Your browser does not support JavaScript! METRONIDAZOLE GEL [SANDOZ INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

METRONIDAZOLE gel
[Sandoz Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Rx only

FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)

DESCRIPTION

Metronidazole topical gel USP, 0.75%, contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, NF; edetate disodium, USP; methylparaben, NF; propylene glycol, USP; propylparaben, NF; purified water, USP; and sodium hydroxide, NF. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

3e9970ae-figure-01

CLINICAL PHARMACOLOGY

Bioavailability studies on the topical administration of 1 gram of metronidazole topical gel USP, 0.75%, (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 USP, 0.75%, acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS & USAGE

Metronidazole topical gel USP, 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS

Metronidazole topical gel USP, 0.75%, is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

PRECAUTIONS

General: Metronidazole topical gel USP, 0.75%, 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.

Information for Patients

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug Interactions

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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 in vitro 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.

Pregnancy

Teratogenic effects: Pregnancy category B: There has been no experience to date with the use of metronidazole topical gel USP, 0.75%, 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.

Nursing Mothers

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole topical gel USP, 0.75%, 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

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.

DOSAGE AND ADMINISTRATION

Apply and rub in a thin film of metronidazole topical gel USP, 0.75%, twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole topical gel USP, 0.75%. Patients may use cosmetics after application of metronidazole topical gel USP, 0.75%.

HOW SUPPLIED

Metronidazole topical gel USP, 0.75%, is supplied as the following:

NDC 0781-7078-24:  1 oz. (28.4 g) aluminum tube
NDC 0781-7078-19:  45 g aluminum tube

Storage conditions: Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

04584 Rev. 3 04/10

Manufactured by
TOLMAR Inc.
Fort Collins, CO 80526 for
Sandoz Inc.
Princeton, NJ  08540

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3e9970ae-figure-02
3e9970ae-figure-03
METRONIDAZOLE 
metronidazole gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0781-7078
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE7.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
METHYLPARABEN 
PROPYLPARABEN 
EDETATE DISODIUM 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-7078-191 in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07754707/13/2006
Labeler - Sandoz Inc. (110342024)
Establishment
NameAddressID/FEIBusiness Operations
TOLMAR Inc.791156578MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 3/2012
 
Sandoz Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services