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TAZOCIN 2G/0.25G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): PIPERACILLIN MONOHYDRATE / PIPERACILLIN SODIUM / TAZOBACTAM SODIUM

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The following information is intended for healthcare professionals only:
✪ Instructions for use
Tazocin 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. When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on 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

4 g / 0.50 g (4 g piperacillin and 0.5 g tazobactam)

20 ml

* Compatible solvents for reconstitution:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Sterile water for injections(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The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled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% (9 mg/ml) sodium chloride
- Lactated Ringers injection
- Hartmann’s solution
- Ringer’s acetate
- Ringer’s acetate/malate
✪ Incompatibilities
Whenever Tazocin 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. However, amikacin and gentamicin were determined to be compatible
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Package leaflet: Information for the user
Tazocin
2 g / 0.25 g powder for solution for infusion
Tazocin®
4 g / 0.5 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, 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. See section 4.
What is in this leaflet:
1. What Tazocin is and what it is used for
2. What you need to know before you use Tazocin
3. How to use Tazocin
4. Possible side effects
5. How to store Tazocin
6. Contents of the pack and other information
1. What Tazocin 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.
Tazocin 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.
Tazocin may be used to treat bacterial infections in patients with
low white blood cell counts (reduced resistance to infections).

Tazocin 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. Tazocin 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
Tazocin in combination with other antibiotics.
2. What you need to know before you use Tazocin
✪ Do not use Tazocin
- 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 Tazocin.
✪ Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tazocin
- 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. 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 Tazocin 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
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 Tazocin
Please tell your doctor or other healthcare professional 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:
- 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,
gentamicin or vancomycin. Tell your doctor if you have
kidney problems.
✪ Effect on laboratory tests
Tell the doctor or laboratory staff that you are taking Tazocin
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
other healthcare professional for advice before receiving this
medicine. Your doctor will decide if Tazocin is right for you.
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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 Tazocin is right for you.
✪ Driving and using machines
The use of Tazocin is not expected to affect the ability to drive
or use machines.
Tazocin contains sodium
Tazocin 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium.
Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
This should be taken into consideration if you are on a controlledsodium diet.
3. How to use Tazocin
Your doctor or other healthcare professional will give you this
medicine through an infusion (a drip for 30 minutes) into one of
your veins.
✪ Dosage
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 above 12 years of age
The usual 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 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 each individual dose will not exceed 4 g / 0.5 g of
Tazocin.
You will be given Tazocin until the sign of infection has gone
completely (5 to 14 days).
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✪ Patients with kidney problems
Your doctor may need to reduce the dose of Tazocin 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 Tazocin than you should
As you will receive Tazocin 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 Tazocin
If you think you have not been given a dose of Tazocin, tell
your doctor or other healthcare professional immediately.
If you have any further questions on the use of this medicine,
ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
See a doctor immediately if you experience any of these
potentially serious side effects of Tazocin:
The serious side effects (with frequency in brackets) of
Tazocin are:
- serious skin rashes [Stevens-Johnson syndrome, dermatitis
bullous (Not known), toxic epidermal necrolysis (Rare)]
appearing initially as reddish target-like spots or circular
patches often with central blisters on the trunk. Additional
signs include ulcers in the mouth, throat, nose, extremities,
genitals and conjunctivitis (red and swollen eyes). The rash
may progress to widespread blistering or peeling of the skin
and potentially may be life threatening
- swelling of the face, lips, tongue or other parts of the body
(Not known)
- shortness of breath, wheezing or trouble breathing (Not known)
- severe rash or hives (Uncommon), itching or rash on the
skin (Common)
- yellowing of the eyes or skin (Not known)

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- damage to blood cells [the signs include: being breathless
when you do not expect it, red or brown urine (Not known),
nosebleeds (Rare) and small spot bruising (Not known),
severe decrease in white blood cells (Rare)]
- severe or persistent diarrhoea accompanied by a fever or
weakness (Rare)
If any of the following side effects gets serious, or if you
notice any side effects not listed in this leaflet, please tell
your doctor or other healthcare professional.
✪ Very common side effects (may affect more than 1 in 10
people):
- diarrhoea
✪ Common side effects (may affect up to 1 in 10 people):
- yeast infection
- decrease in platelets and red blood cells
- prolonged blood clotting time
- abnormal lab test (positive direct Coombs)
- decrease in blood protein
- headache, sleeplessness
- abdominal pain, vomiting, nausea, constipation, upset stomach
- increase in blood liver enzymes
- abnormal kidney blood tests
- fever, injection site reaction
✪ Uncommon side effects (may affect up to 1 in 100
people):
- decrease in white blood cells
- decreased blood potassium, decreased blood sugar
- low blood pressure, inflammation of the veins (felt as tenderness or redness in the
affected area), reddening of skin
- increase of a blood pigment breakdown product (bilirubin)
- joint and muscle pain
- chills
✪ Rare side effects (may affect up to 1 in 1,000 people):
- inflammation of the mucous lining of the mouth
✪ Not known side effects (cannot be estimated from the
available data):

