Drug Labeling and Warnings

Drug Details [pdf]

METRONIDAZOLE - metronidazole cream 
Harris Pharmaceutical, Inc.

----------

DESCRIPTION

Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid, and purified water.  Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically,metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

Metronidazole Chemical Structure

CLINICAL PHARMACOLOGY

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS

Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

PRECAUTIONS

General:

Topical metronidazole 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 frequentlyor 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 warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombintime 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 are no adequate and well-controlled studies with the use of Metronidazole Topical Cream in pregnant women. 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 blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of 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

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metonidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

DOSAGE AND ADMINISTRATION

Apply and rub in a thin layer of Metronidazole Topical Cream twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Metronidazole Topical Cream.

HOW SUPPLIED

Metronidazole Topical Cream, 0.75% is supplied in a 45 g tube 
    NDC 67405-110-45.

STORAGE conditions:

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

Manufactured for:
HARRIS Pharmaceutical, Inc.
Fort Myers, FL 33908
877-RX4-DERM www.HarrisPharmaceutical.com
By G&W Laboratories, Inc.
South Plainfield, NJ 07080

Rev. 04/2014

PRINCIPAL DISPLAY PANEL

NDC: 67405-110-45

Metronidazole Topical
Cream 0.75%

NET WT 45 g           Rx Only

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

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

Usual dosage:  Apply a thin layer to entire affected areas after washing.  Use morning and evening or as directed by physician.  Avoid application close to the eyes.

Each gram contains: Active: metronidazole 0.75% (7.5 mg).  Inactive: emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water.

See end panel for lot number and expiration date.

Manufactured for:
HARRIS Pharmaceutical, Inc.
Fort Myers, FL 33908
By G&W Laboratories, Inc.
South Plainfield, NJ 07080

Metronidazole Carton
METRONIDAZOLE  
metronidazole cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 67405-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Metronidazole (UNII: 140QMO216E) (Metronidazole - UNII:140QMO216E) Metronidazole7.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67405-110-4545 g in 1 TUBE; Type 0: Not a Combination Product03/13/200811/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07754903/13/200811/30/2018
Labeler - Harris Pharmaceutical, Inc. (617204370)

Revised: 5/2019
 
Harris Pharmaceutical, Inc.