Skip to Content

UK Edition. Click here for US version.

AMOXICILLIN SODIUM 250MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): AMOXICILLIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Amoxicillin Sodium 250 mg, 500 mg and 1000 mg Powder for
Solution for Injection
Sodium Amoxicillin (referred to as Amoxicillin in the remainder of the leaflet)
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 is and what it is used for
2. What you need to know before you are given Amoxicillin
3. How Amoxicillin is given
4. Possible side effects
5. How to store Amoxicillin
6. Contents of the pack and other information

Pregnancy and Breast-feeding
If you are pregnant or think you may be pregnant or are planning to have a
baby ask your doctor for advice before you are given Amoxicillin.
Small amounts of this medicine can be passed into breast milk. Ask your
doctor for advice before breast‑feeding.
Important information about some of the ingredients of Amoxicillin
Amoxicillin sodium 250 mg powder for solution for injection contains
14.9 mg of sodium.
Amoxicillin sodium 500 mg powder for solution for injection contains
29.7 mg of sodium.
Amoxicillin sodium 1000 mg powder for solution for injection contains
59.4 mg of sodium.
This should be considered if you are on a controlled sodium diet.

3. How Amoxicillin is given
You will never give yourself this medicine. Amoxicillin will be given to you by
a doctor or nurse.
Your medicine will be given to you by injection into a muscle (intramuscularly)
1. What Amoxicillin is and what it is used for
or into a vein (intravenously) or as an infusion into a vein.
The name of your medicine is Amoxicillin Sodium Powder for Solution for
Your doctor will decide how much you need each day and how often the
Injection. The vials contain a medicine called sodium amoxicillin. Amoxicillin injections should be given.
belongs to a group of medicines called aminopenicillin antibiotics, which
To treat infections the usual doses are:
stop the growth of bacteria that cause infections.
Adults and the elderly
Amoxicillin is used in adults and children to:
• by intramuscular injection: 500 mg every eight hours
• treat infections caused by bacteria in different parts of the body
• 
by intravenous injection or infusion: 500 mg every eight hours (or in
• prevent inflammation of the inner lining of the heart (endocarditis)
severe infection 1 g every six hours) may be given by slow intravenous
• treat Lyme disease.
injection over three to four minutes or by infusion over 30 to 60 minutes.
• 
to prevent infections after surgery: the dose will vary according to
2. What you need to know before you are given Amoxicillin Injection
the type of surgery. Your doctor or nurse will tell you exactly how much
You should not be given Amoxicillin if you
medicine you will need and when you will need it. You may need to have
• are allergic (hypersensitive) to amoxicillin or penicillin. There are no other
1g injection into a vein before surgery, sometimes with another medicine
ingredients in this medicine (see section 6)
called gentamicin. This may be followed by a further 500 mg dose
• have had an allergic (hypersensitive) reaction to any antibiotic
(oral or injection) given 6 hours later.
• have previously been told that your infection cannot be treated with
amoxicillin or ampicillin.
You should not be given Amoxicillin if any of the above applies to you.
If you are unsure speak to your doctor, nurse or pharmacist.
Warnings and precautions
Children up to 10 years of age
Talk to you doctor before you are given Amoxicillin if you:
• most infections: 50 mg – 100 mg for every kilogram of body weight in
• have a history of allergies, especially allergies to drugs
equal doses throughout the day
• have problems passing water (urine) or suffer from repeat urinary tract
• to prevent infections after surgery: the dose will vary according to
infections
the type of surgery. Your doctor or nurse will tell you exactly how much
• have glandular fever
medicine you will need and when you will need it.
• have problems with the functions of your kidneys. Your doctor may
- For children aged 5 to 10 years, the dose is usually half the adult dose,
monitor you during treatment
see above.
• have a problem with your heart
F
or children aged up to 5 years, the dose is usually one-quarter of
- 
• have syphilis, because of the risks of a reaction known as Jarischthe adult dose, see above.
Herxheimer reaction (see also section 4 “Possible side effects”)
• have undiagnosed sore throat (pharyngitis) or a type of cancer known as Patients with kidney problems
If you have kidney problems the dose might be lower than the usual dose.
lymphatic lymphoma, which affects white blood cells
Amoxicillin is removed by dialysis (artificial filtration and purification of the
• have HIV
blood). Therefore, patients receiving dialysis may require another dose of
• are on a sodium controlled diet.
Amoxicillin at the end of their dialysis session.
If any of the above applies to you speak to your doctor or nurse before
being given Amoxicillin.
If you are given too much Amoxicillin
This medicine is given to you by a doctor or a nurse. It is unlikely that you
Children
Care should be taken in newborns and young infants as there is the chance will be given too much. However, if you think you have been given too much
Amoxicillin speak to your doctor or nurse immediately. The symptoms of an
of higher levels of amoxicillin in the blood.
overdose include the presence of crystals in the urine which cannot be seen
Other medicines and Amoxicillin
by the patient.
Tell your doctor if you are taking, have recently taken or might take any
The doctor will assess your condition and decide how to treat an overdose.
other medicines, including medicines obtained without a prescription.
The following medicines can affect or be affected by treatment with Amoxicillin: If you think you have missed a dose of Amoxicillin
If you think that a dose of Amoxicillin has been missed, speak to your doctor
• oral anticoagulants, medicines that stop your blood clotting
or nurse.
• oral contraceptives that contain oestrogen
If you have further questions on the use of this medicine, ask your doctor or
• a medicine known as methotrexate used in the treatment of cancer
nurse.
• other types of antibacterial treatments such as bacteriostatic agents
(e.g. chloramphenicol) and tetracyclines
4. Possible side effects
• medicines used to treat gout, such as probenecid and allopurinol.
Like all medicines, this medicine can cause side effects, although not
Tell your doctor if you are taking Amoxicillin as it may affect the results of
everybody gets them.
blood or urine tests.

