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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 (see sections 4.4 and 5.1). Metronidazole is active against a wide range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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.
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 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. In 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 Duration Adults and Children of dosage in days children over 10 years 7 to 10 years 3 to 7 years 1 to 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 2000mg as a single dose or 200 mg three times daily or 400mg twice daily 40mg/kg orally as a single dose or 15- 30 mg/kg/day divided in 2-3 doses; not to exceed 2000mg/dose 5-7 or 400 mg twice daily Bacterial vaginosis 1 2000mg as a single dose 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 a day 200 mg three times daily 100 mg four times daily 100 mg three times daily c) Amoebic liver 5 400 mg three 200 mg three 100 mg 100 mg abscess also other times daily times daily four three times forms of extra- times daily intestinal amoebiasis daily (d) Symptomless cyst passers 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 Alternatively, doses may be expressed by body weight 35 to 50mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400mg/day 3 2000mg once daily or 1000mg once daily 600-800 mg once daily 500 mg once daily 5 400mg three times daily or 7-10 500mg twice daily Giardiasis Alternatively, as expressed in mg per kg of body weight: 15-40mg/kg/day divided in 2-3 doses.
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. Frequency, type and severity of adverse reactions in children are the same as in adults. 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, pancytopenia Not known Leucopenia, bone marrow depression disorders such as aplastic anaemia Immune system class: Rare anaphylaxis Not known angiodema, urticaria, fever Metabolism and nutrition disorders: Not known Anorexia Psychiatric disorders: Very rare Psychotic disorders, including hallucinations and confusion Not known depressed mood Nervous system disorders; Very rare • Encephalopathy (eg.
Confusion, vertigo, fever, headache, hallucinations paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. Ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve in discontinuation of the drug.
• Drowsiness, dizziness, convulsions, headaches Not known • Depression, paresthesia, 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.
Metronidazole has no direct activity against aerobic or facultative anaerobic bacteria. 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 therefore be used after careful benefit- risk assessment and only 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.
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. There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. In patients undergoing haemodialysis Metronidazole and metabolites are efficiently removed during an eight hour period of dialysis.
1. 4. CLINICAL PARTICULARS
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ChildrenDuration of dosage in days Adults and children over 10 years 7 to 10 years 3 to 7 years 1 to 3 years 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 Leg ulcers and pressure sores 7 400 mg three times daily 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 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 Method of administration For oral use. Metronidazole Tablets should be taken during or after meals, swallowed with water and NOT CHEWED.
Incoordination of movement • Aseptic meningitis • vertigo • PT Cerebellar syndrome: Cerebellar syndrome (eg. ataxia, dysarthria, gait impairment, nystagmus and tremor), which may resolve upon discontinuation of the drug, have been observed with Pylera.
• posterior reversible encephalopathy syndrome (PRES) Eye disorders: Very rare vision disorders such as diplopia, myopia which, in most cases, is transient.
Not known optic neuropathy/neuritis Gastrointestinal disorders:
Not known unpleasant taste in the mouth, taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea, abdominal pain, anorexia Hepatobiliary disorders: Very rare • abnormal liver function tests, 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, pruritus, flushing, acute generalised exanthematous (AGEP) pustulosis, 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) Ear and labyrinth disorders: 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 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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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 the symptoms of the encephalopathy.
Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. 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. 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.