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AMOXICILLIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): AMOXICILLIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin 250mg, 500mg or 1g,
Powder for Solution for Injection or Infusion
Amoxicillin
Read all of this leaflet carefully before you are given 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.
• 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 Amoxicillin Injection is and what it is used for
2. What you need to know before you are given Amoxicillin Injection
3. How Amoxicillin Injection is given
4. Possible side effects
5. How to store Amoxicillin Injection
6. Contents of the pack and other information
The name of your medicine is “Amoxicillin 250mg, 500mg, 1g
Powder for Solution for Injection or Infusion” (referred to as
Amoxicillin Injection throughout this leaflet).
1. WHAT AMOXICILLIN INJECTION IS AND WHAT IT IS
USED FOR
What Amoxicillin Injection is
Amoxicillin Injection is an antibiotic. The active ingredient is
amoxicillin. This belongs to a group of medicines called
‘penicillins’.
What Amoxicillin Injection is used for
Amoxicillin Injection is used to treat infections caused by
bacteria in different parts of the body.
Amoxicillin Injection is usually used for urgent treatment of
severe infection or if patients cannot take Amoxicillin by
mouth.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
AMOXICILLIN INJECTION
You must not be given Amoxicillin Injection:
• if you are allergic to amoxicillin or penicillin
• if you have ever had an allergic reaction to any antibiotic.
This can include a skin rash or swelling of the face or throat.
You must not be given Amoxicillin Injection if any of the above
apply.
If you are not sure, talk to your doctor, pharmacist or nurse
before you are given Amoxicillin Injection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Amoxicillin Injection if you:
• have glandular fever (fever, sore throat, swollen glands and
extreme tiredness)
• have kidney problems
• are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or nurse before you are given Amoxicillin
Injection.
Blood and urine tests
If you are having:
• urine tests ( glucose) or blood tests for liver function
• oestriol tests (used during pregnancy to check the baby is
developing normally)
Tell your doctor, pharmacist or nurse that you are being given
Amoxicillin Injection. This is because Amoxicillin can affect
the results of these tests.
Other medicines and Amoxicillin Injection:
Tell the doctor, pharmacist or nurse if you are taking, have
recently taken or might take any other medicines:
• if you are taking allopurinol (used for gout) while being given
Amoxicillin Injection, it may be more likely that you will have
an allergic skin reaction.
• if you are taking probenecid (used for gout), your doctor may
decide to adjust your dose of Amoxicillin Injection.
• if you are taking medicines to help stop blood clots (such as
warfarin), you may need extra blood tests.
• if you are taking other antibiotics (such as tetracycline)
Amoxicillin Injection may be less effective.
• if you are taking methotrexate (used for the treatment of
cancer and severe psoriasis) Amoxicillin Injection may
cause an increase in side effects.

Pregnancy and breast-feeding:
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask your doctor, pharmacist or
nurse for advice before you are given this medicine.
Driving and using machines
Amoxicillin can have side effects and the symptoms (such as
allergic reactions, dizziness and convulsions) may make you
unfit to drive.
Do not drive or operate machinery unless you are feeling well.
Amoxicillin injection contains sodium
The sodium content of each vial is 19 mg (250 mg vial), 38 mg
(500 mg vial) and 76 mg (1g vial). This should be considered if
you are on a controlled sodium diet.
3. HOW AMOXICILLIN INJECTION IS GIVEN
You will never give yourself this medicine. A qualified person,
like a doctor or a nurse, will give you this medicine.
• Amoxicillin will be given as an injection or an infusion into a
vein (intravenously) or muscle (intramuscularly).
• Your doctor will decide how much you need each day and
how often the injections should be given.
• Make sure you drink plenty of fluids while you are being
treated with Amoxicillin Injection.
The recommended doses are as follows.
Children up to 40 kg
• Most infections: 20 mg to 200 mg for every kilogram of body
weight in divided doses throughout the day.
• Lyme disease (an infection spread by parasites called ticks):
isolated erythema migrans (early stage – red or pink circular
rash) 25 mg to 50 mg for every kilogram of body weight in
divided doses throughout the day; systemic manifestations
(late stage – for more serious symptoms or when the
disease spreads around your body) 100 mg for every
kilogram of body weight in divided doses throughout the day.
Maximum single dose: 50 mg for every kilogram of body
weight.
Intramuscular maximum daily dose: 120 mg for every kilogram
of body weight as 2 to 6 equally divided doses.
Adults, elderly patients and children weighing 40 kg or more
• Recommended daily dosage: 750 mg to 6 g administered in
divided doses.
• Lyme disease (an infection spread by parasites called ticks):
isolated erythema migrans (early stage – red or pink circular
rash) 4 g per day; systemic manifestations (late stage - for
more serious symptoms or when the disease spreads
around your body) 6 g per day.
Intravenous maximum daily dose: 12 g per day.
Intravenous maximum single dose: 2 g by infusion or 1 g by
bolus injection.
Intramuscular maximum daily dose: 4 g per day
Intramuscular maximum single dose: 1 g.
Kidney problems
If you have kidney problems the dose might be lower than the
usual dose.
If more Amoxicillin Injection 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 Amoxicillin Injection, tell your
doctor, pharmacist or nurse immediately. Signs might be an
upset stomach (feeling sick, being sick or diarrhoea) or
crystals in the urine, which may be seen as cloudy urine or
problems urinating.

