Metronidazole - Metronidazole gel

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

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.

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

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.

• Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. 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. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. 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.
  )
• 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.
  )
• If dermatitis occurs, patients may need to discontinue use. (
  5.3 Contact Dermatitis

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

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