Trust Guideline for the Use of Parenteral Vancomycin and Teicoplanin in Adults

Transcription

1 A clinical guideline recommended for use: In: By: For: Division responsible for document: Key words: Names of document authors: Job titles of document authors: Name of document author s Line Manager: Job title of author s Line Manager: Assessed and approved by: All clinical areas where Vancomycin or Teicoplanin is prescribed (excluding critical care complex and theatres) All medical, nursing, pharmacy, microbiology and phlebotomy staff All adult patients receiving Vancomycin, Teicoplanin Trustwide Vancomycin, Teicoplanin, therapeutic drug monitoring, Intravenous, intramuscular Caroline Hallam and Dawn Whitbourn Specialist Pharmacists, Antimicrobial Therapy Helen Williams Consultant Microbiologist Antimicrobial Subcommittee on behalf of the Clinical Guidelines Assessment Panel (CGAP) approved by CGAP chair Reported as approved to the: Clinical Standards Group and Effectiveness Sub-board Date of approval: 16/03/2017 To be reviewed before: 13/01/2019 To be reviewed by: Authors Reference and/or Trustdocs ID No: CA2030 V6.1 ID No: 1192 Version No: 6.2 Description of changes: Compliance links: (is there any NICE related to guidance) If Yes does the strategy/policy deviated from the recommendations of NICE? If so, why? Further amendment to Teicoplanin dose in renal impairment None N/A This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes. The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document. Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 1 of 11

2 CONTENTS - Vancomycin 1. Quick Reference Guide Page 3 2. Prescribing the Initial Maintenance Dose Page 4 3. Taking Levels and Ongoing Monitoring Page 5 4. Administration Details for Vancomycin Page 6 5. Renal Patients (CrCl < 20mL/min or Dialysis Page 6 (peritoneal and haemo-) patients) -Teicoplanin 1. Administration Details for Teicoplanin Page 8 2. Intramuscular Teicoplanin Page 8 3. Prescribing Loading and Maintenance Doses Page 9 and Monitoring of Teicoplanin - Background Information Page Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 2 of 11

3 Vancomycin Table 1: Vancomycin Quick Reference Guide CrCl > 110mL/min CrCl mL/min CrCl 60 90mL/min CrCl 20-60mL/min CrCl <20mL/min or dialysis 1.5 grams BD 1.25 grams BD 1 gram BD 1 gram OD 1 gram STAT Trough level pre 3 rd or 4 th dose Trough level pre 3 rd or 4 th dose Trough level pre 3 rd or 4 th dose Trough level pre 2 nd dose Level after 24 hours Give next dose and when levels reported adjust dosing (see table below) Give next dose and when levels reported adjust dosing (see table below) Give next dose and when levels reported adjust dosing (see table below) Give next dose and when levels reported adjust dosing (see table below) After dose adjustment check levels pre 3 rd new dose After dose adjustment check levels pre 3 rd new dose After dose adjustment check levels pre 3 rd new dose After dose adjustment check levels pre 2 nd new dose When levels in range (10-15mg/L general infections or 15-20mg/L severe infections and bone and joint infections) monitor pre dose levels every 3-4 days For further information please see below. Await level Level <15mg/L Give dose and check level in 24 hours/at each HD session. Level 15-25mg/L Hold dose and recheck level in 24 hours/at each HD session. Level >25mg/L Hold dose and recheck level in 48 hours/at each HD session Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 3 of 11

