METRONIDAZOLE gel

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Prasco Laboratories

INN (Internationale Bezeichnung):

METRONIDAZOLE

Zusammensetzung:

METRONIDAZOLE 10 mg in 1 g

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole Gel, 1% 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 with 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 Metronidazole Gel, 1%. 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 Metronidazole Gel, 1%. Safety and effectiveness of Metronidazole Gel, 1% have not been established in pediatric patients. Sixty-six subjects aged 65 years and older were treated with Metronidazole Gel, 1% 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.

Produktbesonderheiten:

How Supplied Metronidazole Gel, 1% is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 66993-936-61 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).

Berechtigungsstatus:

New Drug Application Authorized Generic

Fachinformation

METRONIDAZOLE- METRONIDAZOLE GEL
PRASCO LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METRONIDAZOLE GEL, 1%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METRONIDAZOLE GEL, 1%.
INITIAL U.S. APPROVAL: 1963
INDICATIONS AND USAGE
Metronidazole Gel, 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 Metronidazole Gel, 1%
(2)
Apply and rub in a thin film of Metronidazole Gel, 1% once daily to
affected area(s). (2)
Cosmetics may be applied after the application of Metronidazole Gel,
1%. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1%. (3)
CONTRAINDICATIONS
Metronidazole Gel, 1% 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.
Immediately reevaluate Metronidazole
Gel therapy if abnormal neurologic signs appear. (5.1)
_Blood Dyscrasias_: Metronidazole Gel, 1% 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 PRASCO LABORATORIES, AT
1-866-525-0688
OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Oral metronidazole has been reported