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Basic Drug Info
Drug Name:Metronidazole
Manufacturer:Prasco Laboratories
Other Info:

Manufactured by:Dermik Laboratoriesa business of sanofi-aventis U.S.

LLCBridgewater, NJ 08807Manufactured for:Prasco LaboratoriesCincinnati, OH 45249 USARevised April 2007© 2007 sanofi-aventis U.S.

LLC



Clinical Trials:


Indications and Usage
Metronidazole Cream, 1%, is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.
Erythema -- Redness of the skin produced by congestion of the capillaries. This condition may result from a variety of causes.

rosacea -- A cutaneous disorder primarily of convexities of the central part of the FACE, such as FOREHEAD; CHEEK; NOSE; and CHIN. It is characterized by FLUSHING; ERYTHEMA; EDEMA; RHINOPHYMA; papules; and ocular symptoms. It may occur at any age but typically after age 30. There are various subtypes of rosacea: erythematotelangiectatic, papulopustular, phymatous, and ocular (National Rosacea Society's Expert Committee on the Classification and Staging of Rosacea, J Am Acad Dermatol 2002; 46:584-7).

Contraindications
Metronidazole Cream, 1%, is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Branded Drugs
The following US Branded drugs contain Metronidazole


PYLERA -- AXCAN SCANDIPHARM INC

HELIDAC -- PROMETHEUS LABORATORIES INC

FLAGYL -- GD SEARLE LLC

METROCREAM -- GALDERMA LABORATORIES LP

NORITATE -- SANOFI AVENTIS US LLC

METROGEL -- GALDERMA LABORATORIES LP

METROGEL-VAGINAL -- GRACEWAY PHARMACEUTICALS LLC

VANDAZOLE -- TEVA PHARMACEUTICALS USA

FLAGYL I.V. RTU IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

FLAGYL I.V. RTU IN PLASTIC CONTAINER -- GD SEARLE LLC

METRO I.V. -- B BRAUN MEDICAL INC

METRO I.V. IN PLASTIC CONTAINER -- B BRAUN MEDICAL INC

METRONIDAZOLE IN PLASTIC CONTAINER -- CLARIS LIFESCIENCES LTD

METRONIDAZOLE IN PLASTIC CONTAINER -- HOSPIRA INC

METROLOTION -- GALDERMA LABORATORIES LP

FLAGYL ER -- GD SEARLE LLC

METROMIDOL -- LABORATORIOS APLICACIONES FARMACEUTICAS SA DE CV

PROTOSTAT -- ORTHO MCNEIL PHARMACEUTICAL INC

SATRIC -- SAVAGE LABORATORIES INC DIV ALTANA INC


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