Rx Item-Metrogel 1% Gel 55Gm By Galderma Labs

FLAGYL- metronidazole capsule
G.D. Searle LLC
METROGEL � metronidazole gel
Galderma Laboratories, L.P.
INDICATIONS AND USAGE

METROGEL� is indicated for the topical treatment of inflammatory lesions of rosacea.
2 DOSAGE AND ADMINISTRATION

Apply and rub in a thin film of METROGEL once daily to affected area(s).

A gentle cleanser should be used before the application of METROGEL.



Cosmetics may be applied after the application of METROGEL.

Not for oral, ophthalmic or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Gel, 1%. METROGEL is a clear, colorless to pale yellow gel. Each gram of METROGEL contains 10mg (1%) of metronidazole.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of FLAGYL� 375 and other antibacterial drugs, FLAGYL 375 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS.) Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.
DESCRIPTION
Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 2-methyl-5-nitroimidazole-1-ethanol.
CLINICAL PHARMACOLOGY

Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms, with an average elimination half-life in healthy humans of 8 hours.

The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation [1-(?-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Renal clearance of metronidazole is approximately 10 mL/min/1.73 m2.
Microbiology
Metronidazole exerts antimicrobial effects in an anaerobic environment by the following possible mechanism: Once metronidazole enters the organism, the drug is reduced by intracellular electron transport proteins. Because of this alteration to the metronidazole molecule, a concentration gradient is maintained, which promotes the drug�s intracellular transport. Presumably, free radicals are formed which, in turn, react with cellular components resulting in death of the microorganism.

RX ITEM-Metrogel 1% Gel 55Gm By Galderma
NDC 00299-3820-01 UPC/GTIN No.3-02993-82001-7 Mfg.Part No.382001

Metrogel 1% Gel 55Gm By Galderma Labs
BRAND: METROGEL NDC: 00299-3820-01,299382001 UPC: 3-02993-82001-7,302993820017

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