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AUGMENTIN INTRAVENOUS 600MG AND AUGMENTIN INTRAVENOUS 1.2 G

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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2

K218301/02218301

K218301

Package Leaflet: Information for the User

Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

GSK-ContractMfg-Eur-Ita-Italy-Biopharma
United Kingdom-GBR

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.

Augmentin

• K
 eep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor, pharmacist or
nurse.
• If you get any side effects, talk to
your doctor or nurse. This includes
any possible side effects not listed
in this leaflet.

N/A
N/A

N/A

What is in this leaflet

N/A
1
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0

0

1 What Augmentin is and what it is used for
2 What you need to know before you have
Augmentin
3 How Augmentin is given
4 Possible side effects
5 How to store Augmentin
6 Contents of the pack and other
information

1 What Augmentin is and what it
is used for
Augmentin is an antibiotic and works by
killing bacteria that cause infections. It
contains two different medicines called
amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called
“penicillins” that can sometimes be stopped
from working (made inactive). The other
active component (clavulanic acid) stops this
from happening.
Augmentin is used in adults and children to
treat the following infections:
• severe ear, nose and throat infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including
dental infections
• bone and joint infections
• intra-abdominal infections
• genital organ infections in women.
Augmentin is used in adults and children to
prevent infections associated with major
surgical procedures.

Other medicines and Augmentin

Tell your doctor, pharmacist or nurse if you
are using, have recently used or might use
any other medicines. This includes medicines
that can be bought without a prescription
and herbal medicines.
• If you are taking allopurinol (used for
gout) with Augmentin, it may be more
likely that you’ll have an allergic skin
reaction.
• If you are taking probenecid (used for
gout), your doctor may decide to adjust
your dose of Augmentin.
• If medicines to help stop blood clots (such
as warfarin) are taken with Augmentin
then extra blood tests may be needed.
• Augmentin can affect how methotrexate
(a medicine used to treat cancer or
rheumatic diseases) works.

2 What you need to know before
you have Augmentin
You should not have Augmentin:

• if you are allergic to amoxicillin, clavulanic
acid, penicillin or any of the other
ingredients of this medicine (listed in
section 6)
• if you have ever had a severe allergic
(hypersensitive) reaction to any other
antibiotic. This can include a skin rash or
swelling of the face or neck
• if you have ever had liver problems or
jaundice (yellowing of the skin) when
taking an antibiotic.
➔ Do not take Augmentin if any of the
above apply to you. If you are not sure,
talk to your doctor, pharmacist or nurse
before having Augmentin.

Take special care with Augmentin

Talk to your doctor or pharmacist or nurse
before having Augmentin if you:
• have glandular fever
• are being treated for liver or kidney
problems
• are not passing water regularly.
If you are not sure if any of the above apply
to you, talk to your doctor, pharmacist or
nurse before taking Augmentin.
In some cases, your doctor may investigate
the type of bacteria that is causing your
infection. Depending on the results, you may
be given a different strength of Augmentin
or a different medicine.

Conditions you need to look out for

Augmentin can make some existing conditions
worse, or cause serious side effects. These
include allergic reactions, convulsions (fits) and
inflammation of the large intestine. You must
look out for certain symptoms while you are
taking Augmentin, to reduce the risk of any
problems. See ‘Conditions you need to look
out for’ in section 4.

Blood and urine tests

If you are having blood tests (such as red
blood cell status tests or liver function tests)
or urine tests (for glucose), let the doctor or
nurse know that you are taking Augmentin.
This is because Augmentin can affect the
results of these types of tests.

• Augmentin can affect how
mycophenolate mofetil (a medicine used
to prevent the rejection of transplanted
organs) works.

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, pharmacist or
nurse for advice before taking this medicine.

Important information about some of the
ingredients of Augmentin

• Augmentin 500 mg/100 mg contains
approximately 31.4 mg (1.4 mmol) of
sodium. This should be considered if you
are on a controlled sodium diet.
• Augmentin 500 mg/100 mg contains
approximately 19.6 mg (0.5 mmol) of
potassium. This should be considered by
patients with kidney problems or patients
on a controlled potassium diet.
• Augmentin 1,000 mg/200 mg contains
approximately 62.9 mg (2.7 mmol) of
sodium. This should be considered if you
are on a controlled sodium diet.
• Augmentin 1,000 mg/200 mg contains
approximately 39.3 mg (1.0 mmol) of
potassium. This should be considered by
patients with kidney problems or patients
on a controlled potassium diet.

