Piperacillin (as sodium) 4 g and tazobactam (as sodium) 500 mg powder for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PipTaz-AFT 4 g/0.5 g. 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 taking PipTaz-AFT 4 g/0.5 g against the benefits this medicine is expected to have for you.
If you have any questions about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What PipTaz-AFT 4 g/0.5 g is used for
The name of your medicine is PipTaz-AFT 4 g/0.5 g. It contains the active ingredients piperacillin and tazobactam. They belong to a group of antibiotics called penicillins that work by killing bacteria.
Piperacillin is an antibiotic that kills many types of bacteria. Tazobactam belongs in the penicillin group but does not have activity against bacteria. It helps piperacillin to overcome bacteria which have become resistant to piperacillin.
PipTaz-AFT 4 g/0.5 g is active against bacteria which cause serious infections such as: –
- Chest infections
- Urine infections
- Stomach infections
- Skin infections
- Gynaecological infections
- Septicaemia (blood poisoning).
It is also used to treat many other infections.
In hospitalised children aged 2 to 12 years, PipTaz-AFT 4 g/0.5 g is used to treat serious infections in the abdomen. PipTaz-AFT 4 g/0.5 g is not recommended to treat abdominal infections in children under 2 years.
PipTaz-AFT 4 g/0.5 g will not work against infections caused by viruses such as colds or flu.
This medicine is available only with a doctor’s prescription.
PipTaz-AFT 4 g/0.5 g is not addictive.
Before you are given PipTaz-AFT 4 g/0.5 g
When you must not be given PipTaz-AFT 4 g/0.5 g
You should not be given PipTaz-AFT 4 g/0.5 g if:
- You have ever had an allergic reaction to:
- piperacillin, tazobactam, or any other penicillin antibiotics
- any antibiotic in the cephalosporin group
- medicines called beta-lactamase inhibitors.
Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
- PipTaz-AFT 4 g/0.5 g should not be given to children under two years of age unless directed by the child’s doctor.
Before you start to receive PipTaz-AFT 4 g/0.5 g
You must tell your doctor if:
- you are allergic to any foods, dyes, preservatives or any other medicines
- you have any other health problems, including kidney or liver disease. The dose of PipTaz-AFT 4 g/0.5 g will be altered, depending on blood tests.
- you are on a low salt diet
- you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of using PipTaz-AFT 4 g/0.5 g if you are pregnant.
- you are breastfeeding. PipTaz-AFT 4 g/0.5 g passes into breast milk. Therefore, if you are breastfeeding, you should discuss with your doctor whether to stop breastfeeding while or stop using PipTaz-AFT 4 g/0.5 g.
- you are being treated with PipTaz-AFT 4 g/0.5 g for gonorrhoea, your doctor should test you for syphilis as well. PipTaz-AFT 4 g/0.5 g in high doses may hide early symptoms of syphilis without curing it long-term.
If you are not sure whether you should be taking PipTaz-AFT 4 g/0.5 g, talk to your doctor.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
There may be interference between PipTaz-AFT 4 g/0.5 g and some other medicines, including:
- medicines for gout (probenicid)
- aminoglycoside antibiotics, including tobramycin
- vancomycin, an antibiotic
- preparations used for thinning blood (warfarin, heparin)
- methotrexate, used to treat cancer, rheumatoid arthritis and other inflammatory conditions
- vecuronium, a muscle relaxant used in surgery
These medicines may be affected by PipTaz-AFT 4 g/0.5 g or may affect how well it works. You may need to be given different amounts of your medicine or you may need to be given different medicines.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking PipTaz-AFT 4 g/0.5 g.
How PipTaz-AFT 4 g/0.5 g will be given to you
How much you will be given
The dosage of PipTaz-AFT 4 g/0.5 g is generally 4.5 g every eight hours. The dose may vary between 2.25 g and 4.5 g and it may also be given every six hours. For children aged 2 to 12 years, weighing up to 40 kg, and with normal kidney function, the recommended dosage is 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) every 8 hours. For children aged 2 to 12 years, weighing over 40 kg, and with normal kidney function, the recommended dose is 4.5 g (4 g piperacillin/0.5 g tazobactam) every 8 hours.
Your doctor may change these dosages.
If you have kidney disease your doctor will adjust the dose to suit you.
How PipTaz-AFT 4 g/0.5 g will be given
PipTaz-AFT 4 g/0.5 g will be given to you by a doctor or nurse in hospital. It will usually be given to you as a slow injection into a vein over 20-30 minutes.
