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Details for: METRONIDAZOLE INJECTION USP

Company: PFIZER CANADA ULC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00649074METRONIDAZOLE INJECTION USPMETRONIDAZOLE5 MG / MLSOLUTIONINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Metronidazole Injection USP is used to:

  • Treat infections of the abdominal cavity, brain, or lung.
  • Prevent infections in patients having colorectal surgery.

Antibacterial drugs like Metronidazole Injection USP treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Metronidazole Injection USP should be used exactly as directed. Misuse or overuse of Metronidazole Injection USP could lead to the growth of bacteria that will not be killed by Metronidazole Injection USP (resistance). This means that Metronidazole Injection USP may not work for you in the future. Do not share your medicine.

What it does

Metronidazole Injection USP kills the bacteria that cause the infection.

When it should not be used

Do not use Metronidazole Injection USP and tell your doctor if you:

  • are allergic (hypersensitive) to metronidazole
  • are allergic (hypersensitive) to any of the nonmedicinal ingredients in the formulation (see “What the nonmedicinal ingredients are”) or components of the flexible container (PVC)
  • have a disease of the nervous system
  • have a history of blood-disorders, hypothyroidism (underactive thyroid gland) or hypoadrenalism (underactive adrenal gland)
What the medicinal ingredient is

Metronidazole

What the non-medicinal ingredients are

Citric Acid
Sodium Chloride
Dibasic Sodium Phosphate
Water for Injection

What dosage form it comes in

5 mg/mL sterile, solution

Warnings and precautions

BEFORE receiving Metronidazole Injection USP talk to your doctor, pharmacist, or nurse if you:

  • have other infections
  • have Cockayne Syndrome
  • have been consuming alcohol
  • have kidney problems
  • have liver problems
  • have an active or chronic severe disease of the nervous system
  • have any blood disorder (e.g., transient eosinophilia, leukopenia or other)
  • have a history of edema (swelling of the legs, ankles and/or feet)
  • are pregnant or plan to get pregnant
  • are breastfeeding, or plan to breastfeed, as metronidazole is excreted in human breast milk
  • are less than 18 years of age
Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with Metronidazole Injection USP:

  • Disulfram
  • Medicines used to thin the blood such as warfarin (Coumadin)
  • Phenobarbital or Phenytoin (Dilantin)
  • Vecuronium
  • Lithium
  • Busulfan (Myleran®)
  • 5-Fluorouracil

If you are not sure, talk to your doctor or pharmacist before using metronidazole.

Do not drink any alcohol while you are receiving Metronizadole Injection USP. Consumption of alcohol with metronizadole may cause headaches and flushing.

Proper use of this medication

Usual adult dose:

The appropriate dose is selected by the Health Care Professional and is administered through a vein.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss your scheduled infusion, contact your doctor or nurse as soon as possible to schedule your next treatment.

Side effects and what to do about them

Side effects may include:

  • Nausea, diarrhea, vomiting, constipation
  • Indigestion, loss of appetite
  • abdominal pain
  • dry mouth, furred tongue
  • unpleasant metallic taste
  • dark urine
  • painful urination
  • flushing
  • headaches
  • trouble sleeping, feeling tired
  • skin rash and itching

Metronidazole Injection USP can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist Only if severe Talk with your doctor, nurse, or pharmacist In all cases Stop taking drug and get immediate medical help
Allergic Reaction: rash, blisters, mouth sores, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, fever.    
Cardiac Disorders: Chest pain, unusually rapid, strong, or irregular heartbeat, difficulty breathing (Dyspnea)    
Eye disorders: blurred vision, vision loss    
Gastrointestinal disorders: Pancreatitis (inflammation of the pancreas) with symptoms such as severe abdominal pain which may reach through to your back, especially associated with nausea, vomiting and fatigue.
Stomach pain, diarrhea which can be bloody, fever
   
Nervous System Disorders:
inability to coordinate voluntary movements, problems using your arms and legs, feel confused, seizures, stiff neck associated with headache, dizziness, drowsiness and insomnia
   
Skin Disorders: Numbness, burning, tingling, pain in the hands and/or feet, sensitivity to touch    
Vaginal Yeast Infection: vaginal dryness, burning and discharge    
Muscular Disorders: Muscle spasms    
General Disorders and Administration Site Conditions: Injection site reaction, Malaise, Face edema, Edema peripheral, Chills, Pain, burning or swelling at the injection site.    

This is not a complete list of side effects. For any unexpected side effects while taking Metronidazole Injection USP, contact your doctor, nurse, or pharmacist.

How to store

Store at room temperature (20C to 25C), and protect from light and freezing.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pfizer Canada Inc., at 1-800-463-6001.

This leaflet was prepared by:

Pfizer Canada Inc.
Kirkland, Québec H9J 2M5

Last revised: September 18, 2018

Date modified: