METRONIDAZOLE gel

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Fougera Pharmaceuticals Inc.

INN (International Adı):

METRONIDAZOLE

Kompozisyon:

METRONIDAZOLE 7.5 mg in 1 g

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Metronidazole Gel USP 0.75% is supplied as follows: 45 gram tube NDC 0168-0275-45 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2275D R07/13 #87

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

METRONIDAZOLE- METRONIDAZOLE GEL
FOUGERA PHARMACEUTICALS INC.
----------
METRONIDAZOLE GEL USP 0.75%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
RX ONLY
INDICATIONS AND USAGE
Metronidazole gel is indicated for topical application in the
treatment of inflammatory papules and
pustules of rosacea.
DOSAGE AND ADMINISTRATION
Apply and rub in a thin film of metronidazole gel twice daily, morning
and evening, to entire affected
areas after washing. Areas to be treated should be cleansed before
application of metronidazole gel.
Patients may use cosmetics after application of metronidazole gel.
CONTRAINDICATIONS
Metronidazole gel is contraindicated in individuals with a history of
hypersensitivity to metronidazole,
parabens, or other ingredients of the formulation.
PRECAUTIONS:
GENERAL: Metronidazole gel 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
coumarin and warfarin resulting in a prolongation of prothrombin time.
The effect of topical
metronidazole on prothrombin time is not known.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Metronidazole has shown evidence of carcinogenic activity in a number
of studies involving chronic,
oral administration in mice and rats but not in studies involving
hamsters.
Metronidazole has shown evidence of mutagenic activity in several _in
vitro_ bacterial assay systems. In
addition, a dose-response increase in the frequency of micronuclei was
observed in mice after
intraperitoneal injections and an increase in chromosome aberration