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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 5 mg/ml Solution for Infusion is indicated in adults and children for the prophylaxis and treatment of infections in which susceptible anaerobic micro- organisms have been identified or are suspected to be the cause (see sections 4.4 and 5.1). 1. The prophylaxis of post-operative infections where…
Verbatim from this product's MHRA label. Tap a section to expand.
The dosage is adjusted according to the patient’s individual response to therapy, her/his age and body weight and according to nature and severity of the disease.
The following dosage guidelines should be followed:
Adults and adolescents: Treatment of anaerobic infections 500 mg (100 ml) every 8 hours. Alternatively, 1000 mg – 1500 mg may be given daily as a single dose. The duration of therapy is dependent on the effect of the treatment. In most cases a treatment course of 7 days will be sufficient.
If clinically indicated, treatment may be continued beyond this time although a duration of 10 days should not normally be exceeded. ) Prophylaxis against post-operative infection caused by anaerobic bacteria: 500 mg, with administration completed approximately one hour before surgery.
The dose is repeated after 8 and 16 hours.
The Elderly:
Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of dosage. 5 mg per kg BW every 8 hours. The daily dose may be increased to 40 mg per kg BW, depending on the severity of the infection.
5 mg per kg BW every 12 hours. • In newborns with a gestational age < 40 weeks, accumulation of metronidazole can occur during the first week of life; therefore the concentrations of metronidazole in serum should preferably be monitored after a few days therapy.
Duration of treatment is usually 7 days. Prophylaxis against postoperative infections caused by anaerobic bacteria: • Children < 12 years: 20 – 30 mg/kg BW as a single dose given 1 – 2 hours before surgery • Newborns with a gestation age < 40 weeks: 10 mg/kg BW as a single dose before surgery Patients with renal insufficiency Limited data are available in this population.
) In patients undergoing haemodialysis the conventional dose of metronidazole should be scheduled after haemodialysis on dialysis days to compensate the removal of metronidazole during the procedure. No routine dose adjustment is necessary in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
2). 4). Method of administration Intravenous use. e. 100 ml max. over not less than 20 minutes, but normally over one hour. Concurrently prescribed antibiotics are to be administered separately.
8. This intestinal disease, precipitated by the antibiotic treatment, may be life-threatening and requires immediate appropriate treatment. Anti-peristaltic medicinal products must not be given. The duration of therapy with metronidazole or drugs containing other nitroimidazoles should not exceed 10 days.
Only in specific elective cases and if definitely needed, the treatment period may be extended, accompanied by appropriate clinical and laboratory monitoring. Repeat therapy should be restricted as much as possible and to specific elective cases only.
These restrictions must be observed strictly because the possibility of metronidazole developing mutagenic activity cannot be safely excluded and because in animal experiments an increase of the incidence of certain tumours has been noted.
Prolonged therapy with metronidazole may be associated with bone marrow depression, leading to an impairment of haematopoiesis. 8. Blood cell counts should be carefully monitored during prolonged therapy. 1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Interference with laboratory tests Metronidazole interferes with the enzymatic-spectrophotometric determination of aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), triglycerides and glucose hexokinase resulting in decreased values (possibly down to zero).
Metronidazole has a high absorbance at the wavelength at which nicotinamideadenine dinucleotide (NADH) is determined. Therefore elevated liver enzyme concentrations may be masked by metronidazole when measured by continuous-flow methods based on endpoint decrease in reduced NADH.
Unusually low liver enzyme concentrations, including zero values, have been reported. Patients should be warned that Metronidazole may darken urine. 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.
Regular clinical and laboratory monitoring (including full blood count) are advised in cases of high-dose or prolonged treatment, in case of antecedents of blood dyscrasia, in case of severe infection and in severe hepatic insufficiency.
g. granulocytopenia) metronidazole should only be used if its expected benefits clearly outweigh potential hazards. 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. 2). Due to the risk of aggravation, metronidazole should also be used in patients with active or chronic severe peripheral and central nervous system diseases only if its expected benefits clearly outweigh potential hazards.
