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MINT-METRONIDAZOLE is a brand name for Metronidazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MINT-METRONIDAZOLE (metronidazole tablets) is indicated for: Bacterial Infections Treatment: Culture and susceptibility studies should be performed to determine the causative organisms and their susceptibility to metronidazole. Based on clinical judgment and anticipated bacteriological findings, therapy may be started…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations A rare case of reversible but profound neurological deterioration has been reported following a single oral dose of metronidazole; it is therefore advisable that a patient taking metronidazole for the first time not be left unattended for a period of two hours.
Patients administered metronidazole longer than the usually recommended duration, should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, vertigo, convulsive seizures).
Treatment with MINT-METRONIDAZOLE should be discontinued if ataxia or any other symptom of CNS involvement occurs (see 7 WARNINGS AND PRECAUTIONS, Neurologic). 2 Recommended Dose and Dosage Adjustment 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 a lack of pharmacokinetic information, specific dosage recommendations cannot be given for these patients. Therefore, close monitoring of blood metronidazole levels and of the patients for signs of toxicity are recommended (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Severe impairment of renal function and anuria:
Patients with severe impairment of renal function who are not undergoing hemodialysis should be monitored closely for signs of toxicity. Dose adjustment may be necessary. See 7 WARNINGS AND PRECAUTIONS, Renal. 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 beexpected.
The potential for toxicity of these metabolites is MINT-METRONIDAZOLE (metronidazole tablets) Page 6 of 32 not known.
Patients on hemodialysis:
The dose of metronidazole need not be specifically reduced since accumulated metabolites may be rapidly removed by hemodialysis.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. MINT-METRONIDAZOLE (metronidazole tablets) Page 12 of 32 The following adverse reactions have been reported with the use of metronidazole: Blood and lymphatic system disorders: transient eosinophilia, neutropenia, leukopenia, very rare cases of agranulocytosis and thrombocytopenia have been reported.
Cardiac disorders: palpitation and chest pain. Ear and labyrinth disorders: hearing impairment/hearing loss (including hypoacusis, deafness, deafness neurosensory), tinnitus. Eye disorders: transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision.
Optic neuropathy/neuritis has been reported. Gastrointestinal disorders: diarrhea, nausea, vomiting, epigastric distress, epigastric pain, dyspepsia, constipation. Reversible cases of pancreatitis havebeen reported infrequently. g. due to fungal overgrowth), dry mouth, taste disorders including unpleasant metallic taste, glossitis, oral mucositis.
General disorders and administration site conditions: fever has been reported. Hepatobiliary disorders: increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice have been reported.
Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs. Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with products containing metronidazole.
, Carcinogenesis and Mutagenesis 01/2024 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery 01/2024 7 WARNINGS AND PRECAUTIONS, Genitourinary 01/2024 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 01/2024 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 01/2024 7 WARNINGS AND PRECAUTIONS, Neurologic 01/2024 7 WARNINGS AND PRECAUTIONS, Psychiatric 01/2024 7 WARNINGS AND PRECAUTIONS, Renal 01/2024 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 01/2024 7 WARNINGS AND PRECAUTIONS, Skin 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics .............................................................................................................. 2 Geriatrics ..........................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations.......................................................................................
2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
01/2024 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 01/2024 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery 01/2024 7 WARNINGS AND PRECAUTIONS, Genitourinary 01/2024 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 01/2024 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 01/2024 7 WARNINGS AND PRECAUTIONS, Neurologic 01/2024 7 WARNINGS AND PRECAUTIONS, Psychiatric 01/2024 7 WARNINGS AND PRECAUTIONS, Renal 01/2024 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 01/2024 7 WARNINGS AND PRECAUTIONS, Skin 01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics .............................................................................................................. 2 Geriatrics ..........................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations.......................................................................................
2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients on peritoneal dialysis:
Peritoneal dialysis does not appear to reduce serum levels of metronidazole metabolites. V. ROUTE. Oral medication may be substituted when it is feasible and/or practical. 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 bedrained or which are liable to endogenous recontamination by anaerobic pathogens, a longer treatment may be required.
Oral Administration: 500 mg every 8 hours.
Pediatrics:
The safety and effectiveness of metronidazole for anaerobic infections in pediatric patients is not known. Due to lack of pharmacokinetic data, no dosage recommendations can be made. 3 Pediatrics. BACTERIAL VAGINOSIS Adults 500 mg orally twice a day for 7 days.
Concurrent treatment of sexual partners is not usually indicated. TRICHOMONIASIS Consideration should be given to use metronidazole therapy (oral or vaginal) in female patients, only when trichomonal infection has been confirmed by appropriate diagnostic techniques.
In the male patient, oral metronidazole is recommended in those who are evidently the source of reinfection in female sexual partners and those with demonstrated urogenital trichomoniasis. See 7 WARNING AND PRECAUTIONS, General.
Single-Dose Treatment:
For both women and men, 2g administered as a single dose after a meal.
Standard Ten-day Treatment:
Women - One 250 mg tablet twice a day, morning and night for 10 consecutive days. Men - One 250 mg tablet twice a day for 10 consecutive days. For both men and women, it may be occasionally necessary to give a second ten-day courseafter 4 to 6 weeks.
AMEBIASIS MINT-METRONIDAZOLE (metronidazole tablets) Page 7 of 32 Adults Intestinal Amebiasis - Three 250 mg tablets (750 mg) three times daily for 5 to 7 days. Amebic abscesses of the liver - Two to three 250 mg tablets (500 to 750 mg) three times daily for 5 to 7 days.