3 How Augmentin is given
You will never give yourself this medicine.
A qualified person, like a doctor or a nurse,
will give you this medicine.
The recommended doses are:

Adults, and children weighing 40 kg and
over
Standard dose 1,000 mg/200 mg every
8 hours.
To stop
1,000 mg/200 mg before
infections
the surgery when you are
during and
given your anaesthetic.
after surgery
The dose can differ
depending on the type of
operation you are having.
Your doctor may repeat
the dose if your surgery
takes longer than 1 hour.

Children weighing less than 40 kg

All doses are worked out depending on the
child’s bodyweight in kilograms.
Children aged
3 months and
over:
Children aged
less than
3 months or
weighing less
than 4 kg

25 mg/5 mg for each
kilogram of bodyweight
every 8 hours.
25 mg/5 mg for each
kilogram of bodyweight
every 12 hours.

Patients with kidney and liver problems

• If you have kidney problems you may be
given a different dose. A different
strength or a different medicine may be
chosen by your doctor.
• If you have liver problems your doctor will
keep a close check on you and you may
have more regular liver function tests.

How Augmentin will be given to you

• Augmentin will be given as an injection
into a vein or by intravenous infusion.
• Make sure you drink plenty of fluids while
having Augmentin.
• You will not normally be given
Augmentin for longer than 2 weeks
without the doctor reviewing your
treatment.

If more Augmentin is given to you than
recommended

It is unlikely you will be given too much, but
if you think you have been given too much
Augmentin, tell your doctor, pharmacist or
nurse immediately. Signs may be an upset
stomach (feeling sick, being sick or
diarrhoea) or convulsions.
If you have any further questions about how
this medicine is given, ask your doctor,
pharmacist or nurse.

Information for the Healthcare Professional

Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)
Please refer to the Summary of Product Characteristics for further information

Administration

Augmentin may be administered either by slow intravenous injection over a period of
3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min.
Augmentin is not suitable for intramuscular administration.

Reconstitution

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 medicinal product or waste material should be disposed of in accordance with
local requirements.
Preparation of solutions for intravenous injection
500 mg/100 mg powder for solution for injection or infusion
Water for Injections Ph.Eur. is the normal solvent. Augmentin 500 mg/100 mg should be
dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use.
A transient pink colouration may or may not develop during reconstitution. Reconstituted
solutions are normally colourless to yellow in colour.
Augmentin should be administered within 20 min of reconstitution.
1,000 mg/200 mg powder for solution for injection or infusion
Water for Injections Ph.Eur. is the normal solvent. Augmentin 1,000 mg/200 mg should be
dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use.
A transient pink colouration may or may not develop during reconstitution. Reconstituted
solutions are normally colourless to yellow in colour.
Augmentin should be administered within 20 min of reconstitution.
Preparation of solutions for intravenous infusion
Augmentin vials are not suitable for multi-dose use.
500 mg/100 mg powder for solution for injection or infusion
Augmentin should be reconstituted as described above for injection. Without delay the
reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line
burette.
1,000 mg/200 mg powder for solution for injection or infusion
Augmentin should be reconstituted as described above for injection. Without delay the
reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line
burette.

Stability of prepared solutions

Reconstituted vials (for intravenous injection or before dilution for infusion)
500 mg/100 mg powder for solution for injection or infusion
The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used
or diluted immediately, within 20 minutes.
1,000 mg/200 mg powder for solution for injection or infusion
The reconstituted solution (1 vial with 20 ml of Water for Injections Ph.Eur.) should be used
or diluted immediately, within 20 minutes.
Diluted for intravenous infusion
500 mg/100 mg powder for solution for injection or infusion
Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours
at 5°C. From a microbiological point of view, the reconstituted and diluted solution
(1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used
immediately.
1,000 mg/200 mg powder for solution for injection or infusion
Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours
at 5°C. From a microbiological point of view, the reconstituted and diluted solution
(1 reconstituted vial in a minimum volume of 100 ml of infusion fluid) should be used
immediately.
Intravenous infusions of amoxicillin/clavulanic acid may be given in a range of different
intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room
temperature (25°C) in the recommended volumes of the following infusion fluids. If
reconstituted and maintained at room temperature (25°C), infusions should be completed
within the times stated in the table below.

