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Indications/Uses
The indications are based on the anti-parasitic and antibacterial activity, and on the pharmacokinetic characteristics of Metronidazole. They are restricted to infections caused by the microorganism defined previously as susceptible to Metronidazole: Amoebiasis.
Urogenital trichomoniasis.
Non specific vaginalis.
Giardiasis.
Curative treatment of medico-surgical infections due to susceptible anaerobic pathogens.
Prophylaxis against infections caused susceptible anaerobic pathogens in high risk surgical contents.
Conversion from prophylactic or curative injectable treatment of infections due to susceptible anaerobic pathogens.
Metronidazole is also indicated in the treatment of trichomoniasis in both male and female patients when the presence of trichomonas has been demonstrated by wet smear or culture and for sexual partners of those patients who have recurrence of infections. Trichomonal infection is demonstrated for other protozoa including Entamoeba histolytica, giardiasis and liver abscess.
Urogenital trichomoniasis.
Non specific vaginalis.
Giardiasis.
Curative treatment of medico-surgical infections due to susceptible anaerobic pathogens.
Prophylaxis against infections caused susceptible anaerobic pathogens in high risk surgical contents.
Conversion from prophylactic or curative injectable treatment of infections due to susceptible anaerobic pathogens.
Metronidazole is also indicated in the treatment of trichomoniasis in both male and female patients when the presence of trichomonas has been demonstrated by wet smear or culture and for sexual partners of those patients who have recurrence of infections. Trichomonal infection is demonstrated for other protozoa including Entamoeba histolytica, giardiasis and liver abscess.
Dosage/Direction for Use
Children: 5 to 16.7 mg per kg body-weight daily in divided doses for 7 to 10 days, taken with meals. Or as prescribed by a physician.
Administration
Should be taken with food.
Contraindications
It should not be administered to patients with active neurological disorders or history of blood dyscrasias, hypothyroidism and hypoadrenalism.
Warnings
Metronidazole has been shown to be carcinogenic in mice. Unnecessary use of the drug should be reserved for conditions described in the indications.
The use of this drug in the first trimester of pregnancy should be avoided. During the second trimester of pregnancy, its use should be restricted to those patients in whom topical measures have been proven inadequate. Metronidazole is secreted in the breast milk when administered to nursing mothers. Its use should be avoided although there is no reported effect to the newborn.
The use of this drug in the first trimester of pregnancy should be avoided. During the second trimester of pregnancy, its use should be restricted to those patients in whom topical measures have been proven inadequate. Metronidazole is secreted in the breast milk when administered to nursing mothers. Its use should be avoided although there is no reported effect to the newborn.
Special Precautions
When there is clinical evidence of a trichomonal infestation, the sexual partner should be treated concomitantly to avoid re-infestations. Although no persistent hematologic abnormalities have been reported in clinical studies, total and differential leukocyte counts should be made before and after treatment especially if a second course of therapy is needed. Treatment should be discontinued if ataxia or any symptoms CNS occur.
Adverse Reactions
Infrequent and minor adverse effect reactions include metallic taste, furred tongue and dry mouth, gastrointestinal disturbances such as diarrhea, anorexia, vomiting, epigastric distress, constipation, occasional flushing, and headaches, especially with concomitant ingestion with alcohol, dizziness and rarely incoordination and ataxia have been reported. Occasionally, patients have complained of numbness' or paresthesia of extremities, fleeting joint pains have been experienced, as have confusion, irritability, depression, urticaria, pruritus, dysuria, cystitis, urethral discomfort and darkening of the urine have occurred in patients receiving the drug.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Metronidazole is an anti-infective agent belonging to the 5-nitroimidazole group. The antimicrobial spectrum of Metronidazole concerns exclusively anaerobic microorganisms.
Susceptible species: More than 90% are susceptible: Bacteroides sp., Fusobacterium, Clostridium sp., Bacteroides sp., C. perfringens, Bacteroides fragilis, Fusobacterium, Peptostreptococcus.
The antiparasitic activity concerns: Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica.
Pharmacokinetics: Absorption: Metronidazole is rapidly absorbed following oral administration, at least 80% in less than one hour. The peak serum concentration achieved following oral administration are similar to those obtained following intravenous administration of equivalent doses. The oral bioavailability is 100% and is not modified by simultaneous ingestion of food.
Distribution: Approximately one hour after a single dose administration of 500 mg of Metronidazole, the peak serum concentration is on average 10 µg/mL. The plasma half-life is between 8 to 10 hours. The protein binding is low: <20%. The volume of distribution is large, on average 40 L (i.e. 0.66 L/kg). Diffusion of the drug is rapid and extensive with concentrations close to serum levels in the lungs, kidneys, liver, skin, bile, CSF, saliva, seminal fluid and vaginal secretion. Metronidazole crosses the placental barrier and is excreted in breast milk.
Metabolism: Metronidazole is primarily metabolized in the liver. Oxidation yields two main metabolites: the alcoholic metabolites, the primary metabolite, with a bactericidal activity against anaerobic bacteria equal to approximately 30% of that of Metronidazole; and with an elimination half-life of 11 hours.
The acid metabolite, in small amounts, and with bactericidal activity approximately equal to 5% of that of Metronidazole.
Elimination: High liver and biliary concentration. Low concentration in the colon. Little fecal elimination. Excretion is primarily urinary, shown by the fact that the Metronidazole and its oxidation metabolites excreted in the urine account for approximately 35 to 85% of the administered dose.
Susceptible species: More than 90% are susceptible: Bacteroides sp., Fusobacterium, Clostridium sp., Bacteroides sp., C. perfringens, Bacteroides fragilis, Fusobacterium, Peptostreptococcus.
The antiparasitic activity concerns: Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica.
Pharmacokinetics: Absorption: Metronidazole is rapidly absorbed following oral administration, at least 80% in less than one hour. The peak serum concentration achieved following oral administration are similar to those obtained following intravenous administration of equivalent doses. The oral bioavailability is 100% and is not modified by simultaneous ingestion of food.
Distribution: Approximately one hour after a single dose administration of 500 mg of Metronidazole, the peak serum concentration is on average 10 µg/mL. The plasma half-life is between 8 to 10 hours. The protein binding is low: <20%. The volume of distribution is large, on average 40 L (i.e. 0.66 L/kg). Diffusion of the drug is rapid and extensive with concentrations close to serum levels in the lungs, kidneys, liver, skin, bile, CSF, saliva, seminal fluid and vaginal secretion. Metronidazole crosses the placental barrier and is excreted in breast milk.
Metabolism: Metronidazole is primarily metabolized in the liver. Oxidation yields two main metabolites: the alcoholic metabolites, the primary metabolite, with a bactericidal activity against anaerobic bacteria equal to approximately 30% of that of Metronidazole; and with an elimination half-life of 11 hours.
The acid metabolite, in small amounts, and with bactericidal activity approximately equal to 5% of that of Metronidazole.
Elimination: High liver and biliary concentration. Low concentration in the colon. Little fecal elimination. Excretion is primarily urinary, shown by the fact that the Metronidazole and its oxidation metabolites excreted in the urine account for approximately 35 to 85% of the administered dose.
MedsGo Class
Other Antibiotics
Features
Dosage
125mg / 5mL
Ingredients
- Metronidazole
Packaging
Suspension 60ml
Generic Name
Metronidazole Benzoate
Registration Number
DR-XY19879
Classification
Prescription Drug (RX)
Product Questions
Questions
