Joint Trust Guideline for the Use of Intravenous Vancomycin in Paediatrics

Transcription

1 A clinical guideline recommended For use in: All clinical areas where vancomycin is prescribed for Children aged 1 month to 16 years By: All medical, nursing, pharmacy, microbiology and phlebotomy paediatric staff For: All children receiving vancomycin aged 1month to 16 years Division responsible for document: Division 3 Key words: Vancomycin, therapeutic drug monitoring, Intravenous Dr Caroline Kavanagh, Consultant Paediatrician, Names and job titles Dr.Chavakula Srinivas ST5 of document authors: Caroline Hallam, Specialist Pharmacist, Antimicrobials Name of document author s Line Manager: David Booth Job title of document author s Line Manager: Clinical Director - Paediatrics Supported by: Dr Catherine Tremlett, Consultant Microbiologist NNUH Assessed and approved by the: Date of approval: 20 December 2016 Ratified by or reported as approved to (if applicable): To be reviewed before: This document remains current after this date but will be under review To be reviewed by: Dr John Chapman, Consultant Paediatrician JPUH Clinical Guidelines Assessment Panel (CGAP) Accepted by James Paget University Hospital under the Tri- Hospital Clinical Guidelines Assessment Panel (THCGAP) Clinical Standards Group and Effectiveness Sub - Board 20 December 2019 Dr Caroline Kavanagh Reference and / or JCG0040 ID No: Trustdocs ID No: Version No: 2 Description of changes: No clinical changes. New front page and footers. Compliance links: (is there any NICE related to No guidance) If Yes does the strategy/policy deviate from the recommendations of NICE? If so, why? N/A Available via Trust Docs Version: 2 Trust Docs ID: Page 1 of 6

2 Objective/s The aim of this guideline is to offer guidance on vancomycin dosing and monitoring for children aged 1 month to 16 years old. Rationale Vancomycin is a narrow spectrum, glycopeptides antibiotic with potent anti-staphylococcal activity. Vancomycin is potentially ototoxic and nephrotoxic and it must be prescribed and monitored carefully. This policy offers advice on vancomycin dosing and monitoring in patients with normal renal function. Broad recommendations Vancomycin should only be used if indicated, which will be informed by the patient s clinical condition, the Antibiotic Policy and any microbiological reports and sensitivity pattern of the organisms if available. Patients with an impaired renal function must be treated with a reduced dose of vancomycin according to their renal function. Patients must have their vancomycin levels and renal function monitored according to the guidelines below. Background Vancomycin is a glycopeptide antimicrobial. It is essential and invaluable in the management of infections due to MRSA and coagulase negative staphylococci, Staphylococcus aureus and other Gram positive organisms in penicillin allergic patients. Resistance in staphylococci and enterococci has been reported. This has serious implications for patient care. It is therefore imperative that vancomycin is used prudently by clinicians. This will ensure that patients receive maximum benefit from these agents and resistance and side effects minimised. Indications for Use Vancomycin should be prescribed where a glycopeptide antibiotic is specifically required or recommended. Vancomycin is potentially ototoxic and nephrotoxic. The risk of toxicity increases with high plasma concentration, concomitant use of nephrotoxic agents, reduced perfusion medications, Patients with extended use of vancomycin > 14days, patients receiving chemotherapy protocols employing nephrotoxic agents or protocols that require an intact renal clearance of chemotherapies. Toxicity also increases in patients with a renal transplant or single kidney and patients with reduced renal perfusion. Available via Trust Docs Version: 2 Trust Docs ID: Page 2 of 6

3 This guideline offer advice on dosing and monitoring of vancomycin in children with normal renal function. For further advice contact Microbiology. Dosing of Vancomycin Intravenous dose depends on renal function and weight. There is no need for loading dose as vancomycin kills bacteria in a time-dependent manner versus the concentrationdependent manner of aminoglycosides or fluoroquinolones. Patients should receive a vancomycin based on actual weight at 15mg/kg 8 hourly. The dose should then be adjusted according to pre dose levels as appropriate. Then any adjustments of dosage will be dependent on resulting levels. Administration Details for Vancomcyin Reconstitute each 500mg of vancomycin vial with 9.6mL of water for injection(0.4ml displacement) and is further diluted with 5% glucose or 0.9% sodium chloride infusion so that the final concentration is no greater that 500mg per 100mL (5mg/mL) to minimize infusion-related side effect such as thrombophlebitis. 10mg/mL concentration can be if infused via central venous line over at least 60 minutes. The required dose is administered over at least 60 minutes (rate not to exceed over 10mg/min for doses over 500mg). Infuse over 120 minutes with antihistamine cover for patients with previous reactions (red man syndrome) Nurses should state on the drug chart the exact time of administration to facilitate the accurate interpretation of levels Monitoring of Vancomycin a. Approximate time to reach steady state is 1-2 days. Take a pre-dose (trough) level before the 4 th dose. b. Measure serum creatinine within 24 hours after initiating vancomycin to verify renal function and repeat twice weekly. c. Check blood urea and provide fluids to correct any pre-renal issues to ensure patient has adequate hydration within 24 hours of starting Vancomycin. d. If renal function is stable, give the next dose before the trough results is available and follow advice. e. Interpret levels as below. If the trough is within the normal range and renal function remains stable, repeat trough levels twice weekly. If 30% unintended increase in vancomycin trough occurs (i.e. while on therapy without dose changes), then serum trough levels and serum creatinine should be monitored more closely and dose reduction considered. f. Monitor serum creatinine mmol/l TWICE weekly during therapy. If an increase in serum creatinine 45 micromoles/l from baseline is noted, serum vancomycin Available via Trust Docs Version: 2 Trust Docs ID: Page 3 of 6