- increase of platelets
- inflammation of the liver
- kidney failure, inflammation of the kidney
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly (see
details below). By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
5. How to store Tazocin
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 house­
hold waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help protect the
environment.
6. Contents of the pack and other information
✪ What Tazocin 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).
Each vial contains 4 g piperacillin (as sodium salt) and
0.5 g tazobactam (as sodium salt).
- The other ingredients are citric acid monohydrate and edetate
disodium (EDTA).
✪ What Tazocin looks like and contents of the pack
Tazocin 2 g / 0.25 g is a white to off-white powder supplied in
a vial.
Packs containing 1, 5, 10, 12, 25 or 50 vials.
Tazocin 4 g / 0.5 g is a white to off-white powder supplied in
a vial.
Packs containing 1, 5, 10, 12, 25 or 50 vials.
Not all pack sizes may be marketed.
✪ Marketing Authorisation Holder and Manufacturer
UK MA Holder: Pfizer Limited, Ramsgate Road,
Sandwich, Kent CT13 9NJ, United Kingdom.
Ireland MA Holder: Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park,
Citywest Business Campus, Dublin 24, Ireland
Malta MA Holder: Pfizer Hellas S.A.
243, Messoghion Avenue, 154 51 N. Psychiko, Greece
Manufacturer:
Wyeth Lederle s.r.l.
Via Franco Gorgone, Zona Industriale
95100 Catania Italy
This leaflet was last revised in
UK: 11/2015
IE: MM/YYYY
Ref: TA 11_0 UK & IE

with Tazocin in vitro in certain diluents at specific concentrations (see Co-administration of Tazocin with aminoglycosides below).
Tazocin should not be mixed with other substances in a syringe or infusion bottle
since compatibility has not been established.
Because of chemical instability, Tazocin should not be used with solutions containing
only sodium bicarbonate.
Tazocin is compatible with lactated Ringer’s solution and for co-administration via a
Y-site.
Tazocin should not be added to blood products or albumin hydrolysates.
✪ Co-administration of Tazocin with aminoglycosides
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics,
Tazocin and the aminoglycoside are recommended for separate administration.
Tazocin and the aminoglycoside should be reconstituted and diluted separately when
concomitant therapy with aminoglycosides is indicated.
In circumstances where co-administration is recommended, Tazocin is compatible
for simultaneous co‑administration via Y‑site infusion only with the following aminoglycosides under the following conditions:
Tazocin
Dose

Tazocin
Diluent
volume
(ml)

Aminoglycoside
concentration
range* (mg/ml)

Acceptable diluents

Amikacin

2 g / 0.25 g
4 g / 0.5 g

50, 100,
150

1.75 – 7.5

0.9% sodium chloride or
5% glucose

Gentamicin

2 g / 0.25 g
4 g / 0.5 g

50, 100,
150

0.7 – 3.32

0.9% sodium chloride or
5% glucose

Aminoglycoside

* The dose of aminoglycoside should be based on patient weight, status of infection
(serious or life‑threatening) and renal function (creatinine clearance).
Compatibility of Tazocin with other aminoglycosides has not been established. Only
the concentration and diluents for amikacin and gentamicin with the dose of Tazocin
listed in the above table have been established as compatible for co‑administration
via Y‑site infusion. Simultaneous co-administration via Y‑site in any manner other
than listed above may result in inactivation of the aminoglycoside by Tazocin.

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Artwork Center
Catania Plant

Item Code 2016-0002000_PIL_1
Descript ion F.ILL. TAZOCIN EF N.F (GB/IE/MT)
Market GREAT BRITAIN/IRELAND/MALTA
Drawing PP3L5
Size (mm) 155 x 435
Pharmacode 27
Artwork Pass # 2
Date 16 MAR 16
Text Size (body) 9 pt
Colour :

2016-0002000_PIL_1.indd 3

Black

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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