In the U.S.—

In Canada—

• Antirosacea agent, topical

Topical metronidazole (me-troe-NI-da-zole) is applied to the skin in adults to help control rosacea ( roe-ZAY-she-ah) , also known as acne rosacea and “adult acne.” This medicine helps to reduce the redness of the skin and the number of pimples, usually found on the face, in patients with rosacea.

Topical metronidazole is available only with your doctor's prescription, in the following dosage forms:

Topical
• Cream (U.S. and Canada)
• Gel (U.S. and Canada)
• Lotion (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For topical metronidazole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to metronidazole, clotrimazole, or tioconazole. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Topical metronidazole has not been studied in pregnant women. However, metronidazole given by mouth (e.g., Flagyl) has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—Topical metronidazole is absorbed into the mother's body only in small amounts. The small amounts of this medicine that are absorbed are unlikely to cause serious problems in nursing babies.

Children—Rosacea is usually considered an adult disease. Therefore, topical metronidazole is not generally used in children.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical metronidazole in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

• Blood disease or a history of blood disease—Metronidazole may make the condition worse

Do not use this medicine in or near the eyes. Watering of the eyes may occur when the medicine is used too close to the eyes.

If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Before applying this medicine, thoroughly wash the affected area(s) with a mild, nonirritating cleanser, rinse well, and gently pat dry.

To use:

• After washing the affected area(s), apply this medicine with your fingertips.
• Apply and rub in a thin film of medicine, using enough to cover the affected area(s) lightly. You should apply the medicine to the whole area usually affected by rosacea, not just to the pimples themselves .
• Wash the medicine off your hands.

To help keep your rosacea under control, keep using this medicine for the full time of treatment. You may have to continue using this medicine every day for 9 weeks or longer. Do not miss any doses.

Dosing—

The dose of topical metronidazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of topical metronidazole. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage forms (cream, gel, and lotion):
  • For rosacea:
    • Adults—Apply to the affected area(s) of skin two times a day, morning and evening, for nine weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If your rosacea does not improve within 3 weeks, or if it becomes worse, check with your doctor. However, treatment of rosacea may take up to 9 weeks or longer before you see full improvement.

Stinging or burning of the skin may be expected after this medicine is applied. These effects may last up to a few minutes or more. If irritation continues, check with your doctor. You may have to use the medicine less often or stop using it altogether. Follow your doctor's directions.

You may continue to use cosmetics (make-up) while you are using this medicine for rosacea. However, it is best to use only “oil-free” cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your rosacea worse. If you have any questions about this, check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of these effects continue or are bothersome:

• Less common
  • Dry skin;  redness or other signs of skin irritation not present before use of this medicine;  stinging or burning of the skin;  watering of eyes  
  
  

• Rare
  • Metallic taste in the mouth;  nausea ;  tingling or numbness of arms, legs, hands, or feet  
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.