Patient Medication Information: uses, side effects, how to take - Meropenem for Injection USP (Pfizer Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Meropenem for Injection USP is used to treat bacterial infections which may occur in the lungs, bladder and kidneys, abdomen, skin, brain (meningitis), female reproductive organs (including infections which may occur after child birth) and infections of the blood which may include the whole body.
Antibacterial drugs like Meropenem for Injection USP treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, Meropenem for Injection USP should be used exactly as directed. Misuse or overuse of Meropenem for Injection USP could lead to the growth of bacteria that will not be killed by Meropenem for Injection USP (resistance). This means that Meropenem for Injection USP may not work for you in the future.
What it does:
Meropenem for Injection USP prevents the formation of the bacterial cell wall, leading to bacterial death and a reduction in the infection.
When it should not be used:
If you are allergic to Meropenem or any of the other ingredients of Meropenem for Injection USP.
What the medicinal ingredient is:
Meropenem (as meropenem trihydrate)
What the important nonmedicinal ingredients are: Sodium carbonate
What dosage forms it comes in:
Meropenem for Injection USP is available as an injection for intravenous use (into a large vein) containing either 500 mg or 1 g of meropenem.
Meropenem for Injection USP comes in clear, glass vial containers.
WARNINGS AND PRECAUTIONS
| BEFORE you use Meropenem for Injection USP, talk to your doctor or pharmacist if you: | ||
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While being treated with Meropenem for Injection USP:
- tell your doctor immediately if you develop a severe skin rash or blisters.
- Your injection must not be mixed with or added to solutions containing other drugs.
Meropenem for Injection USP is not recommended for children under 3 months of age.
- Meropenem for Injection USP should only be given to the patients for whom it has been prescribed.
You should only stop receiving Meropenem for
Injection USP when your doctor tells you.
Driving and using machines:
Meropenem for Injection USP has been associated with adverse effects such as headache and involuntary muscle movements, shaking or convulsions that could result in loss of consciousness. Do not drive or operate machinery if you have these symptoms.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist about any other medicines you are taking including probenecid (for gout) or sodium valproate (antiepileptic).
PROPER USE OF THIS MEDICATION
Usual dose:
Meropenem for Injection USP will be given to you by your doctor or a nurse.
Intravenous injection: this will be dissolved in the liquid specified by your doctor and will be given to you intravenously (in the vein) by the healthcare professional.
The exact dose you are given will be decided by your doctor. It will vary depending on the type of infection that you have, where the infection is in the body and the severity of the infection.
Adults
The dose for adults is usually 500 mg to 1 g given every 8 hours. For meningitis (infection of the brain), the dose is 2 grams given every 8 hours.
The dose for children over 3 months old and up to 12 years of age is decided using the weight of the child. The usual dose range is 10 to 40 mg of Meropenem for Injection USP for each kilogram of body weight given every 8 hours.
The dose of Meropenem for Injection USP may need to be reduced if your kidneys are not working properly.
Your injections should normally be given at the same times each day.
Overdose:
If you are accidentally given more than the prescribed dose, you should talk to a doctor or pharmacist immediately.
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you feel an injection was missed during treatment, talk to your (attending) healthcare professional.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Meropenem for Injection USP can have side effects.
Common side effects include: inflammation at site of injection, nausea, vomiting, diarrhoea, skin rash, itchiness, headache, and tingling.
Other side effects include: sore veins where Meropenem for Injection USP is injected, fungal infections of the mouth or the vagina, rare allergic reactions and very rarely damage to red blood cells. Signs of this include unexpected breathlessness and/or red/brown urine, and should be reported to your doctor immediately.
Occasionally Meropenem for Injection USP may be associated with changes in your blood which may require your doctor to do certain blood tests.
Convulsions have been reported very occasionally.
Do not be alarmed by this list of possible events. You may not have any of them.
If you notice any side effects whilst using Meropenem for Injection USP, please inform your doctor or pharmacist.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking Meropenem for
Injection USP and contact your healthcare professional immediately.
| SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT | |||||
| THEM | |||||
| Symptom / Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help* | |||
| Only if severe | In all cases | ||||
| Common | |||||
| n/a | |||||
| Uncommon | |||||
Serious hypersensitivity and allergic reactions, occasionally fatal, with symptoms such as severe rash with or without high fever, with itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing | √ | ||||
| Seizures | √ | ||||
Inflammation of the colon caused by a bacteria, Clostridium (Pseudomembranous colitis ) | √ | ||||
Severe skin reactions like erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever.) | √ | ||||
| Not Known | |||||
Serious hypersensitivity reactions involving fever, skin rash, enlarged lymph nodes, and changes in blood tests (increased liver enzymes and white blood cells†). These may be signs of a multi-organ sensitivity disorder known as DRESS or of a skin reaction known as AGEP. | √ | ||||
*If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.
†These would only be seen if a blood test was done.
This is not a complete list of side effects. For any unexpected effects while taking Meropenem for Injection USP, contact your doctor or pharmacist.
HOW TO STORE IT
The healthcare professional will store, prepare, dispense, administer and dispose of the medication. Before vials are prepared, the medication should be stored at 15°C to 30°C and not frozen.
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
NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.
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.
Pfizer Canada Inc., Kirkland, Québec H9J 2M5