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metronidazole

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Overview

What is Noritate?

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Cream, 1%

H

Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has a solubility in water of 10 mg/mL at 20°C. Metronidazole is a member of the imidazole class of antibacterial agents and is classified as an antiprotozoal and anti-bacterial agent.

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What does Noritate look like?



What are the available doses of Noritate?

Sorry No records found.

What should I talk to my health care provider before I take Noritate?

Sorry No records found

How should I use Noritate?

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Areas to be treated should be cleansed before application of . Apply and rub in a thin film of once daily to entire affected area(s). Patients may use cosmetics after application of .


What interacts with Noritate?

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What are the warnings of Noritate?

Sorry No Records found


What are the precautions of Noritate?

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:

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Patients using 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 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 , )

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/m/day or greater (approximately 37 times the human topical dose on a mg/m 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/m/day (144 times the topical human dose).

Metronidazole has shown evidence of mutagenic activity in several 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/m/day (approximately 7 times the human topical dose on a mg/m basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with or any marketed metronidazole formulations.

Pregnancy:

There are no adequate and well-controlled studies with the use of 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, 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.


What are the side effects of Noritate?

Safety data from 302 patients who used (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 ( 1, vehicle 1), condition aggravated ( 1, vehicle 0), paresthesia ( 0, vehicle 1), acne ( 1, vehicle 0), dry skin ( 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity.

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

Additional clinical adverse effects reported spontaneously since the drug was marketed are uncommon and include tingling or numbness of extremities, allergic reactions, skin and eye irritation, rash, headache, nausea and dry mouth.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


What should I look out for while using Noritate?

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What might happen if I take too much Noritate?

Sorry No Records found


How should I store and handle Noritate?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Cream - 60 g aluminum tube NDC 0187-5202-60.Keep out of reach of children.Cream - 60 g aluminum tube NDC 0187-5202-60.Keep out of reach of children.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

When a one gram dose of cream, 1%, was applied in a single application to the face of 16 healthy volunteers, low concentrations of metronidazole were detected in the plasma of 7 of the volunteers. The mean ± SD C of metronidazole was 27.6 ± 7.3 ng/mL, which is about 1% of the value reported for a single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (T) in the volunteers with detectable metronidazole was 8–12 hours after topical application.

Non-Clinical Toxicology
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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 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 , )

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.

Safety data from 302 patients who used (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 ( 1, vehicle 1), condition aggravated ( 1, vehicle 0), paresthesia ( 0, vehicle 1), acne ( 1, vehicle 0), dry skin ( 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity.

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

Additional clinical adverse effects reported spontaneously since the drug was marketed are uncommon and include tingling or numbness of extremities, allergic reactions, skin and eye irritation, rash, headache, nausea and dry mouth.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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