{"adverse_reactions":["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. To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"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. 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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Bioavailability studies on the topical administration of 1 gram of Rosadan ® (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 Rosadan ® (metronidazole) Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect."],"contraindications":["CONTRAINDICATIONS Rosadan ® (metronidazole) Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation."],"description":["DESCRIPTION Rosadan ® (metronidazole) Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply and rub in a thin film of Rosadan ® (metronidazole) Gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of Rosadan ® (metronidazole) Gel. Patients may use cosmetics after application of Rosadan ® (metronidazole) Gel."],"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. The effect of topical metronidazole on prothrombin time is not known."],"effective_time":"20221207","general_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."],"how_supplied":["HOW SUPPLIED Rosadan ® (metronidazole) Gel USP, 0.75% is supplied in a 45 g tube NDC 43538-182-45 Storage conditions Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]."],"id":"0af61b42-07f5-4a57-a67d-defe86a15317","indications_and_usage":["INDICATIONS AND USAGE Rosadan ® (metronidazole) Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea."],"information_for_patients":["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."],"nursing_mothers":["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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 45 g Tube Carton MEDIMETRIKS PHARMACEUTICALS, INC. NDC 43538-182-45 R x Only Rosadan ® GEL Metronidazole Gel USP, 0.75% NET WT 45 g PRINCIPAL DISPLAY PANEL - 45 g Tube Carton","PRINCIPAL DISPLAY PANEL - Kit Carton NDC 43538-183-45 R x Only Rosadan ® Metronidazole Gel USP, 0.75% GEL KIT CONTENTS: 1- Rosadan ® Metronidazole Gel USP, 0.75% Tube (Net wt. 45 g) 1- Rehyla ® Wash Moisturizing Daily Wash Bottle (16 fl. oz.) MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - Kit Carton"],"pediatric_use":["Pediatric use Safety and effectiveness in pediatric patients have not been established."],"precautions":["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."],"pregnancy":["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."],"set_id":"99eaa138-0cfa-45e1-abbf-a88271707979","spl_product_data_elements":["Rosadan metronidazole metronidazole metronidazole edetate disodium methylparaben propylene glycol propylparaben water sodium hydroxide Rosadan metronidazole Rosadan metronidazole metronidazole metronidazole edetate disodium methylparaben propylene glycol propylparaben water sodium hydroxide Rehyla Wash inert water glyceryl monostearate glycerin cetyl alcohol disodium oleamido mipa-sulfosuccinate cholesterol disodium laureth sulfosuccinate caprylyl glycol propylene glycol phenoxyethanol sodium cocoyl isethionate cocamidopropyl betaine sodium methyl cocoyl taurate C13-14 isoparaffin sodium chloride niacinamide edetate disodium hexylene glycol laureth-7 chamaemelum nobile flower hyaluronate sodium"],"spl_unclassified_section":["FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE) Rx Only","Manufactured for: MEDIMETRIKS PHARMACEUTICALS, INC. 383 Route 46 West Fairfield, NJ 07004-2402 www.medimetriks.com Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080 8-0637BFMDMLNC2 Rev. 08/2019 GW 7313 IP024-R4"],"storage_and_handling":["Storage conditions Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]."],"teratogenic_effects":["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."],"version":"5"}