-------------------------------------------------------------------------------------INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only.

Intravenous administration
Vial
250 mg
500 mg
1g

Diluent (ml)
5
10
20

Final volume (ml)
5.2
10.4
20.8

Water for injections is the normal diluent.
A transient pink colouration may or may not develop during
reconstitution. Reconstituted solutions are normally
colourless or a pale straw colour. All solutions should be
shaken vigorously before injection.

Preparation of intravenous infusions and stability:
250 mg: add without delay the reconstituted solution of 250 mg
(as prepared above - these are minimum volumes) to 50 ml of
infusion fluid.
500 mg: add without delay the reconstituted solution of 500 mg
(as prepared above - these are minimum volumes) to 50 ml of
infusion fluid.
1g: add without delay the reconstituted solution of 1 g (as
prepared above - these are minimum volumes) to 100 ml
infusion fluid (e.g. using a mini bag or in-line burette).

If you think you have missed an injection
Speak to your doctor, pharmacist or nurse.
How long will you be given Amoxicillin Injection for?
You will not normally be given Amoxicillin for more than 2
weeks without the doctor reviewing your treatment.
Thrush (a yeast infection of moist areas of the body which can
cause soreness, itching and white discharge) may develop if
Amoxicillin is used for a long time. If this occurs, tell your
doctor, pharmacist or nurse.
If you are given Amoxicillin for a long time, your doctor bay
perform additional tests to check your kidneys, liver and blood
are working normally.
If you have any further questions about how this product is
given, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Talk to a doctor or nurse straight away if you notice any of
the following very rare serious side effects – you may need
urgent medical treatment:
Very rare (may affect up to 1 in 10,000 people)
• allergic reactions, the signs may include: skin itching or rash,
swelling of the face, lips, tongue, body or breathing
difficulties. These can be serious and occasionally deaths
have occurred
• rash or pinpoint flat red round spots under the skin surface
or bruising of the skin. This is due to inflammation of blood
vessel walls due to an allergic reaction. It can be associated
with joint pain (arthritis) and kidney problems
• a delayed allergic reaction can occur usually 7 to 12 days
after having Amoxicillin, some signs include: rashes, fever,
joint pains and enlargement of the lymph nodes especially
under the arms
• a skin reaction known as ‘erythema multiforme’ where you
may develop: itchy reddish purple patches on the skin
especially on the palms of the hands or soles of the feet,
‘hive-like’ raised swollen areas on the skin, tender areas on
the surfaces of the mouth, eyes and genitals. You may have
a fever and be very tired
• other severe skin reactions can include: changes in skin
colour, bumps under the skin, blistering, pustules, peeling,
redness, pain, itching, scaling. These may be associated
with fever, headaches and body aches
• fever, chills, a sore throat or other signs of an infection, or if
you bruise easily. These may be signs of a problem with your
blood cells
• the Jarisch-Herxheimer reaction which occurs during
treatment with Amoxicillin for Lyme disease and causes
fever, chills, headache, muscle pain and skin rash.
• inflammation of the large bowel (colon) with diarrhoea
(sometimes containing blood), pain and fever
• serious liver side effects may occur. They are mainly
associated with people having treatment over a long period,
males and the elderly. You must tell your doctor urgently if
you get:
• severe diarrhoea with bleeding
• blisters, redness or bruising of the skin
• darker urine or paler stools
• yellowing of the skin or the whites of the eyes (jaundice).
See also anaemia below which might result in jaundice.
These serious side effects can happen when you are being
given the medicine or for up to several weeks after. If any of
the above occurs, talk to your doctor or nurse straight away.
Sometimes you may get less severe skin reactions such as:
• a mildly itchy rash (round, pink-red patches), ‘hive-like’
swollen areas on forearms, legs, palms, hands or feet. This
is uncommon (may affect up to 1 in 100 people).
If you have any of these talk to your doctor or nurse as
Amoxicillin will need to be stopped.
Other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea
Uncommon (may affect up to 1 in 100 people)
• being sick (vomiting)
Very rare (may affect up to 1 in 10,000 people)
• thrush (a yeast infection of the vagina, mouth or skin folds);
you can get treatment for thrush from your doctor,
pharmacist or nurse
• kidney problems
• fits (convulsions), seen in patients on high doses or with
kidney problems
• dizziness
• hyperactivity

