Video: Latest Treatment for Hep C.

Metronidazole Cream

Pronunciation

Dosage Form: topical cream

Metronidazole
Topical Cream, 0.75%

Rx only
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)

DESCRIPTION:

Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H- imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

Slideshow: Breaking Down Bipolar Disorder - 12 Things You Need To Know

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 g aluminum tube - NDC 66993-960-45.


Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° TO 86°F (15° TO 30°C).

Manufactured for:
Prasco Laboratories
Mason, OH 45040 USA

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
P51807-0
Issued: June 2013

Package Label

PRASCO NDC 66993-960-45

NET WT. 45 g

Metronidazole Topical Cream 0.75%

Rx Only

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° TO 86°F (15° TO 30°C).

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% (7.5 mg).

Inactive: benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH.

See closure for lot number and expiration date.

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

Iss. 06/13

P51806-0

METRONIDAZOLE 
Metronidazole Cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66993-960
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 7.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
GLYCERIN  
ISOPROPYL PALMITATE  
WATER  
SORBITOL  
LACTIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:66993-960-45 1 TUBE in 1 CARTON
1 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020531 06/18/2009
Labeler - Prasco Laboratories (065969375)
Establishment
Name Address ID/FEI Operations
DPT Laboratories Ltd. 832224526 manufacture(66993-960)
Revised: 09/2013
 
Prasco Laboratories



Hide
(web3)