Metronidazole

Prasco Laboratories
Human Prescription Drug
NDC 66993-961

Metronidazole is a human prescription drug labeled by 'Prasco Laboratories'. National Drug Code (NDC) number for Metronidazole is 66993-961. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Metronidazole drug includes Metronidazole - 7.5 mg/g . The currest status of Metronidazole drug is Active.

Drug Information:

Drug NDC:	66993-961
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Metronidazole
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Metronidazole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Prasco Laboratories
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Lotion
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	METRONIDAZOLE - 7.5 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA AUTHORIZED GENERIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	28 May, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA020901
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Prasco Laboratories
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	242736
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175435 M0014907
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	140QMO216E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Nitroimidazole Antimicrobial [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Nitroimidazoles [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Nitroimidazole Antimicrobial [EPC] Nitroimidazoles [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
66993-961-59	1 BOTTLE in 1 CARTON (66993-961-59) / 59.7 g in 1 BOTTLE	28 May, 2009	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Metronidazole metronidazole metronidazole metronidazole benzyl alcohol carbomer homopolymer type a cyclomethicone glycerin glyceryl monostearate light mineral oil peg-100 stearate polyethylene glycol 400 potassium sorbate water steareth-21 stearyl alcohol sodium hydroxide lactic acid p53363-0-metronidazole-lotion-carton-image

Drug Interactions:

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 prothrombin time is not known.

Indications and Usage:

Indications and usage metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

General Precautions:

General: topical metronidazole formulations have 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 or history of blood dyscrasia.

Dosage and Administration:

Dosage and administration 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. patients may use cosmetics after waiting for the metronidazoletopical lotion to dry (not less than 5 minutes).

Contraindications:

Contraindications metronidazole topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.

Adverse Reactions:

Adverse reactions in a controlled clinical trial, safety data from 141 patients who used metronidazole topical lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, metronidazole topical lotion 2 (3%), lotion vehicle 0; contact dermatitis, metronidazole topical lotion 2 (3%), lotion vehicle 1 (1%); pruritus, metronidazole topical lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), metronidazole topical lotion 1 (1%), lotion vehicle 2 (3%); erythema, metronidazole topical lotion 4 (6%), lotion vehicle 0; dry skin, metronidazoletopical lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, metronidazole topical lotion 1 (1%), lotion vehicle 7 (10%). the following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness o Read more...

f extremities, and nausea.

Drug Interactions:

Use in Pregnancy:

Pregnancy: teratogenic effects: pregnancy category b: there are no adequate and well-controlled studies with the use of metronidazole topical lotion in pregnant women. metronidazole crosses the placental barrier and enters the fetal circulation rapidly. no fetotoxicity was observed after oral administration of 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.

Pediatric Use:

Pediatric use: safety and effectiveness in pediatric patients have not been established.

Description:

Description metronidazole topical lotion contains metronidazole, usp, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, peg-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust ph. metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. chemically, metronidazole is 2-methyl-5-nitro-1 h -imidazole-1-ethanol. the molecular formula is c 6 h 9 n 3 o 3 and molecular weight is 171.16. metronidazole is represented by the following structural formula: metro-chem-struct

Clinical Pharmacology:

Clinical pharmacology the mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. pharmacokinetics: absorption of metronidazole after topical application of metronidazole topical lotion is less complete and more prolonged than after oral administration. detectable plasma levels were found in all subjects following the administration of a 1 gram dose of metronidazole topical lotion (containing 7.5 mg of metronidazole) applied every morning and evening for 4 days to the faces of 8 patients. the highest concentration (96 ng/ml) seen following the morning dose on day 5 was approximately 80 times lower than the peak concentrations produced by a single 250 mg tablet of metronidazole. the mean (Â± sd) auc 0-24 after twice daily administration was 962 Â± 373 ng.hr/ml.

