Metrolotion

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Metronidazole has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from metronidazole, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

If you take too much metronidazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If metronidazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Use this medicine exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash and gently dry your skin before applying metronidazole topical

Apply the medication in a thin layer and rub in completely. You may apply cosmetics after using metronidazole topical.

Do not use metronidazole topical to treat any skin condition that has not been checked by your doctor.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Call your doctor if your symptoms do not improve, or if they get worse while using metronidazole topical.

Store metronidazole topical at room temperature away from moisture or heat.

Do not take by mouth. Metronidazole topical is for use only on the skin. If this medication gets in your eyes, rinse with water.

Do not use topical metronidazole in the vagina.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

General: Topical metronidazole formulations have 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 or history of blood dyscrasia.

Information for Patients: Patients using MetroLotion® Topical Lotion should receive the following information and instructions:

1. This medication is to be used only as directed by the physician.
2. It is for external use only.
3. Avoid contact with the eyes.
4. Cleanse affected area(s) before applying this medication.
5. Patients should report any adverse reaction to their physician.

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. Metronidazole has not been assessed for carcinogenic activity following topical administration. In several long term studies in mice, oral doses of approximately 200 mg/m2/day (approximately 20 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater were associated with increase incidences of lung tumors in male mice and lymphomas in female mice. In several long-term studies in rats, oral administration of metronidazole resulted in increased incidences of mammary and hepatic tumors in female rats and testicular tumors and pituitary adenomas in male rats at dosages of approximately 1600 mg/m2/day (approximately 170 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater. In another oral study, an increase of mammary tumors was observed in female rats that received approximately 160 mg/m2/day (approximately 17 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and the following normalization of the data on the basis of the body surface area)).

Ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal injection of metronidazole at a dosage of 45 mg/m2/day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms. It is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. This study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation.

Metronidazole exhibited mutagenic activity in several in vitro bacterial and mammalian assay systems. Intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with Crohn`s disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. However, similar results were not observed in another study, in which humans were treated for 8 months.

In rats, oral metronidazole at a dosage of approximately 1800 mg/m2/day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of body surface area)) induced inhibition of spermatogenesis and severe testicular degeneration.

Pregnancy: Teratogenic Effects: Pregnancy Category B: There are no adequate and well-controlled studies with the use of MetroLotion® Topical Lotion 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. 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.

Rx only

NDC 0299-3838-02

MetroLotion®

(metronidazole lotion)

TOPICAL LOTION 0.75%

2 FL OZ

(59 mL)

GALDERMA

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.

Each Gram Contains: Active: metronidazole, 0.75% w/w (7.5 mg). Inactive: benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. See lot number and expiration date on bottom of carton.

Store at controlled room temperature 68º to 77ºF (20º – 25ºC).

Protect from freezing.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Galderma is a registered trademark.

P52498-0

LOT:

EXP.:

MetroLotion Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which MetroLotion Topical Lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. MetroLotion Topical Lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigators' global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table:

The scale is based on the following definitions:

Worse:

Exacerbation of either erythema or quantitative assessment of papules and/or pustules.

No Change:

Condition remains the same.

Minimal Improvement:

Slight improvement in the quantitative assessment of papules and/or pustules, and/or slight improvement in erythema.

Definite Improvement:

More pronounced improvement in the quantitative assessment of papules and/or pustules, and/or more pronounced improvement in erythema.

Marked Improvement:

Obvious improvement in the quantitative assessment of papules and/or pustules, and/or obvious improvement in erythema.

Clear:

No papules or pustules and minimal residual or no erythema.