Metronidazole Topical Cream, 0.75% Rx only FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Owen Laboratories

DCI (Dénomination commune internationale):

METRONIDAZOLE

Composition:

METRONIDAZOLE 7.5 mg in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Metronidazole topical cream, 0.75% is supplied in a 45 g aluminum tube - NDC 69007-836-45. Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° - 25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° - 30°C). Distributed by: Owen Laboratories, Inc., a Galderma Company Fort Worth, TX 76177 USA P52425-0 Revised: June 2014

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

METRONIDAZOLE- METRONIDAZOLE CREAM
OWEN LABORATORIES
----------
METRONIDAZOLE
TOPICAL CREAM, 0.75%
RX ONLY
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION:
Metronidazole topical cream contains metronidazole, USP, at a
concentration of 7.5 mg per gram
(0.75%) in an emollient cream consisting of benzyl alcohol,
emulsifying wax, glycerin, isopropyl
palmitate, purified water, sorbitol solution, lactic acid and/or
sodium hydroxide to adjust pH.
Metronidazole is a member of the imidazole class of antibacterial
agents 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.
INDICATIONS AND USAGE:
Metronidazole topical cream is indicated for topical application in
the treatment of inflammatory papules
and pustules of rosacea.
CONTRAINDICATIONS:
Metronidazole topical cream is contraindicated in individuals with a
history of hypersensitivity to
metronidazole, or other ingredients of the formulation.
PRECAUTIONS:
6
9
3
3
GENERAL:
Topical metronidazole has been reported to cause tearing of the eyes.
Therefore, contact with the eyes
should be avoided. If a reaction suggesting local irritation occurs,
patients should be directed to use the
medication less frequently or discontinue use. Metronidazole is a
nitroimidazole and should be used
with care in patients with evidence of, or history of blood dyscrasia.
INFORMATION FOR PATIENTS:
This medication is to be used as directed by the physician. It is for
external use only. Avoid contact
with the eyes.
DRUG INTERACTIONS:
Oral metronidazole has been reported to potentiate the anticoagulant
effect of warfarin and coumarin
anticoagulants, resulting in a prolongation of prothrombin time. The
effec