Notice: Undefined index: HTTP_REFERER in D:\CNES\index.php on line 3
Rosadan (Metronidazole Gel): Side Effects, Uses, Dosage, Interactions, Warnings

Rosadan Gel

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 3/1/2023

Drug Summary

What Is Rosadan Gel?

Rosadan (metronidazole) Gel 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 Gel?

Rosadan Gel 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 applying the medicine

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

Common side effects of Rosadan Gel 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.

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, lightheadedness, 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 Gel

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

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

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

Rosadan Gel During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Rosadan Gel; 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 Gel is not recommended.

Additional Information

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

FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Description for Rosadan

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-1H-imidazole-1-ethanol and has the following structure:

Rosadan (metronidazole) Structural Formula Illustration

Uses for Rosadan

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

Dosage for Rosadan

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.

HOW SUPPLIED

Rosadan® (metronidazole) Gel 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].

Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080. Revised: June 2013

Side Effects for Rosadan

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.

Drug Interactions for Rosadan

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.

Warnings for Rosadan

No Information Provided

Precautions for Rosadan

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.

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.

Overdose Information for Rosadan

No Information Provided

Contraindications for Rosadan

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

Clinical Pharmacology for Rosadan

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.

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.

From WebMD Logo

Skin Care Resources
Featured Centers
FDA Logo

Report Problems to the Food and Drug Administration

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.