• crystals in the urine, (which may be seen as cloudy urine, or
difficulty or discomfort in passing urine
• make sure you drink plenty of fluids to reduce the chance of
these symptoms
• an excessive breakdown of red blood cells causing a type
of anaemia. Signs include: tiredness, headaches, shortness
of breath, dizziness, looking pale and yellowing of the skin
and the whites of the eyes
• low number of white blood cells
• low number of cells involved with blood clotting the blood
may take longer to clot than it normally would. You may
notice this if you have a nosebleed or cut yourself.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse, or
pharmacist. 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 AMOXICILLIN INJECTION
Amoxicillin Injection is for use in hospital only. The expiry date
and storage instructions stated on the label are for the doctor,
pharmacist or nurse’s information. The doctor, pharmacist or
nurse will make up your medicine. When administered directly
into a muscle or a vein, it should be used immediately
following reconstitution (usually this process takes about 5
minutes). If Amoxicillin Injection is being administered by slow
infusion this takes about half to one hour.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Amoxicillin Injection contains
The active substance in each vial is 250 mg, 500 mg or 1 g
amoxicillin.
There are no other ingredients. However, for information about
sodium in Amoxicillin Injection, please see section 2.
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 Amoxicillin Injection looks like and contents of the
pack:
Amoxicillin Injection is a white or almost white powder filled
into a glass vial.
Each carton contains 1, 5, 10, 20 or 50 glass vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ibigen S.r.l.
04011 Aprilia (Lt), Via Fossignano, 2, Italy
Manufacturer:
Istituto Biochimico Italiano G. Lorenzini S.p.A.
04011 Aprilia (Lt), Via Fossignano, 2, Italy
This leaflet was last revised in May 2016
General advice regarding the use of antibiotics
Antibiotics are used to treat infections caused by bacteria.
They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond
to a course of an antibiotic. One of the commonest reasons
for this to occur is because the bacteria causing the infection
are resistant to the antibiotic that is being taken. This means
that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many
reasons. Using antibiotics carefully can help to reduce the
chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is
intended to treat only your current illness. Paying attention to
the following advice will help prevent the emergence of
resistant bacteria that could stop the antibiotic working.
1. It is very important that you take the antibiotic at the right
dose, at the right times and for the right number of days.
Read the instructions on the label and if you do not
understand anything ask your doctor or pharmacist to
explain.
2. You should not take an antibiotic unless it has been
prescribed specifically for you and you should use it only to
treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed
for other people even if they had an infection that was
similar to yours.
4. You should not give antibiotics that were prescribed for you
to other people.
5. If you have any antibiotic left over when you have taken the
course as directed by your doctor you should take the
remainder to a pharmacy for appropriate disposal.

--------------------------------------------------------------------------------------

Intravenous amoxicillin may be given in a range of different
intravenous fluids:
• Water for Injection
• NaCl
• Ringer NaCl
• Sodium lactate
• Ringer sodium lactate
• Glucose
• NaCl - Glucose
Amoxicillin is less stable in infusions containing carbohydrate.
Reconstituted solutions of amoxicillin may be injected into the
drip tubing over a period of 0.5 to 1 hour.

Intramuscular administration
Vial

Diluent

250 mg

1.5 ml water for injections (final volume: 1.7
ml)

500 mg

2.5 ml water for injections (final volume: 2.9
ml)or 5.1 ml benzyl alcohol solution (final
volume: 5.5 ml)

2.5 ml lidocaine hydrochloride solution
(final volume: 3.3.ml)
All solutions should be shaken vigorously before injection and
administered within 30 minutes of reconstitution.
Any residual antibiotic solution should be discarded.
For single use only.
800573/04
1g

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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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