Page 1 of 2

2

Intravenous infusion

K218301

Water for Injections Ph.Eur.
0.9% w/v Sodium Chloride intravenous infusion (9 mg/ml)
Compound Sodium Chloride Injection 1959 (Ringer’s)
Compound Sodium Lactate Intravenous Infusion
(Ringer-Lactate:Hartmann’s)
0.3% w/v Potassium Chloride and 0.9% w/v Sodium Chloride
Intravenous Infusion (3 mg/ml and 9 mg/ml)

GSK-ContractMfg-Eur-Ita-Italy-Biopharma
United Kingdom-GBR

Stability period at 25°C
3 hours
3 hours
2 hours
2 hours

N/A
N/A

N/A

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate.
Reconstituted solutions of amoxicillin/clavulanic acid may be injected into the drip tubing
over a period of 3 to 4 min.

➔ 
Contact a doctor immediately if you get
any of these symptoms. Stop taking
Augmentin.

Leaflet date: February 2015

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Conditions you need to look out for
Allergic reactions:

The stability of Augmentin IV solutions is concentration dependent. In the event that the use
of more concentrated solutions is required, the stability period should be adjusted
accordingly.

Any residual antibiotic solution should be discarded.

N/A

Like all medicines, this medicine can cause
side effects, although not everybody gets
them. The side effects below may happen
with this medicine.

• skin rash
• inflammation of blood vessels (vasculitis)
which may be visible as red or purple
raised spots on the skin, but can affect
other parts of the body
• fever, joint pain, swollen glands in the
neck, armpit or groin
• swelling, sometimes of the face or mouth
(angioedema), causing difficulty in
breathing
• collapse.

2 hours

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated
infusion bags containing either Water for Injections Ph.Eur. or sodium chloride BP (0.9% w/v),
which may be stored for up to 8 hours. Thereafter, the infusion should be administered
immediately after reaching room temperature.

Augmentin

4 Possible side effects

Augmentin is a registered trademark of the GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies. All rights reserved

Inflammation of large intestine

Inflammation of the large intestine, causing
watery diarrhoea usually with blood and
mucus, stomach pain and/or fever.
➔ Contact your doctor as soon as possible
for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the
vagina, mouth or skin folds)
• diarrhoea

Uncommon side effects

These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when
taking high doses
• vomiting
• indigestion
• dizziness
• headache.
Uncommon side effects that may show up in
your blood tests:
• increase in some substances (enzymes)
produced by the liver.

Rare side effects

These may affect up to 1 in 1,000 people
• skin rash, which may blister, and looks
like small targets (central dark spots
surrounded by a paler area, with a dark
ring around the edge - erythema
multiforme)
➔ if you notice any of these symptoms
contact a doctor urgently.
• swelling and redness along a vein which is
extremely tender when touched
Rare side effects that may show up in your
blood tests:
• low number of cells involved in blood
clotting
• low number of white blood cells.

Other side effects

Other side effects have occurred in a very
small number of people but their exact
frequency is unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine (see
above)
• Inflammation of the protective
membrane surrounding the brain (aseptic
meningitis)
• Serious skin reactions:
- a widespread rash with blisters and
peeling skin, particularly around the
mouth, nose, eyes and genitals
(Stevens-Johnson syndrome), and a
more severe form, causing extensive
peeling of the skin (more than 30% of
the body surface - toxic epidermal
necrolysis)
- widespread red skin rash with small
pus-containing blisters (bullous
exfoliative dermatitis)
- a red, scaly rash with bumps under the
skin and blisters (exanthemous
pustulosis).
➔ Contact a doctor immediately if you get
any of these symptoms.
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood
of bilirubin (a substance produced in the
liver) which may make your skin and
whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• convulsions (in people taking high doses
of Augmentin or who have kidney
problems).
Side effects that may show up in your blood
or urine tests:
• severe reduction in the number of white
blood cells
• low number of red blood cells (haemolytic
anaemia)
• crystals in urine.

If you get any side effects

➔ Talk to your doctor or pharmacist or
nurse. This includes any side effects not
listed in this leaflet.

