METRONIDAZOLE Topical Cream 0.75% | Metronidazole

09:36 EDT 17th September 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Rx only

DESCRIPTION

Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid, and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-Methyl-5-nitroimidazole-1-ethanol. The molecular formula is CHNO and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

IMAGE metronidazole-cm-01.jpg

CLINICAL PHARMACOLOGY

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

PRECAUTIONS

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 metronidazole 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.

ADVERSE REACTIONS

In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole 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.

DOSAGE AND ADMINISTRATION

Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of metronidazole topical cream.

HOW SUPPLIED

Metronidazole Topical Cream 0.75% is supplied in a

45 gram tube        NDC 0168-0323-46

Storage conditions: STORE AT CONTROLLED ROOM

TEMPERATURE: 15°-30°C (59°-86°F). (See USP)

E. FOUGERA & CO. A division of Nycomed US Inc.MELVILLE, NEW YORK 11747

I2323AR12/07#29

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE

NDC 0168-0323-46

Fougera

METRONIDAZOLETopical Cream 0.75%

Rx only

FOR TOPICAL USE ONLYNOT FOR OPHTHALMIC USESTORE AT CONTROLLED TEMPERATURE15°-30°C (59°-86°F). (See USP)WARNING: Keep out of reach of children.

NET WT 45 grams

IMAGE metronidazole-cm-02.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

NDC 0168-0323-46

Fougera

METRONIDAZOLETopical Cream 0.75%

Rx only

FOR TOPICAL USE ONLYNOT FOR OPHTHALMIC USE

NET WT 45 grams

IMAGE metronidazole-cm-03.jpg

Manufacturer

E.FOUGERA & COMPANY A division of Nycomed US Inc.

Active Ingredients

Source

Clinical Trials [74 Associated Clinical Trials listed on BioPortfolio]

Prevention of Persistence of Bacterial Vaginosis

This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intra...

Response of Clostridium Difficile Infection to Metronidazole Therapy

In this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.

A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy

The purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidect...

Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

What is the difference between the use of one drug (Oral Metronidazole) versus the use of this same drug combined with another drug (Rifampin) in treatment of bacteria and infection-associ...

PubMed Articles [82 Associated PubMed Articles listed on BioPortfolio]

Proteomic Analysis of a NAP1 Clostridium difficile Clinical Isolate Resistant to Metronidazole.

Clostridium difficile is an anaerobic, Gram-positive bacterium that has been implicated as the leading cause of antibiotic-associated diarrhea. Metronidazole is currently the first-line treatment for ...

Subjective adverse reactions to metronidazole in patients with amebiasis.

Subjective adverse reactions to metronidazole were analyzed in 111 patients with amebiasis. Metronidazole was administered to 36 patients at a daily dose of 2,250mg and 75 patients at daily doses lowe...

Indirect electroreduction as pretreatment to enhance biodegradability of metronidazole.

The removal of metronidazole, a biorecalcitrant antibiotic, by coupling an electrochemical reduction with a biological treatment was examined. Electroreduction was performed in a home-made flow cell a...

The mutation of the rdxA gene in metronidazole-resistant Helicobacter pylori clinical isolates.

Antibiotic resistance is an increasing problem throughout the developed world, and knowledge about different resistance mechanisms is consequential for efficient treatment of bacterial infections. Alt...

Study on The Reproductive Organs and Fertility of The Male Mice following Administration of Metronidazole.

: Metronidazole (MTZ) is commonly used as an antibacterial and antiprotozoal drug. Various doses of MTZ have been reported to inhibit spermatogenic activity and sperm indices.

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Mirvaso (brimonidine)
Latest News Clinical Trials Research Drugs Reports Corporate
MIRVASO® (BRIMONIDINE) TOPICAL GEL, 0.33%* IS THE FIRST & ONLY FDA-APPROVED TREATMENT DEVELOPED AND INDICATED FOR PERSISTENT FACIAL REDNESS OF ROSACEA Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for th...

Ophthalmology
Latest News Clinical Trials Research Drugs Reports Corporate
Ophthalmology is the branch of medicine that is devoted to the study and treatment of eye diseases. As well as mild visual defects correctable by lenses, ophthalmology is concerned with glaucoma, uveitis and other serious conditions affecting the eye, ...

Advertisement

Drugs and Medication Quicklinks


Searches Linking to this Drug Record