Pharmacokinetics:

Pharmacokinetics: absorption of metronidazole after topical application of metronidazole topical lotion is less complete and more prolonged than after oral administration. detectable plasma levels were found in all subjects following the administration of a 1 gram dose of metronidazole topical lotion (containing 7.5 mg of metronidazole) applied every morning and evening for 4 days to the faces of 8 patients. the highest concentration (96 ng/ml) seen following the morning dose on day 5 was approximately 80 times lower than the peak concentrations produced by a single 250 mg tablet of metronidazole. the mean (Â± sd) auc 0-24 after twice daily administration was 962 Â± 373 ng.hr/ml.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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. metronidazole has not been assessed for carcinogenic activity following topical administration. in several long term studies in mice, oral doses of approximately 200 mg/m 2 /day (approximately 20 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater were associated with increase incidences of lung tumors in male mice and lymphomas in female mice. in several long-term studies in rats, oral administration of metronidazole resulted in increased incidences of mammary and hepatic tumors in female rats and testicular tumors and pituitary adenomas in male rats at dosages of approximately 1600 mg/m 2 /day (approximately 170 times the exposure of a Read more...

patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater. in another oral study, an increase of mammary tumors was observed in female rats that received approximately 160 mg/m 2 /day (approximately 17 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and the following normalization of the data on the basis of the body surface area)). ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal injection of metronidazole at a dosage of 45 mg/m 2 /day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms. it is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. this study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation. metronidazole exhibited mutagenic activity in several in vitro bacterial and mammalian assay systems. intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with crohnâs disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. however, similar results were not observed in another study, in which humans were treated for 8 months. in rats, oral metronidazole at a dosage of approximately 1800 mg/m 2 /day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of body surface area)) induced inhibition of spermatogenesis and severe testicular degeneration.

Clinical Studies:

Clinical studies a controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which metronidazole topical lotion was compared with its vehicle. applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. metronidazole topical lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigators' global assessment of improvement. the results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table: efficacy outcomes at week 12 mean percent reduction in inflammatory lesion counts from baseline metronidazole topic Read more...

al lotion n=65 vehicle lotion n=60 55% 20% investigators' global assessment of improvement (percent change from baseline) worse no change minimal improvement definite improvement marked improvement clear metronidazole topical lotion n=65 5% 12% 11% 32% 32% 8% vehicle lotion n=60 15% 27% 23% 15% 20% 0% the scale is based on the following definitions: worse: exacerbation of either erythema or quantitative assessment of papules and/or pustules. no change: condition remains the same. minimal improvement: slight improvement in the quantitative assessment of papules and/or pustules, and/or slight improvement in erythema. definite improvement: more pronounced improvement in the quantitative assessment of papules and/or pustules, and/or more pronounced improvement in erythema. marked improvement: obvious improvement in the quantitative assessment of papules and/or pustules, and/or obvious improvement in erythema. clear: no papules or pustules and minimal residual or no erythema.

How Supplied:

How supplied metronidazole topical lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 ml) plastic bottle â ndc 66993-961-59 storage: store at controlled room temperature 68Â° - 77Â°f (20Â° - 25Â°c). protect from freezing. marketed by: prasco laboratories mason, oh 45040 usa made in canada p53362-0 revised: january 2017

Information for Patients:

Information for patients: patients using metronidazole topical lotion should receive the following information and instructions: 1. this medication is to be used only as directed by the physician. 2. it is for external use only. 3. avoid contact with the eyes. 4. cleanse affected area(s) before applying this medication. 5. patients should report any adverse reaction to their physician.

Package Label Principal Display Panel:

Package label ndc 66993-961-59 prasco metronidazole lotion 0.75% topical lotion 2 fl oz (59 ml) rx only store at controlled room temperature 68Â° to 77Â° (20Â°-25Â°c). protect from freezing. marketed by: prasco laboratories mason, oh 45040 usa p53363-0 made in canada for topical use only. not for ophthalmic use. 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% w/w (7.5 mg). inactive: benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, peg-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust ph. see lot number and expiration date on bottom of carton.

Comments/ Reviews:

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