Drugs List

Therapeutic Indications

Uses

Infections due to amoxicillin-resistant beta-lactamase producing bacteria
Prophylaxis against infection during surgical procedures

Treatment of the following bacterial infections when caused by organisms that are resistant to amoxicillin but susceptible to amoxicillin with clavulanic acid:

Severe infections of the ear, nose and throat e.g. mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms
Acute exacerbations of chronic bronchitis (adequately diagnosed)
Community acquired pneumonia
Cystitis
Pyelonephritis
Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
Bone and joint infections, in particular osteomyelitis
Intra-abdominal infections
Female genital infections
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the gastrointestinal tract, pelvic cavity, head and neck, biliary tract surgery

Administration

For intravenous administration by injection or infusion. Co-amoxiclav 2.2g must be given by infusion only.

Children aged less than 3 months should be administered co-amoxiclav by infusion only.

Injection
Administer by slow intravenous injection over 3 to 4 minutes. The reconstituted solution may be injected directly into a vein or via a drip tube.

Infusion
Infuse over 30 to 40 minutes.

Contraindications

Infectious mononucleosis
History of drug induced hepatic impairment
History of drug induced jaundice

Precautions and Warnings

Allergic disposition
Atopy
Cytomegalovirus infection
Restricted potassium intake
Restricted sodium intake
Asthma
Breastfeeding
Hepatic impairment
Lymphatic leukaemia
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute

Reduce dose in patients with creatinine clearance below 30ml/min
Some formulations contain more than 1mmol (23mg) sodium per dose
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Contains potassium; caution in low potassium diets
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Maintain hydration and urinary output
Monitor hepatic function in patients with hepatic impairment
Monitor liver function on prolonged therapy
Monitor patency of urinary catheters regularly, precipitation may occur
Monitor renal function during prolonged/high dose therapy
Perform blood counts on prolonged use of this treatment
Cholestatic jaundice may occur during or after treatment
Erythematous rash common in glandular fever, CMV inf, lymphocytic leukaemia
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
May cause false positive Coomb's test and glycosuria test
Discontinue at once if pseudomembranous colitis occurs
Discontinue if drug-related rash or other hypersensitivity reactions occur

Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases, may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events can potentially be severe and extremely rarely can result in death. These usually occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.

Pregnancy and Lactation

Pregnancy

Use co-amoxiclav with caution during pregnancy.

The manufacturers suggest that co-amoxiclav should be avoided during pregnancy unless considered essential.

At the time of writing, there is limited experience with the use of co-amoxiclav during human pregnancy. Available data do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with co-amoxiclav may be associated with an increased risk of necrotising enterocolitis in neonates.

There is no evidence that amoxicillin has a teratogenic effect, and its suitability for use during pregnancy has been well documented in clinical studies.

Lactation

Use co-amoxiclav with caution during breastfeeding.

The manufacturers suggest that co-amoxiclav should only be used during breastfeeding after an assessment of the risks and benefits. The Drugs and Lactation Database (LactMed) suggests that co-amoxiclav is acceptable for use during breastfeeding. If co-amoxiclav is required by the mother it is not a reason to discontinue breastfeeding. At the time of writing limited information indicates that serious reactions in infants are very uncommon during the use of co-amoxiclav during nursing, with restlessness, diarrhoea and rash occurring occasionally. The infant should be monitored for these reactions during breastfeeding.

Both amoxicillin and potassium clavulanate are excreted into breast milk.

Side Effects

Acute generalised exanthematous pustulosis
Agranulocytosis
Anaemia
Anaphylactic shock
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Aseptic meningitis
Black tongue
Candidiasis (mouth or throat)
Cholestatic jaundice
Convulsions
Crystalluria
Cutaneous reactions
Decreased appetite
Diarrhoea
Dizziness
Drug fever
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Enanthema
Eosinophilia
Erythema multiforme
Erythematous rash
Exanthema
Exfoliative dermatitis
Flatulence
Gastric upset
Granulocytopenia
Haemolytic anaemia
Haemorrhagic colitis
Headache
Hepatitis
Hyperactivity
Hypersensitivity reactions
Increase in serum ALT/AST
Indigestion
Interstitial nephritis
Laryngeal oedema
Leucopenia
Myelosuppression
Nausea
Neutropenia
Overgrowth by non-susceptible organisms
Pancytopenia
Prolonged bleeding
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Soft or liquid stools
Stevens-Johnson syndrome
Taste disturbances
Thrombocytopenia
Thrombophlebitis (injection site)
Toxic epidermal necrolysis
Urticaria
Vaginal candidiasis
Vasculitis (allergic)
Vomiting

Presentation

Powder for reconstitution for injection or infusion containing amoxicillin (as amoxicillin sodium) and clavulanic acid (as potassium clavulanate)

Drugs List

Therapeutic Indications

Uses

Infections due to amoxicillin-resistant beta-lactamase producing bacteria
Prophylaxis against infection during surgical procedures

Treatment of the following bacterial infections when caused by organisms that are resistant to amoxicillin but susceptible to amoxicillin with clavulanic acid:

Severe infections of the ear, nose and throat e.g. mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms
Acute exacerbations of chronic bronchitis (adequately diagnosed)
Community acquired pneumonia
Cystitis
Pyelonephritis
Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
Bone and joint infections, in particular osteomyelitis
Intra-abdominal infections
Female genital infections
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the gastrointestinal tract, pelvic cavity, head and neck, biliary tract surgery

Dosage

Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.

