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Metronidazole
Overview
What is Metronidazole500 mg?
Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:
Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, colloidal silicon dioxide and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.
What does Metronidazole500 mg look like?
What are the available doses of Metronidazole500 mg?
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What should I talk to my health care provider before I take Metronidazole500 mg?
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How should I use Metronidazole500 mg?
Symptomatic Trichomoniasis.
T. vaginalis
Asymptomatic Trichomoniasis.
T. vaginalis
Treatment of Asymptomatic Sexual Partners.
T. vaginalis
Amebiasis.
In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus.
Anaerobic Bacterial Infections.
INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by species including the
group (
,
,
,
,
), species, species, , and species.
SKIN AND SKIN STRUCTURE INFECTIONS caused by species including the group, species,
, species, and species.
GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by species including the
group, species,
, species, and species.
BACTERIAL SEPTICEMIA caused by species including the group and species.
BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by species including the group.
CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by species including the group.
LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by species including the group.
ENDOCARDITIS caused by species including the
group.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole 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.
In the Female:
− two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each, given in the same day.
Seven-day course of treatment
The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.
Pregnant patients should not be treated during the first trimester (see ). In pregnant patients for whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see ).
When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.
In the Male: Treatment should be individualized as it is for the female.
What interacts with Metronidazole500 mg?
Hypersensitivity
In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see ).
Psychotic Reaction with Disulfiram
PRECAUTIONS
Interaction with Alcohol
PRECAUTIONS
Drug Interactions
What are the warnings of Metronidazole500 mg?
Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. IV use in eclampsia should be reserved for immediate control of life-threatening convulsions.
Central and Peripheral Nervous System Effects
Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.
Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.
Convulsive seizures have been reported in patients treated with metronidazole.
Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.
The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see
).
What are the precautions of Metronidazole500 mg?
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General
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Information for Patients
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Drug Interactions
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Carcinogenesis, Mutagenesis, Impairment of Fertility
Tumors affecting the liver, lungs, mammary, and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters.
Pulmonary tumors have been observed in all six reported studies in the mouse, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). Malignant liver tumors were increased in male mice treated at approximately 1500 mg/m (similar to the maximum recommended daily dose, based on body surface area comparisons). Malignant lymphomas and pulmonary neoplasms were also increased with lifetime feeding of the drug to mice. Mammary and hepatic tumors were increased among female rats administered oral metronidazole compared to concurrent controls. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.
Metronidazole has shown mutagenic activity in assay systems including the Ames test. Studies in mammals have failed to demonstrate a potential for genetic damage.
Metronidazole failed to produce any adverse effects on fertility or testicular function in male rats at doses up at 400 mg/kg/day (similar to the maximum recommended clinical dose, based on body surface area comparisons) for 28 days. However, rats treated at the same dose for 6 weeks or longer were infertile and showed severe degeneration of the seminiferous epithelium in the testes as well as marked decreases in testicular spermatid counts and epididymal sperm counts. Fertility was restored in most rats after an eight week, drug-free recovery period.
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Pregnancy:
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Metronidazole is present in human milk at concentrations similar to maternal serum levels, and infant serum levels can be close to or comparable to infant therapeutic levels. Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Alternatively, a nursing mother may choose to pump and discard human milk for the duration of metronidazole therapy, and for 24 hours after therapy ends and feed her infant stored human milk or formula.
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In elderly geriatric patients, monitoring for metronidazole associated adverse events is recommended (see ). Decreased liver function in geriatric patients can result in increased concentrations of metronidazole that may necessitate adjustment of metronidazole dosage (see ).
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Safety and effectiveness in pediatric patients have not been established, except for the treatment of amebiasis.
What are the side effects of Metronidazole500 mg?
The following reactions have been reported during treatment with metronidazole:
Central Nervous System:
WARNINGS
Gastrointestinal:
Mouth:
Candida
Dermatologic:
Hematopoietic:
Cardiovascular:
Hypersensitivity:
Renal:
Other:
Candida
Patients with Crohn’s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn’s disease is not an approved indication for metronidazole tablets.
What should I look out for while using Metronidazole500 mg?
Hypersensitivity
In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see ).
Psychotic Reaction with Disulfiram
PRECAUTIONS
Interaction with Alcohol
PRECAUTIONS
Drug Interactions
Central and Peripheral Nervous System Effects
Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.
Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.
Convulsive seizures have been reported in patients treated with metronidazole.
Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.
The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see
).
What might happen if I take too much Metronidazole500 mg?
Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia.
Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.
Treatment of Overdosage:
How should I store and handle Metronidazole500 mg?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with “H569” on one side and plain on the other side. They are supplied as follows: NDC 70882-131-14, Unit of Use Bottles of 14 TabletsStorage and Stability:Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with “H569” on one side and plain on the other side. They are supplied as follows: NDC 70882-131-14, Unit of Use Bottles of 14 TabletsStorage and Stability:Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with “H569” on one side and plain on the other side. They are supplied as follows: NDC 70882-131-14, Unit of Use Bottles of 14 TabletsStorage and Stability:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between one and two hours after administration.
Plasma concentrations of metronidazole are proportional to the administered dose. Oral administration of 250 mg, 500 mg, or 2,000 mg produced peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively. Studies reveal no significant bioavailability differences between males and females; however, because of weight differences, the resulting plasma levels in males are generally lower.
Non-Clinical Toxicology
HypersensitivityIn patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see ).
Psychotic Reaction with Disulfiram
PRECAUTIONS
Interaction with Alcohol
PRECAUTIONS
Drug Interactions
Central and Peripheral Nervous System Effects
Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.
Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.
Convulsive seizures have been reported in patients treated with metronidazole.
Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.
The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see ).
The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
Hepatic Impairment
CLINICAL
PHARMACOLOGY
DOSAGE AND ADMINISTRATION
Renal Impairment
CLINICAL
PHARMACOLOGY
Fungal Superinfections
Use in Patients with Blood Dyscrasias
Drug-Resistant Bacteria and Parasites
The following reactions have been reported during treatment with metronidazole:
Central Nervous System:
WARNINGS
Gastrointestinal:
Mouth:
Candida
Dermatologic:
Hematopoietic:
Cardiovascular:
Hypersensitivity:
Renal:
Other:
Candida
Patients with Crohn’s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn’s disease is not an approved indication for metronidazole tablets.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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