4 Follow instructions below 1) Prescribing the Initial Maintenance Dose 2) Taking levels and Ongoing Monitoring NB: for renal patients (CrCl < 20mL/min or dialysis (peritoneal and haemo-) patients), go to pg 6 1. Prescribing the Initial Maintenance Dose Table 2: Initial maintenance dose Dose Frequency CrCl >110mL/min 1.5g 12 hourly CrCl mL/min 1.25g 12 hourly CrCl 60 90mL/min 1g 12 hourly CrCl 20 60mL/min 1g 24 hourly Calculate the patients Creatinine Clearance if patient has impaired renal function a. Calculate the patient s creatinine clearance (CrCl) using the Cockcroft-Gault equation. Click here for the Cockcroft & Gault Calculator or use the calculation below: CrCl (ml/min) = F (140-age) x weight (kg) Serum creatinine (micromols/l) F = 1.04 for females, 1.23 for males Use actual body weight or ideal body weight, whichever is lower Ideal body weight (kg): Men = 50 + (2.3 x no. of inches over 5 ft.) Women = (2.3 x no. of inches over 5 ft.) In patients with low creatinine (<60micromol/L), use 60micromol/L. Do not use egfr 2. Taking Levels and Ongoing Monitoring Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 4 of 11

5 a) Take a pre-dose (trough) level pre 3 rd or 4 th dose if 12 hourly dosing or pre 2 nd dose for 24 hourly dosing. b) If the renal function is stable, give the next dose before the trough result is available. If the renal function is deteriorating, withhold until the result is available and follow advice in table 2. Please discuss with microbiology/pharmacy if further advice is needed. c) Interpret levels as below. If the trough is within the normal range and renal function remains stable repeat trough level every 3-4 days. If the renal function is unstable, daily levels are required. Table 3: Adjustment of Vancomycin Dosage Regimen Pre dose Level <10mg/L 10-15mg/L Recommendation Below therapeutic range increase the dose by 50% or consider reducing the dosage interval or seek advice. If patient is responding, maintain the present dosage regimen. If the patient is seriously ill, consider increasing the dose amount or reducing the dosage interval to achieve trough of 15-20mg/L mg/L Within target range for treatment of severe infections (bacteraemia, infective endocarditis, osteomyelitis, meningitis, pneumonia and severe skin and soft tissue infections e.g. necrotising fasciitis). Maintain present dosage regimen. If treating less severe infections, a pre-dose level of 15-20mg/L is acceptable so maintain present dosage regimen. >20 mg/l Dose reduction or increase in dosing interval necessary. NB it may be necessary to increase the dose up to 1.5g 12 hourly in patients with good renal function and low levels. a) Levels should rarely be required between 5.00pm and 9.00am as dosing regimens allow for the vast majority of assays to be performed between 9.00 am and 5.00pm. b) Always check the dosage history and sampling time are appropriate before interpreting the result. Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 5 of 11

6 3. Administration Details for Vancomycin: Reconstitute each 500mg vancomycin with 10mLs of water for injection and add to 5% glucose or 0.9% sodium chloride infusion fluid so that the final concentration is no greater than 500mg per 100mL. Each 500mg must be administered over at least fifty minutes ie 1g over 100 mins and 1.5g (rarely required) over 150 mins. If this rate is exceeded red-neck/red-man syndrome, pain or muscle spasm can result. Nurses should state on the drug chart the exact time of administration to facilitate the accurate interpretation of levels. 4. Renal patients (CrCl < 20mL/min or dialysis (peritoneal and haemo-) patients) 1. Maintenance Dose in Renal Patients The maintenance dose to be administered as follows: 1g Vancomycin in 250ml 0.9% sodium chloride over 2 hours 2. Sampling A blood sample for a Vancomycin serum concentration should be taken after 24 hours for non-dialysis/peritoneal dialysis patients and at the start of each subsequent haemodialysis sessions for haemodialysis patients. Notes: Samples taken from dialysis patients should be labelled as urgent before sending to the lab Larger loading doses of vancomycin can be administered during dialysis so to avoid causing delays Vancomycin is NOT dialysed Table 4: Interpretation of Vancomycin levels in Renal Patients Vancomycin level Action <15mg/L Give a further dose of Vancomycin. Recheck levels in 24 hours for non-dialysis/pd patients Recheck levels just before the start of the next dialysis session for haemodialysis patients 15-25mg/L Do not give a further dose. Recheck levels in 24 hours for non-dialysis/pd patients and at each dialysis session for HD patients >25mg/L Do not give a further dose. Recheck levels in 48 hours for non-dialysis/pd patients and at each dialysis session for HD patients Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 6 of 11

