Metronidazole description, usages, side effects, indications, overdosage, supplying and lots more!

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Metronidazole

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only


WARNING

PRECAUTIONS). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in theINDICATIONS AND USAGEsection below.

METRONIDAZOLE DESCRIPTION


Metronidazole

C6H9N3O3 M.W. 171.15

CLINICAL PHARMACOLOGY









Microbiology















Susceptibility Tests
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to metronidazole; however, the rapid, routine susceptibility testing of individuals isolates of anaerobic bacteria is not always practical, and therapy may be started while awaiting these results.





INDICATIONS & USAGE

Symptomatic Trichomoniasis


Asymptomatic Trichomoniasis


Treatment of Asymptomatic Consorts


Amebiasis


Anaerobic Bacterial Infections











METRONIDAZOLE CONTRAINDICATIONS


WARNINGS).

WARNINGS

Central and Peripheral Nervous System Effects

PRECAUTIONS

General




Information for Patients
Drug Interactions).


Laboratory Tests
Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of or history of blood dyscrasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended before and after therapy for trichomoniasis and amebiasis, especially if a second course of therapy is necessary, and before and after therapy for anaerobic infections.


Drug Interactions






Drug/Laboratory Test Interactions
Metronidazole


Carcinogenesis, Mutagenesis, Impairment of Fertility







Pregnancy







Nursing Mothers


Geriatric Use


Pediatric Use

METRONIDAZOLE ADVERSE REACTIONS












OVERDOSAGE




Treatment


DOSAGE & ADMINISTRATION



Trichomoniasis










CONTRAINDICATIONS). In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (seePRECAUTIONS, Pregnancy).





Amebiasis












Anaerobic Bacterial Infections





HOW SUPPLIED


333on one side and unscored on the other side. Available in bottles of 100, 250 and 500.
334on one side and unscored on the other side. Available in bottles of 100 and 500.

STORAGE AND HANDLING


PROTECT FROM LIGHT


REFERENCES



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Metronidazole


Metronidazole

Metronidazole

METRONIDAZOLE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-719(NDC:50111-333)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METRONIDAZOLE METRONIDAZOLE 250 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSPOVIDONE
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL

Product Characteristics

Color Size Imprint Code Shape
white 9 mm PLIVA;333 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-719-05 21 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070027 2012-09-10


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