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| Product NDC Code | 68682-202 | ||||
|---|---|---|---|---|---|
| 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 | CREAM | ||||
| RxCUI drug identifier | 311680 | ||||
| Application Number | NDA020743 | ||||
| Labeler Name | Oceanside Pharmaceuticals | ||||
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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 Safety data from 302 patients who used METRONIDAZOLE CREAM (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 ( METRONIDAZOLE CREAM 1, vehicle 1), condition aggravated ( METRONIDAZOLE CREAM 1, vehicle 0), paresthesia ( METRONIDAZOLE CREAM 0, vehicle 1), acne ( METRONIDAZOLE CREAM 1, vehicle 0), dry skin ( METRONIDAZOLE CREAM 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity. Two patients treated with METRONIDAZOLE CREAM 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 Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METRONIDAZOLE CREAM 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 . )
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Pharmacokinetics: When a one gram dose of METRONIDAZOLE 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 mean±SD C max of metronidazole was 27.6±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 METRONIDAZOLE CREAM 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 METRONIDAZOLE CREAM or vehicle applications are listed below. Inflammatory Lesion Counts and Erythema Severity Scores in Two Clinical Trials for Rosacea METRONIDAZOLE CREAM 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 METRONIDAZOLE CREAM and vehicle groups with p≤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 METRONIDAZOLE CREAM were conducted. No evidence of sensitization or phototoxicity was seen in these studies.
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 CREAM is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this 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 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 20°C. Metronidazole is a member of the imidazole class of antibacterial agents and is classified as an antiprotozoal and antibacterial agent. METRONIDAZOLE CREAM 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
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 Areas to be treated should be cleansed before application of METRONIDAZOLE CREAM . Apply and rub in a thin film of METRONIDAZOLE CREAM once daily to entire affected area(s). Patients may use cosmetics after application of METRONIDAZOLE CREAM .
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 CREAM is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.
Spl product data elements
Usually a list of ingredients in a drug product.Metronidazole metronidazole metronidazole metronidazole water stearic acid glyceryl monostearate glycerin methylparaben trolamine propylparaben
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 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 Crohn’s disease who were treated 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 Crohn’s 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 METRONIDAZOLE CREAM or any marketed metronidazole formulations.
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.PRINCIPAL DISPLAY PANEL - 60 g Tube NDC 68682-202-60 Rx only METRONIDAZOLE CREAM 1% Net Wt. 60 g ONCE-A-DAY FOR TOPICAL USE ONLY OCEANSIDE PHARMACEUTICALS carton.jpg
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 NOT FOR OPHTHALMIC USE
Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada © 2019 Bausch Health Companies Inc. or its affiliates 9685700 Rev. 07/19
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 CREAM 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 METRONIDAZOLE CREAM . 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.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.Clinical Studies: Safety and efficacy of METRONIDAZOLE CREAM 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 METRONIDAZOLE CREAM or vehicle applications are listed below. Inflammatory Lesion Counts and Erythema Severity Scores in Two Clinical Trials for Rosacea METRONIDAZOLE CREAM 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 METRONIDAZOLE CREAM and vehicle groups with p≤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 METRONIDAZOLE CREAM were conducted. No evidence of sensitization or phototoxicity was seen in these studies.
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 taken after topical metronidazole application 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 and the risk to the infant.
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: There are no adequate and well-controlled studies with the use of METRONIDAZOLE CREAM 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, METRONIDAZOLE CREAM should be used during pregnancy only if clearly needed.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects: There are no adequate and well-controlled studies with the use of METRONIDAZOLE CREAM 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, METRONIDAZOLE CREAM 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 Cream - 60 g aluminum tube - NDC 68682-202-60. Keep out of reach of children. Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F).
Storage and handling
Information about safe storage and handling of the drug product.Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F).
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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. Information for Patients: Patients using METRONIDAZOLE CREAM 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 METRONIDAZOLE CREAM . 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. 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 METRONIDAZOLE CREAM 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 . ) 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 Crohn’s disease who were treated 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 Crohn’s 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 METRONIDAZOLE CREAM or any marketed metronidazole formulations. Pregnancy: Teratogenic Effects: There are no adequate and well-controlled studies with the use of METRONIDAZOLE CREAM 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, METRONIDAZOLE CREAM 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 taken after topical metronidazole application 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 and the risk to the infant. 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