METRONIDAZOLE TOPICAL GEL - metronidazole gel

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Owen Laboratories

INN (International Nazwa):

METRONIDAZOLE

Skład:

METRONIDAZOLE 7.5 mg in 1 g

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Metronidazole topical gel is supplied in a 45 g aluminum tube – NDC 69007-835-45. STORE AT CONTROLLED ROOM TEMPERATURE: 68° to 77°F (20° to 25°C). Distributed by: Owen Laboratories, Inc., a Galderma Company Galderma is a registered trademark. Made in Canada P52445-0 Revised: June 2014

Status autoryzacji:

New Drug Application Authorized Generic

Charakterystyka produktu

METRONIDAZOLE TOPICAL GEL - METRONIDAZOLE GEL
OWEN LABORATORIES
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METRONIDAZOLE TOPICAL GEL, 0.75%
RX ONLY
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION:
Metronidazole topical 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-1H-imidazole-1-ethanol
and has the following structure:
CLINICAL PHARMACOLOGY:
Bioavailability studies on the topical administration of 1 gram of
metronidazole topical 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 topical gel acts
in the treatment of rosacea are
unknown, but appear to include an anti-inflammatory effect.
INDICATIONS AND USAGE:
Metronidazole topical gel is indicated for topical application in the
treatment of inflammatory papules
and pustules of rosacea.
CONTRAINDICATIONS:
Metronidazole topical gel is contraindicated in individuals with a
history of hypersensitivity to
metronidazole, parabens, or other ingredients of the formulation.
PRECAUTIONS:
GENERAL:
Metronidazole topical gel has been reported to cause tearing of the
eyes. Therefore, contact wit