Rosadan Cream

DESCRIPTION

Rosadan® (metronidazole) Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg pergram(0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropylpalmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class ofantibacterialagents and is classified therapeutically as anantiprotozoaland antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C₆H₉N₃O₃and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

INDICATIONS

Rosadan^®(metronidazole) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

DOSAGE AND ADMINISTRATION

应用和摩擦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 SUPPLIED

Rosadan^®(metronidazole) Topical Cream, 0.75%是supplied in a 45 g tubeNDC43538-180-45.

Storage Conditions

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from Freezing.

Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge Street, South Plainfield, NJ 07080. Revised: Sep 2019

SIDE EFFECTS

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.

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.

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.

警告

No Information Provided

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.

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 severalin vitrobacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice afterintraperitonealinjections 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 thefetal circulationrapidly. 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 acarcinogenin 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.

OVERDOSE

No Information Provided

CONTRAINDICATIONS

Rosadan^®(metronidazole) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

CLINICAL PHARMACOLOGY

The mechanisms by which metronidazole acts in the treatment ofrosaceaare unknown, but appear to include an anti-inflammatory effect.

PATIENT INFORMATION

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.