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Metronidazole
Overview
What is Metronidazole?
Metronidazole topical gel contains metronidazole, USP, at a concentration of 7.5
mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium,
methylparaben, propylene glycol, propylparaben, purified water, and sodium
hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and
antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1-imidazole-1-ethanol and has the following structure:
What does Metronidazole look like?
What are the available doses of Metronidazole?
Sorry No records found.
What should I talk to my health care provider before I take Metronidazole?
Sorry No records found
How should I use Metronidazole?
Metronidazole topical gel is indicated for topical application in the treatment
of inflammatory papules and pustules of rosacea.
Apply and rub in a thin film of metronidazole topical gel twice
daily, morning and evening, to entire affected areas after washing.
Areas to be treated should be cleansed before application of metronidazole
topical gel. Patients may use cosmetics after application of metronidazole
topical gel.
What interacts with Metronidazole?
Metronidazole topical gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.
What are the warnings of Metronidazole?
Sorry No Records found
What are the precautions of Metronidazole?
Metronidazole topical gel has been reported to cause tearing of
the eyes. Therefore, contact with the eyes should be avoided. If a reaction
suggesting local irritation occurs, patients should be directed to use the
medication less frequently or discontinue use.
Metronidazole is a nitroimidazole and should be used with care in patients
with evidence of, or history of blood dyscrasia.
This medication is to be used as directed by the physician. It is
for external use only. Avoid contact with the eyes.
Oral metronidazole has been reported to potentiate the
anticoagulant effect of coumarin and warfarin resulting in a prolongation of
prothrombin time. The effect of topical metronidazole on prothrombin time is not
known.
Metronidazole has shown evidence of carcinogenic activity in a
number of studies involving chronic, oral administration in mice and rats but
not in studies involving hamsters.
Metronidazole has shown evidence of mutagenic activity in several bacterial assay systems. In addition, a
dose-response increase in the frequency of micronuclei was observed in mice
after intraperitoneal injections and an increase in chromosome aberrations have
been reported in patients with Crohn's disease who were treated with 200-1200
mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal
aberrations in circulating human lymphocytes have been observed in patients
treated for 8 months.
There has been no experience to date with the use of
metronidazole topical gel in pregnant patients. Metronidazole crosses the
placental barrier and enters the fetal circulation rapidly. No fetotoxicity was
observed after oral metronidazole in rats or mice. However, because animal
reproduction studies are not always predictive of human response and since oral
metronidazole has been shown to be a carcinogen in some rodents, this drug
should be used during pregnancy only if clearly needed.
After oral administration, metronidazole is secreted in breast
milk in concentrations similar to those found in the plasma. Even though
metronidazole topical gel blood levels are significantly lower than those
achieved after oral metronidazole, 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.
Safety and effectiveness in pediatric patients have not been
established.
What are the side effects of Metronidazole?
The following adverse experiences have been reported with the topical use of
metronidazole: burning, skin irritation, dryness, transient redness, metallic
taste, tingling or numbness of extremities and nausea.
What should I look out for while using Metronidazole?
Metronidazole topical gel is contraindicated in individuals with a history of
hypersensitivity to metronidazole, parabens, or other ingredients of the
formulation.
What might happen if I take too much Metronidazole?
Sorry No Records found
How should I store and handle Metronidazole?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Metronidazole Topical Gel USP, 0.75% is supplied in aluminum tubes containing:45 g NDC 54868-6181-0Store at 20°-25°C (68°-77°F)Metronidazole Topical Gel USP, 0.75% is supplied in aluminum tubes containing:45 g NDC 54868-6181-0Store at 20°-25°C (68°-77°F)Metronidazole Topical Gel USP, 0.75% is supplied in aluminum tubes containing:45 g NDC 54868-6181-0Store at 20°-25°C (68°-77°F)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Bioavailability studies on the topical administration of 1 gram of metronidazole
topical gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed
a maximum serum concentration of 66 nanograms per milliliter in one patient.
This concentration is approximately 100 times less than concentrations afforded
by a single 250 mg oral tablet. The serum metronidazole concentrations were
below the detectable limits of the assay at the majority of time points in all
patients. Three of the patients had no detectable serum concentrations of
metronidazole at any time point. The mean dose of gel applied during clinical
studies was 600 mg which represents 4.5 mg of metronidazole per application.
Therefore, under normal usage levels, the formulation affords minimal serum
concentrations of metronidazole. The mechanisms by which metronidazole topical
gel acts in the treatment of rosacea are unknown, but appear to include an
anti-inflammatory effect.
Non-Clinical Toxicology
Metronidazole topical gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.Metronidazole topical gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.
Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.
Metronidazole has shown evidence of mutagenic activity in several bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.
There has been no experience to date with the use of metronidazole topical gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.
After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole topical gel blood levels are significantly lower than those achieved after oral metronidazole, 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.
Safety and effectiveness in pediatric patients have not been established.
The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
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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