Product Name: Metronidazole intravenous infusion
Nombre del Producto:Metronidazol solución inyectable
Package: 1bottle/box, 1bottle/bag
Standard: BP & USP & CP
- The prophylaxis of postoperative infections due to sensitive anaerobic bacteria particularly species of Bacteroides and anaerobic Streptococci, during abdominal, gynaecological gastrointestinal or colorectal surgery which carries a high risk of occurrence of this type of infection. The solution may also be used in combination with an antibiotic active against aerobic bacteria.
- The treatment of severe intraabdominal and gynaecological infections in which sensitive anaerobic bacteria particularly Bacteriodes and anaerobic Streptococci have been identified or are suspected to be the cause.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
Method of Administration
Metronidazole 500mg/100ml Intravenous Infusion should be infused intravenously at an approximate rate of 5 ml/minute (or one bag infused over 20 to 60 minutes). Oral medication should be substituted as soon as feasible.
Prophylaxis against postoperative infections caused by anaerobic bacteria:
Primarily in the context of abdominal, (especially colorectal) and gynaecological surgery.
Antibiotic prophylaxis duration should be short, mostly limited to the post operative period (24 hours but never more than 48 hours). Various schedules are possible.
Adults: Intra-venous injection of single dose of 1000mg-1500mg, 30-60 minutes preoperatively or alternatively 500mg immediately before, during or after operation, then 500mg 8 hourly.
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.
Intravenous route is to be used initially if patient symptoms preclude oral therapy. Various schedules are possible.
Adults: 1000mg – 1500mg daily as a single dose or alternatively 500mg every 8 hours.
Children > 8 weeks to 12 years of age: The usual daily dose is 20-30mg/kg/day as a single dose or divided into 7.5 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.
Children < 8 weeks of age: 15 mg/kg as a single dose daily or divided into 7.5 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 preferably be monitored after a few days of therapy.
Oral medication could be given, at the same dose regimen. Oral medication should be substituted as soon as feasible.
Duration of Treatment
Treatment for seven to ten days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician might decide to prolong treatment e.g.; for the 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.
Adolescents: 400 mg twice daily for 5-7 days or 2000 mg as a single dose
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
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
Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of dosage.
Patients with renal failure
Routine adjustments of the dosage of Metronidazole are not considered necessary in the presence of renal failure.
No routine adjustment in the dosage of Metronidazole needs to be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD). However dosage reduction may be necessary when excessive concentrations of metabolites are found.
In patients undergoing haemodialysis, Metronidazole should be re-administered immediately after haemodialysis
Patients with advanced hepatic insufficiency
In patients with advanced hepatic insufficiency a dosage reduction with serum level monitoring is necessary.
Known hypersensitivity to Metronidazole or other imidazole derivatives or any of the excipients. Metronidazole is contraindicated in the first trimester of pregnancy.
Use of Metronidazole is contraindicated in patients with end stage liver damage, haematopoietic disorders and uncontrolled diseases of the central or peripheral nervous system.
Special warnings and precautions for use
Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of Metronidazole clearance may occur in the presence of advanced hepatic insufficiency. The risk/benefit ratio of using Metronidazole to treat trichomoniasis in such patients should be carefully considered.Plasma levels of Metronidazole should be closely monitored.
Active Central Nervous System disease:
Metronidazole should be used with caution in patients with active disease of the Central Nervous System. The treatment should be withdrawn in case of ataxia, dizziness, or confusion. The risk of aggravation of the neurological state should be considered in patients suffering from severe central and peripheral neurological diseases, fixed or progressive paraesthesia and epilepsy. Caution is required in patients with active disease of the central nervous system except for brain abscess.
Metronidazole is removed during haemodialysis and should be administered after the procedure is finished.
Sodium restricted patients:
May be harmful to patients on a low sodium diet.
Patients should be advised not to take alcohol during Metronidazole therapy and at least 48 hours afterwards because of a disulfram-like effect (flushing, vomiting, tachycardia).
Intensive or prolonged Metronidazole therapy:
As a rule, the usual duration of therapy with i.v Metronidazole or other imidazole derivatives is usually less than 10 days. This period may only be exceeded in individual cases after a very strict benefit-risk assessment. Only in the rarest possible case should the treatment be repeated. Limiting the duration of treatment is necessary because damage to human germ cells cannot be excluded.
Intensive or prolonged Metronidazole therapy should be conducted only under conditions of close surveillance for clinical and biological effects and under specialist direction. If prolonged therapy is required, the physician should bear in mind the possibility of peripheral neuropathy or leucopenia. Both effects are usually reversible.
In case of prolonged treatment, occurrence of undesirable effects such as paraesthesia, ataxia, dizziness and convulsive crises should be checked. High dose regimes have been associated with transient epileptiform seizures.
Regular clinical and laboratory monitoring (including leukocyte formula) 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.
Patients should be warned that Metronidazole may darken urine (due to Metronidazole metabolite).
Interaction with other medicinal products and other forms of interaction
Not recommended concomitant therapy:
Alcohol: Disulfram-like effect (warmth, redness, vomiting, tachycardia).
Alcohol beverage and drugs containing alcohol should be avoided. Patients should be advised not to take alcohol during Metronidazole therapy and at least 48 hours afterwards because of a disulfram-like (antabuse effect) reaction (flushing, vomiting, tachycardia).
Concomitant therapy requiring special precautions:
Oral anticoagulants (warfarin): increase of the effects of oral anticoagulants and the risk of haemorrhage (decrease in its liver catabolism). Prothrombin time should be monitored more frequently. The dose of oral anticoagulants should be adjusted during the treatment with Metronidazole and 8 days after withdrawal.
A large number of patients have been reported showing an increase in oral anticoagulant activity whilst receiving concomitant antibiotic therapy. The infectious and inflammatory status of the patient, together with their age and general well-being are all risk factors in this context. However, in these circumstances it is not clear as to the part played by the disease itself or its treatment in the occurrence of prothrombin time disorders. Some classes of antibiotics are more likely to result in this interaction, notably fluoroquinolones, macrolides, cyclines, cotrimoxazole and some cephalosporins.
Vecuronium (non depolarising curaremimetic): Metronidazole can potentialise the effects of vecuronium.
Combinations to be considered:
5 Fluoro-uracile: increase in the toxicity of 5 fluoro-uracile due to a decrease of its clearance.
Lithium: lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and Metronidazole. 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.
Barbiturates – Phenobarbital might induce the metabolism of Metronidazole, which could lead to decreased efficacy of Metronidazole.
Cholestyramine may delay or reduce the absorption of Metronidazole.
Concomitant administration of phenytoin and Metronidazole may affect the metabolism of Metronidazole.
Cimetidine inhibits the metabolism of Metronidazole.
Cyclosporine – Case reports indicate that concomitant treatment with Metronidazole and Cyclosporine might lead to increased serum levels of cyclosporine. Cyclosporine concentrations and creatinine levels should be monitored.
Busulfan: Plasma concentrations of busulfan may increase during concomitant treatment with metronidazole, which can result in serious busulfan toxicity.
Metronidazole may immobilise Treponema and thus may lead to falsely positive Nelson's test.
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