6 Contents of the pack and
other information
What Augmentin contains:

500 mg/100 mg powder for injection
or infusion
• The active substances are
amoxicillin and clavulanic acid.
Each vial or bottle contains
sodium amoxicillin equivalent to
500 mg amoxicillin and potassium
clavulanate equivalent to 100 mg
of clavulanic acid.
1,000 mg/200 mg powder for
injection or infusion
• The active substances are
amoxicillin and clavulanic acid.
Each vial or bottle contains
sodium amoxicillin equivalent to
1,000 mg amoxicillin and
potassium clavulanate equivalent
to 200 mg of clavulanic acid.

5 How to store Augmentin
Augmentin Intravenous is for use in hospital
only and the expiry date and storage
instructions stated on the label are for the
doctor, nurse or pharmacist’s information.
The doctor, pharmacist or nurse will make up
your medicine. It should be used within
20 minutes of reconstitution.
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date shown on the carton. The expiry date
refers to the last day of that month.
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.

There are no other ingredients.
However, please see section 2 for further
important information about sodium and
potassium in Augmentin.
The doctor, nurse or pharmacist will make up
the injection before use using an appropriate
fluid (such as Water for Injections or an
injection/infusion fluid).

What Augmentin looks like and contents
of the pack
Augmentin IV 500 mg/100 mg powder for
solution for injection or infusion is supplied
as clear glass vials of sterile powder for
making up as an injection or infusion. The
vials are supplied in packs of 1, 5 or 10.

Augmentin IV 1,000 mg/200 mg powder for
solution for injection is supplied as clear
glass vials or bottles of sterile powder for
making up as an injection or infusion. The
vials are supplied in packs of 1, 5, 10, 25 or
100. The bottles are supplied in packs of 5.
Not all pack sizes may be marketed.

Marketing authorisation holder and
manufacturer

Marketing Authorisation Holder:
Beecham Group Ltd, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer: Biopharma S.r.l., Via delle
Gerbere 22/30, 00134 Santa Palomba,
Roma - Italy

Other formats

To listen or to request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name Augmentin Intravenous
Reference number 00038/0320
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: November 2013
Augmentin is a registered trademark of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies.
All rights reserved

Page 2 of 2

3
10000000130906
GSK-GBR-Worthing-UKWOR

1000000
0130906

Package Leaflet: Information for the User

United Kingdom-GBR

Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

Augmentin

Other medicines and Augmentin

Tell your doctor, pharmacist or nurse if you
are using, have recently used or might use
any other medicines. This includes medicines
that can be bought without a prescription
and herbal medicines.
• If you are taking allopurinol (used for
gout) with Augmentin, it may be more
likely that you’ll have an allergic skin
reaction.

N/A
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.

LF040

• K
 eep this leaflet. You may
need to read it again.
• If you have any further
questions, ask your doctor,
pharmacist or nurse.
• If you get any side effects, talk
to your doctor or nurse.
This includes any possible side
effects not listed in this leaflet.

N/A
N/A
1
K

What is in this leaflet

1 What Augmentin is and what it is used for
2 What you need to know before you have
Augmentin
3 How Augmentin is given
4 Possible side effects
5 How to store Augmentin
6 Contents of the pack and other
information

0

1 What Augmentin is and what it
is used for

0

Augmentin is an antibiotic and works by
killing bacteria that cause infections. It
contains two different medicines called
amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called
“penicillins” that can sometimes be stopped
from working (made inactive). The other
active component (clavulanic acid) stops this
from happening.
Augmentin is used in adults and children to
treat the following infections:





s evere ear, nose and throat infections
respiratory tract infections
urinary tract infections
skin and soft tissue infections including
dental infections
• bone and joint infections
• intra-abdominal infections
• genital organ infections in women.
Augmentin is used in adults and children to
prevent infections associated with major
surgical procedures.

2 What you need to know before
you have Augmentin
You should not have Augmentin:

• if you are allergic to amoxicillin,
clavulanic acid, penicillin or any of the
other ingredients of this medicine (listed
in section 6)
• if you have ever had a severe allergic
(hypersensitive) reaction to any other
antibiotic. This can include a skin rash or
swelling of the face or neck
• if you have ever had liver problems or
jaundice (yellowing of the skin) when
taking an antibiotic.
➔ Do not take Augmentin if any of the
above apply to you. If you are not sure,
talk to your doctor, pharmacist or nurse
before having Augmentin.

