METRONIDAZOLE lotion

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Fougera Pharmaceuticals Inc.

Designación común internacional (DCI):

METRONIDAZOLE

Composición:

METRONIDAZOLE 7.5 mg in 1 mL

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which metronidazole topical lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. Metronidazole topical lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigator's global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table: Efficacy Outcomes at Wee

Resumen del producto:

Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 Fl Oz (59 mL) plastic bottle – NDC 0168-0383-60 Store at controlled room temperature, 20°to 25°C (68° to 77°F). Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2383C/IF2383C R07/16 #124

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

METRONIDAZOLE- METRONIDAZOLE LOTION
FOUGERA PHARMACEUTICALS INC.
----------
METRONIDAZOLE TOPICAL LOTION, 0.75%
FOR TOPICAL USE ONLY
RX ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION
Metronidazole Topical Lotion, 0.75% contains metronidazole, USP, at a
concentration of
7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol,
carbomer 941,
cyclomethicone, glycerin, glyceryl stearate, light mineral oil,
PEG-100 stearate,
polyethylene glycol 400, potassium sorbate, purified water,
steareth-21, stearyl alcohol,
and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is
an imidazole and
is classified therapeutically as an antiprotozoal and antibacterial
agent. Chemically,
metronidazole is 2-methyl-5-nitro-1_H_-imidazole-1-ethanol. The
molecular formula is
C H N O and molecular weight is 171.16. Metronidazole is represented
by the following
structural formula:
CLINICAL PHARMACOLOGY
The mechanisms by which metronidazole acts in the treatment of rosacea
are unknown,
but appear to include an anti-inflammatory effect.
PHARMACOKINETICS
Absorption of metronidazole after topical application of metronidazole
topical lotion is
less complete and more prolonged than after oral administration.
Detectable plasma
levels were found in all subjects following the administration of a 1
gram dose of
metronidazole topical lotion (containing 7.5 mg of metronidazole)
applied every morning
and evening for 4 days to the faces of 8 patients. The highest
concentration (96 ng/mL)
seen following the morning dose on Day 5 was approximately 80 times
lower than the
peak concentrations produced by a single 250 mg tablet of
metronidazole. The mean (±
SD) AUC
after twice daily administration was 962 ± 373 ng.hr/mL.
6
9
3
3
0-24
INDICATIONS AND USAGE
Metronidazole topical lotion is indicated for topical application in
the treatment of
inflammatory papules and pustules of rosacea.
CLINICAL STUDIES
A controlled clinical study was conducted in 144 patients with
moderate to severe
rosacea, in which metronidazole topical lotion was comp