Metronidazole Cream

Name: Metronidazole Cream

What brand names are available for metronidazole cream?

Noritate, Metrocream

What are the side effects of metronidazole cream?

Side effects are rare and minor. These include:

  • irritation,
  • skin dryness,
  • scaling, and
  • itching at the site of application.

Individuals that are allergic to metronidazole should not use metronidazole cream.

What else should I know about metronidazole cream?

What preparations of metronidazole cream are available?

Cream: 0.75 and 1%

How should I keep metronidazole cream stored?

Metronidazole cream should be stored at room temperature, 15 C - 30 C (59 F - 86 F)

Clinical pharmacology

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

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.

Read the entire FDA prescribing information for Rosadan Cream (Metronidazole Cream)

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Description

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:

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately10%. 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 G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How is Metronidazole Cream Supplied

Metronidazole Topical Cream, 0.75% is supplied in a 45 g tube - NDC 0713-0633-37.

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