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| Product NDC Code | 0168-0383 | ||||
|---|---|---|---|---|---|
| Drug Name | Metronidazole |
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| Type | Generic | ||||
| Pharm Class | Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 242736 | ||||
| Application Number | ANDA077197 | ||||
| Labeler Name | Fougera Pharmaceuticals Inc. | ||||
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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, metronidazole topical lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, metronidazole topical lotion 1 (1%), and 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 of extremities, and nausea.
Metronidazole Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 (± SD) AUC 0-24 after twice daily administration was 962 ± 373 ng.hr/mL.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.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 (± SD) AUC 0-24 after twice daily administration was 962 ± 373 ng.hr/mL.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Metronidazole topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Metronidazole Topical Lotion, 0.75% 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: Structural Formula
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 metronidazole topical lotion to dry (not less than 5 minutes).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. 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 investigator's 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 Topical 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.
Spl product data elements
Usually a list of ingredients in a drug product.Metronidazole Metronidazole METRONIDAZOLE METRONIDAZOLE BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERIN GLYCERYL MONOSTEARATE LIGHT MINERAL OIL PEG-100 STEARATE POLYETHYLENE GLYCOL 400 POTASSIUM SORBATE WATER STEARETH-21 STEARYL ALCOHOL SODIUM HYDROXIDE LACTIC ACID, UNSPECIFIED FORM CYCLOMETHICONE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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 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 Crohn's 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.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 59 ML LABEL NDC 0168-0383-60 Fougera METRONIDAZOLE TOPICAL LOTION, 0.75% Rx Only For Topical Use Only. Not for Ophthalmic Use. WARNING: Keep away from children. 2 Fl Oz (59 mL) E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 59 ML LABEL
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 59 ML CARTON NDC 0168-0383-60 Fougera METRONIDAZOLE TOPICAL LOTION, 0.75% Rx only For Topical Use Only. Not for Ophthalmic Use. WARNING: Keep away from children. 2Fl Oz (59 mL) E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 59 ML CARTON
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.FOR TOPICAL USE ONLY Rx Only (NOT FOR OPHTHALMIC USE)
Metronidazole: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.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 investigator's 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 Topical 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.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 Fl Oz (59 mL) plastic bottle – NDC 0168-0383-60 Store at controlled room temperature, 20°to 25°C (68° to 77°F). Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2383C/IF2383C R07/16 #124
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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. 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. 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. 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 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 Crohn's 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. 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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API