Take special care with Augmentin

Talk to your doctor or pharmacist or nurse
before having Augmentin if you:
• have glandular fever
• are being treated for liver or kidney
problems
• are not passing water regularly.
If you are not sure if any of the above apply
to you, talk to your doctor, pharmacist or
nurse before taking Augmentin.
In some cases, your doctor may investigate
the type of bacteria that is causing your
infection. Depending on the results, you may
be given a different strength of Augmentin
or a different medicine.

Conditions you need to look out for

Augmentin can make some existing conditions
worse, or cause serious side effects. These
include allergic reactions, convulsions (fits) and
inflammation of the large intestine. You must
look out for certain symptoms while you are
taking Augmentin, to reduce the risk of any
problems. See ‘Conditions you need to look
out for’ in section 4.

Blood and urine tests

If you are having blood tests (such as red
blood cell status tests or liver function tests)
or urine tests (for glucose), let the doctor or
nurse know that you are taking Augmentin.
This is because Augmentin can affect the
results of these types of tests.

• If you are taking probenecid (used for
gout), your doctor may decide to adjust
your dose of Augmentin.
• If medicines to help stop blood clots (such
as warfarin) are taken with Augmentin
then extra blood tests may be needed.
• A
 ugmentin can affect how methotrexate
(a medicine used to treat cancer or
rheumatic diseases) works.
• A
 ugmentin may affect how
mycophenolate mofetil (a medicine used
to prevent the rejection of transplanted
organs) works.

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, pharmacist or
nurse for advice before taking this medicine.

Important information about some of the
ingredients of Augmentin

• A
 ugmentin 500 mg/100 mg contains
approximately 31.4 mg (1.4 mmol) of
sodium. This should be considered if you
are on a controlled sodium diet.
• Augmentin 500 mg/100 mg contains
approximately 19.6 mg (0.5 mmol) of
potassium. This should be considered by
patients with kidney problems or patients
on a controlled potassium diet.
• A
 ugmentin 1,000 mg/200 mg contains
approximately 62.9 mg (2.7 mmol) of
sodium. This should be considered if you
are on a controlled sodium diet.
• Augmentin 1,000 mg/200 mg contains
approximately 39.3 mg (1.0 mmol) of
potassium. This should be considered by
patients with kidney problems or patients
on a controlled potassium diet.

1000000
0130906

3 How Augmentin is given
You will never give yourself this medicine.
A qualified person, like a doctor or a nurse,
will give you this medicine.
The recommended doses are:

Adults, and children weighing 40 kg and
over
Standard dose 1,000 mg/200 mg every
8 hours.
To stop
1,000 mg/200 mg before
infections
the surgery when you are
during and
given your anaesthetic.
after surgery
The dose can differ
depending on the type of
operation you are having.
Your doctor may repeat
the dose if your surgery
takes longer than 1 hour.

Children weighing less than 40 kg

All doses are worked out depending on the
child’s bodyweight in kilograms.
Children aged
3 months and
over:
Children aged
less than
3 months or
weighing less
than 4 kg

25 mg/5 mg for each
kilogram of bodyweight
every 8 hours.
25 mg/5 mg for each
kilogram of bodyweight
every 12 hours.

Patients with kidney and liver problems

• If you have kidney problems you may be
given a different dose. A different
strength or a different medicine may be
chosen by your doctor.
• If you have liver problems your doctor will
keep a close check on you and you may
have more regular liver function tests.

How Augmentin will be given to you

• A
 ugmentin will be given as an injection
into a vein or by intravenous infusion.
• Make sure you drink plenty of fluids while
having Augmentin.
• You will not normally be given
Augmentin for longer than 2 weeks
without the doctor reviewing your
treatment.

If more Augmentin is given to you than
recommended

It is unlikely you will be given too much, but
if you think you have been given too much
Augmentin, tell your doctor, pharmacist or
nurse immediately. Signs may be an upset
stomach (feeling sick, being sick or
diarrhoea) or convulsions.
If you have any further questions about how
this medicine is given, ask your doctor,
pharmacist or nurse.

