METRONIDAZOLE lotion

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Prasco Laboratories

INN (Nome Internazionale):

METRONIDAZOLE

Composizione:

METRONIDAZOLE 7.5 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.

Dettagli prodotto:

Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 mL) plastic bottle – NDC 66993-961-59 Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Prasco Laboratories Mason, OH 45040 USA Made in Canada P53362-0 Revised: January 2017

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Scheda tecnica

METRONIDAZOLE- METRONIDAZOLE LOTION
PRASCO LABORATORIES
----------
METRONIDAZOLE TOPICAL LOTION, 0.75%
RX ONLY
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION
Metronidazole Topical Lotion 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
6
9
3
3
0-24
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