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NDC 00168-0275-45 Metronidazole 7.5 mg/g Details

Metronidazole 7.5 mg/g

Metronidazole is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is METRONIDAZOLE.

MedlinePlus Drug Summary

Metronidazole is used to treat rosacea (a skin disease that causes redness, flushing, and pimples on the face). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.

Related Packages: 00168-0275-45
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metronidazole Topical

Product Information

NDC	00168-0275
Product ID	0168-0275_b5c8edbe-eed2-40ef-8426-f128363aad58
Associated GPIs	90060040004010
GCN Sequence Number	041798
GCN Sequence Number Description	metronidazole GEL (GRAM) 0.75 % TOPICAL
HIC3	L5G
HIC3 Description	ROSACEA AGENTS, TOPICAL
GCN	43202
HICL Sequence Number	004157
HICL Sequence Number Description	METRONIDAZOLE
Brand/Generic	Generic
Proprietary Name	Metronidazole
Proprietary Name Suffix	n/a
Non-Proprietary Name	Metronidazole
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	7.5
Active Ingredient Units	mg/g
Substance Name	METRONIDAZOLE
Labeler Name	Fougera Pharmaceuticals Inc.
Pharmaceutical Class	Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077018
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00168-0275-45 (00168027545)

Pricing Information
NDC Package Code	0168-0275-45
Billing NDC	00168027545
Package	1 TUBE in 1 CARTON (0168-0275-45) / 45 g in 1 TUBE
Marketing Start Date	2006-06-06
NDC Exclude Flag	N
Price Per Unit	0.55348
Pricing Unit	GM
Effective Date	2022-02-23
NDC Description	METRONIDAZOLE TOPICAL 0.75% GL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-03-16

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL ab766931-e685-4a81-9939-06da80d9099e Details

SPL UNCLASSIFIED SECTION

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.

CONTRAINDICATIONS

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

PRECAUTIONS:

General: Metronidazole 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.

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 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.

Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole 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.

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.

DESCRIPTION

Metronidazole Gel USP 0.75% contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of purified water, methylparaben, propylparaben, propylene glycol, carbomer 940, sodium hydroxide, and edetate disodium. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitroimidazole-1-ethanol and has the following structure:

CLINICAL PHARMACOLOGY

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

HOW SUPPLIED

Metronidazole Gel USP 0.75% is supplied as follows:

45 gram tube NDC 0168-0275-45

Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, New York 11747

I2275D

R07/13

#87

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE

NDC 0168-0275-45

Fougera®

METRONIDAZOLE

GEL USP 0.75%

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

WARNING: KEEP OUT OF

REACH OF CHILDREN.

NET WT 45 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON