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METRONIDAZOLE is a brand name for Metronidazole, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: METRONIDAZOLE INJECTION, USP is indicated for: • Treatment of bacterial infections The treatment of serious anaerobic intra-abdominal infections due to susceptible anaerobic bacteria, such as Bacteroides fragilis (and other species of Bacteroides), Clostridium, Fusobacterium, Peptococcus, and Peptostreptococcus…
Verbatim from this product's HC label. Tap a section to expand.
) infusion. • Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition and concomitant treatment, and on the patient’s clinical and laboratory response to the treatment.
V. , at the rate of 5 mL/min) every 8 hours. 5 g once per day in a limited number of patients. The decision to employ the once-a-day dosing schedule should be determined by careful evaluation of the risk chances for infection. V. infused (over 40 minutes) just prior to surgery and a second and third 500 mg dose administered at 8-hour intervals after the initial dose.
METRONIDAZOLE INJECTION, USP Product Monograph Page 6 of 34 Although METRONIDAZOLE INJECTION, USP has been employed alone, serious consideration should be given to the concomitant administration of an antibiotic with activity against aerobic bacteria in order to minimize the possibilities of post-operative infection.
Severe Hepatic Disease:
Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites. Accordingly, doses below those usually recommended should be administered and with caution. However, due to lack of pharmacokinetic information, specific dosage recommendations cannot be given for these patients.
Therefore, close monitoring of blood metronidazole levels and of patients for signs of toxicity are recommended (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Severe Impairment of Renal Function and Anuria:
The elimination half-life of metronidazole in anuric patients is not significantly altered. However, the elimination half-lives of the metabolites of metronidazole are significantly increased (3- to 13- fold). Consequently, although metronidazole would not be expected to accumulate in these patients, accumulation of the metabolites would be expected.
The potential for toxicity of these metabolites is not known (see 7 WARNINGS AND PRECAUTIONS, Renal).
Patients on Hemodialysis:
The dose of metronidazole need not be specifically reduced since accumulated metabolites may be rapidly removed by hemodialysis (see 7 WARNINGS AND PRECAUTIONS, Renal).
5 Post-Market Adverse Reactions The following adverse reactions have been reported with the use of metronidazole. These reactions are listed by MedDRA System Organ Class (SOC). Blood and lymphatic system disorders: agranulocytosis, leukopenia, neutropenia, thrombocytopenia, eosinophilia.
Cardiac disorders: tachycardia, palpitation, chest pain, dyspnea. 4 Drug-Drug Interactions). Flattening of the T- wave may be seen in electrocardiographic tracings. Eye disorders: optic neuropathy. Gastrointestinal disorders: pancreatitis, abdominal pain, diarrhea, constipation, vomiting, nausea, anorexia, glossitis, dry mouth, tongue discoloration, dyspepsia, rare cases of pseudomembranous colitis.
General disorders and administration site conditions: injection site reaction, malaise, face edema, edema peripheral, chills, asthenia. Hepatobiliary disorders: jaundice. Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days) (see 2 CONTRAINDICATIONS).
Immune systems disorders: anaphylactic reaction, hypersensitivity. Investigations: hepatic enzyme increased, reversible lowering of serum lipids has been reported. Metabolism and nutrition disorders: decreased appetite. An antithyroid effect has been reported by some investigators but three different clinical studies failed to confirm this.
Musculoskeletal and connective tissue disorders: muscle spasms, arthralgia, myalgia. Nervous system disorders: encephalopathy, aseptic meningitis, seizure, neuropathy peripheral, ataxia, hypoacusis, somnolence, dysarthria, dizziness, hypoesthesia, paresthesia, dysgeusia, headache.
Peripheral neuropathies have been reported in a few patients on moderately high to high-dose prolonged oral treatment with metronidazole. V. medication for several weeks or months. Profound neurological METRONIDAZOLE INJECTION, USP Product Monograph Page 13 of 34 deterioration, within 2 hours after metronidazole administration has been reported.
, General). Treatment of a small number of cases of brain and lung infections (some with abscesses) caused by anaerobic bacteria. • Prevention of bacterial infections The prevention of the incidence of post-operative infections in patients undergoing elective colorectal surgery.
If there are signs of infections, specimens for culture should be obtained for the identification of causative organisms so that appropriate therapy may be given. To reduce the development of drug-resistant bacteria and maintain the effectiveness of METRONIDAZOLE INJECTION, USP and other antibacterial drugs, METRONIDAZOLE INJECTION, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS • METRONIDAZOLE INJECTION, USP is contraindicated in patients who are hypersensitive to metronidazole or other nitroimidazole derivatives or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • METRONIDAZOLE INJECTION, USP is contraindicated in patients with Cockayne syndrome. 5 Post-Market Adverse Reactions). • METRONIDAZOLE INJECTION, USP should not be administered to patients with active neurological disorders, a history of blood dyscrasia, hypothyroidism or hypoadrenalism.
