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AMOXICILLIN 250MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): AMOXICILLIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin 250mg, 500mg or 1g,
Powder for Solution for Injection or Infusion
Amoxicillin as Amoxicillin Sodium
Read all of this leaflet carefully before you start using this medicine.
 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. Do not pass it on to others. It may harm them even if
their symptoms 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.
 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).
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. Content of the pack and other information

1.

What Amoxicillin Injection is and what it is used for

What Amoxicillin is
Amoxicillin is an antibiotic. The active ingredient is amoxicillin. This belongs to group medicines
called ‘penicillin’.
What Amoxicillin is used for
Amoxicillin 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

Do not take Amoxicillin:
 if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed
in section 6).
 if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling
of the face or throat.
Do not take Amoxicillin if any of the above apply. If you are not sure, talk to your doctor, pharmacist
or nurse before taking Amoxicillin.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Amoxicillin 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
taking Amoxicillin.
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 taking Amoxicillin. This is because Amoxicillin can
affect the results of these tests.

Other medicines and Amoxicillin:
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) with Amoxicillin, it may be more likely that you will have an
allergic skin reaction.
 probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin.
 medicines to help stop blood clots (such as warfarin), you may need extra blood tests.
 other antibiotics (such as tetracycline) Amoxicillin may be less effective.
 methotrexate (used for the treatment of cancer and severe psoriasis) Amoxicillin may cause
an increase in side effects.

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, pharmacist or nurse for advice before taking 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 Powder for Solution for Injection or Infusion 250mg contains sodium
• Amoxicillin contains 16 mg (0.68 mmol) of sodium and is essentially “sodium free”.
Amoxicillin Powder for Solution for Injection or Infusion 500 mg contains sodium
• Amoxicillin contains 32 mg (1.37 mmol) of sodium. This should be considered if you are on a
sodium controlled diet.
Amoxicillin Powder for Solution for Injection or Infusion 1 g contains sodium
• Amoxicillin contains 63 mg (2.74 mmol) of sodium. This should be considered if you are on a
sodium controlled 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 having Amoxicillin.
To treat infections
The usual 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
 Usual daily dosage: 750 mg to 6 g administered in divided doses.
 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.
 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.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If more Amoxicillin 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,
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.
If you think you have missed an injection of Amoxicillin
Speak to your doctor, pharmacist or nurse.
How long will you need to take Amoxicillin 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.
Stop taking Amoxicillin and see a doctor straight away, if you notice any of the following serious
side effects – you may need urgent medical treatment:
The following are 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 can happen when having 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.
The 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, pharmacist or nurse. 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 Powder for Solution for Injection or Infusion 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 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, 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 in a glass vial.
Each carton contains 1, 5, 10, 20 or 50 glass vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Manufacturer:
Istituto Biochimico Italiano, 04011 Aprilia (Lt), Via di Fossignano, 2, Italy
This leaflet was last revised in November 2015

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.
------------------------------------------------------------------------------------------------------------INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only.
Intravenous administration
Vial
Diluent (ml)
250 mg
5
500 mg
10
1g
20
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.
250 mg powder for solution for injection or infusion
Preparation of intravenous infusions and stability: add without delay the reconstituted solution of
250 mg (as prepared above - these are minimum volumes) to 50 ml of infusion fluid.

500 mg powder for solution for injection or infusion
Preparation of intravenous infusions and stability: add without delay the reconstituted solution of
500 mg (as prepared above - these are minimum volumes) to 50 ml of infusion fluid.
1 g powder for solution for injection or infusion
Preparation of intravenous infusions and stability: 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).
Intravenous amoxicillin may be given in a range of different intravenous fluids.
Intravenous solution
Water for Injection
NaCI
Ringer NaCI
Sodium lactate
Ringer sodium lactate
Dextrose
NaCI - dextrose
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
250 mg
500 mg
1g

Diluent
1.5 ml water for injections
2.5 ml water for injections
or 5.1 ml benzyl alcohol solution
2.5 ml lidocaine hydrochloride solution

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.


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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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