Convulsive seizures, myoclonus and peripheral neuropathy, the latter mainly characterized by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. 8). g. 8), treatment with Metronidazole 5 mg/ml Solution for Infusion must be discontinued immediately and established emergency treatment must be initiated by qualified healthcare professionals.
8. This intestinal disease, precipitated by the antibiotic treatment, may be life-threatening and requires immediate appropriate treatment. Anti-peristaltic medicinal products must not be given. The duration of therapy with metronidazole or drugs containing other nitroimidazoles should not exceed 10 days.
Only in specific elective cases and if definitely needed, the treatment period may be extended, accompanied by appropriate clinical and laboratory monitoring. Repeat therapy should be restricted as much as possible and to specific elective cases only.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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). 5 Interaction with other medicinal products and other forms of interaction Interactions with other medicinal products Amiodarone QT interval prolongation and torsade de pointes have been reported with the coadministration of metronidazole and amiodarone.
It may be appropriate to monitor QT interval on the ECG if amiodarone is used in combination with metronidazole. Patients treated on an outpatient basis should be advised to seek medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, palpitations, or syncope.
Barbiturates Phenobarbital may increase the hepatic metabolism of metronidazole, reducing its plasma half-life to 3 hours. Busulfan Coadministration with metronidazole may significantly increase the plasma concentrations of busulfan.
The mechanism of interaction has not been described. Due to the potential for severe toxicity and mortality associated with elevated busulfan plasma levels, concomitant use with metronidazole should be avoided. Carbamazepine Metronidazole may inhibit the metabolism of carbamazepine and raise the plasma concentrations as a consequence.
Cimetidine Concurrently administered cimetidine may reduce the elimination of metronidazole in isolated cases and subsequently lead to increased metronidazole concentrations in serum. Coumarin derivatives Concomitant treatment with metronidazole may potentiate the anticoagulant effect of these and increase the risk for bleeding as a consequence of decreased hepatic degradation.
Dose adjustment of the anticoagulant can be necessary. Cyclosporine During simultaneous therapy with cyclosporine and metronidazole there is a risk for increased serum concentrations of cyclosporine. Frequent monitoring of cyclosporine and creatinine is required.
Disulfiram Simultaneous administration of disulfiram may cause states of confusion or even psychotic reactions. Combination of both agents must be avoided. e. the plasma concentration of fluorouracil is increased. Lithium Caution is to be exercised when metronidazole is administered simultaneously with lithium salts, because under metronidazole therapy raised serum concentrations of lithium have been observed.
Lithium treatment should be tapered or withdrawn before administering metronidazole. Plasma concentrations of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.
, antibiotics) may reduce the oral bioavailability of mycophenolic acid products. Close clinical and laboratory monitoring for evidence of diminished immunosuppressive effect of mycophenolic acid is recommended during concomitant therapy with anti-infective agents.
e. the plasma concentration of phenytoin is increased. On the other hand, the efficacy of metronidazole is reduced when phenytoin is administered concurrently. […]
These restrictions must be observed strictly because the possibility of metronidazole developing mutagenic activity cannot be safely excluded and because in animal experiments an increase of the incidence of certain tumours has been noted.
Prolonged therapy with metronidazole may be associated with bone marrow depression, leading to an impairment of haematopoiesis. 8. Blood cell counts should be carefully monitored during prolonged therapy. 1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Interference with laboratory tests Metronidazole interferes with the enzymatic-spectrophotometric determination of aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), triglycerides and glucose hexokinase resulting in decreased values (possibly down to zero).
Metronidazole has a high absorbance at the wavelength at which nicotinamideadenine dinucleotide (NADH) is determined. Therefore elevated liver enzyme concentrations may be masked by metronidazole when measured by continuous-flow methods based on endpoint decrease in reduced NADH.
Unusually low liver enzyme concentrations, including zero values, have been reported. Patients should be warned that Metronidazole may darken urine. 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).