METROGEL- metronidazole gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

METRONIDAZOLE

Composition:

Metronidazole 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

METROGEL is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of METROGEL in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, METROGEL should be used during pregnancy only if clearly needed. After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole a decision should be

Product summary:

METROGEL® a clear, colorless to pale yellow in color, and is supplied as follows: 60 gram tube - NDC 54868-5585-1 Storage Conditions: Store at controlled room temperature: 20˚ to 25˚C (68˚ to 77˚F), excursions permitted between 15˚ and 30˚C (59˚ and 86˚F).

Authorization status:

New Drug Application

Summary of Product characteristics

METROGEL - METRONIDAZOLE GEL
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METROGEL (METRONIDAZOLE) GEL, 1% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METROGEL
(METRONIDAZOLE) GEL, 1% METROGEL®
(METRONIDAZOLE) GEL, 1% FOR TOPICAL USE ONLY. INITIAL U.S. APPROVAL
1963
INDICATIONS AND USAGE
METROGEL® (metronidazole) Gel, 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)
Apply and rub in a thin film of METROGEL once daily to affected
area(s). ( 2)
Treated areas should be cleansed before the application of METROGEL. (
2)
Cosmetics may be applied after the application of METROGEL. ( 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
Peripheral neuropathy, characterized by numbness or paresthesia of an
extremity has been reported in patients treated
with systemic metronidazole. Although not evident in clinical trials
for topical metronidazole, peripheral neuropathy has
been reported with the post approval use. The appearance of abnormal
neurologic signs should prompt immediate
reevaluation of METROGEL therapy. ( 5.1)
Metronidazole is a nitroimidazole and should be used with care in
patients with evidence of, or history of, blood
dyscrasia. ( 5.2)
If dermatitis occurs, patients may need to discontinue use. ( 5.3)
Topical metronidazole has been reported to cause tearing of the eyes.
Therefore, contact with the eyes should be
avoided. ( 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 WW