How long you will be given PipTaz-AFT 4 g/0.5 g
The length of time you will be given PipTaz-AFT 4 g/0.5 g depends on the type and severity of your infection. It should be given for at least five days, and for 48 hours after all signs of illness and fever have gone.
Overdose
It is unlikely that you will ever receive an overdose of PipTaz-AFT 4 g/0.5 g because it will be given by a trained nurse or doctor.
While you are being given PipTaz-AFT 4 g/0.5 g
If you are given PipTaz-AFT 4 g/0.5 g for a prolonged time, your doctor may wish to do some blood tests. Sometimes blood disorders can occur if you take PipTaz-AFT 4 g/0.5 g.
If a doctor asks you for a urine sample, tell them that you are receiving PipTaz-AFT 4 g/0.5 g. Antibiotics in the penicillin family, including PipTaz-AFT 4 g/0.5 g, can cause interference in some tests for glucose in urine. Penicillins that are excreted in urine can cause a false-positive result. The doctor will request a test, which is not affected by penicillins.
Things you must do
If you develop severe diarrhoea, tell your doctor immediately. Do this even if it occurs several weeks after stopping PipTaz-AFT 4 g/0.5 g. This may be a sign of a serious side effect that affects the bowel. You may need urgent medical care. Do not take any medicines to treat this diarrhoea without checking with your doctor.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PipTaz-AFT 4 g/0.5 g.
PipTaz-AFT 4 g/0.5 g is effective in most people, but may have unwanted side effects in some. 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 of the side effects.
The more common side effects are:
- nausea or indigestion
- vomiting
- diarrhoea or constipation
- rash, itchy or red skin
- allergic reactions such as hives (urticaria)
- a new infection caused by bacteria that are resistant to PipTaz-AFT 4 g/0.5 g (superinfection)
- difficulty sleeping
- headache, dizziness or light-headedness
Rare side effects are:
- increased sweating
- eczema
- severe skin reactions
- inflammation of the mouth
- dry mouth
- weakness and tiredness
- hallucinations
- muscle or joint pain or prolonged muscle relaxation
- fever
- hot flushes
- swelling of the hands, feet and ankles
- swelling or redness along a vein which is extremely tender when touched
- changes in liver function including jaundice (yellowing of skin and eyes) or hepatitis
- injection site pain or inflammation
- severe diarrhoea caused by a certain superinfection in the gut
- convulsions (‘fits’) if PipTaz-AFT 4 g/0.5 g is given in high doses
- short-term changes in kidney function
- thrush, especially with prolonged treatment.
Less often, serious effects have occurred in people taking PipTaz-AFT 4 g/0.5 g.
Tell your doctor immediately if you notice any of the following:
- tiredness, being short of breath and looking pale
- frequent infections such as fever, severe chills, sore throat or mouth ulcers
- bleeding or bruising more easily than normal, nose bleeds.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything on this list or anything else that is making you feel unwell.
Importantly, tell your doctor if you have severe diarrhoea in the next few weeks after PipTaz-AFT 4 g/0.5 g treatment. Do not try to treat it yourself with medicines that you can buy without a prescription.
Ask your doctor or pharmacist if you do not understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using PipTaz-AFT 4 g/0.5 g
Storage
It is unlikely that you will be asked to store this medication. If you are:
Keep this medicine where young children cannot reach it. A locked cupboard at least 1 and a half metres above the ground is a good place to store medicines.
Keep PipTaz-AFT 4 g/0.5 g in a cool, dry place where it stays below 25°C. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking PipTaz-AFT 4 g/0.5 g, or it has passed its expiry date, ask your pharmacist what to do with any left over.
Product Description
What it looks like
PipTaz-AFT 4 g/0.5 g is a white powder in glass vials. It comes in packs of 1 and 10 vials.
AUST R 241172.
The powder is mixed with a sterile liquid by your doctor or nurse to produce a solution for injection.
Ingredients
PipTaz-AFT 4 g/0.5 g vials contain piperacillin sodium equivalent to 4 g piperacillin and tazobactam sodium equivalent to 500 mg (0.5 g) tazobactam.
Distributor
AFT Pharmaceuticals Pty Ltd
Suite 3, 113 Wicks Road
North Ryde
NSW 2113
Date of preparation
This leaflet was prepared on 22 November 2017.
Published by MIMS February 2018