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

See PRECAUTIONSINDICATIONS AND USAGE

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

WARNINGS

Convulsive Seizures and Peripheral Neuropathy


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




NURSING MOTHERS



GERIATRIC USE



PEDIATRIC USE



METRONIDAZOLE ADVERSE REACTIONS







OVERDOSAGE



Treatment


DOSAGE & ADMINISTRATION


Trichomoniasis
In the Female



CONTRAINDICATIONS.)PRECAUTIONS, Pregnancy).

In the Male

Amebiasis
Adults



Pediatric Patients

Anaerobic Bacterial Infections





HOW SUPPLIED



STORAGE AND HANDLING




REFERENCES




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Metronidazole

Metronidazole

Metronidazole

Metronidazole TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-970(NDC:0591-2522)
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
hydroxypropyl cellulose
ANHYDROUS LACTOSE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 16 mm WPI;39;70 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-970-04 14 in 1 BLISTER PACK
2 NDC:49349-970-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018764 2012-07-10


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