Information for the Healthcare Professional

Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)
Please refer to the Summary of Product Characteristics for further information

Administration

Augmentin may be administered either by slow intravenous injection over a period of
3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min.
Augmentin is not suitable for intramuscular administration.

Reconstitution

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 medicinal product or waste material should be disposed of in accordance with
local requirements.
Preparation of solutions for intravenous injection
500 mg/100 mg powder for solution for injection or infusion
Water for Injections Ph.Eur. is the normal solvent. Augmentin 500 mg/100 mg should be
dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use.
A transient pink colouration may or may not develop during reconstitution. Reconstituted
solutions are normally colourless to yellow in colour.
Augmentin should be administered within 20 min of reconstitution.
1,000 mg/200 mg powder for solution for injection or infusion
Water for Injections Ph.Eur. is the normal solvent. Augmentin 1,000 mg/200 mg should be
dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use.
A transient pink colouration may or may not develop during reconstitution. Reconstituted
solutions are normally colourless to yellow in colour.
Augmentin should be administered within 20 min of reconstitution.
Preparation of solutions for intravenous infusion
Augmentin vials are not suitable for multi-dose use.
500 mg/100 mg powder for solution for injection or infusion
Augmentin should be reconstituted as described above for injection. Without delay the
reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line
burette.
1,000 mg/200 mg powder for solution for injection or infusion
Augmentin should be reconstituted as described above for injection. Without delay the
reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line
burette.

Stability of prepared solutions

Reconstituted vials (for intravenous injection or before dilution for infusion)
500 mg/100 mg powder for solution for injection or infusion
The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used
or diluted immediately, within 20 minutes.
1,000 mg/200 mg powder for solution for injection or infusion
The reconstituted solution (1 vial with 20 ml of Water for Injections Ph.Eur.) should be used
or diluted immediately, within 20 minutes.
Diluted for intravenous infusion
500 mg/100 mg powder for solution for injection or infusion
Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours
at 5°C. From a microbiological point of view, the reconstituted and diluted solution
(1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used
immediately.
1,000 mg/200 mg powder for solution for injection or infusion
Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours
at 5°C. From a microbiological point of view, the reconstituted and diluted solution
(1 reconstituted vial in a minimum volume of 100 ml of infusion fluid) should be used
immediately.
Intravenous infusions of amoxicillin/clavulanic acid may be given in a range of different
intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room
temperature (25°C) in the recommended volumes of the following infusion fluids. If
reconstituted and maintained at room temperature (25°C), infusions should be completed
within the times stated in the table below.

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Intravenous infusion

Stability period at 25°C

Like all medicines, this medicine can cause
side effects, although not everybody gets
them. The side effects below may happen
with this medicine.

United Kingdom-GBR
Water for Injections Ph.Eur.
0.9% w/v Sodium Chloride intravenous infusion (9 mg/ml)
Compound Sodium Chloride Injection 1959 (Ringer’s)
Compound Sodium Lactate Intravenous Infusion
(Ringer-Lactate:Hartmann’s)
0.3% w/v Potassium Chloride and 0.9% w/v Sodium Chloride
Intravenous Infusion (3 mg/ml and 9 mg/ml)

Augmentin
N/A
LF040

3 hours
3 hours
2 hours
2 hours

Conditions you need to look out for
Allergic reactions:

2 hours

N/A

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated
infusion bags containing either Water for Injections Ph.Eur. or sodium chloride BP (0.9% w/v),
which may be stored for up to 8 hours. Thereafter, the infusion should be administered
immediately after reaching room temperature.

N/A

The stability of Augmentin IV solutions is concentration dependent. In the event that the use
of more concentrated solutions is required, the stability period should be adjusted
accordingly.
Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate.
Reconstituted solutions of amoxicillin/clavulanic acid may be injected into the drip tubing
over a period of 3 to 4 min.

1
K

Any residual antibiotic solution should be discarded.

• s kin rash
• inflammation of blood vessels (vasculitis)
which may be visible as red or purple
raised spots on the skin, but can affect
other parts of the body
• fever, joint pain, swollen glands in the
neck, armpit or groin
• swelling, sometimes of the face or mouth
(angioedema), causing difficulty in
breathing
• collapse.
➔ 
Contact a doctor immediately if you get
any of these symptoms. Stop taking
Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing
watery diarrhoea usually with blood and
mucus, stomach pain and/or fever.

