METRONIDAZOLE gel

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Cosette Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

Metronidazole

Samsetning:

Metronidazole 7.5 mg in 1 g

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Metronidazole Gel USP 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.

Vörulýsing:

Metronidazole Gel USP, 0.75% is supplied in a 45 g tube NDC 0713-0637-37 Storage conditions: Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0637BFCPLNC3 Rev. 07/2022 VC7647

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

METRONIDAZOLE- METRONIDAZOLE GEL
COSETTE PHARMACEUTICALS, INC.
----------
METRONIDAZOLE GEL USP, 0.75%
FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)
RX ONLY
DESCRIPTION:
Metronidazole Gel USP, 0.75% contains metronidazole, USP, at a
concentration of 7.5
mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF,
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 USP 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 avo