Piperacillin /Tazobactam 2g / 0.25g
Piperacillin /Tazobactam 4g / 0.5g
Powder for Solution for Injection or Infusion
(Piperacillin/Tazobactam)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- The full name of this medicine is Piperacillin/ Tazobactam 2g/0.25g or 4g/0.5g Powder for Solution for Injection or Infusion but within the leaflet it will be referred to as Piperacillin/ tazobactam powder.
In this leaflet
1 What Piperacillin /Tazobactam Powder for Solution for Injection or Infusion is and what it is used for
2 Before you are given Piperacillin /tazobactam powder
3 How Piperacillin /tazobactam powder is given
4 Possible side effects
5 Storing Piperacillin/tazobactam powder
6 Further information
What Piperacillin /Tazobactam Powder for Solution for Injection or Infusion is and what it is used for
Piperacillin belongs to the group of medicines called broad-spectrum penicillin antibiotics, which can kill many types of bacteria. Tazobactam prevents some bacteria from resisting the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.
Piperacillin /tazobactam powder is used in adults to treat bacterial infections affecting your chest, urinary tract (kidneys and bladder), abdomen or skin.
Piperacillin /tazobactam powder is used in children aged 2-12 to treat bacterial infections in children with low white cell counts (reduced resistance to infections).
Before you are given Piperacillin /tazobactam powder
Do not use Piperacillin /tazobactam powder
- if you are allergic (hypersensitive) to piperacillin, other antibiotics called penicillins or cephalosporins, tazobactam or other medicines called beta-lactamase inhibitors.
Take special care with Piperacillin /tazobactam powder
- if you have allergies. If you have several allergies make sure you tell your doctor or nurse before receiving this product.
- if you are pregnant, think you may be pregnant, or are breast-feeding
- if you have low levels of potassium in your blood. Your doctor may want to perform regular blood tests during treatment
- if you have kidney or liver problems, or are receiving haemodialysis. Your doctor may want to check your kidneys
before you take this medicine, and may perform regular blood tests during treatment - if you are on a low sodium diet
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may interact with piperacillin and tazobactam. These include:
- Probenecid (for gout). This can increase the time it takes for piperacillin and tazobactam to leave your body.
- Medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
- Medicines used to relax your muscles during surgery. Tell your doctor if you are going to have a general anaesthetic.
- Methotrexate (for cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.
- Medicines that reduce the level of potassium in your blood (e.g. water tablets, or some medicines for cancer).
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are trying for a baby, tell your doctor or nurse before receiving this product.
Piperacillin and Tazobactam can pass to a baby in the womb or through breast milk. If you are pregnant or breast-feeding, your doctor will decide whether Piperacillin /tazobactam powder is right for you.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
However, side effects could occur which may influence your ability to drive or use machines (see section 4).
Important information about some of the ingredients of this product
Piperacillin /Tazobactam 2g / 0.25g Powder for Solution for Injection or Infusion
This medicinal product contains 4.7 mmol (or 108 mg) of sodium per vial of powder for solution for injection or infusion.
To be taken into consideration by patients on a controlled sodium diet.
Piperacillin /Tazobactam 4g / 0.5g Powder for Solution for Injection or Infusion
This medicinal product contains 9.4 mmol (or 216 mg) of sodium per vial of powder for solution for injection or infusion.
To be taken into consideration by patients on a controlled sodium diet.
How Piperacillin /tazobactam powder is given
Your doctor or nurse will give you this medicine by slow injection (for 3-5 minutes) or through a drip (for 20-30 minutes)
into one of your veins. The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.
Adults and children aged 2-12
The usual dose is 4g/0.5g piperacillin/tazobactam given every 8 hours. Your doctor may reduce the dose depending on how serious your infection is.
If you are unable to fight infections normally, the usual dose is 4g/0.5g piperacillin/tazobactam given every 6 hours at the same time as another antibiotic called an aminoglycoside, which is given into one of your veins. The two medicines should be given in separate syringes or drips.
In children, the doctor will calculate the dose depending on your child’s weight.
