Skip to Content

CO-AMOXICLAV 500MG/100MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): AMOXICILLIN / AMOXICILLIN SODIUM / CLAVULANATE POTASSIUM / CLAVULANIC ACID / POTASSIUM CLAVULANATE / AMOXICILLIN / AMOXICILLIN SODIUM / CLAVULANATE POTASSIUM / CLAVULANIC ACID / POTASSIUM CLAVULANATE / AMOXICILLIN / AMOXICILLIN SODIUM / CLAVULANATE POTASSIUM / CLAVULA

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
Co-amoxiclav 500mg/100mg or 1000mg/200mg powder for solution for injection
or infusion
(Amoxicillin/clavulanic acid)
Read all of this leaflet carefully before you start taking this medicine.
• 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, or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
Co-amoxiclav 500mg/100mg powder for solution for injection or infusion and Co-amoxiclav
1000mg/200mg powder for solution for injection or infusion will both be referred to as Coamoxiclav in the rest of this leaflet.
What is in this leaflet:
1. What Co-amoxiclav is and what it is used for
2. What you need to know before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other information

1.

What Co-amoxiclav is and what it is used for

Co-amoxiclav 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.
Co-amoxiclav 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.
Co-amoxiclav is used in adults and children to prevent infections associated with major surgical
procedures.

2. What you need to know before you take Co-amoxiclav
You should not have Co-amoxiclav:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other
ingredients of Co-amoxiclav (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 Co-amoxiclav if any of the above apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having Co-amoxiclav.
Take special care with Co-amoxiclav
Talk to your doctor, pharmacist or nurse before taking this medicine 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 Co-amoxiclav.
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 Co-amoxiclav or a different
medicine.
Conditions you need to look out for
Co-amoxiclav 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 Co-amoxiclav, 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 Co-amoxiclav. This is because Coamoxiclav can affect the results of these types of tests.
Using other medicines
Please tell your doctor, pharmacist or nurse if you are using or have recently used 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 Co-amoxiclav, 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
Co-amoxiclav.
If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav then extra
blood tests may be needed.
Co-amoxiclav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases)
works.
Pregnancy and breast-feeding
Ask your doctor, pharmacist or nurse for advice if you are pregnant or breast-feeding.

Important information about some of the ingredients of Co-amoxiclav
500 mg/100 mg powder for injection or infusion
• contains approximately 31.4 mg (1.4 mmol) of sodium. This should be considered if you are on a
controlled sodium diet.
• 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.
1000 mg/200 mg powder for injection or infusion
• contains approximately 62.9 mg (2.7 mmol) of sodium. This should be considered if you are on a
controlled sodium diet.
• 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 to take Co-amoxiclav
You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give
you this medicine.
The usual doses are:
Adults, and children weighing 40 kg and over
Standard dose

1000 mg/200 mg every 8 hours.

To stop infections during and after surgery

1000 mg/200 mg before the surgery when you
are given your anaesthetic.
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 Co-amoxiclav will be given to you
• Co-amoxiclav will be given as an injection into a vein or by intravenous infusion.
• Make sure you drink plenty of fluids while having Co-amoxiclav.

• You will not normally be given Co-amoxiclav for longer than 2 weeks without the doctor
reviewing your treatment.
If more Co-amoxiclav 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 Coamoxiclav, 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 product is given, ask your doctor, pharmacist or
nurse.

4. Possible side effects
Like all medicines, Co-amoxiclav can cause side effects, although not everybody gets them. The
side effects below may happen with this medicine.
Conditions you need to look out for
Allergic reactions:
• 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.
→ Contact a doctor immediately if you get any of these symptoms. Stop taking Co-amoxiclav.
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 (may affect up to 1 in 10 people)
• thrush (candida - a yeast infection of the vagina, mouth or skin folds)
• diarrhoea
Uncommon side effects ( may affect up to 1 in 100 people)
• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when taking high doses
→ if affected take Co-amoxiclav before food
• 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 ( may affect up to 1 in 1000 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 Co-amoxiclav 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.
Reporting of side effects
If you get any side effects, talk to your doctor 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 Co-amoxiclav
You will not be asked to store your medicine. It will be brought to you ready to be administered
straight away. It will be stored below 30°C and kept in the outer carton.
Keep out of the sight and reach of children

Do not use Co-amoxiclav after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Co-amoxiclav contains
• The active substances are amoxicillin 500mg or 1000mg (as sodium) and clavulanic acid 100mg
or 200mg (as potassium).
• There are no other ingredients.
What Co-amoxiclav looks like and contents of the pack
Co-amoxiclav comes in clear glass vials. Available in packs of 10 vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
Reig Jofre S.A., C/Gran Capitan, 10, 08970-Sant Joan Despi, Barcelona, Spain.
The leaflet was last revised in March 2017.
PL 00289/1571-1572

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

The following information is intended for medical or healthcare professionals only:
Please refer to the Summary of Product Characteristics for further information

Administration
Co-amoxiclav 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. Co-amoxiclav is not suitable
for intramuscular administration.

Reconstitution
Preparation of solutions for intravenous injection
500 mg/100 mg powder for solution for injection or infusion
Water for Injection Ph.Eur. is the normal solvent. Co-amoxiclav 500/100 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 or a pale straw colour.
1000 mg/200 mg powder for solution for injection or infusion
Water for Injection Ph.Eur.is the normal solvent. Co-amoxiclav 1000 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 or a pale straw colour.
Co-amoxiclav should be administered within 20 min of reconstitution.
Preparation of solutions for intravenous infusion
Co-amoxiclav vials are not suitable for multi-dose use.
500 mg/100 mg powder for solution for injection or infusion
Co-amoxiclav 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.
1000 mg/200 mg powder for solution for injection or infusion
Co-amoxiclav 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
From a microbiological point of view, the product should be used immediately after reconstitution.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of
the user.
Solutions for injection, prepared as indicated in Section 6.6, should be administered within 20
minutes of reconstitution.

Solutions for infusion should be completed within the times stated in section 6.6 (see individual
infusion fluids in section 6.6).

Expand Transcript

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