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

PRECAUTIONSINDICATIONS AND USAGE

METRONIDAZOLE DESCRIPTION



Metronidazole



CLINICAL PHARMACOLOGY








MICROBIOLOGY

Trichomonas vaginalis, Entamoeba histolytica


Anaerobic Bacteria










Susceptibility Tests






INDICATIONS & USAGE

Symptomatic Trichomoniasis


Asymptomatic Trichomoniasis


Treatment of Asymptomatic Consorts


Amebiasis


Anaerobic Bacterial Infections












METRONIDAZOLE CONTRAINDICATIONS


WARNINGS

WARNINGS



PRECAUTIONS

General




INFORMATION FOR PATIENTS

Drug Interactions


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 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




CONTRAINDICATIONSPRECAUTIONS, Pregnancy


In the Male


Amebiasis

Adults



Pediatric Patients


Anaerobic Bacterial Infections






HOW SUPPLIED





















INACTIVE INGREDIENT

INACTIVE INGREDIENTS
CELLULOSE, MICROCRYSTALLINE

CROSPOVIDONE
COLLOIDAL SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION




















Metronidazole





Metronidazole

Metronidazole

Metronidazole TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-243(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:49349-243-06 28 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070027 2011-05-03


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