4 trough levels should be monitored more closely (i.e. no less than three times per week or as the dosing changes/permits. Dose reduction and/or increase in dosing interval should be considered). Table 1. Adjustment of vancomycin Dosage Regimen. Vancomycin level Level < 5mg/L Action Consider increasing dose by 20% or QDS? Discuss with consultant. Check renal function Level is 5 mg/l and < 10mg/L Increase dose by 10% Level is 10mg/L and < 15mg/L Level 15mg/L Continue current dose and repeat level every 3 days Omit dose until level is < 15mg/L repeat level in 8 hours time. Check renal function If renal impairment or if high risk of nephrotoxicity discuss with consultant on call (consider Dr.Upton or renal team at Nottingham). Consider increasing drug interval to 12 hourly with standard 15mg/kg/dose. Further advice During working hours contact Microbiology on extension 4587 or 4589, your paediatric ward pharmacist Rosalind Howe on bleep number: 0825 Out of hours contact the on call microbiologist (bleep via switchboard) or on call pharmacist (bleep via switchboard). Patients under the care of the Renal Team Refer to the renal team Dr Upton or liaise with Nottingham renal team for advice. Addendum Children with abnormal renal function/renal patients should be discussed with the renal team as above and their GFR measured as below and prescribe the vancomycin doses appropriately. a) Calculate the patient s creatinine clearance (CrCl) using the Schwartz equation Schwartz equation: CrCl(mL/min/1.73m 2 ) = K X height in cm Available via Trust Docs Version: 2 Trust Docs ID: Page 4 of 6

5 Serum creatinine (mg/dl) Table2. Proportionality constant (K) for different ages AGE K Low birth weight 1 year 0.33 Full-term 1 year years years (Girls) years (Boys) 0.7 b) Based on the CrCl choose the correct dose and frequency as below. Table 3. Interval adjustment for renal insufficiency in paediatric patient Creatinine clearance Dosing interval 90mL/min Every 6-8 hours 70 89mL/min Every 8 hours 46 69mL/min Every 12 hours 30 45mL/min Every 18 hours 15 29mL/min Every 24 hours < 15mL/min Dose & interval based on levels Clinical audit standards All children over the age of one month when vancomycin is the drug of choice should be given vancomcyin in a dose appropriate recommended in BNFc which is 15mg/kg every 8 hours by intravenous infusion. The form accompanying the sample (pre-dose only) must state the time the sample was taken and the time of the start of the previous infusion. Medical notes should reflect review of the dosing regimen depending on vancomycin levels. Vancomycn levels should be taken at the appropriate time depending on the dosing regimen. Available via Trust Docs Version: 2 Trust Docs ID: Page 5 of 6

6 Summary of development and consultation process undertaken before registration and dissemination The authors listed above drafted this guideline on behalf of the antimicrobial subcommitee who has 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 areas where children are cared for via ward pharmacists, medical staff via Trust intranet All pharmacists via Caroline Hallam References/ source documents 1. Theresa S Cole and Andrew Riodan: Vancomycin dosing in children: what is the question? Arch Dis Child : Eiland LS, English TM, Eiland EH III, assessment of vancomycin dosing and subsequent serum concentration in pediatric patients. Ann Pharmacother 2011;45: Liu C, Bayer A, Cosgrove SE,et al. Clinical practice guidelines by the infectious disease society of America for the treatment of Methicillin resistant staphyloccus aureus infection in adults and children:executive summary infect dis 2011;52: UK British National Formulary for children(bnfc) 2013/ Nakamura T, Takano M, Yasuhara M, Inui K. In-vivo clearance study of vancomycin in rats. J Pharm Pharmacol 1996;48: Dieterich C, Puey A, Lin S, Swezey R, Furimsky A, Fairchild D, et al. Gene expression analysis reveals new possible mechanisms of vancomycin-induced nephrotoxicity and identifies gene markers candidates. Toxicol Sci 2009;107: Cantu TG, Yamanaka-Yuen NA, Lietman PS. Serum vancomycin concentrations: reappraisal of their clinical value. Clin Infect Dis 1994;18: Hidayat L, Hsu D, Quist R, et al. High-dose vancomycin therapy for Methicillin- Resistant Staphylococcus aureus infections: Efficacy and toxicity. Arch Intern Med 2006;166: Version Information Version No Updated By Updated On Description of Changes JCG0040 v1 THCGAP 14 October 2014 Change of header and reference to joint hospital version JCG0040 v2 THCGAP 20 December New front page and footers 2016 Available via Trust Docs Version: 2 Trust Docs ID: Page 6 of 6