Drugs List

Therapeutic Indications

Uses

Bacterial endocarditis
Endocarditis - prophylaxis
Infections due to Gram-positive organisms incl. penicillin-resistant staph.
Pseudomembranous colitis due to Clostridium difficile

Unlicensed Uses

Cerebral ventriculitis
Peritonitis associated with dialysis

Administration

Intravenous administration
Vancomycin should be administered as a slow intravenous infusion of at least one hour duration or at a maximum rate of 10mg/min whichever is longer.
Continuous vancomycin infusion may be considered, for example, in patients with unstable vancomycin clearance.

Oral administration
The contents of the vials for parenteral administration may be used.
Each dose may be reconstituted in 30ml water and either given to the patient to drink, or administrated by nasogastic tube. Common flavouring syrups may be added to the solution at the time of administration to improve the taste.

Contraindications

Auditory impairment

Precautions and Warnings

Elderly
Breastfeeding
Inflammatory bowel disease - if administered orally/enterally
Pregnancy
Renal impairment

Potentially ototoxic and nephrotoxic-use with care in renal insufficiency
Reduce dose in patients with renal impairment
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all indications
Not all available brands are licensed for all routes of administration
Avoid rapid infusion rates
Infuse over at least 60 minutes
Vary infusion site
Monitor auditory function in at risk patients before and during treatment
Consider pseudomembranous colitis if patient presents with severe diarrhoea
During treatment perform blood counts, BUN/creatinine and urine analysis
History of hearing loss - monitor drug levels
Monitor drug levels in patients with C.difficile taking multiple oral doses
Monitor haematological parameters periodically
Monitor hepatic function regularly
Monitor peak and trough serum levels
Monitor periodically for overgrowth of non-susceptible organisms
Monitor renal function regularly
Discontinue if hypersensitivity reactions occur
Discontinue if tinnitus occurs
Discontinue permanently if severe skin reaction occurs

Significant systemic absorption of oral vancomycin may occur in patients with inflammatory disorders of the intestinal mucosa, therefore these patients may be at risk of developing adverse reactions associated with the parenteral administration of vancomycin. The risk is greater in patients with renal impairment.

Although very little vancomycin is absorbed from the gastrointestinal tract following oral administration, clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active Clostridium difficile -induced pseudomembranous colitis. Monitoring of serum concentrations may be appropriate in these patients.

Total systemic and renal clearance of vancomycin are reduced in the elderly.

Concurrent anaesthesia may enhance some adverse effects of vancomycin. Vancomycin infusions should be completed before induction of anaesthesia.
Anaesthetic induced myocardial depression may be enhanced by vancomycin. Doses should be well reduced and close cardiac monitoring is recommended. Position changes should be delayed until infusion is complete to allow for postural hypotension.

Pregnancy and Lactation

Pregnancy

Use vancomycin with caution during pregnancy.

The manufacturer recommends that vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity. There is very limited data on the use of vancomycin in human pregnancy. It has been reported that pregnant patients may require significantly increased doses of vancomycin to achieve therapeutic serum concentrations. Teratology studies have been performed at 5 times human dose in rats and 3 times human dose in rabbits and have shown no evidence of foetal harm. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when it was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood but no sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted (one infant had conduction hearing loss reported). Vancomycin was administered only in the second or third trimesters, therefore it is unknown if it causes foetal harm when administered earlier in pregnancy.

Lactation

Use vancomycin with caution during breastfeeding.

The manufacturer advises caution should be exercised when vancomycin is administered to a nursing mother. Vancomycin is excreted in human milk. It is unlikely that an infant can absorb a significant amount of vancomycin from its gastro-intestinal tract and it is not expected to cause any adverse effects.

Side Effects

"Red man" syndrome (flushing of upper body)
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaphylactoid reaction
Anaphylaxis
Blood urea increased
Bradycardia
Bullous dermatoses
Bullous eruption
Cardiac arrest
Cardiogenic shock
Chills
Deafness
Diarrhoea
Dizziness
Drug fever
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspnoea
Eosinophilia
Exfoliative dermatitis
Hearing loss
Hypersensitivity reactions
Hypotension
Infusion-related symptoms
Interstitial nephritis
Macular abnormalities
Muscle spasm and pain of back and chest
Nausea
Nephrotoxicity
Neutropenia
Ototoxicity
Overgrowth by non-susceptible organisms
Pancytopenia
Phlebitis
Pruritus
Pseudomembranous colitis
Rash
Renal failure
Serum creatinine increased
Stevens-Johnson syndrome
Stridor
Thrombocytopenia
Thrombophlebitis
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Vomiting
Wheezing

Presentation

Powder for solution for infusion or oral solution of vancomycin hydrochloride

Drugs List

Therapeutic Indications

Uses

Bacterial endocarditis
Endocarditis - prophylaxis
Infections due to Gram-positive organisms incl. penicillin-resistant staph.
Pseudomembranous colitis due to Clostridium difficile

Unlicensed Uses

Cerebral ventriculitis
Peritonitis associated with dialysis

Dosage

Pre-dose serum concentrations must be determined daily and the dose adjusted accordingly.