Leaflet date: February 2015
Augmentin is a registered trademark of the GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline group of companies. All rights reserved

0

4 Possible side effects

➔ Contact your doctor as soon as possible
for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the
vagina, mouth or skin folds)
• diarrhoea

0

Uncommon side effects

These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when
taking high doses
• vomiting
• indigestion
• dizziness
• headache.
Uncommon side effects that may show up in
your blood tests:
• increase in some substances (enzymes)
produced by the liver.

Rare side effects

These may affect up to 1 in 1,000 people
• skin rash, which may blister, and looks
like small targets (central dark spots
surrounded by a paler area, with a dark
ring around the edge - erythema
multiforme)
➔ if you notice any of these symptoms
contact a doctor urgently.
• s welling and redness along a vein which is
extremely tender when touched
Rare side effects that may show up in your
blood tests:
• low number of cells involved in blood
clotting
• low number of white blood cells.

Other side effects

Other side effects have occurred in a very
small number of people but their exact
frequency is unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine (see
above)
• Inflammation of the protective
membrane surrounding the brain (aseptic
meningitis)
• Serious skin reactions:
- a widespread rash with blisters and
peeling skin, particularly around the
mouth, nose, eyes and genitals
(Stevens-Johnson syndrome), and a
more severe form, causing extensive
peeling of the skin (more than 30% of
the body surface - toxic epidermal
necrolysis)
- widespread red skin rash with small
pus-containing blisters (bullous
exfoliative dermatitis)
- a red, scaly rash with bumps under the
skin and blisters (exanthemous
pustulosis).
➔ Contact a doctor immediately if you get
any of these symptoms.
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood
of bilirubin (a substance produced in the
liver) which may make your skin and
whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• convulsions (in people taking high doses
of Augmentin or who have kidney
problems).
Side effects that may show up in your blood
or urine tests:
• severe reduction in the number of white
blood cells
• low number of red blood cells (haemolytic
anaemia)
• crystals in urine.

If you get any side effects

➔ Talk to your doctor or pharmacist or
nurse. This includes any side effects not
listed in this leaflet.

5 How to store Augmentin
Augmentin Intravenous is for use in hospital
only and the expiry date and storage
instructions stated on the label are for the
doctor, nurse or pharmacist’s information.
The doctor, pharmacist or nurse will make up
your medicine. It should be used within
20 minutes of reconstitution.
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date shown on the carton. The expiry date
refers to the last day of that month.
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 Augmentin contains:

500 mg/100 mg powder for
injection or infusion
• The active substances are
amoxicillin and clavulanic
acid. Each vial or bottle
contains sodium amoxicillin
equivalent to 500 mg
amoxicillin and potassium
clavulanate equivalent to
100 mg of clavulanic acid.
1,000 mg/200 mg powder for
injection or infusion
• The active substances are
amoxicillin and clavulanic
acid. Each vial or bottle
contains sodium amoxicillin
equivalent to 1,000 mg
amoxicillin and potassium
clavulanate equivalent to
200 mg of clavulanic acid.
There are no other ingredients. However,
please see section 2 for further important
information about sodium and potassium in
Augmentin.
The doctor, nurse or pharmacist will make up
the injection before use using an appropriate
fluid (such as Water for Injections or an
injection/infusion fluid).

What Augmentin looks like and contents
of the pack
Augmentin IV 500 mg/100 mg powder for
solution for injection or infusion is supplied
as clear glass vials of sterile powder for
making up as an injection or infusion. The
vials are supplied in packs of 1, 5 or 10.

Augmentin IV 1,000 mg/200 mg powder for
solution for injection is supplied as clear
glass vials or bottles of sterile powder for
making up as an injection or infusion. The
vials are supplied in packs of 1, 5, 10, 25 or
100. The bottles are supplied in packs of 5.
Not all pack sizes may be marketed.

Marketing authorisation holder and
manufacturer

Marketing Authorisation Holder:
Beecham Group Ltd, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer: SmithKline Beecham,
Worthing, West Sussex BN14 8QH

Other formats

To listen or to request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name Augmentin Intravenous
Reference number 00038/0320
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: July 2013
Augmentin is a registered trademark of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies.
All rights reserved

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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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