METRONIDAZOLE gel

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Metronidazole (UNII: 140QMO216E) (Metronidazole - UNII:140QMO216E)

Disponible desde:

Prugen, Inc.

Designación común internacional (DCI):

Metronidazole

Composición:

Metronidazole 7.5 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

Resumen del producto:

Metronidazole Gel USP, 0.75% is supplied in aluminum tubes containing: 45 g NDC 42546-700-45 Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

METRONIDAZOLE- METRONIDAZOLE GEL
PRUGEN, INC.
----------
METRONIDAZOLE
GEL USP, 0.75%
RX ONLY
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Metronidazole gel contains metronidazole, USP, at a concentration of
7.5 mg per gram (0.75%) in a gel
consisting of carbomer 940, edetate disodium, methylparaben, propylene
glycol, propylparaben,
purified water, and sodium hydroxide. Metronidazole is classified
therapeutically as an antiprotozoal
and antibacterial agent. Chemically, metronidazole is named
2-methyl-5-nitro-1_H_-imidazole-1-ethanol
and has the following structure:
CLINICAL PHARMACOLOGY
Bioavailability studies on the topical administration of 1 gram of
metronidazole gel (7.5 mg of
metronidazole) to the face of 10 rosacea patients showed a maximum
serum concentration of 66
nanograms per milliliter in one patient. This concentration is
approximately 100 times less than
concentrations afforded by a single 250 mg oral tablet. The serum
metronidazole concentrations were
below the detectable limits of the assay at the majority of time
points in all patients. Three of the patients
had no detectable serum concentrations of metronidazole at any time
point. The mean dose of gel
applied during clinical studies was 600 mg which represents 4.5 mg of
metronidazole per application.
Therefore, under normal usage levels, the formulation affords minimal
serum concentrations of
metronidazole. The mechanisms by which metronidazole gel acts in the
treatment of rosacea are
unknown, but appear to include an anti-inflammatory effect.
INDICATIONS AND USAGE
Metronidazole gel is indicated for topical application in the
treatment of inflammatory papules and
pustules of rosacea.
CONTRAINDICATIONS
Metronidazole gel is contraindicated in individuals with a history of
hypersensitivity to metronidazole,
parabens, or other ingredients of the formulation.
PRECAUTIONS
GENERAL
Metronidazole gel has been reported to cause tearing of the eyes.
Therefore, contact with the eyes
should be avoided. If a reaction suggesting local irritation occu