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Piperacillin / Tazobactam

What Piperacillin/Tazobactam 2g/0.25g 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 2g/0.25g Powder for Solution for Injection or Infusion is used in adults to treat bacterial infections affecting your chest, urinary tract (kidneys and bladder), abdomen or skin.
  • Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion 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 2g/0.25g Powder for Solution for Injection or Infusion

Do not use Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion

  • 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 2g/0.25g Powder for Solution for Injection or Infusion

  • 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 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 2g/0.25 g Powder for Solution for Injection or Infusion 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

This medicinal product contains 4.72 mmol (109 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 2g/0.25g Powder for Solution for Injection or Infusion 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 2g/0.25g Powder for Solution for Injection or Infusion 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 2g/0.25g Powder for Solution for Injection or Infusion 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 2g/0.25g Powder for Solution for Injection or Infusion than you should

As you will be given Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion 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 Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion

If you think you have not been given a dose of Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion, 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  2g/0.25g  Powder  for   Solution  for Injection or Infusion can cause side effects, although not everybody gets them.

If any of the following happens, stop taking Piperacillin/Tazobactam 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) of:

  • 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.

How to store Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion

Keep out of the reach and sight of children.

Do not use Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion after the expiry date which is stated on the vial label and carton.

The expiry date refers to the last day of that month.

Powder:

This medicinal product does not require any special temperature storage conditions.

Keep the vials in the outer carton.

Further information

What Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion contains

Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt)

There are no other ingredients.

What Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion looks like and contents of the pack

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion is a white to off-white powder for solution for injection or infusion packaged in glass vials, packed in cartons containing 1 or 12 vials.

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion

This is an extract from the Summary of Product Characteristics to assist in the administration of Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SmPC.

For Slow Intravenous Injection and Slow Intravenous Infusion

Incompatibilities with diluents and other medicinal products

Lactated Ringer’s solution is not compatible with Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion.

When used concurrently with another antibiotic (e.g. aminoglycosides), Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion must be administered separately. Mixing with an aminoglycoside in vitro can cause inactivation of the aminoglycoside.

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion should be administered through an infusion set separately from any other drugs unless compatibility is proven.

Due to chemical instability, Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion should not be used in solutions that contain sodium bicarbonate.

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion should not be added to blood products or albumin hydrolysates.

Reconstitution Directions

Intravenous Injection

Each vial of Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion should be reconstituted with 10ml of one of the following diluents:

Sterile Water for Injection

9 mg/ml (0.9%) Sodium Chloride for Injection

Swirl until dissolved.

Intravenous injection should be given over at least 3-5 minutes.

Intravenous Infusion

Each vial of Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Injection or Infusion should be reconstituted with 10ml of one of the following diluents:

Sterile Water for Injection

9 mg/ml (0.9%) Sodium Chloride for Injection

The reconstituted solution should be further diluted to at least 50ml with one of the reconstitution diluents, or with Dextrose 5% in Water.

Intravenous infusion should be given over 20-30 minutes.

For single use only. Discard any unused solution.

The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.

Any unused product or waste material should be disposed of in accordance with local requirements.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep vial(s) in outer carton.

After reconstitution, chemical and in-use stability has been demonstrated for 24 hours when stored in a refrigerator at 2-8°C

From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C,  unless reconstitution has taken place in  controlled and validated aseptic conditions.

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