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Rosadan (Metronidazole Cream): Side Effects, Uses, Dosage, Interactions, Warnings

Rosadan Cream

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 7/21/2022

Drug Summary

What Is Rosadan Cream?

Rosadan (metronidazole) Topical Cream is an antiprotozoal and antibacterial agent indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

What Are Side Effects of Rosadan Cream?

Common side effects of Rosadan Topical Cream include:

  • skin discomfort (burning and stinging),
  • skin redness,
  • skin irritation,
  • itching,
  • worsening of rosacea,
  • dry skin,
  • metallic taste,
  • tingling or numbness of the extremities, and
  • nausea.

Rosadan Cream may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • numbness, tingling, or burning pain in your hands or feet, and
  • stinging or burning when you apply metronidazole topical

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Rosadan Cream

Apply and rub in a thin layer dose of Rosadan Topical Cream twice daily, morning and evening, to entire affected areas after washing.

What Drugs, Substances, or Supplements Interact with Rosadan Cream?

Rosadan Topical Cream may interact with warfarin and coumarin anticoagulants. Tell your doctor all medications and supplements you use.

Rosadan Cream During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Rosadan Topical Cream; it is unknown if it would affect a fetus. Oral metronidazole passes into breast milk. Because of the potential for adverse effects on a nursing infant, breastfeeding while using Rosadan Topical Cream is not recommended.

Additional Information

Our Rosadan (metronidazole) Topical Cream Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Description for Rosadan

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 antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

Rosadan® (metronidazole) Structural Formula Illustration

Uses for Rosadan

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

Dosage for Rosadan

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 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]. Protect from Freezing.

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

Side Effects for Rosadan

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 for Rosadan

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.

Warnings for Rosadan

No Information Provided

Precautions for Rosadan

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 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.

Overdose Information for Rosadan

No Information Provided

Contraindications for Rosadan

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

Clinical Pharmacology for Rosadan

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

Patient Information for Rosadan

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

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.