INFORMATION FOR HEALTH CARE PROFESSIONALS
Amoxicillin Sodium 250mg Powder for Solution for Injection
Amoxicillin Sodium 500mg Powder for Solution for Injection
Amoxicillin Sodium 1g Powder for Solution for Injection
Please refer to the Summary of Product Characteristics for further information
• Presentation
Amoxicillin Injection is available in vials containing the equivalent of 250mg, 500mg or 1g amoxicillin as amoxicillin sodium, presented as a powder for
reconstitution.
• Posology and method of administration
Treatment of Infections in Adults and the Elderly
By intramuscular injection:
500mg every eight hours
By intravenous injection or infusion:
500mg every eight hours (or in severe infection 1g every six hours) may be given by slow iv injection over three to four minutes or by infusion over
30 to 60 minutes.
Treatment of Infection in Children up to 10 years
By intramuscular or intravenous injection or infusion:
50-100mg per kg bodyweight daily in divided doses.
Renal impairment
It may be necessary to reduce the total daily dosage depending on the degree of renal impairment.
As amoxicillin is removed by haemodialysis, patients receiving haemodialysis may require another dose of amoxicillin at the end of their dialysis.
Endocarditis prophylaxis
Dental procedures No special risk
under general
(ie, no prosthetic heart
anaesthesia
valves, no history of
endocarditis, not more
than a single dose
of a penicillin in the
previous month)
Upper respiratory Special risk (with
tract procedures prosthetic heart
under general
valves, history
anaesthesia:
of endocarditis,
or receipt of more
than a single dose
of a penicillin in the
previous month)

Adults and the elderly:
1g amoxicillin iv at induction, followed by 500mg oral, iv or im amoxicillin six hours later
Children under 5 years:
Quarter adult dose
Children 5-10 years:
Half adult dose
Adults and the elderly:
1g amoxicillin iv with im or iv gentamicin at induction, followed by 500mg oral, iv or im amoxicillin six hours later
Children under 5 years:
Quarter adult dose plus gentamicin
Children 5-10 years:
Half adult dose plus gentamicin
NB Amoxicillin and gentamicin should not be mixed in the same syringe

Tell your doctor or nurse straight away if you notice any of the
following serious side effects – you may need urgent medical
treatment:
The following are very rare (affects less than 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
• delayed allergic reaction (that can occur more than seven days after
starting treatment with amoxicillin), symptoms include rashes, high
temperature (fever), joint pain, and enlargement of lymph nodes (glands)
• a skin reaction known as ‘erythema multiforme’ which has symptoms
such as: itchy reddish purple patches on the skin, especially on the
palms of the hands and soles of the feet, ‘hive-like’ raised swollen areas
on the skin, tender areas on the surfaces of the mouth, eyes and private
parts. You may have a high temperature (fever) and feel 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
• high temperature (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
• inflammation of the large bowel (colon) with diarrhoea sometimes
containing blood, pain and fever
• serious liver side effects may occur which are often reversible. They are
mainly associated with people having treatment over a long period, males
and the elderly. You must tell your doctor or nurse 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.
• patients with syphilis leptospirosis may experience a reaction known as
Jarisch-Herxheimer, which can cause high temperature (fever), chills,
headache and worsening of skin lesions. The frequency of this reaction
is unknown.
If any of the above happen to you talk to your doctor or nurse
straight away as your medicine should be stopped.
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 (affects less
than 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 (affects less than 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (affects less than 1 in 100 people)
• being sick (vomiting).
Very rare (affects less than 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 form of anaemia.
Signs include: tiredness, headaches, shortness of breath, dizziness,
looking pale and yellowing of the skin and the whites of the eyes
• the blood may take longer to clot than it normally would. You may notice
this if you have a nosebleed or cut yourself.

