Metronidazole Gel

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) 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

Apply and rub in a thin film of metronidazole once daily to affected area(s).

A gentle cleanser should be used before the application of metronidazole.

Cosmetics may be applied after the application of metronidazole. Not for oral, ophthalmic or intravaginal use.

Metronidazole Gel USP, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when metronidazole is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption.

Pregnancy

Teratogenic Effects: Pregnancy Category B.

There are no adequate and well-controlled studies with the use of metronidazole in pregnant women.

Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, metronidazole 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 taken after topical metronidazole application 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 and the risk to the infant.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Sixty-six subjects aged 65 years and older were treated with Metronidazole Gel USP, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Metronidazole Gel USP, 1% is colorless to slightly yellow in color, and supplied as follows:

45 g tube - (NDC 51672-4164-6)

60 g tube - (NDC 51672-4164-3)

55 g pump - (NDC 51672-4164-9)

Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].