METRONIDAZOLE gel

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Taro Pharmaceuticals U.S.A., Inc.

INN (Jina la Kimataifa):

Metronidazole

Tungo:

Metronidazole 10 mg in 1 g

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of metronidazole 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, metronidazole 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 top

Bidhaa muhtasari:

Metronidazole Gel USP, 1% is colorless to slightly yellow in color, and supplied as follows: 45 g tube - (NDC 51672-4164-6) 60 g tube - (NDC 51672-4164-3) 55 g pump - (NDC 51672-4164-9) Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

METRONIDAZOLE- METRONIDAZOLE GEL
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METRONIDAZOLE GEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METRONIDAZOLE GEL
METRONIDAZOLE GEL, 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.
Apply and rub in a thin film of metronidazole once daily to affected
area(s). (2)
Treated areas should be cleansed before the application of
metronidazole. (2)
Cosmetics may be applied after the application of metronidazole. (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
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 metronidazole 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 TARO PHARMACEUTICALS
U.S.A., INC. AT 1-866-923-4914
OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DR