Genito-urinary procedures under general
anaesthesia in patients with no urinary
tract infection:
Gastrointestinal, obstetric and
gynaecological procedures under general
anaesthesia for patients with prosthetic
heart valves or history of endocarditis:

Not known (frequency cannot be estimated from the available data)
• difficulty breathing, or shortness of breath
• hallucinations (hearing or seeing things that aren’t there
• changes in your salt and electrolyte levels (shown in blood tests)
• patients with glandular fever and other lymphoid disorders (e.g. lymphatic
leukaemia or HIV) may be at higher risk of developing a rash (see also
section 2 “Warnings and precautions”)
• sore mouth and tongue
• coma
• a drug rash associated with changes to the white blood cells.
If any of the side effects gets serious, or if you have any side effects not
listed in this leaflet, please tell your doctor, pharmacist or nurse.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This also includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
http://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
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 label.
The expiry date refers to the last day of that month.
• Store below 25°C, in the original container.
• Reconstituted solutions should be used immediately after preparation.
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 Amoxicillin contains
The active ingredient is sodium amoxicillin.
Each vial of amoxicillin sodium 250 mg powder for solution for injection
contains 250 mg sodium amoxicillin.
Each vial of amoxicillin sodium 500 mg powder for solution for injection
contains 500 mg sodium amoxicillin.
Each vial of amoxicillin sodium 1000 mg powder for solution for injection
contains 1000 mg sodium amoxicillin.
There are no other ingredients. However, please see section 2 for further
important information about sodium in Amoxicillin.
What Amoxicillin looks like and the contents of the pack
Amoxicillin is supplied as a vial of powder for making up as an injection.
Vials containing 250 mg or 500 mg of amoxicillin sodium powder for solution
for injection are available in packs of 10 vials.
Vials containing 1000 mg of amoxicillin powder for solution for injection are
available in single packs.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or 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
Amoxicillin Sodium for injection 250 mg
Amoxicillin Sodium for injection 500 mg
Amoxicillin Sodium for injection 1000 mg

Reference numbers
PL 29831/0010
PL 29831/0012
PL 29831/0011

This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call + 44 1978 669272.
Leaflet Prepared: 01/2016

105842/5

Adults and the elderly:
1g amoxicillin iv with im or iv gentamicin at induction, followed by 500mg oral, iv or im amoxicillin six hours later
Children under 5 years:
Quarter adult dose plus gentamicin
Children 5-10 years:
Half adult dose plus gentamicin
NB Amoxicillin and gentamicin should not be mixed in the same syringe

Method of Administration
Intravenous Injection:
Dissolve 250mg in 5mL Water for Injections Ph Eur (final volume 5.2mL).
Dissolve 500mg in 10mL Water for Injections Ph Eur (final volume 10.4mL).
Dissolve 1g in 20mL Water for Injections Ph Eur (final volume 20.8mL).
Amoxicillin Sodium for Injection BP, when diluted may be injected slowly into a vein or infusion line over three to four minutes.
Intravenous Infusion:
Prepare as above and add to an iv solution in a minibag or in-line burette. Administer over 30 to 60 minutes. Alternatively the appropriate volume of iv fluid
may be transferred from the infusion bag into the vial, using a suitable reconstitution device, and drawn back into the bag after dissolution.
Intramuscular Injection:
Add 1.5mL Water for Injections Ph Eur to 250mg and shake vigorously (final volume 1.7mL).
Add 2.5mL Water for Injections Ph Eur to 500mg and shake vigorously (final volume 2.9mL).
• Incompatibilities
If amoxicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving
set because under these conditions, loss of activity of the aminoglycoside can occur. Amoxicillin and aminoglycoside injections should be administered at
separate sites.
Amoxicillin should not be mixed with blood products or other proteinaceous fluids (eg protein hydrolysates) or with intravenous lipid emulsions.
Amoxicillin should not be mixed with ciprofloxacin.
• Shelf life and special precautions for storage
Unopened: 36 months.
Store below 25°C.
Reconstituted solutions should be administered immediately after preparation.
• Instructions for use/handling
The vials are not suitable for multidose use.
Date leaflet last revised: 01/2016
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
105842/5

Expand view ⇕

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.

Hide