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

BOXED WARNING



METRONIDAZOLE DESCRIPTION


Metronidazole






CLINICAL PHARMACOLOGY







Microbiology











Susceptibility Tests






INDICATIONS & USAGE

Symptomatic Trichomoniasis


Asymptomatic Trichomoniasis


Treatment of Asymptomatic Consorts


Amebiasis



Anaerobic Bacterial Infections












METRONIDAZOLE CONTRAINDICATIONS






WARNINGS

Convulsive Seizures and Peripheral Neuropathy


PRECAUTIONS

General




INFORMATION FOR PATIENTS




LABORATORY TESTS



DRUG INTERACTIONS






DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY








PREGNANCY

Teratogenic Effects

Pregnancy category B

Use of metronidazole for trichomoniasis during pregnancy should be restricted to those in whom alternative treatment has been inadequate. Use of metronidazole for trichomoniasis in the first trimester of pregnancy should be carefully evaluated because metronidazole crosses the placental barrier and its effects on the human fetal organogenesis are not known (see above).

NURSING MOTHERS



GERIATRIC USE



PEDIATRIC USE




METRONIDAZOLE ADVERSE REACTIONS










OVERDOSAGE




Treatment


DOSAGE & ADMINISTRATION



Trichomoniasis

In the Female






In the Male


Amebiasis

Adults



Pediatric Patients


Anaerobic Bacterial Infections





HOW SUPPLIED






REFERENCES







PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Metronidazole



Metronidazole



Metronidazole

Metronidazole TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-164(NDC:0591-3970-05)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METRONIDAZOLE METRONIDAZOLE 500 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
white 17 mm 93;93;852 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-164-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070044 2011-04-13


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