazole is well tolerated by the elderly, but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group. 4.
Eradication of Helicobacter pylori in paediatric 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. Renal impairment The elimination half-life of metronidazole remains unchanged in the presence of renal failure.
Therefore, the dosage of metronidazole needs no reduction. However, such patients 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.
Therefore, metronidazole should be re-administered immediately after haemodialysis. No routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Hepatic impairment Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant accumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the 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. Method of administration For oral use. Metronidazole tablets should be swallowed, with water (not chewed).
It is recommended that the tablets be taken during or after a meal.
Not known: hearing impaired/hearing loss (including sensorineural), tinnitus.
Cardiac disorders:
Not known: QT prolongation has been reported particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval.
Gastrointestinal disorders:
Not known: taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro- intestinal disturbances such as epigastric pain and diarrhoea.
Hepatobiliary disorders:
Very rare: -increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, jaundice and pancreatitis which is reversible on drug withdrawal. -cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.
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.
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.