workplaces Rosadan Cream Generic Name: metronidazole Dosage Form: cream Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Rosadan Metronidazole Topical Cream, 0.75% FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE) Rx only Slideshow Sexual Health Q+A: Your Questions Answered Rosadan Cream Description Rosadan (metronidazole) Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents 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: Rosadan Cream - Clinical Pharmacology The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. Indications and Usage for Rosadan Cream Rosadan (metronidazole) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Contraindications Rosadan (metronidazole) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation. Precautions General Topical metronidazole 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 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 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 are no adequate and well-controlled studies with the use of Rosadan (metronidazole) Topical Cream in pregnant women. 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 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. Adverse Reactions In controlled clinical trials, the total incidence of adverse reactions associated with the use of topical metronidazole cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea. Rosadan Cream Dosage and Administration Apply and rub in a thin layer of Rosadan (metronidazole) Topical Cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Rosadan (metronidazole) Topical Cream. How is Rosadan Cream Supplied Rosadan (metronidazole) Topical Cream, 0.75% is supplied in a 45 g tube - NDC 43538-180-45. Storage conditions Store at 20 -25 C (68 -77 F) [see USP Controlled Room Temperature]. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Manufactured for: MEDIMETRIKS PHARMACEUTICALS, INC. 363 Route 46 West Fairfield, NJ 07004-2402 USA www.medimetriks.com Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080 IP019 8-0633MDM1 Issued 02/11 PRINCIPAL DISPLAY PANEL - 45 g Tube Carton MEDIMETRIKS PHARMACEUTICALS, INC. NDC 43538-180-45 R X Only Rosadan Metronidazole Topical Cream, 0.75% NET WT 45 g PRINCIPAL DISPLAY PANEL - Kit Carton NDC 43538-181-45 R X Only Rosadan Metronidazole Topical Cream, 0.75% CREAM KIT CONTENTS: 1-Rosadan Metronidazole Topical Cream, 0.75% Tube (Net wt. 45 g) 1-Rehyla Wash Moisturizing Daily Wash Bottle (16 fl. oz.) MEDIMETRIKS PHARMACEUTICALS, INC. ROSADAN metronidazole cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-180 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metronidazole (metronidazole) metronidazole 7.5 mg in 1 g Inactive Ingredients Ingredient Name Strength sorbitol glycerin isopropyl palmitate benzyl alcohol lactic acid sodium hydroxide water Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:43538-180-45 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077549 08/30/2011 ROSADAN metronidazole cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-181 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metronidazole (metronidazole) metronidazole 7.5 mg in 1 g Inactive Ingredients Ingredient Name Strength sorbitol glycerin isopropyl palmitate benzyl alcohol lactic acid sodium hydroxide water Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:43538-181-45 1 TUBE (TUBE) in 1 KIT 1 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077549 08/30/2011 Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) Establishment Name Address ID/FEI Operations G&W Laboratories 001271188 MANUFACTURE Revised: 08/2011 Medimetriks Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about Rosadan (metronidazole topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical anti-rosacea agents Consumer resources Rosadan Rosadan Cream Kit Topical (Advanced Reading) Rosadan Topical (Advanced Reading) Professional resources Rosadan Gel (FDA) Metronidazole topical (AHFS Monograph) Other brands: MetroGel , MetroGel-Vaginal , MetroCream , Noritate , ... +5 more Related treatment guides Rosacea} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Drug Class Topical anti-rosacea agents Related Drugs topical anti-rosacea agents metronidazole topical , brimonidine topical , MetroGel , Finacea , oxymetazoline topical , MetroGel-Vaginal Rosacea doxycycline , metronidazole topical , brimonidine topical , Lotemax , MetroGel , Vibramycin , ivermectin topical , Finacea , Monodox , oxymetazoline topical , Alrex , Soolantra , Oracea , MetroCream , Mirvaso , Doryx , Noritate , azelaic acid topical , Azelex , Vibra-Tabs , Rhofade , MetroLotion , Sumadan , More... 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