Patient Medication Information: uses, side effects, how to take - Doribax
ABOUT THIS MEDICATION
What the medication is used for:
DORIBAX® is used for the treatment of bacterial infections. Your doctor prescribed DORIBAX® to treat one of the following infections:
Pneumonia that occurs in a hospital or similar
setting including pneumonia that occurs when a patient is on a breathing machine
- Complicated abdominal infections
Complicated urinary tract infections, including
kidney infections and cases that have spread to the bloodstream
What it does:
DORIBAX® is an antibiotic that has the ability to kill a wide range of bacteria that cause infections. DORIBAX® inhibits bacterial cell wall growth, resulting in bacterial cell death in numerous bacteria which cause various infections.
When it should not be used:
You should not receive DORIBAX® if you:
- are allergic to doripenem,
are allergic to other $-lactam antibiotics such as
penicillins, cephalosporins or other carbapenems.
What the medicinal ingredient is:
Doripenem monohydrate
What the nonmedicinal ingredients are:
DORIBAX® contains no nonmedicinal ingredients.
What dosage forms it comes in:
DORIBAX® is supplied as a sterile powder in glass vials containing 500 mg of doripenem (as doripenem monohydrate) This powder is dissolved in solution to provide an intravenous infusion.
WARNINGS AND PRECAUTIONS
Serious and occasionally fatal allergic reactions (anaphylaxis) have been reported in patients taking other beta-lactam antibiotics such as penicillins and cephalosporins and could occur for DORIBAX®.
Seizures have occurred with the use of carbapenems, including DORIBAX®, especially in patients with a history of central nervous system disorders (e.g. stroke, seizure). These conditions should be considered before driving or operating machinery.
BEFORE you use DORIBAX®, talk to your doctor or pharmacist if you:
- have kidney disease so that your doctor can prescribe the correct dose of DORIBAX®
- are allergic to any drugs, including antibiotics,
have diarrhea during or after your treatment with
DORIBAX®. This is because you may have a condition known as colitis (an inflammation of the bowel).
- have a history of central nervous system disorders such as stroke or seizure.
are pregnant or planning to become pregnant.
- are breast-feeding or if you intend to breast-feed.
INTERACTIONS WITH THIS MEDICATION
You should tell your physician about all drugs that you are taking or planning to take.
Probenecid may interact with the actions of doripenem and should not be taken with DORIBAX®.
Valproic acid interacts with doripenem; therefore your doctor may prescribe another anti-seizure medication or prescribe another antibiotic.
PROPER USE OF THIS MEDICATION
Usual adult dose:
DORIBAX® will always be prepared and given to you by a doctor or another healthcare professional.
The usual dose of DORIBAX® is 500 mg given intravenously (into a vein) over a period of 1 or 4 hours every eight hours for 5 to 14 days, depending on the condition. Your doctor will decide for how long you should be treated. It is very important that you continue to receive DORIBAX® for as long as your doctor prescribes it.
Overdose:
If an overdose of DORIBAX® is suspected (even if there are no symptoms), talk to your doctor or another healthcare professional immediately. If DORIBAX® is administered to you outside a hospital environment, contact your hospital emergency department or your regional Poison Control Centre.
Missed dose:
If you are concerned that you have missed a dose of DORIBAX®, talk to your doctor or healthcare professional immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, DORIBAX® can cause side effects, although not everybody gets them. Should you experience any of the following side effects, please consult your doctor or pharmacist.
The most common side effects due to DORIBAX® include:
- headache
- nausea
- vomiting
- diarrhea
- rash
- itching or hives
- fungal infection (thrush) in mouth or vagina
- increase in level of some liver enzymes
- redness, pain, or swelling at the injection site.
The following serious side effects were observed:
- an irregular and fast heartbeat
- kidney problems (much more or less urination than usual, or no urination)
- low blood pressure (lightheadedness, dizziness, or fainting)
- a decrease of white blood cells (which may increase your risk of infection)
- seizures.
These are not all the side effects that have been reported with DORIBAX®. If you notice side effects not mentioned in this leaflet, or you have concerns about the side effects you are experiencing, please talk to your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
| Only if severe | In all cases | |||||
| Uncommon | Clostridium difficile colitis with symptoms such as severe (watery or bloody) diarrhea with or without fever, abdominal pain or tenderness | ✓ | ||||
| Liver problems (hepatitis or cholestasis with symptoms such as dark-coloured urine and pale stools, yellowing of skin and eyes (jaundice), stomach pain) | ✓ | |||||
| Rare | Convulsion or seizure | ✓ | ||
| Very rare | Serious allergic reactions (anaphylaxis), with symptoms such as severe rash, itching or hive on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing | ✓ | ||
| Very rare | Serious skin reactions: symptoms include widespread rash, itching, or hives, peeling of the skin, blisters on the skin, mouth, nose, eyes and genitals | ✓ |
This is not a complete list of side effects. For any unexpected effects while taking DORIBAX®, contact your doctor or pharmacist.
HOW TO STORE IT
The healthcare professional will store the dry powder at 15°-30°C.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345
$ Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals can be found at:
http://www.janssen.ca
or by contacting the sponsor, Janssen Inc., at:
1-800-567-3331 or 1-800-387-8781
Janssen Inc.
Toronto, Ontario M3C 1L9