Co-amoxiclav | Drugs | BNF content published by NICE (2024)

Co-amoxiclav may be used as detailed below, although these situations are considered unlicensed:

• treatment of acute exacerbation of bronchiectasis A
• treatment of hospital-acquired pneumonia A
• duration of treatment for acute sinusitis A
• duration of treatment for acute otitis media A

In adults:

Co-amoxiclav is used for the treatment of acute diverticulitis A , but is not licensed orally for this indication.

General cautions:

Acute lymphocytic leukaemia (increased risk of erythematous rashes); chronic lymphocytic leukaemia (increased risk of erythematous rashes); cytomegalovirus infection (increased risk of erythematous rashes); glandular fever (erythematous rashes common); maintain adequate hydration with high doses (particularly during parental therapy)

Specific cautions:

With intravenous use

Accumulation of electrolytes contained in parenteral preparations can occur with high doses

Common or very common

Diarrhoea; hypersensitivity; nausea; skin reactions; thrombocytopenia; vomiting

Uncommon

Antibiotic associated colitis; arthralgia; leucopenia

Rare or very rare

Agranulocytosis; angioedema; haemolytic anaemia; hepatic disorders; nephritis tubulointerstitial; neutropenia; seizure; severe cutaneous adverse reactions (SCARs)

Side-effects, further information

Diarrhoea frequently occurs during oral penicillin therapy. It is most common with broad-spectrum penicillins, which can cause antibiotic-associated colitis.

General side-effects:

Common or very common

Increased risk of infection

Uncommon

Dizziness; dyspepsia; headache

Frequency not known

Colitis haemorrhagic; crystalluria; hypersensitivity vasculitis; meningitis aseptic

Specific side-effects:

Frequency not known

With oral use

Akathisia; black hairy tongue; cholangitis; Kounis syndrome

Side-effects, further information

Hepatic events have been reported mostly in males and elderly patients and may be associated with prolonged treatment.

Signs and symptoms usually occur during or shortly after treatment but in some cases may occur several weeks after discontinuation.

The most important side-effect of the penicillins is hypersensitivity which causes rashes and anaphylaxis and can be fatal. Allergic reactions to penicillins occur in 1–10% of exposed individuals; anaphylactic reactions occur in fewer than 0.05% of treated patients. Patients with a history of atopic allergy (e.g. asthma, eczema, hay fever) are at a higher risk of anaphylactic reactions to penicillins. Individuals with a history of anaphylaxis, urticaria, or rash immediately after penicillin administration are at risk of immediate hypersensitivity to a penicillin; these individuals should not receive a penicillin.

Individuals with a history of a minor rash (i.e. non-confluent, non-pruritic rash restricted to a small area of the body) or a rash that occurs more than 72 hours after penicillin administration are probably not allergic to penicillin and in these individuals a penicillin should not be withheld unnecessarily for serious infections; the possibility of an allergic reaction should, however, be borne in mind. Other beta-lactam antibiotics (including cephalosporins) can be used in these patients.

Patients who are allergic to one penicillin will be allergic to all because the hypersensitivity is related to the basic penicillin structure. Patients with a history of immediate hypersensitivity to penicillins may also react to the cephalosporins and other beta-lactam antibiotics, they should not receive these antibiotics. If a penicillin (or another beta-lactam antibiotic) is essential in an individual with immediate hypersensitivity to penicillin then specialist advice should be sought on hypersensitivity testing or using a beta-lactam antibiotic with a different structure to the penicillin that caused the hypersensitivity.

Manufacturer advises caution.

Monitoring

Monitor liver function in liver disease.

Risk of crystalluria with high doses (particularly during parenteral therapy).

With intravenous use:

Accumulation of electrolytes contained in parenteral preparations can occur in patients with renal failure.

Dose adjustments

With oral use in adults:

Co-amoxiclav 250/125 tablets or 500/125 tablets : if eGFR 10–30mL/minute/1.73m ² , one 250/125 strength tablet every 12 hours or one 500/125 strength tablet every 12 hours; if eGFR less than 10mL/minute/1.73m ² , one 250/125 strength tablet every 24 hours or one 500/125 strength tablet every 24 hours.

With oral use in adults:

Co-amoxiclav 400/57 suspension : avoid if eGFR less than 30mL/minute/1.73m ² .

With intravenous use in adults:

Co-amoxiclav injection (expressed as co-amoxiclav): if eGFR 10–30mL/minute/1.73m ² , 1.2g initially, then 600mg every 12 hours; if eGFR less than 10mL/minute/1.73m ² , 1.2g initially, then 600mg every 24 hours.

With oral use in children:

Co-amoxiclav 125/31 suspension , 250/62 suspension, 250/125 tablets, or 500/125 tablets : use normal dose every 12 hours if estimated glomerular filtration rate 10–30mL/minute/1.73m ² . Use the normal dose recommended for mild or moderate infections every 12 hours if estimated glomerular filtration rate less than 10mL/minute/1.73m ² .

With oral use in children:

Co-amoxiclav 400/57 suspension : avoid if estimated glomerular filtration rate less than 30mL/minute/1.73m ² .

With intravenous use in children:

Co-amoxiclav injection : use normal initial dose and then use half normal dose every 12 hours if estimated glomerular filtration rate 10–30mL/minute/1.73m ² ; use normal initial dose and then use half normal dose every 24 hours if estimated glomerular filtration rate less than 10mL/minute/1.73m ² .

With intravenous use in children:

For intravenous infusion, manufacturer advises dilute reconstituted solution to a concentration of 10mg/mL with Sodium Chloride 0.9%; give intermittently over 30–40 minutes.

For intravenous injection, administer over 3–4 minutes.

With intravenous use in adults:

For intravenous infusion (Augmentin®), manufacturer advises give intermittently in Sodium Chloride 0.9%. Reconstitute 600mg initially with 10mL Water for Injections, then dilute with 50mL infusion fluid; reconstitute 1.2g initially with 20mL Water for Injections, then dilute with 100mL infusion fluid; give over 30–40 minutes.

For intravenous injection, administer over 3–4 minutes.

Via drip tubing in Sodium Chloride 0.9%.

Doses are expressed as co-amoxiclav: a mixture of amoxicillin (as the trihydrate or as the sodium salt) and clavulanic acid (as potassium clavulanate); the proportions are expressed in the form x/y where x and y are the strengths in milligrams of amoxicillin and clavulanic acid respectively.

For choice of antibacterial therapy, see Antibacterials, use for prophylaxis, Ear infections, antibacterial therapy, Gastro-intestinal system infections, antibacterial therapy, Musculoskeletal system infections, antibacterial therapy, Nose infections, antibacterial therapy, Respiratory system infections, antibacterial therapy, Skin infections, antibacterial therapy, Urinary-tract infections.

In adults:

For choice of antibacterial therapy, see Diabetic foot infections, antibacterial therapy.

Medicines for Children leaflet: Co-amoxiclav for bacterial infections

In children:

https://www.medicinesforchildren.org.uk/medicines/co-amoxiclav-for-bacterial-infections/

Dental practitioners' formulary

Co-amoxiclav 250/125 Tablets may be prescribed.

Co-amoxiclav 125/31 Suspension may be prescribed.

Co-amoxiclav 250/62 Suspension may be prescribed.