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metronidazole injection, USP NDC 0409-7811-XX

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metronidazole injection, USP NDC 0409-7811-XX Quick Finder

WARNING

Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS). Unnecessary use of...

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INDICATIONS AND USAGE

Treatment of Anaerobic Infections

Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible...

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DOSAGE AND ADMINISTRATION

In elderly patients the pharmacokinetics of metronidazole may be altered and, therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

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CONTRAINDICATIONS

Hypersensitivity

Metronidazole Injection, USP is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives....

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WARNINGS

Hypersensitivity Reactions

Hypersensitivity reactions including toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), drug reaction with...

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ADVERSE REACTIONS

The following reactions have been reported during treatment with metronidazole injection:

Central Nervous System

The most serious adverse reactions reported in patients...

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OVERDOSAGE

Use of dosages of intravenous metronidazole hydrochloride higher than those recommended has been reported. These include the use of 27 mg/kg three times a day for 20 days, and the use of 75 mg/kg as a single...

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DESCRIPTION

Metronidazole Injection, USP is a sterile, nonpyrogenic, isotonic, buffered parenteral dosage form of metronidazole in water for injection.

Each 100 mL contains metronidazole 500 mg (5 mg/mL) and sodium...

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CLINICAL PHARMACOLOGY

In patients treated with metronidazole injection using a dosage regimen of 15 mg/kg loading dose followed six hours later by 7.5 mg/kg every six hours, the average peak steady-state concentrations (C...

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HOW SUPPLIED

Metronidazole Injection, USP, sterile, is supplied in 100 mL single dose flexible containers, each containing 500 mg (5 mg/mL) of metronidazole (List 7811).

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Injection, USP

500 mg (5 mg/mL)

Single Dose Container...

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