Vancomycin-containing medicines

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EMA recommends changes to prescribing information for vancomycin antibiotics

Changes aim to ensure appropriate use in context of fight against antimicrobial resistance

On 19 May 2017, the European Medicines Agency (EMA) recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.

Vancomycin has been used since the 1950s and to this day it remains an important therapeutic option for the treatment of serious infections.The Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed the available data on vancomycin medicines given by infusion (drip) and injection and taken by mouth as part of its strategy to update the product information of old antibacterial agents in the context of the fight against antimicrobial resistance.

The CHMP concluded that infusion of vancomycin can continue to be used for the treatment of serious infections caused by certain bacteria including MRSA (meticillin-resistant Staphylococcus aureus) in patients of all ages. Vancomycin can also be used to prevent bacterial endocarditis (an infection in the heart) in patients undergoing surgery and to treat infections in patients undergoing a procedure called peritoneal dialysis. When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).

Because the available data do not adequately support the use of vancomycin in the treatment of staphylococcal enterocolitis (inflammation of the gut caused by S. aureus) and its use to clear the gut of bacteria in patients with a weakened immune (defence) system, the CHMP concluded that vancomycin should no longer be used for these indications.

In addition, the Committee reviewed the recommended dosage for vancomycin for the various indications and patient groups, and concluded that the starting dose of vancomycin by infusion should be calculated according to the age and weight of the patient. The updated recommendations are based on data which showed that the previously recommended dose often resulted in less than optimal levels of vancomycin in the blood, reducing the effectiveness of the antibiotic.

Information for patients
  • Vancomycin is an antibiotic used for serious infections, often caused by bacteria that have become resistant to other treatments. It is given as an infusion (drip) into a vein or by injection in the abdomen (belly). It can also be taken by mouth (as capsules or liquid) to treat an infection of the lining of the gut caused by bacteria called Clostridium difficile.
  • The available information on vancomycin has been reviewed and recommendations have been made on its safe use and appropriate dosage.
  • The product information for medicines containing vancomycin will be updated to take these recommendations into account.
  • Patients who have any questions about their treatment should talk to their doctor or pharmacist.
Information for healthcare professionals

The Agency’s recommendations are based on a review of the available pharmacological and clinical data for vancomycin. The product information for vancomycin will be updated to reflect the following:

Vancomycin solution for infusion

  • Vancomycin solution for infusion can be used in patients of all ages for the treatment of complicated soft-tissue infections, bone and joint infections, community- and hospital-acquired pneumonia (including ventilator-associated pneumonia), infective endocarditis, acute bacterial meningitis, and bacteraemia associated with the above infections. It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.
  • The recommended starting dose of vancomycin solution for infusion should be based on the age and weight of the patient. Available data showed that the previously recommended daily dose often resulted in suboptimal vancomycin serum concentrations.
  • Any subsequent dose adjustments should be based on serum concentrations to achieve the target therapeutic concentrations.
  • Vancomycin parenteral formulations authorised for oral use can be used by mouth in patients of all ages for the treatment of Clostridium difficile infection (CDI).
  • Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.

Vancomycin capsules

  • The available data do not adequately support the use of oral vancomycin in the treatment of staphylococcal enterocolitis and for the decontamination of the GI tract in immunocompromised patients. Therefore, oral vancomycin should no longer be used in these indications.
  • Vancomycin capsules can be used in patients aged 12 years and older for the treatment of CDI. For younger children, the use of age-appropriate formulations is recommended.
  • The maximum dose should not exceed 2 g per day.
  • In patients with inflammatory intestinal disorders, the serum concentration of vancomycin after oral administration should be closely monitored.
More about the medicine

Vancomycin is one of a group of antibiotics known as glycopeptides. It is given by infusion (drip) into a vein to treat serious infections due to Gram-positive bacteria such as meticillin-resistant Staphylococcus aureus (MRSA) that are resistant to other antibiotics, or in patients in whom other antibiotics cannot be used. It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.

Vancomycin is also given by mouth to treat infections caused by Clostridium difficile, which mostly develop in hospital patients treated with other antibiotics.

Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.

More about the procedure

The review of vancomycin-containing medicines was initiated on 1 April 2016 at the request of the Spanish medicines agency (AEMPS), under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/09/2017.

