Noritate

Metronidazole

Bausch Health Us, Llc
Human Prescription Drug
NDC 0187-5202

Noritate also known as Metronidazole is a human prescription drug labeled by 'Bausch Health Us, Llc'. National Drug Code (NDC) number for Noritate is 0187-5202. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Noritate drug includes Metronidazole - 10 mg/60g . The currest status of Noritate drug is Active.

Drug Information:

Drug NDC:	0187-5202
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:	Noritate
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:	Bausch Health Us, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
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 - 10 mg/60g
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
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:	09 Aug, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 Jun, 2026
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:	NDA020743
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:	Bausch Health US, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	213120 311680
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
0187-5202-60	60 g in 1 TUBE (0187-5202-60)	09 Aug, 2013	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:

Noritate metronidazole metronidazole metronidazole water stearic acid glyceryl monostearate glycerin methylparaben trolamine propylparaben

Drug Interactions:

Drug interactions: oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. drug interactions should be kept in mind when noritate is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. (see clinical pharmacology , pharmacokinetics .)

Indications and Usage:

Indications and usage noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

General Precautions:

General: if a reaction suggesting local skin irritation occurs, patients should be directed to discontinue use of the medication. conjunctivitis associated with topical use of metronidazole on the face has been reported. contact with the eyes should be avoided. metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia.

Dosage and Administration:

Dosage and administration areas to be treated should be cleansed before application of noritate . apply and rub in a thin film of noritate once daily to entire affected area(s). patients may use cosmetics after application of noritate .

Contraindications:

Contraindications noritate is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation.

Adverse Reactions:

Adverse reactions safety data from 302 patients who used noritate (n=200) or vehicle control (n=102) once daily in clinical trials and experienced an adverse event considered to be treatment related include: application site reaction ( noritate 1, vehicle 1), condition aggravated ( noritate 1, vehicle 0), paresthesia ( noritate 0, vehicle 1), acne ( noritate 1, vehicle 0), dry skin ( noritate 0, vehicle 2). the majority of adverse reactions were mild to moderate in severity. two patients treated with noritate once daily discontinued treatment because of adverse events: one for a severe flare of comedonal acne and one for rosacea aggravated. additional clinical adverse effects reported spontaneously since the drug was marketed are uncommon and include tingling or numbness of extremities, allergic reactions, skin and eye irritation, rash, headache, nausea and dry mouth. to report suspected adverse reactions, contact bausch health us, llc at 1-800-321-4576 or fda at 1-800-fda-1088 or www. Read more...

fda.gov/medwatch.

Drug Interactions:

Use in Pregnancy:

Pregnancy: teratogenic effects: there are no adequate and well-controlled studies with the use of noritate in pregnant women. metronidazole crosses the placental barrier and enters the fetal circulation rapidly. no fetotoxicity was observed after oral administration of metronidazole to rats or mice at 200 and 20 times, respectively, the expected clinical dose. however, oral metronidazole has shown carcinogenic activity in rodents. because animal reproduction studies are not always predictive of human response, noritate 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 noritate Â® (metronidazole cream) cream, 1%, contains metronidazole usp. chemically, metronidazole is 2-methyl-5-nitro-1 h -imidazole-1-ethanol. the molecular formula for metronidazole is c 6 h 9 n 3 o 3 . it has the following structural formula: metronidazole has a molecular weight of 171.16. it is a white to pale yellow crystalline powder. it is slightly soluble in alcohol and has a solubility in water of 10 mg/ml at 20Â°c. metronidazole is a member of the imidazole class of antibacterial agents and is classified as an antiprotozoal and antibacterial agent. noritate is an emollient cream; each gram contains 10 mg micronized metronidazole usp, in a base of glycerin usp, glyceryl monostearate nf, methylparaben nf, propylparaben nf, purified water usp, stearic acid nf and trolamine nf. noritate chemical structure

Clinical Pharmacology:

Clinical pharmacology pharmacokinetics: when a one gram dose of noritate cream, 1%, was applied in a single application to the face of 16 healthy volunteers, low concentrations of metronidazole were detected in the plasma of 7 of the volunteers. the meanÂ±sd c max of metronidazole was 27.6Â±7.3 ng/ml, which is about 1% of the value reported for a single 250 mg oral dose of metronidazole. the time to maximum plasma concentration (t max ) in the volunteers with detectable metronidazole was 8-12 hours after topical application. pharmacodynamics: the mechanisms by which metronidazole acts in reducing inflammatory lesions of rosacea are unknown. clinical studies: safety and efficacy of noritate were evaluated in two randomized vehicle-controlled clinical studies for the treatment of rosacea, which excluded patients who had nodules, moderate or severe rhinophyma, dense telangiectases, plaque-like facial edema or ocular involvement and those who had a history of not responding to metronid Read more...

