ROSADAN- metronidazole gel ROSADAN- metronidazole kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

metronidazole (UNII: 140QMO216E) (metronidazole - UNII:140QMO216E)

Commercializzato da:

Medimetriks Pharmaceuticals, Inc.

INN (Nome Internazionale):

metronidazole

Composizione:

metronidazole 7.5 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Rosadan ® (metronidazole) Gel USP, 0.75% is supplied in a 45 g tube NDC 43538-182-45 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ROSADAN- METRONIDAZOLE GEL
ROSADAN- METRONIDAZOLE
MEDIMETRIKS PHARMACEUTICALS, INC.
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ROSADAN GEL
METRONIDAZOLE GEL USP, 0.75%
FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)
RX ONLY
DESCRIPTION
Rosadan (metronidazole) Gel 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
Rosadan (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 Rosadan (metronidazole) Gel
acts in the treatment of
rosacea are unknown, but appear to include an anti-inflammatory
effect.
INDICATIONS AND USAGE
Rosadan (metronidazole) Gel is indicated for topical application in
the treatment of inflammatory
papules and pustules of rosacea.
CONTRAINDICATIONS
Rosadan (metronidazole) Gel is contraindicated in individuals with a
history of hypersensitivity to
metronidazole, parabens, or other ingredients of the formulation.
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PRECAUTIONS
GENERAL
Metronidazole Gel has been report