Metronidazole

Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.

For topical use only, not for oral, ophthalmic, or intravaginal use.

Cleanse treated areas before the application of metronidazole gel.

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

Cosmetics may be applied after the application of metronidazole gel.

Gel, 1%. Metronidazole is a colorless to slightly yellow gel. Each gram of metronidazole gel contains 10 mg (1%) of metronidazole.

• •Lactation: Breastfeeding not recommended. (
  8.2 Lactation

  Risk Summary

  It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with metronidazole gel.
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• •Neurologic Disease: Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole therapy. (
  5.1 Neurologic Disease

  Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.
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• •Blood Dyscrasias: Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. (
  5.2 Blood Dyscrasias

  Metronidazole is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.
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• •Contact Dermatitis: If dermatitis occurs, patients may need to discontinue use. (
  5.3 Contact Dermatitis

  Irritant and allergic contact dermatitis have been reported with metronidazole gel. If dermatitis occurs, patients may need to discontinue use.
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• •Eye Irritation: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, avoid contact with the eyes. (
  5.4 Eye Irritation

  Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.
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