azole therapy for rosacea. of the patients included in the efficacy database (n=416), there were 142 men and 274 women. endpoint efficacy data comparisons for patients treated with daily noritate or vehicle applications are listed below. inflammatory lesion counts and erythema severity scores in two clinical trials for rosacea noritate vehicle study 1 study 2 study 1 study 2 n result n result n result n result papules + pustules count baseline 89 15 92 19 50 18 49 17 week 10 80 7* 82 8 45 15 41 12 reduction 49%* 58%* 17% 30% papules count baseline 89 13 92 17 50 15 49 15 week 10 80 7* 82 7 45 12 41 11 reduction 41%* 55%* 14% 28% erythema score baseline 89 2.2 92 2.3 50 2.2 49 2.2 week 10 80 1.3* 82 1.4* 45 1.7 40 1.8 reduction 42%* 40%* 25% 19% *statistically significant differences between noritate and vehicle groups with pâ¤0.05. erythema scores: 0=none, 1=mild, 2=moderate and 3=severe. safety studies: studies of contact sensitization (n=258), phototoxicity (n=21), and photocontact sensitization (n=29) of noritate were conducted. no evidence of sensitization or phototoxicity was seen in these studies.

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 but not in studies involving hamsters. in several long-term studies in mice, oral doses of approximately 225 mg/m 2 /day or greater (approximately 37 times the human topical dose on a mg/m 2 basis) were associated with an increase in pulmonary tumors and lymphomas. several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m 2 /day (144 times the topical human dose). metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. in addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. an increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with crohnâs disease who were treated Read more...

with 200 to 1200 mg/day of metronidazole for 1 to 24 months. however, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with crohnâs disease treated with the drug for 8 months. in one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 mg/m 2 /day (approximately 7 times the human topical dose on a mg/m 2 basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with noritate or any marketed metronidazole formulations.

Clinical Studies:

Clinical studies: safety and efficacy of noritate were evaluated in two randomized vehicle-controlled clinical studies for the treatment of rosacea, which excluded patients who had nodules, moderate or severe rhinophyma, dense telangiectases, plaque-like facial edema or ocular involvement and those who had a history of not responding to metronidazole therapy for rosacea. of the patients included in the efficacy database (n=416), there were 142 men and 274 women. endpoint efficacy data comparisons for patients treated with daily noritate or vehicle applications are listed below. inflammatory lesion counts and erythema severity scores in two clinical trials for rosacea noritate vehicle study 1 study 2 study 1 study 2 n result n result n result n result papules + pustules count baseline 89 15 92 19 50 18 49 17 week 10 80 7* 82 8 45 15 41 12 reduction 49%* 58%* 17% 30% papules count baseline 89 13 92 17 50 15 49 15 week 10 80 7* 82 7 45 12 41 11 reduction 41%* 55%* 14% 28% erythema score b Read more...

aseline 89 2.2 92 2.3 50 2.2 49 2.2 week 10 80 1.3* 82 1.4* 45 1.7 40 1.8 reduction 42%* 40%* 25% 19% *statistically significant differences between noritate and vehicle groups with pâ¤0.05. erythema scores: 0=none, 1=mild, 2=moderate and 3=severe. safety studies: studies of contact sensitization (n=258), phototoxicity (n=21), and photocontact sensitization (n=29) of noritate were conducted. no evidence of sensitization or phototoxicity was seen in these studies.

How Supplied:

How supplied cream - 60 g aluminum tube - ndc 0187-5202-60. keep out of reach of children. storage: store at controlled room temperature 20Â° to 25Â°c (68Â° to 77Â°f).

Information for Patients:

Information for patients: patients using noritate should receive the following information and instructions: 1. this medication is to be used as directed. 2. it is for external use only. 3. avoid contact with the eyes. 4. cleanse affected area(s) before applying noritate . 5. this medication should not be used for any disorder other than that for which it is prescribed. 6. patients should report any adverse reaction to their physician.

Package Label Principal Display Panel:

Principal display panel ndc 0187-5202-60 rx only noritate Â® metronidazole cream cream, 1% net wt. 60 g once-a-day for topical use only ortho dermatologics carton

Comments/ Reviews:

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