7 INTRAVENOUS (IV) VANCOMYCIN FOR HAEMODIALYSIS PATIENTS Standard Flux Dialyser Vancomycin can be given post, or start from last hour of dialysis Give a stat dose of 1 gram in 250mL 0.9% sodium chloride Take pre-dialysis vancomycin level If level < 15mg/L give a repeat stat dose of 1 gram in 250mL 0.9% sodium chloride Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 7 of 11

8 Teicoplanin Patients should receive a teicoplanin loading dose (based on ACTUAL body weight see below) to ensure optimum drug levels in the blood are achieved as rapidly as possible. After the loading dose, a maintenance dose should be prescribed once daily (based on renal function / ACTUAL body weight - see below). The dose depends on the indication (refer to 3 tables below) The monitoring requirements depend on the indication and duration. Levels are usually only required for deep seated infections requiring an extended course of teicoplanin beyond 5-7 days Administration Details for Teicoplanin Reconstitute with water for injection provided. Give by IV bolus over 3-5 minutes or infuse over 30 minutes. The reconstituted solution may be injected directly, or alternatively diluted with a convenient volume of 0.9% Sodium Chloride or 5% Glucose if given by infusion. Teicoplanin can also be given by intramuscular injection (see below). Intramuscular Teicoplanin There are some specific situations where IM teicoplanin is recommended e.g. patients with no IV access and the treatment of outpatients with diabetic foot infections. Occasionally, IM teicoplanin is indicated in other patients where they require a glycopeptides and IV access is impossible or inappropriate. Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 8 of 11

9 1. Prescribing Loading and Maintenance Doses & Monitoring of Teicoplanin Table 5: Complicated skin and soft tissue infections, pneumonia, complicated urinary tract infections Loading Dose Maintenance Dose Renal impairment Levels Under 70kg: 400mg bd every 12 hours for 3 doses Over 70kg 6mg/kg every 12 hours for 3 doses Under 70kg: 400mg od Over 70kg: 6mg/kg od Dose adjustment required from 4 th day of treatment. CrCL* 30-80: Dose as in normal renal function then reduce dose after 4 th day to half of the dose daily or normal dose every 48 hours CrCL*<30mL/min and in haemodialysis: Dose as in normal renal function, then reduce dose after 4 th day to 30% of the dose daily or normal dose every 72 hours If the duration of therapy is expected to be <5 days then no monitoring is required. If the duration of therapy is expected to be longer then take a trough level at day 3-5. Therapeutic Range: 10mg/L-60mg/L Table 6: Bone and Joint Infections Loading Dose Maintenance Dose Renal impairment Levels 10mg/kg every 12 hours for 3 administrations 10mg/kg IV od Dose adjustment required from 4 th day of treatment. CrCL* 30-80: Dose as in normal renal function then reduce dose after 4 th day to half of the dose daily or normal dose every 48 hours CrCL*<30mL/min and in haemodialysis: Dose as in normal renal function, then reduce dose after 4 th day to 30% of the dose daily or normal dose every 72 hours Target trough level at 3-5 days, then once a week during maintenance Therapeutic Range: >20mg/L-60mg/L Table 7: Endocarditis Loading Dose Maintenance Dose Renal impairment Levels 10mg/kg every 12 hours for 3 administrations 10mg/kg IV or IM od Dose adjustment required from 4 th day of treatment. CrCL* 30-80: Dose as in normal renal function then reduce dose after 4 th day to half of the dose daily or normal dose every 48 hours CrCL*<30mL/min and in haemodialysis: Dose as in normal renal function, then reduce dose after 4 th day to 30% of the dose daily or normal dose every 72 hours Target trough level at 3-5 days, then once a week during maintenance Therapeutic Range: >20mg/L-60mg/L * Click here for the Cockcroft & Gault Calculator or use the calculation below: Use actual body weight or ideal body weight whichever is lower *CrCl (ml/min) = F (140-age) x weight (kg) Ideal body weight (kg): Men = 50 + (2.3 x no. of inches over 5 ft.) Serum creatinine (micromols/l) F = 1.04 for females, 1.23 for males Women = (2.3 x no. of inches over 5 ft.) In patients with low creatinine (<60micromol/L), use 60micromol/L. Do not use egfr Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 9 of 11

