Piperacillin/Tazobactam 4 G/0.5 G Powder For Solution For Infusion
Package leaflet: Information for the user
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion Piperacillin/T azobactam
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is and what it is used for
2. What you need to know before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
4. Possible side effects
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
6. Contents of the pack and other information
1. What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is and what it is used for
Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”. It can kill many kinds of bacteria. Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is used in children aged 212 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
In certain serious infections, your doctor may consider using Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion in combination with other antibiotics.
2. What you need to know before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Do not use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion:
- If you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6)
- If you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
- If you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product.
- If you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor.
- If you have low levels of potassium in your blood. Y our doctor may want to check your kidneys before you take this medicine and may 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 taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Other medicines and Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately.
- If you develop convulsions during the treatment. In this case, you should inform your doctor or other healthcare professional.
- If you think you developed a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.
Children below 2 years
Piperacillin / tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness.
Other medicines and Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may interact with piperacillin and tazobactam.
These include:
- medicine for gout (probenecid ). 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.
- methotrextate (medicine used to treat 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. tablets enhancing urination or some medicines for cancer).
- medicines containing the other antibiotics tobramycin or gentamycin. Tell your doctor if you have kidney problems.
Effect on laboratory tests
Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion if you have to provide a blood or urine sample.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine. Your doctor will decide if Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is right for you.
Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If you are breast-feeding, your doctor will decide if Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is not expected to affect the ability to drive or use machines.
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion contains sodium This medicinal product contains 9.44 mmol (217 mg) of sodium per vial of powder for solution for infusion. This should be taken into consideration if you are on a controlled sodium diet.
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Your doctor or other healthcare professional will give you this medicine through an infusion (a drip for 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.
Use in adults and adolescents aged 12 years or older
The usual dose for adults is 4 g/0.5 g piperacillin/tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).
Use in children aged 2 to12 years
The usual dose for children with abdominal infections is 100 mg / 12.5 mg / kg of body weight of piperacillin / tazobactam given every 8 hours into one of your veins (directly into the blood stream). The usual dose for children with low white blood cell counts is 80 mg / 10 mg / kg of body weight of piperacillin / tazobactam given every 6 hours into one of your veins (directly into the blood stream).
Your doctor will calculate the dose depending on your child’s weight but the daily dose will not exceed 4 g / 0.5 g of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion.
You will be given Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion until the sign of infection has gone completely (5 to 14 days).
Patients with kidney problems
Your doctor may need to reduce the dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for 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 receive more Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion than you should
As you will receive Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion from a doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions, or think you have been given too much, tell your doctor immediately.
If you miss a dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion If you think you have not been given a dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion, tell your doctor or other healthcare professional immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
The serious side effects of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion are:
- swelling of the face, lips, tongue or other parts of the body
- shortness of breath, wheezing or trouble breathing
- severe rash, itching or hives on the skin
- yellowing of the eyes or skin
- damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)
If you notice any of the above, see a doctor straight away. For frequency of these reactions, refer to the information below.
Possible side effects are listed according to the following categories:
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
Common side effects:
- diarrhoea, vomiting, nausea
- skin rashes
Uncommon side effects:
- thrush
- (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia)
- allergic reaction
- headache, sleeplessness
- low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)
- jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset
- increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased)
- itching, nettle rash
- increase of muscle metabolism product in the blood (blood creatinine increased)
- fever, injection site reaction
- yeast infection (candidal superinfection)
Rare side effects:_
- (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia)
- severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock)
- flushed red skin
- a certain form of infection of the colon (pseudomembranous colitis), abdominal pain
- inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gamma-glutamyltransferase increased)
- skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis)
- joint and muscle pain
- poor kidney functions and kidney problems
- rigors chill / rigidity
Very rare side effects:
- severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia)
- prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia)
- decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein
- detachment of the top layer of the skin all over the body (toxic epidermal necrolysis), serious bodywide allergic reaction with skin and mucous lining rashes and various skin eruptions (Stevens-Johnson Syndrome)
- blood urea nitrogen increased
Piperacillin therapy has been associated with an increased incidence of fever and rash in
cystic fibrosis patients.
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”. The expiry date refers to the last day of that month.
Unopened vials: Do not store above 25°C.
For single use only. Discard any unused solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion contains
- The active substances are piperacillin and tazobactam.
Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
- There are no other ingredients.
What Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion looks like and the contents of the pack
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion comes in packs containing one small bottle of powder which must be dissolved into a solution before it is given to you by infusion (a slow ‘drip’) into your vein.
Packs containing 1 vial; 10 vials (clinical package); 50 vials (clinical package); 100 vials (clinical package).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder Laboratorio Reig Jofre S.A.
Gran Capitan, 10
08970 Sant Joan Despi - Barcelona Spain
Manufacturer Laboratory Reig Jofre SA C/ Jarma S/n Pol.Ind 45007, Toledo Spain
This leaflet was last revised in April 2014
The following information is intended for healthcare professionals only:
Instructions for use
Piperacillin/Tazobactam will be given by intravenous infusion (a drip for 30 minutes). Intravenous use
Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved.
|
Content of vial |
Volume of solvent* to be added to vial |
|
2 g / 0.25 g (2 g piperacillin and 0.25 g tacobactam) |
10 ml |
4 g / 0.5 g (4 g piperacillin and 0.5 g tacobactam)_
20 ml
* Compatible solvents for reconstitution:
-0.9% (9 mg/ml) sodium chloride solution for injection -Sterile water for injections -Glucose 5%
The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.
The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:
-0.9% (9 mg/ml) sodium chloride solution for injection -Glucose 5%
-Sterile water for injections -Dextran 6% in 0.9% sodium chloride
Incompatibilities
Whenever piperacillin/tazobactam is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.
Piperacillin/tazobactam should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Piperacillin/tazobactam should be administered through an infusion set separately from any other substances unless compatibility is proven.
Due to chemical instability, piperacillin/tazobactam should not be used in solutions that contain sodium bicarbonate.
Lactated Ringer's (Hartmann’s) solution is not compatible with piperacillin/tazobactam. Piperacillin/tazobactam should not be added to blood products or albumin hydrolysates.