Product Description
Products name:
Amoxicillin Powder For Injection
Contains:
Amoxicillin 250mg, 500mg or 1g
Package:
1 vial/ box;25 vials/ box ; 50 vials/ box.
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 to treat gout), concomitant use of probenecid may reduce the
excretion of amoxicillin and is not recommended.
• 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 to treat cancer and severe psoriasis), penicillins may
reduce the excretion of methotrexate causing a potential 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
250 mg vial: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say
essentially ‘sodium-free’.
500 mg/1 g vials: This medicine contains 38 mg sodium in each 500 mg vial and 76 mg sodium in
each 1g vial (main component of cooking/table salt). This is equivalent to 1.9% or 3.8% of the
recommended maximum daily dietary intake of sodium for an adult.
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.
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 may 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 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
• flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including
increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia
and Systemic Symptoms (DRESS))
• 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.
Frequency not known (frequency cannot be estimated from available data)
• chest pain in the context of allergic reactions, which may be a symptom of allergy triggered
cardiac infarction (Kounis syndrome)
• drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children
receiving amoxicillin. It is a certain kind of allergic reaction with the leading symptom of
repetitive vomiting (1-4 hours after drug administration). Further symptoms could comprise
abdominal pain, lethargy, diarrhoea, and low blood pressure.
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
• 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.
Frequency not known (frequency cannot be estimated from the available data)
• crystals in urine leading to acute kidney injury
• rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA
disease)
• inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
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 or search for MHRA Yellow Card in the Google Play or Apple App
Store. 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
