Metrogel
(Metronidazole)Metrogel Prescribing Information
METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
- Cleanse treated areas before the application of METROGEL.
- Apply and rub in a thin film of METROGEL once daily to affected area(s).
- Cosmetics may be applied after the application of METROGEL.
- For topical use only, not for oral, ophthalmic, or intravaginal use.
Gel, 1%. METROGEL is a clear, colorless to pale yellow gel. Each gram of METROGEL contains 10 mg (1%) of metronidazole.
METROGEL is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Neurologic Disease [see Warnings and Precautions (])
5.1 Neurologic DiseasePeripheral 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. Immediately reevaluate METROGEL therapy if abnormal neurologic signs appear. Administer metronidazole with caution to patients with central nervous system diseases.
- Contact Dermatitis [see Warnings and Precautions (])
5.3 Contact DermatitisIrritant and allergic contact dermatitis have been reported with METROGEL. If dermatitis occurs, patients may need to discontinue use.
- Eye Irritation [see Warnings and Precautions (])
5.4 Eye IrritationTopical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.
Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Use caution when prescribing for patients who are receiving anticoagulant treatment.