Details for: METRONIDAZOLE INJECTION USP
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00649074 | METRONIDAZOLE INJECTION USP | METRONIDAZOLE | 5 MG / ML | SOLUTION | INTRAVENOUS |
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
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.
| 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 (20C to 25C), 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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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