Doripenem monohydrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DORIBAX. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given DORIBAX against the benefits this medicine is expected to have for you.
If you have any concerns about being given this medicine, ask your doctor.
Keep this leaflet while being treated. You may need to read it again.
What DORIBAX is used for
DORIBAX belongs to a class of antibiotics called carbapenems. It works by killing the bacteria (germs) that cause infections in various parts of the body.
These infections include:
- pneumonia (lung infection) that occurs in a hospital or similar setting including pneumonia that occurs when on a breathing machine
- complicated abdominal (stomach) infections
- complicated infections of the urinary tract including kidney and bladder infections, and cases that may have spread to the bloodstream.
DORIBAX will not work against infections caused by a bacteria known as methicillin resistant Staphylococcus aureus (MRSA). It will also not work against infections caused by viruses such as colds or the flu.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is available only with a doctor’s prescription.
Before DORIBAX is given
When DORIBAX must not be given
You must not be given the medicine if you have an allergy to:
- doripenem, the active ingredient in the medicine
- other antibiotics such as penicillins, cephalosporins or carbapenems.
Symptoms of an allergic reaction may include rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before the medicine is given:
Tell your doctor if you have or have had any medical conditions, especially the following:
- kidney disease. It is particularly important that your doctor knows if there is anything wrong with your kidneys or if you undergo or have undergone dialysis treatment
- allergies to any medicines, including antibiotics
- a stroke or history of seizures
- diarrhoea before, during or after your treatment with the medicine. This is because you may have a condition known as colitis (an inflammation of the bowel). Do not take any medicine to treat diarrhoea without first checking with your doctor.
- any other stomach problems.
You must tell your doctor if you:
- are pregnant or planning to become pregnant. DORIBAX is not recommended for use during pregnancy. However, if there is a need to consider using it during pregnancy, your doctor will discuss the possible risks and benefits to you and your unborn baby.
- are breastfeeding or wish to breastfeed. It is not known whether DORIBAX passes into breast milk. Therefore there is a possibility that the breast-fed baby may be affected. Your doctor will discuss the possible risks and benefits of using this medicine while breastfeeding.
If you have not told your doctor about any of the above, tell them before you start treatment with the medicine.
The medicine must not be given beyond the expiry date (month and year) printed on the pack.
The medicine must not be given to children or adolescents (under 18 years of age).
Taking other medicines:
Tell your doctor if you are taking or have recently taken any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking any of the following:
- valproic acid, a medicine used to treat epilepsy or mania
- probenecid, a medicine used to treat gout.
These medicines may be affected by DORIBAX or may affect how well it works. Your doctor can tell you what to do if you are using any of these medicines.
Treatment with DORIBAX
Your treatment with DORIBAX will take place in a hospital.
How much is given:
Your doctor will decide what dose you will receive and how long you should be treated. The usual dose is 500mg given every 8 hours.
How it is given:
The medicine will always be prepared and given to you as an infusion into a vein by a doctor or nurse. Your doctor or nurse can explain how the solution for infusion is prepared.
If a dose of DORIBAX is missed
If you are concerned that you have missed a dose of the medicine, talk to your doctor or nurse. It is important that you receive treatment with it as long as your doctor feels it is necessary.
If you have received too much (overdose)
As the medicine is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. Your doctor or nurse will be closely observing you during this time. Talk to your doctor or nurse immediately if you are concerned that you may have been given too much of this medicine.
If at some later time you feel really unwell and you think this medicine may be responsible, immediately telephone your doctor or the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital.
Poisons Information Centre telephone numbers:
- Australia: 13 11 26
- New Zealand: 0800 POISON or 0800 764 766.
Keep these telephone numbers handy.
While you are given DORIBAX
Things you must do
- Always follow your doctor’s instructions carefully
- If you are about to start taking a new medicine, tell your doctor and pharmacist that you are receiving DORIBAX.
Things you must not do
- Do not recommend this medicine to anyone else, even if their symptoms seem similar to yours.
Side Effects
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following and they worry you:
- nausea
- indigestion
- inability to sleep
- constipation
- stomach pain or discomfort
- back pain
- nervousness or feeling anxious
- dizziness
- vomiting
- constipation
- headache
- rash
- swelling of hands, ankles or feet
- thrush or fungal infection of the mouth characterised by sore, cream-yellow, raised patches in the mouth
- infection of the female genitals with vaginal discharge
Tell your doctor as soon as possible if you have any of the following as you may need medical attention:
- increase in some liver test enzymes
- high blood pressure, characterised by blurred vision
- low blood pressure, characterised by dizziness or lightheadedness
- low potassium levels in the blood
- bed sore, a skin ulcer that comes from lying in one position too long
- shortness of breath or difficulty in breathing
- diarrhoea
- infection that affects any part of the urinary tract
- fever or high temperature
Tell your doctor immediately if you notice any of the following:
- diarrhoea, usually with blood and mucus, stomach pain, fever
- a condition in which there is a decreased number of red blood cells characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale (anaemia)
- a condition in which there is a lack of white blood cells characterised by frequent infections such as fever, severe chills, sore throat or mouth ulcers (neutropenia)
- a condition in which there is low blood platelet count leading to bleeding or bruising more easily than normal (thrombocytopenia)
- signs of allergy such as rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body
- severe skin reaction that starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell
- rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
- swelling and redness along a vein which is extremely tender when touched
- fits or convulsions.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
Product Description
Storage
DORIBAX is stored at a temperature below 25°C.
What it looks like:
DORIBAX is a white to slightly yellowish off-white powder in a glass vial.
Each pack contains 10 single-use vials.
Before injection, the powder is dissolved in a small quantity of Sterile Water for Injection or Normal Saline and is shaken to form a suspension. The suspension is then added to an infusion bag containing Normal Saline or 5% Dextrose and is mixed to complete dissolution.
Ingredients
The active ingredient is 500mg doripenem monohydrate.
There are no inactive ingredients.
Sponsor
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
North Ryde NSW 2113 Australia
Telephone: 1800 226 334
This leaflet was prepared in April 2013.
TGA registration number:
AUST R 148517
DORIBAX® is a registered trademark of Ortho-McNeil Janssen Pharmaceuticals Inc.
Published by MIMS June 2013