Metronidazole Injection

Name: Metronidazole Injection

How supplied

Metronidazole Injection, USP RTU is supplied in 100 mL single dose plastic containers, each containing an iso-osmotic, buffered solution of 500 mg metronidazole as follows:

2B3421 -NDC 0338-1055-48 -500 mg/100 mL

Store at controlled room temperature, 59° to 86°F (15° to 30°C) and protect from light during storage. Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Directions For Use Of Viaflex Plus Plastic Container

Metronidazole Injection, USP RTU is a ready-to-use iso-osmotic solution. No dilution or buffering is required. Do not refrigerate. Each container of Metronidazole Injection, USP RTU contains 14 mEq of sodium.

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for leaks. Do not add supplementary medication.

Preparation for Administration
  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

REFERENCES

3. Ralph, E.D. and Kirby, W.M.M.: Bioassay of Metronidazole with Either Anaerobic and Aerobic Incubation, J. Infect. Dis. 132:587-591 (Nov.) 1975; or Gulaid, et al.: Determination of Metronidazole and its Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography. BR.J.Clin. Pharmacol. 6:430-432, 1978.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Rev. April, 2011

Warnings

Central And Peripheral Nervous System Effects

Encephalopathy and peripheral neuropathy: Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole.

Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.

Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.

Convulsive seizures have been reported in patients treated with metronidazole.

Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.

The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in balance.
  • Dizziness or passing out.
  • Trouble speaking.
  • Seizures.
  • Change in eyesight.
  • Feeling irritable.
  • Low mood (depression).
  • Feeling tired or weak.
  • Not able to sleep.
  • Redness or white patches in mouth or throat.
  • Some people who took this medicine for a long time have had nerve problems that lasted for a long time. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal.
  • This medicine may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
  • Pain and irritation where metronidazole injection goes into the body.
  • Swelling in the feet or hands.

References

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved StandardEighth Edition. CLSI Document M11-A8, CLSI, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087-1898 USA, 2012. 2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI Document M100-S25, CLSI, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087-1898, USA, 2015.

Manufactured by
Hospira, Inc., Lake Forest, IL 60045 USA

N+ and NOVAPLUS are registered trademarks of Vizient, Inc.

PRINCIPAL DISPLAY PANEL - 5 mg/mL Bag Label

TO OPEN – TEAR AT NOTCH

NDC 0409-7811-09
One Unit

METRONIDazole
Injection, USP
500 mg/100 mL (5 mg/mL)

Rx only

Each mL contains metronidazole 5 mg; sodium chloride 7.9 mg; dibasic sodium
phosphate, anhydrous 0.48 mg; citric acid, anhydrous 0.23 mg. Sodium 14 mEq/100 mL.
314 mOsmol/liter (CALC.). pH 5.8 (4.5 to 7.0).

ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION

DO NOT REFRIGERATE

Single-dose container. For I.V. use. Usual dose: See insert. Sterile, nonpyrogenic.
Protect from light. Use only if solution is clear. After removing the overwrap, check
for minute leaks by squeezing container firmly. If leaks are found, discard unit as
sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for
use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See
USP Controlled Room Temperature.] Protect from freezing. See insert.

F WR-0431

Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA
N+ and NOVAPLUS are registered trademarks of Novation, LLC.
NOVAPLUS®

Im-3541

METRONIDAZOLE 
Metronidazole Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-7811
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 500 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 790 mg  in 100 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 48 mg  in 100 mL
ANHYDROUS CITRIC ACID 23 mg  in 100 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:0409-7811-10 24 POUCH in 1 CASE
1 1 BAG in 1 POUCH
1 NDC:0409-7811-09 100 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018890 03/16/2016
Labeler - Hospira, Inc. (141588017)
Revised: 06/2017   Hospira, Inc.
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