METROGEL- metronidazole gel

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Galderma Laboratories, L.P.

INN (International Adı):

METRONIDAZOLE

Kompozisyon:

Metronidazole 10 mg in 1 g

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.  METROGEL is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Risk Summary Available data have not established an association between metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of METROGEL. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with METROGEL. Safety and effectiveness of METROGEL have not been established in pediatric patients. Sixty-six subjects aged 65 years and older were treated with METROGEL in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Ürün özeti:

How Supplied METROGEL®is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 0299-3820-60 Storage and Handling Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

METROGEL - METRONIDAZOLE GEL
GALDERMA LABORATORIES, L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METROGEL, 1% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METROGEL, 1%
METROGEL® (METRONIDAZOLE) TOPICAL GEL
INITIAL U.S. APPROVAL 1963
INDICATIONS AND USAGE
METROGEL, 1% is a nitroimidazole indicated for the topical treatment
of inflammatory lesions of rosacea.
(1)
DOSAGE AND ADMINISTRATION
Cleanse treated areas before the application of METROGEL. (2)
Apply and rub in a thin film of METROGEL once daily to affected
area(s). (2)
Cosmetics may be applied after the application of METROGEL. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1% (3)
CONTRAINDICATIONS
METROGEL is contraindicated in those patients with a history of
hypersensitivity to metronidazole or to any
other ingredient in this formulation. (4)
WARNINGS AND PRECAUTIONS
_Neurologic Disease_: Peripheral neuropathy, characterized by numbness
or paresthesia of an extremity
has been reported in patients treated with systemic metronidazole.
Peripheral neuropathy has been
reported with the post approval use of topical metronidazole.
Immediate reevaluate METROGEL therapy
if abnormal neurologic signs appear. (5.1)
_Blood Dyscrasias_: METROGEL is a nitroimidazole; use with care in
patients with evidence of, or history
of, blood dyscrasia. (5.2)
_Contact Dermatitis_: If dermatitis occurs, patients may need to
discontinue use. (5.3)
_Eye Irritation_: Topical metronidazole has been reported to cause
tearing of the eyes. Avoid contact with
the eyes. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are nasopharyngitis,
upper respiratory tract infection,
and headache. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GALDERMA LABORATORIES,
L.P. AT 1-866-
735-4137, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_
DRUG INTERACTIONS
Oral metronidazole has been reported to potentiate the anticoagulant
effect of coumarin and