Metrocream

There are no adequate studies of metronidazole cream in pregnant women.

When metronidazole is administered orally it is secreted into breast milk in concentrations similar to the concentration in the mothers body. Therefore, small amounts of metronidazole that are absorbed into the body when metronidazole cream is used may be secreted into breast milk.

Metronidazole is a prescription medication used to treat infections of the reproductive system, gastrointestinal tract, respiratory system, skin, bones and joints, and other areas of the body. Metronidazole may also be used to prevent postoperative infections.

Metronidazole is also available as an over-the-counter medication. The over-the-counter form is used to treat bacterial infections of the vagina. This medication page refers to the prescription forms of metronidazole.

Metronidazole belongs to a group of drugs called nitroimidazole antibiotics. These work by killing organisms that cause infections.

Metronidazole comes in oral, topical, and injectable forms. The directions and frequency of use will vary with the indication for metronidazole.

Do not chew, divide, or break extended release metronidazole tablets. Swallow these tablets whole.

The injectable form of metronidazole will be given directly into a vein (IV) by a healthcare professional.

Common side effects of metronidazole include vomiting, upset stomach, diarrhea, loss of appetite, dry mouth or mouth irritation, and numbness or tingling of the hands and feet.

Metronidazole can also cause dizziness. Do not drive or operate heavy machinery until you know how metronidazole affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of metronidazole, there are no specific foods that you must exclude from your diet when receiving this medication.

It is not likely that other drugs you take orally or inject will have an effect on topically applied metronidazole. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

• If you have an allergy to metronidazole or any other part of MetroCream (metronidazole cream, gel, and lotion).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take MetroCream with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use MetroCream as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to take this medicine as you have been told by your doctor. Do not use more than you were told to use.
• Wash your hands before and after use.
• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Do not take MetroCream by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Makeup may be used after the skin has dried.
• Talk with your doctor before you use other drugs or products on your skin.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

MetroCream® (metronidazole topical cream) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn’s disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy: Teratogenic effects: Pregnancy category B: There are no adequate and well-controlled studies with the use of MetroCream® (metronidazole topical cream) Topical Cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug 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 are significantly lower with topically applied metronidazole than those achieved after oral administration of 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.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

In controlled clinical trials, the total incidence of adverse reactions associated with the use of MetroCream® Topical Cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

General:   Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients:   This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug Interactions:   Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility:   Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy:    Teratogenic effects: Pregnancy category B There are no adequate and well-controlled studies with the use of MetroCream (metronidazole topical cream) Topical Cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug 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 are significantly lower with topically applied metronidazole than those achieved after oral administration of 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.

Pediatric Use:   Safety and effectiveness in pediatric patients have not been established.