METRONIDAZOLE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc.

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metronidazole gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole gel USP, 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 USP, 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 to 4% and 15 to 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 reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. 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 USP, 1%. Safety and effectiveness in pediatric patients have not been established. Sixty-six subjects aged 65 years and older were treated with metronidazole gel USP, 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.

Product summary:

Metronidazole Gel USP, 1% is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 0781-7080-35 55 gram pump – NDC 0781-7080-55 Storage Conditions:   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE GEL
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METRONIDAZOLE GEL USP,
1% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METRONIDAZOLE GEL USP, 1%.
METRONIDAZOLE GEL USP, 1% FOR TOPICAL USE.
INITIAL U.S. APPROVAL: 1963
INDICATIONS AND USAGE
Metronidazole gel USP, 1% is a nitroimidazole indicated for the
topical treatment of inflammatory lesions
of rosacea. (1)
DOSAGE AND ADMINISTRATION
● Not for oral, ophthalmic, or intravaginal use. (2)
● Cleanse treated areas before the application of metronidazole gel
USP, 1%. (2)
● Apply and rub in a thin film of metronidazole gel USP, 1% once
daily to affected area(s). (2)
● Cosmetics may be applied after the application of metronidazole
gel USP, 1%. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1%. (3)
CONTRAINDICATIONS
Metronidazole gel USP, 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. The
appearance of abnormal neurologic
signs should prompt immediate reevaluation of metronidazole gel USP,
1% therapy. (5.1)
Blood Dyscrasias: Metronidazole gel USP, 1% is a nitroimidazole and
should be used 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. Therefore, avoid
contact with the eyes. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are nasopharyngitis,
upper respiratory tract infection,
and headache.
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
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