METRONIDAZOLE lotion

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Physicians Total Care, Inc.

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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: Metronidazole topical lo

Ürün özeti:

Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 Fl Oz (59 mL) plastic bottle – NDC 54868-5882-0 Store at controlled room temperature, 20°– 25°C (68°– 77°F). Protect from freezing. December 2007 E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 R12/07 Relabeling of "Additional Barcode" label by: Physicians Total Care, Inc. Tulsa, Oklahoma    74146

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

METRONIDAZOLE - METRONIDAZOLE LOTION
PHYSICIANS TOTAL CARE, INC.
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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.
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 compared with its