) infusion. • Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition and concomitant treatment, and on the patient’s clinical and laboratory response to the treatment.
• METRONIDAZOLE INJECTION, USP is contraindicated in patients who are hypersensitive to metronidazole or other nitroimidazole derivatives or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• METRONIDAZOLE INJECTION, USP is contraindicated in patients with Cockayne syndrome. 5 Post-Market Adverse Reactions). • METRONIDAZOLE INJECTION, USP should not be administered to patients with active neurological disorders, a history of blood dyscrasia, hypothyroidism or hypoadrenalism.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Patients on Peritoneal Dialysis:
Peritoneal dialysis does not appear to reduce serum levels of metronidazole metabolites. Patients with severe impairment of renal function who are not undergoing hemodialysis should be monitored closely for signs of toxicity (see 7 WARNINGS AND PRECAUTIONS, Renal).
1 Pediatrics). V. route. Oral medication may be substituted when it is feasible and/or practical.
Risk of Air Embolism:
Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. 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.
METRONIDAZOLE INJECTION, USP Product Monograph Page 7 of 34 Consideration should be given to official guidance on the appropriate use of antibacterial agents to reduce the development of drug resistance and maintain the effectiveness of metronidazole and other antibacterial drugs.
In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection may be used in combination with metronidazole. Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless the solution is clear and the seal is intact. Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
Additives known or determined to be incompatible should not be used. 00). 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 11 STORAGE, STABILITY AND DISPOSAL).
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.
Discard any unused portion. For single use only. Duration of therapy depends upon clinical and bacteriological assessment. Treatment for seven days should be satisfactory for most patients. However, in cases where infection sites cannot be drained or which are liable to endogenous recontamination by anaerobic pathogens, a longer treatment may be required.
METRONIDAZOLE INJECTION, USP is ready-to-use solutions which require no further dilution. Metronidazole has a theoretical calculated osmolarity of 297 mOsmol/L. 5 Missed Dose Management of a missed dose should be reviewed by an appropriate healthcare professional.
METRONIDAZOLE INJECTION, USP Product Monograph Page 8 of 34
The occurrence is not directly related to the dosage level. Psychiatric disorders: depression, confusional state, insomnia. Renal and urinary disorders: chromaturia, dysuria. Darkening of the urine has been reported. This is probably due to a metabolite of metronidazole and seems to have no clinical significance.
Reproductive systems and breast disorders: proliferation of Candida albicans in the vagina, vaginal dryness and burning. A single case of gynecomastia has been reported which resolved on discontinuing metronidazole administration. Skin and subcutaneous disorders: toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), fixed eruption, drug reaction with eosinophilia and systemic symptoms (DRESS), swelling face, pruritus, urticaria, hyperhidrosis, erythema, rash.
V. administration, occasional flushing and headaches, especially with concomitant ingestion of alcohol, altered taste of alcoholic beverages.
V. , at the rate of 5 mL/min) every 8 hours. 5 g once per day in a limited number of patients. The decision to employ the once-a-day dosing schedule should be determined by careful evaluation of the risk chances for infection. V. infused (over 40 minutes) just prior to surgery and a second and third 500 mg dose administered at 8-hour intervals after the initial dose.
METRONIDAZOLE INJECTION, USP Product Monograph Page 6 of 34 Although METRONIDAZOLE INJECTION, USP has been employed alone, serious consideration should be given to the concomitant administration of an antibiotic with activity against aerobic bacteria in order to minimize the possibilities of post-operative infection.
Severe Hepatic Disease:
Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites. Accordingly, doses below those usually recommended should be administered and with caution. However, due to lack of pharmacokinetic information, specific dosage recommendations cannot be given for these patients.
Therefore, close monitoring of blood metronidazole levels and of patients for signs of toxicity are recommended (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Severe Impairment of Renal Function and Anuria:
The elimination half-life of metronidazole in anuric patients is not significantly altered. However, the elimination half-lives of the metabolites of metronidazole are significantly increased (3- to 13- fold). Consequently, although metronidazole would not be expected to accumulate in these patients, accumulation of the metabolites would be expected.
The potential for toxicity of these metabolites is not known (see 7 WARNINGS AND PRECAUTIONS, Renal).
Patients on Hemodialysis:
The dose of metronidazole need not be specifically reduced since accumulated metabolites may be rapidly removed by hemodialysis (see 7 WARNINGS AND PRECAUTIONS, Renal).
Patients on Peritoneal Dialysis:
Peritoneal dialysis does not appear to reduce serum levels of metronidazole metabolites. Patients with severe impairment of renal function who are not undergoing hemodialysis should be monitored closely for signs of toxicity (see 7 WARNINGS AND PRECAUTIONS, Renal).
1 Pediatrics). V. route. Oral medication may be substituted when it is feasible and/or practical.
Risk of Air Embolism:
Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. 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.
METRONIDAZOLE […]