10 Background: Vancomycin and teicoplanin are glycopeptide antimicrobials. They are essential and invaluable in the management of infections due to Methicillin-Resistant Staphylococcus aureus (MRSA), Coagulase-negative Staphylococci and other gram positive microorganisms in penicillin allergic patients. Resistance to glycopeptides in Staphylococcus species and Enterococcus species has been reported and has serious implications for patient care. It is therefore imperative that vancomycin and teicoplanin are used prudently by clinicians and this will ensure that patients receive maximum benefit from these agents while ensuring resistance and side effects are minimised. Indications for Use: Vancomycin and teicoplanin should only be prescribed where a glycopeptide antibiotic is specifically required or recommended. Both drugs are potentially ototoxic and nephrotoxic, though teicoplanin is associated with a lower incidence of toxicity than vancomycin. The risk of toxicity increases with prolonged use (>3 weeks), high plasma concentration, concomitant use of aminoglycosides and loop diuretics. All patients on vancomycin require plasma vancomycin measurement. Plasma teicoplanin levels are required depending on the indication and duration of treatment. Vancomycin levels can be measured in the Trust, whereas teicoplanin levels can be measured in only one laboratory in the UK (Bristol). Therefore in patients where knowledge of therapeutic or toxic levels is critical, vancomycin is preferable. Teicoplanin may be preferable in patients where levels are not deemed necessary, particularly if difficult to bleed, and in patients who will be transferred to outpatient antimicrobial therapy (OPAT). Teicoplanin can be administered intramuscularly, for example in the management of outpatients with diabetic foot infections and inpatients with no intravenous access. For advice on whether vancomycin or teicoplanin are appropriate antibiotics please consult the following resources via the trust intranet. Trust Antibiotic Policy for the Management of Common Infections in Adults with General Medicine and Surgery (CA4022v9) Trust Guideline for the Management of Antibiotic Prophylaxis in Adults undergoing Surgery (CA2096V2) Further advice During working hours contact microbiology on extension 4587 or 4589, your ward pharmacist or pharmacy medicines information on extension 3139 or bleep Out of hours contact the on call microbiologist (bleep via switchboard) or on call pharmacist (bleep via switchboard). Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 10 of 11

11 Summary of development and consultation process undertaken before registration and dissemination The authors listed above drafted this guideline on behalf of the antimicrobial subcommittee who have agreed the final content. During its development the guideline has been circulated for comment to the microbiologists. Comments were addressed and incorporated if appropriate. This version has been endorsed by the Clinical Guidelines Assessment Panel. Distribution list/dissemination method All Microbiologists via Dr Williams, all wards via ward pharmacists, medical staff via Trust intranet. All pharmacists via Caroline Hallam/Dawn Whitbourn. References/source documents - AH Thomson et al, Development and evaluation of vancomycin dosage guidelines designed to achieve new target concentrations, Journal of Antimicrobial Chemotherapy, 63: (2009) - MJ Rybak et al, Vancomycin Therapeutic Guidelines: A Summary of Consensus Recommendations from the Infectious Disease Society of America, the American Society of Health-System Pharmacists and the Society of Infectious Disease Pharmacists, Clinical Infectious Diseases, 49: (2009) - British National Formulary March 2014 Available via Trust Docs Version: 6.2 Trust Docs ID: 1192 Page 11 of 11