Once vancomycin powder has been reconstituted it requires further dilution before administration. Concentrations of no more than 5 mg/ml are recommended with the exception of fluid-restricted patients where concentrations up to 10 mg/ml may be used. Infusion rates of more than 10 mg/minute increase the risk of infusion related adverse events. Infusion related adverse events are related to both concentration and rate of administration.

Duration of therapy is determined by type and severity of infection and clinical response.

Vancomycin is not to be given orally for systemic infections due to poor absorption.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

Intravenous administration
Vancomycin should be administered as a slow intravenous infusion of at least one hour duration or at a maximum rate of 10mg/min whichever is longer.
Continuous vancomycin infusion may be considered, for example, in patients with unstable vancomycin clearance.

Oral administration
The contents of the vials for parenteral administration may be used.
Each dose may be reconstituted in 30ml water and either given to the patient to drink, or administrated by nasogastic tube. Common flavouring syrups may be added to the solution at the time of administration to improve the taste.

Contraindications

Auditory impairment

Precautions and Warnings

Elderly
Breastfeeding
Inflammatory bowel disease - if administered orally/enterally
Pregnancy
Renal impairment

Potentially ototoxic and nephrotoxic-use with care in renal insufficiency
Reduce dose in patients with renal impairment
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all indications
Not all available brands are licensed for all routes of administration
Avoid rapid infusion rates
Infuse over at least 60 minutes
Vary infusion site
Monitor auditory function in at risk patients before and during treatment
Consider pseudomembranous colitis if patient presents with severe diarrhoea
During treatment perform blood counts, BUN/creatinine and urine analysis
History of hearing loss - monitor drug levels
Monitor drug levels in patients with C.difficile taking multiple oral doses
Monitor haematological parameters periodically
Monitor hepatic function regularly
Monitor peak and trough serum levels
Monitor periodically for overgrowth of non-susceptible organisms
Monitor renal function regularly
Discontinue if hypersensitivity reactions occur
Discontinue if tinnitus occurs
Discontinue permanently if severe skin reaction occurs

Significant systemic absorption of oral vancomycin may occur in patients with inflammatory disorders of the intestinal mucosa, therefore these patients may be at risk of developing adverse reactions associated with the parenteral administration of vancomycin. The risk is greater in patients with renal impairment.

Although very little vancomycin is absorbed from the gastrointestinal tract following oral administration, clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active Clostridium difficile -induced pseudomembranous colitis. Monitoring of serum concentrations may be appropriate in these patients.

Total systemic and renal clearance of vancomycin are reduced in the elderly.

Concurrent anaesthesia may enhance some adverse effects of vancomycin. Vancomycin infusions should be completed before induction of anaesthesia.
Anaesthetic induced myocardial depression may be enhanced by vancomycin. Doses should be well reduced and close cardiac monitoring is recommended. Position changes should be delayed until infusion is complete to allow for postural hypotension.

Pregnancy and Lactation

Pregnancy

Use vancomycin with caution during pregnancy.

The manufacturer recommends that vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity. There is very limited data on the use of vancomycin in human pregnancy. It has been reported that pregnant patients may require significantly increased doses of vancomycin to achieve therapeutic serum concentrations. Teratology studies have been performed at 5 times human dose in rats and 3 times human dose in rabbits and have shown no evidence of foetal harm. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when it was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood but no sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted (one infant had conduction hearing loss reported). Vancomycin was administered only in the second or third trimesters, therefore it is unknown if it causes foetal harm when administered earlier in pregnancy.

Lactation

Use vancomycin with caution during breastfeeding.

The manufacturer advises caution should be exercised when vancomycin is administered to a nursing mother. Vancomycin is excreted in human milk. It is unlikely that an infant can absorb a significant amount of vancomycin from its gastro-intestinal tract and it is not expected to cause any adverse effects.

Side Effects

"Red man" syndrome (flushing of upper body)
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaphylactoid reaction
Anaphylaxis
Blood urea increased
Bradycardia
Bullous dermatoses
Bullous eruption
Cardiac arrest
Cardiogenic shock
Chills
Deafness
Diarrhoea
Dizziness
Drug fever
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspnoea
Eosinophilia
Exfoliative dermatitis
Hearing loss
Hypersensitivity reactions
Hypotension
Infusion-related symptoms
Interstitial nephritis
Macular abnormalities
Muscle spasm and pain of back and chest
Nausea
Nephrotoxicity
Neutropenia
Ototoxicity
Overgrowth by non-susceptible organisms
Pancytopenia
Phlebitis
Pruritus
Pseudomembranous colitis
Rash
Renal failure
Serum creatinine increased
Stevens-Johnson syndrome
Stridor
Thrombocytopenia
Thrombophlebitis
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Vomiting
Wheezing

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: January 2023

Reference Sources

Summary of Product Characteristics: Vancomycin 1g Powder for Concentrate for Solution for Infusion and oral solution. Kent Pharma UK Ltd. Revised April 2021.
Summary of Product Characteristics: Vancomycin 500mg Powder for Concentrate for Solution for Infusion and oral solution. Kent Pharma UK Ltd. Revised April 2021.

The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 January 2023