METRONIDAZOLE gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Rebel Distributors Corp

INN (International namn):

METRONIDAZOLE

Sammansättning:

METRONIDAZOLE 7.5 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Metronidazole topical gel USP, 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole topical gel USP, 0.75%, is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation. Safety and effectiveness in pediatric patients have not been established.

Produktsammanfattning:

Metronidazole topical gel USP, 0.75%, is supplied as the following: NDC 42254-069-45:  45 g aluminum tube Storage conditions: Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088. 04584 Rev. 2 10/08 Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ  08540

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

METRONIDAZOLE- METRONIDAZOLE GEL
REBEL DISTRIBUTORS CORP
----------
METRONIDAZOLE TOPICAL GEL USP, 0.75%
Rx only
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION
Metronidazole topical gel USP, 0.75%, contains metronidazole, USP, at
a concentration of 7.5 mg per
gram (0.75%) in a gel consisting of carbomer 940, NF; edetate
disodium, USP; methylparaben, NF;
propylene glycol, USP; propylparaben, NF; purified water, USP; and
sodium hydroxide, NF.
Metronidazole is classified therapeutically as an antiprotozoal and
anti-bacterial 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 topical gel USP, 0.75%,
(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 USP,
0.75%, acts in the treatment
of rosacea are unknown, but appear to include an anti-inflammatory
effect.
INDICATIONS & USAGE
Metronidazole topical gel USP, 0.75%, is indicated for topical
application in the treatment of
inflammatory papules and pustules of rosacea.
CONTRAINDICATIONS
Metronidazole topical gel USP, 0.75%, is contraindicated in
individuals with a history of
hypersensitivity to metronidazole, parabens, or other ingredients of
the formulation.
PRECAUTIONS
General: Metronidazol