Name Language First published Last updated
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics BG = bălgarski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics ES = español 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics CS = čeština 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics DA = dansk 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics DE = Deutsch 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics ET = eesti keel 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics EL = elliniká 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics EN = English 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics FR = français 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics IT = italiano 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics LV = latviešu valoda 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics LT = lietuvių kalba 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics HU = magyar 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics MT = Malti 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics NL = Nederlands 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics PL = polski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics PT = português 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics RO = română 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics SK = slovenčina 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics SL = slovenščina 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics FI = suomi 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics SV = svenska 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics HR = Hrvatski 2017-05-19 2017-11-17

Key facts

Approved nameVancomycin-containing medicines
International non-proprietary name (INN) or common name

vancomycin

Associated names
Class
Reference numberEMEA/H/A-31/1440
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date18/05/2017

All documents

Name Language First published Last updated
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics BG = bălgarski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics ES = español 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics CS = čeština 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics DA = dansk 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics DE = Deutsch 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics ET = eesti keel 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics EL = elliniká 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics EN = English 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics FR = français 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics IT = italiano 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics LV = latviešu valoda 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics LT = lietuvių kalba 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics HU = magyar 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics MT = Malti 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics NL = Nederlands 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics PL = polski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics PT = português 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics RO = română 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics SK = slovenčina 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics SL = slovenščina 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics FI = suomi 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics SV = svenska 2017-05-19 2017-11-17
Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics HR = Hrvatski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Assessment report (English only) 2017-11-17  
Vancomycin Article-31 referral - Annex I BG = bălgarski 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I ES = español 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I CS = čeština 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I DA = dansk 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I DE = Deutsch 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I ET = eesti keel 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I EL = elliniká 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I EN = English 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I FR = français 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I IT = italiano 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I LV = latviešu valoda 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I LT = lietuvių kalba 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I HU = magyar 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I MT = Malti 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I NL = Nederlands 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I PL = polski 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I PT = português 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I RO = română 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I SK = slovenčina 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I SL = slovenščina 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I FI = suomi 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I SV = svenska 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I HR = Hrvatski 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex I NO = Norsk 2016-04-11 2017-11-17
Vancomycin Article-31 referral - Annex II BG = bălgarski 2017-11-17  
Vancomycin Article-31 referral - Annex II ES = español 2017-11-17  
Vancomycin Article-31 referral - Annex II CS = čeština 2017-11-17  
Vancomycin Article-31 referral - Annex II DA = dansk 2017-11-17  
Vancomycin Article-31 referral - Annex II DE = Deutsch 2017-11-17  
Vancomycin Article-31 referral - Annex II ET = eesti keel 2017-11-17  
Vancomycin Article-31 referral - Annex II EL = elliniká 2017-11-17  
Vancomycin Article-31 referral - Annex II EN = English 2017-11-17  
Vancomycin Article-31 referral - Annex II FR = français 2017-11-17  
Vancomycin Article-31 referral - Annex II IT = italiano 2017-11-17  
Vancomycin Article-31 referral - Annex II LV = latviešu valoda 2017-11-17  
Vancomycin Article-31 referral - Annex II LT = lietuvių kalba 2017-11-17  
Vancomycin Article-31 referral - Annex II HU = magyar 2017-11-17  
Vancomycin Article-31 referral - Annex II MT = Malti 2017-11-17  
Vancomycin Article-31 referral - Annex II NL = Nederlands 2017-11-17  
Vancomycin Article-31 referral - Annex II PL = polski 2017-11-17  
Vancomycin Article-31 referral - Annex II PT = português 2017-11-17  
Vancomycin Article-31 referral - Annex II RO = română 2017-11-17  
Vancomycin Article-31 referral - Annex II SK = slovenčina 2017-11-17  
Vancomycin Article-31 referral - Annex II SL = slovenščina 2017-11-17  
Vancomycin Article-31 referral - Annex II FI = suomi 2017-11-17  
Vancomycin Article-31 referral - Annex II SV = svenska 2017-11-17  
Vancomycin Article-31 referral - Annex II HR = Hrvatski 2017-11-17  
Vancomycin Article-31 referral - Annex III BG = bălgarski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III ES = español 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III CS = čeština 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III DA = dansk 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III DE = Deutsch 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III ET = eesti keel 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III EL = elliniká 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III EN = English 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III FR = français 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III IT = italiano 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III LV = latviešu valoda 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III LT = lietuvių kalba 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III HU = magyar 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III MT = Malti 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III NL = Nederlands 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III PL = polski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III PT = português 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III SK = slovenčina 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III SL = slovenščina 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III FI = suomi 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III SV = svenska 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III HR = Hrvatski 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III IS = Islenska 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Annex III NO = Norsk 2017-05-19 2017-11-17
Vancomycin Article-31 referral - Review started (English only) 2016-04-01  
Vancomycin Article-31 referral - CHMP list of questions (English only) 2016-04-01  
Vancomycin Article-31 referral - Timetable for the procedure (English only) 2016-04-01 2017-03-03
Vancomycin Article-31 referral - Notification (English only) 2016-04-01  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on Vancomycin-containing medicines

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