You will be given Piperacillin /tazobactam powder until the signs of infection have gone, and then, normally, for another 48 hours to make sure the infection has gone completely.
Children under 2 years of age
Piperacillin/tazobactam is not recommended for use in children below 2 years old due to insufficient data on safety.
If you have kidney problems
Your doctor may need to reduce the dose of Piperacillin/tazobactam powder or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.
If you are given more Piperacillin /tazobactam powder than you should
As you will be given Piperacillin /tazobactam powder by a doctor or nurse, you are unlikely to be given the wrong dose. However, if you experience bad side effects or think you have been given too much, tell your doctor immediately.
If you miss a dose of Piperacillin /tazobactam powder
If you think you have not been given a dose of Piperacillin/tazobactam powder, tell your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or healthcare professional.
Possible side effects
Like all medicines, Piperacillin /tazobactam powder can cause side effects, although not everybody gets them.
If any of the following happens, stop taking Piperacillin/tazobactam powder and tell your doctor or nurse immediately:
- Rare side effects (that affect less than 1 person in 1, 000):
- Severe allergic reaction (sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat), bloody diarrhoea.
- Very rare side effects (that affect less than 1 person in 10, 000):
- Peeling and blistering of the skin, mouth, eye and genitals.
The following side effects have also been reported:
Common side effects (affecting less than 1 in 10 patients but more than 1 in 100) are:
- diarrhoea
- nausea and vomiting
- skin rashes
Uncommon side effects (affecting less than 1 in 100 patients but more than 1 in 1000) are:
- thrush
- mild allergic reactions
- headache
- difficulty sleeping
- low blood pressure (felt as light-headedness)
- inflammation of the veins (felt as tenderness or redness in the affected area)
- constipation
- upset stomach
- jaundice (yellowing of the skin or whites of the eyes)
- mouth ulcers
- itching
- fever or hot flushes
- swelling or redness around the injection site
- changes in results of blood tests of kidney and liver function
- changes in the number of cells in the blood (red cells, white cells and platelets)
Rare side effects (affecting less than 1 in 1,000 patients but more than 1 in 10,000) are:
- unusual bruising and bleeding
- weakness
- hallucinations (seeing or hearing things)
- convulsions or twitching
- dry mouth
- flushed red skin
- abdominal pain
- increased sweating
- eczema and other skin problems
- joint and muscle pain
- kidney problems
- tiredness
- water retention (seen as swollen hands, ankles or feet).
There have been very rare reports (in less than 1 in 10,000 patients):
- low blood glucose levels which may make you confused and shaky
- reduced blood concentration of potassium which can cause muscle weakness, twitching or abnormal heart rhythm
Your doctor may want to perform tests during your treatment to measure any changes. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Storing Piperacillin/tazobactam powder
Keep out of the reach and sight of children.
Do not use Piperacillin /tazobactam powder after the expiry date which is stated on the carton and the vials after EXP. The expiry date refers to the last day of that month.
Powder: Store in the original package in order to protect from light.
Store below 25°C.
For single use only.
Discard any unused solution.
Reconstituted and/or diluted Piperacillin/tazobactam powder should be used immediately.
From a microbiological point of view, the product should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Piperacillin /tazobactam powder contains
The active substances are piperacillin and tazobactam.
Piperacillin /Tazobactam 2g / 0.25g Powder for Solution for Injection or Infusion
Each vial contains piperacillin sodium corresponding to 2 g piperacillin and tazobactam sodium corresponding to 0.25 g tazobactam.
Piperacillin /Tazobactam 4g / 0.5g Powder for Solution for Injection or Infusion
Each vial contains piperacillin sodium corresponding to 4 g piperacillin and tazobactam sodium corresponding to 0.5 g tazobactam.
There are no other ingredients.
What Piperacillin /tazobactam powder looks like and contents of the pack
Powder for solution for injection or infusion
White to off-white powder.
Piperacillin /tazobactam powder is supplied in packs of 1 vial and enclosed in a carton with a package leaflet.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in April 2010.
If you would like a leaflet with larger text, please contact 01271 311257.
AURPL005
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