Pediatrics (< 18 years of age):
Administer 35 to 50 mg/kg/day in three divided doses for 5 to 7 days.
Note:
Pediatric dosing may not be possible for all weights. GIARDIASIS Adults One 250 mg tablet twice daily for 5 to 7 days.
Pediatrics (< 18 years of age):
Administer 25 to 35 mg/kg/day in two divided doses for 5 to 7 days. Note: • Pediatric dosing may not be possible for all weights. • The efficacy of the recommended dosages for the treatment of amebiasis and giardiasis has been demonstrated.
However, the optimal dose, the duration oftreatment and the risk of recurrence have not been completely established. 4 Administration Tablets are for oral administration. Warn patients not to take alcohol or alcohol-containing medicines during metronidazole therapy and for at least one day afterwards (See 7 WARNINGS AND PRECAUTIONS, Neurologic).
5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.
Immune system disorders: angioedema, exceptional anaphylactic shocks. Infections and infestations: rare cases of pseudomembranous colitis have been reported. Investigations: reversible lowering of serum lipids has been reported. Metabolism and nutrition disorders: an antithyroid effect has been reported by some investigators but three different clinical studies failed to confirm this.
Anorexia has been reported. Nervous system disorders: convulsive seizures, peripheral sensory neuropathy, transient ataxia, dizziness, drowsiness, insomnia, headache, aseptic meningitis. Peripheral neuropathies have been reported in a few patients on moderately high to high-doseprolonged oral treatment with metronidazole.
V. medication for several weeks or months. Profound neurological deterioration, within 2 hours after metronidazole administration has been reported. The occurrence is not directly related to the dosage level. Psychiatric disorders: psychotic disorders including confusion and hallucinations, depressed mood.
Renal and urinary disorders: dysuria. Darkening of the urine has been reported. This is probably due to a metabolite of metronidazoleand seems to have no clinical significance. Reproductive system 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 MINT-METRONIDAZOLE (metronidazole tablets) Page 13 of 32 administration. Skin and subcutaneous tissue disorders: hypersensitivity reactions including flushing, urticaria, rash, and pruritus, very rare pustular eruptions, acute generalized exanthematous pustulosis (AGEP), fixed drug eruption.
Cases of Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Many of these case reports revealed the use of concomitant medications known to be associated with SJS or TEN.
V. administration, occasional flushing and headaches, especially with concomitant ingestion of alcohol; altered taste of alcoholic beverages. 5 Post-Market Adverse Reactions Cardiac disorders: tachycardia, dyspnea. QT interval prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval.
Flattening of the T-wave may be seen in electrocardiographic tracings. General disorders and administration site conditions: malaise, face edema, edema peripheral, chills, asthenia. Musculoskeletal and connective tissue disorders: muscle spasms, arthralgia, myalgia.
Nervous system disorders: vertigo, somnolence, hypoesthesia, paresthesia, dysgeusia. Skin and subcutaneous disorders: hyperhidrosis, erythema.
7 5 OVERDOSAGE ............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations .......................................................................................... 1 Pregnant Women ......................................................................................... 2 Breast-feeding..............................................................................................
3 Pediatrics ..................................................................................................... 4 Geriatrics ..................................................................................................... 11 8 ADVERSE REACTIONS ................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 5 Post-Market Adverse Reactions........................................................................ 13 9 DRUG INTERACTIONS................................................................................................
2 Drug Interactions Overview.............................................................................. 3 Drug-Behavioural Interactions.......................................................................... 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
16 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics..........................................................................................
3 Pharmacokinetics ............................................................................................ 17 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
19 PART II: SCIENTIFIC INFORMATION ...................................................................................... 20 13 PHARMACEUTICAL INFORMATION............................................................................ 20 14 CLINICAL TRIALS........................................................................................................
2 Comparative Bioavailability Studies .................................................................. 21 15 MICROBIOLOGY ........................................................................................................ 21 16 NON-CLINICAL TOXICOLOGY .....................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS.................................................................... 26 PATIENT MEDICATION INFORMATION ................................................................................. 27 MINT-METRONIDAZOLE (metronidazole tablets) Page 4 of 32 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MINT-METRONIDAZOLE (metronidazole tablets) is indicated for: Bacterial Infections Treatment: […]
7 5 OVERDOSAGE ............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations .......................................................................................... 1 Pregnant Women ......................................................................................... 2 Breast-feeding..............................................................................................
3 Pediatrics ..................................................................................................... 4 Geriatrics ..................................................................................................... 11 8 ADVERSE REACTIONS ................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 5 Post-Market Adverse Reactions........................................................................ 13 9 DRUG INTERACTIONS................................................................................................
2 Drug Interactions Overview.............................................................................. 3 Drug-Behavioural Interactions.......................................................................... 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
16 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics..........................................................................................
3 Pharmacokinetics ............................................................................................ 17 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
19 PART II: SCIENTIFIC INFORMATION ...................................................................................... 20 13 PHARMACEUTICAL INFORMATION............................................................................ 20 14 CLINICAL TRIALS........................................................................................................
2 Comparative Bioavailability Studies .................................................................. 21 15 MICROBIOLOGY ........................................................................................................ 21 16 NON-CLINICAL TOXICOLOGY .....................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS.................................................................... 26 PATIENT MEDICATION INFORMATION ................................................................................. 27 MINT-METRONIDAZOLE (metronidazole tablets) Page 4 of 32 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MINT-METRONIDAZOLE (metronidazole tablets) is indicated […]