Noritate

Contraindications

Hypersensitivity

Cautions

For external use only

Avoid contact with eyes; tearing may occur

Nitroimidazole; use caution with evidence or history of blood dyscrasia

Discontinue use if dermatitis occurs

Administer with caution in patients with CNS diseases due to risk of numbess or paresthesia of an extremity

NORITATE (metronidazole) is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

Cream - 30 gram aluminum tube NDC 0066-9850-30. Keep out of the reach of children.

Storage Conditions: Store at controlled room temperature: 20 to 25°C (68 to 77°F).

Manufactured by: PanGeo Quebec Pharma Inc. Montreal, Quebec, Canada Marketed by: Dermik Laboratories, Inc. Berwyn, PA 19312 USA Made in Canada

Do not use metronidazole topical if you have ever had an allergic reaction to it.

Before using metronidazole topical, tell your doctor if you are allergic to any drugs, or if you have a blood cell disorder such as anemia or decreased white blood cells.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole topical.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Metronidazole passes into breast milk and could harm a nursing infant. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Safety data from 302 patients who used NORITATE (metronidazole) (n=200) or vehicle control (n=102) once daily in clinical trials and experienced an adverse event considered to be treatment-related include: application site reaction (NORITATE (metronidazole) 1, vehicle 1), condition aggravated (NORITATE (metronidazole) 1, vehicle 0), paresthesia (NORITATE (metronidazole) 0, vehicle 1), acne (NORITATE (metronidazole) 1, vehicle 0), dry skin (NORITATE (metronidazole) 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity.

Two patients treated with NORITATE (metronidazole) once daily discontinued treatment because of adverse events: one for a severe flare of comedonal acne and one for rosacea aggravated.

Read the entire FDA prescribing information for Noritate (Metronidazole)

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.

Serious side effects have been reported with metronidazole. See the “Metronidazole Precautions” section.

Oral forms:

Common side effects of oral metronidazole include the following:

• Vomiting
• Diarrhea
• Upset stomach
• Loss of appetite
• Dry mouth
• Sharp, unpleasant metallic taste
• Dark or reddish-brown urine
• Mouth or tongue irritation
• Numbness or tingling of hands or feet

Topical forms:

Common side effects of topical metronidazole include the following:

• Skin irritation, including redness, dryness, burning, or stinging, at the site of application

Injectable forms:

Common side effects of injectable metronidazole include the following:

• Vomiting
• Diarrhea
• Upset stomach
• Loss of appetite
• Dry mouth
• Sharp, unpleasant metallic taste
• Dark or reddish-brown urine
• Mouth or tongue irritation
• Numbness or tingling of hands or feet

This is not a complete list of metronidazole side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Warfarin (Coumadin)
• Astemizole (Hismanal)
• Disulfiram (Antabuse)
• Busulfan (Busulfex, Myleran)
• Lithium (Lithobid)
• Phenobarbital
• Phenytoin (Dilantin)
• Cimetidine (Tagamet)
• Vitamins        

This is not a complete list of metronidazole drug interactions. Ask your doctor or pharmacist for more information.

Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

General:

If a reaction suggesting local skin irritation occurs, patients should be directed to discontinue use of the medication. Conjunctivitis associated with topical use of metronidazole on the face has been reported. Contact with the eyes should be avoided. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia.

Information for Patients:

Patients using Noritate should receive the following information and instructions:

Drug Interactions:

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when Noritate is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

Carcinogenesis, Mutagenesis and 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.

In several- long term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times the human topical dose on a mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several- long term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the topical human dose).

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn's disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn's disease treated with the drug for 8 months.

In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with Noritate or any marketed metronidazole formulations.

Pregnancy:

There are no adequate and well-controlled studies with the use of Noritate in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole to rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, Noritate 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 taken after topical metronidazole application 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 and the risk to the infant.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.