Piperacillin/Tazobactam 2 G/0.25 G Powder For Solution For Injection Or Infusion.
Package leaflet: Information for the user Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
piperacillin/tazobactam
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 or healthcare professional.
- If you get any of the side effects, talk to your doctor or healthcare professional. This includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Piperacillin/Tazobactam is and what it is used for
2. What you need to know before you are given Piperacillin/Tazobactam
3. How Piperacillin/Tazobactam is given
4. Possible side effects
5. How to store Piperacillin/Tazobactam
6. Contents of the pack and other information
1. What Piperacillin/Tazobactam 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. Tazobactam 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 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 may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam is used in children aged 2-12 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 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 in combination with other antibiotics.
2. What you need to know before you are given Piperacillin/Tazobactam Do not use Piperacillin/ Tazobactam:
- 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.
Warnings and precautions
Talk to your doctor or other healthcare professional before using Piperacillin/Tazobactam:
- if you have allergies. If you have several allergies, make sure you tell your doctor or 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. Your 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" 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
Tell your doctor or other healthcare professional if you are using, have recently used or might use
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.
- methotrexate (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 if you have to provide a blood or urine sample.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or other healthcare professional for advice before taking this medicine. Your doctor will decide if Piperacillin/Tazobactam is right for you.
Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If you are breastfeeding, your doctor will decide if Piperacillin/Tazobactam is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam is not expected to affect the ability to drive or use machines. Piperacillin/Tazobactam contains sodium
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion contains 4.69 mmol (108 mg) of sodium.
This should be taken into consideration if you are on a controlled-sodium diet.
3. How Piperacillin/Tazobactam is given
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.
Adults and adolescents aged 12 years or older
The recommended dose is 4 g/0.5 g of piperacillin/tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).
Children aged 2 to 12 years
The recommended 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 recommended 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.
You will be given Piperacillin/Tazobactam 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 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 PiperaciHin/Tazobactam than you should
As you will receive Piperacillin/Tazobactam 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
If you think you have not been given a dose of Piperacillin/Tazobactam, tell your doctor or other healthcare professional immediately.
If you have any further questions on the use of this medicine, ask your doctor or other healthcare professional.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or healthcare professional immediately if you notice any of the following side effects:
- 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, nose bleeds and bruising).
For frequency of these reactions, refer to the information below.
The following side effects may also occur:
Common side effects (may affect up to 1 in 10 people):
- diarrhoea, vomiting, nausea
- skin rashes.
Uncommon side effects (may affect up to 1 in 100 people):
- thrush
- (abnormal) decrease in while 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 (may affect up to 1 in 1,000 people):
- (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 pigment's 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
- rigor chill/rigidity.
Very rare side effects (may affect up to 1 in 10,000 people):
- 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 body wide 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.
Reporting of side effects
If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to Store PiperaciHin/Tazobactam
Keep this medicine out of the sight and reach of children.
Do not use Piperacillin/Tazobactam 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.
Reconstituted solution in vial: Chemical and physical in-use stability has been demonstrated for 12 hours when stored at 25°C and 48 hours when stored in a refrigerator at 2-8°C, when reconstituted with one of the compatible solvents for reconstitution.
Diluted infusion solution: After reconstitution, chemical and physical in-use stability of diluted infusion solutions has been demonstrated for 12 hours at 25°C and for 48 hours when stored in a refrigerator at 2-8°C, when reconstituted using one of the compatible solvents for further dilution of the reconstituted solution at the suggested dilution volumes.
From a microbiological point of view, the reconstituted and diluted solutions 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 12 hours at 25°C and for 48 hours at 2-8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
For single use only. Discard any unused solution.
The reconstitution and 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.
6. Contents of the pack and other information
What Piperacillin/Tazobactam contains
The active substances are piperacillin and tazobactam.
Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
What Piperacillin/Tazobactam looks like and contents of the pack
White to off white powder filled in flint vials with rubber plug and aluminium seal. Each vial is packed in a carton.
Pack sizes: 1 vial per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer Marketing authorisation holder
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
UK
Manufacturer
Agila Specialties Polska Sp. z o. o.
10, Daniszewska Str 03-230 Warsaw Poland
Ph: 0048 22 6140081
This leaflet was last revised in 11/2015
The following information is intended for medical or healthcare professionals only: Piperacillin/Tazobactam 2 g/ 0.25 g powder for solution for infusion
Instructions for use
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion 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 (details for handling, please see below).
|
Content of vial |
Volume of solvent* to be added to vial |
|
2 g/0.25 g (2 g piperacillin and 0.25 g tazobactam) |
10 ml |
*Compatible solvents for reconstitution:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Sterile water for injection(1)
- Glucose 5%
(1) Maximum recommended volume of sterile water for injection per dose is 50 ml.
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%
- Dextran 6% in 0.9% sodium chloride
Incompatibilities
• Piperacillin/Tazobactam is not compatible with Lactated Ringer's (Hartmann's) solution. Piperacillin/Tazobactam must not be reconstituted or diluted with Lactated Ringer's (Hartmann's) solution.
• Piperacillin/Tazobactam must not be mixed or co-administered with any aminoglycosides. 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 aminoglycosides, 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 drugs unless compatibility is proven.
• Because of chemical instability, Piperacillin/Tazobactam should not be used with solutions that contain only sodium bicarbonate.
• Piperacillin/Tazobactam should not be added to blood products or albumin hydrolysates. Co-administration of Piperacillin/Tazobactam with aminoglycosides
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Piperacillin/Tazobactam and the aminoglycoside are recommended for separate administration. Piperacillin/Tazobactam and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.
Special precautions for storage
Unopened Vials: Do not store above 25°C.
Reconstituted solution in vial: Chemical and physical in-use stability has been demonstrated for 12 hours when stored at 25°C and 48 hours when stored in a refrigerator at 2-8°C, when reconstituted with one of the compatible solvents for reconstitution (see above).
Diluted infusion solution: After reconstitution, chemical and physical in-use stability of diluted infusion solutions has been demonstrated for 12 hours at 25°C and for 48 hours when stored in a refrigerator at 2-8°C, when reconstituted using one of the compatible solvents for further dilution of the reconstituted solution at the suggested dilution volumes (see above).
From a microbiological point of view, the reconstituted and diluted solutions 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 12 hours at 25°C and for 48 hours at 2-8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
For single use only. Discard any unused solution.