METROGEL® Topical Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propyl-paraben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

Last updated on RxList: 9/4/2008

METROGEL® Topical Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Apply and rub in a thin film of METROGEL® Topical Gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of METROGEL® (metronidazole topical gel) Topical Gel. Patients may use cosmetics after application of METROGEL® Topical Gel.

METROGEL® (metronidazole topical gel) Topical Gel is supplied in a 45 g aluminum tube - NDC 0299-3835-45 and a 60 g aluminum tube - NDC 0299-3835-60.

Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE: 68° to 77°F (20° to 25°C).

Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177, USA. Manufactured by: Galderma Production Canada, Inc. Montreal, QC H9X 3N7 Canada. www.metrogel.com.. Revised: June 2004. FDA Rev date: 6/4/2002

Last updated on RxList: 9/4/2008

The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

Oral metronidazole has been reported to potenti-ate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronida-zole on prothrombin time is not known.

Last updated on RxList: 9/4/2008

No information provided.

General: METROGEL® Topical Gel 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.

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 has been no experience to date with the use of METROGEL® (metronidazole topical gel) Topical Gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronida-zole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metron-idazole 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 METROGEL® Topical Gel blood levels are significantly lower than those achieved after oral 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.

Last updated on RxList: 9/4/2008

No information provided.

METROGEL® Topical Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

Last updated on RxList: 9/4/2008

Bioavailability studies on the topical administration of 1 gram of METROGEL® Topical Gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which METROGEL® (metron-idazole topical gel) Topical Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

Last updated on RxList: 9/4/2008

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

Last updated on RxList: 9/4/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

METRONIDAZOLE - TOPICAL

(meh-troh-NID-uh-zole)

COMMON BRAND NAME(S): Metrocream, Metrogel, Metrolotion, Noritate

USES: This medication is used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It may help to decrease redness, swelling and the number of pimples caused by rosacea.

This medication is an antibiotic. For the treatment of rosacea, metronidazole is believed to work by decreasing swelling (inflammation).

HOW TO USE: Use this medication on the skin only. Wash and dry your hands before and after applying this medication. Wash and dry the area to be treated. Wait 15 minutes, then apply a thin layer of medication usually once or twice daily, or as directed by your doctor. Wait 5 minutes before applying cosmetics.

Avoid using this medication around the eye area, unless directed by your doctor. Watery eyes or tearing of the eyes may occur if this medication is applied too close to the eyes. Avoid getting this medication in your eyes. If this occurs, rinse your eyes with large amounts of cool water.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

It may take about three weeks before any improvement is seen, and up to nine weeks for full benefit. If no improvement is seen after three weeks, consult your doctor.

SIDE EFFECTS: Stinging, burning, skin irritation, dryness, redness, metallic taste, nausea, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have this unlikely but serious side effect: tingling or numbness of the hands and feet.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (e.g., tinidazole); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (blood dyscrasias).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Breast-feeding while using this medication is not recommended. Consult with your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.

Avoid certain triggers that may worsen rosacea such as excessive sunlight, wind, hot beverages, spicy foods, alcohol, and extreme cold. Discuss with your doctor.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. If using the lotion, do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.