Adults

Elderly

Children

Neonates

Patients with Renal Impairment

Administration

For intravenous administration by injection or infusion. Co-amoxiclav 2.2g must be given by infusion only.

Children aged less than 3 months should be administered co-amoxiclav by infusion only.

Injection
Administer by slow intravenous injection over 3 to 4 minutes. The reconstituted solution may be injected directly into a vein or via a drip tube.

Infusion
Infuse over 30 to 40 minutes.

Contraindications

Infectious mononucleosis
History of drug induced hepatic impairment
History of drug induced jaundice

Precautions and Warnings

Allergic disposition
Atopy
Cytomegalovirus infection
Restricted potassium intake
Restricted sodium intake
Asthma
Breastfeeding
Hepatic impairment
Lymphatic leukaemia
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute

Reduce dose in patients with creatinine clearance below 30ml/min
Some formulations contain more than 1mmol (23mg) sodium per dose
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Contains potassium; caution in low potassium diets
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Maintain hydration and urinary output
Monitor hepatic function in patients with hepatic impairment
Monitor liver function on prolonged therapy
Monitor patency of urinary catheters regularly, precipitation may occur
Monitor renal function during prolonged/high dose therapy
Perform blood counts on prolonged use of this treatment
Cholestatic jaundice may occur during or after treatment
Erythematous rash common in glandular fever, CMV inf, lymphocytic leukaemia
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
May cause false positive Coomb's test and glycosuria test
Discontinue at once if pseudomembranous colitis occurs
Discontinue if drug-related rash or other hypersensitivity reactions occur

Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases, may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events can potentially be severe and extremely rarely can result in death. These usually occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.

Pregnancy and Lactation

Pregnancy

Use co-amoxiclav with caution during pregnancy.

The manufacturers suggest that co-amoxiclav should be avoided during pregnancy unless considered essential.

At the time of writing, there is limited experience with the use of co-amoxiclav during human pregnancy. Available data do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with co-amoxiclav may be associated with an increased risk of necrotising enterocolitis in neonates.

There is no evidence that amoxicillin has a teratogenic effect, and its suitability for use during pregnancy has been well documented in clinical studies.

Lactation

Use co-amoxiclav with caution during breastfeeding.

The manufacturers suggest that co-amoxiclav should only be used during breastfeeding after an assessment of the risks and benefits. The Drugs and Lactation Database (LactMed) suggests that co-amoxiclav is acceptable for use during breastfeeding. If co-amoxiclav is required by the mother it is not a reason to discontinue breastfeeding. At the time of writing limited information indicates that serious reactions in infants are very uncommon during the use of co-amoxiclav during nursing, with restlessness, diarrhoea and rash occurring occasionally. The infant should be monitored for these reactions during breastfeeding.

Both amoxicillin and potassium clavulanate are excreted into breast milk.

Side Effects

Acute generalised exanthematous pustulosis
Agranulocytosis
Anaemia
Anaphylactic shock
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Aseptic meningitis
Black tongue
Candidiasis (mouth or throat)
Cholestatic jaundice
Convulsions
Crystalluria
Cutaneous reactions
Decreased appetite
Diarrhoea
Dizziness
Drug fever
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Enanthema
Eosinophilia
Erythema multiforme
Erythematous rash
Exanthema
Exfoliative dermatitis
Flatulence
Gastric upset
Granulocytopenia
Haemolytic anaemia
Haemorrhagic colitis
Headache
Hepatitis
Hyperactivity
Hypersensitivity reactions
Increase in serum ALT/AST
Indigestion
Interstitial nephritis
Laryngeal oedema
Leucopenia
Myelosuppression
Nausea
Neutropenia
Overgrowth by non-susceptible organisms
Pancytopenia
Prolonged bleeding
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Soft or liquid stools
Stevens-Johnson syndrome
Taste disturbances
Thrombocytopenia
Thrombophlebitis (injection site)
Toxic epidermal necrolysis
Urticaria
Vaginal candidiasis
Vasculitis (allergic)
Vomiting

Effects on Laboratory Tests

Enzymatic glucose oxidase methods should be used during amoxicillin therapy whenever testing for the presence of glucose in urine because false positive results may occur with non-enzymatic methods.

The presence of clavulanic acid may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.

There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving co-amoxiclav who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving co-amoxiclav should be interpreted cautiously and confirmed by other diagnostic methods.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: April 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Augmentin Intravenous. GlaxoSmithKline UK. Revised October 2013.
Summary of Product Characteristics: Co-amoxiclav injection 2000/200 mg. Bowmed Ibisqus Limited. Revised November 2021.
Summary of Product Characteristics: Co-amoxiclav injection 500/100 mg. Teva UK Ltd. Revised April 2011.
Summary of Product Characteristics: Co-amoxiclav injection 500/100 mg. Wockhardt UK Ltd. Revised April 2012.
Summary of Product Characteristics: Co-amoxiclav injection 1000/200 mg. Wockhardt UK Ltd. Revised April 2012.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 December 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Amoxicillin and clavulanic acid. Last revised: January 16, 2014.
Last accessed: April 10, 2014.