Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Metronidazole 500mg/100ml Intravenous Infusion is indicated in adults and children when oral medication is not possible for the following indications:
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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.
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.
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.
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.
>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.
>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.
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.
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.
In patients with advanced hepatic insufficiency a dosage reduction with serum level monitoring is necessary.
In cases of overdose in adults, the clinical symptoms are usually limited to nausea, vomiting and neurotoxic effects, including ataxia, slight disorientation, confusion, seizures and peripheral neurophathy.
There is no specific treatment for Metronidazole overdose, Metronidazole infusion should be discontinued. Patients should be treated symptomatically.
2 years.
Keep container in the outer carton in order to protect from light.
The bags are composed of polyolefin/polyamide co-extruded plastic (PL 2442) known as Viaflo.
The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene, which serves only to provide physical protection to the bags.
The bag size is 100ml.
Outer carton contents: 20 bags of 100ml, 50 bags of 100ml and 60 bags of 100ml.
Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set.
Do not remove unit from overpouch until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.
In patients maintained on intravenous fluids, Metronidazole 500mg/100ml Intravenous Infusion may be diluted with appropriate volumes of 0.9% sodium chloride solution, dextrose 5%-0.9% sodium chloride solution, dextrose 5% w/v or potassium chloride infusions (20 and 40 mmol/litre).
Using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In the case of adverse reaction, infusion must be stopped immediately.
Additives known or determined to be incompatible should not be used.
Before adding a substance or medication, verify that it is soluble and stable in metronidazole, and that the pH range of metronidazole is appropriate. Additives may be incompatible. When introducing additives, the instructions for use of the medication to be added and other relevant literature must be consulted (see Section 6.2).
Mix the solution thoroughly when additives have been introduced.
After addition, if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.
Do not store solutions containing additives.
The product should be used immediately after opening.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
Opening:
Preparation for administration: Use sterile material for preparation and administration.
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