METRONIDAZOLE cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Physicians Total Care, Inc.

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Metronidazole Topical Cream 0.75% is supplied in a 45 gram tube        NDC 54868-5655-0 Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE: 15°-30°C (59°-86°F). (See USP) E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I2323A R12/07 #29 Relabeling of "Additional Barcode" label by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METRONIDAZOLE - METRONIDAZOLE CREAM
PHYSICIANS TOTAL CARE, INC.
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METRONIDAZOLE
TOPICAL CREAM 0.75%
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
RX ONLY
DESCRIPTION
Metronidazole Topical Cream contains metronidazole, USP, at a
concentration of 7.5 mg per gram
(0.75%) in an emollient cream consisting of emulsifying wax, sorbitol
solution, glycerin, isopropyl
palmitate, benzyl alcohol, lactic acid, and/or sodium hydroxide to
adjust pH, and purified water.
Metronidazole is a member of the imidazole class of anti-bacterial
agents and is classified
therapeutically as an antiprotozoal and antibacterial agent.
Chemically, metronidazole is 2-Methyl-5-
nitroimidazole-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
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
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warfarin and coumarin anticoagulants, resulting in a prolongation of
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