Vancomycin HCl

Vancomycin HCl: Pediatric Injectable Drugs
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Vancomycin HCl
Brand names
Medication error potential
USP reports confusion with clindamycin, gentamicin, tobramycin, valacyclovir, vecuronium, and Vibramycin.(1)
Contraindications and warnings
Contraindications: Documented hypersensitivity to vancomycin or any of its components.(2) If possible,
avoid in patients with previous severe hearing loss.(2)
Warnings: Rapid administration may cause exaggerated hypotension, including shock, and, rarely, cardiac
Transient or permanent hearing loss has been reported in those given excessive doses of vancomycin, who
have underlying hearing loss, or received therapy with other ototoxic agents.(2) (See Rare Adverse Effects in
the Comments section.)
Use cautiously in renal insufficiency.(2) (See Dosage Adjustment in Organ Dysfunction section.)
Prolonged use may cause superinfection and/or Clostridium difficile-associated diarrhea (CDAD), which has
been reported and may range in severity from mild diarrhea to fatal colitis.(2) If CDAD is suspected or
confirmed, appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated.(2)
Infusion-related cautions
Administration over <60 minutes may cause red man syndrome.(2) (See Rare Adverse Effects in the
Comments section.) Concomitant administration with anesthetic agents has resulted in erythema histaminelike flushing and anaphylaxis.(2)
Thrombophlebitis can be minimized by using dilute solutions (e.g., 2.5-5 mg/mL) and rotating injection sites.
Extravasation should be avoided.(2) (See Appendix E for information regarding infiltration.)
The following dosing recommendations are based on the traditional therapeutic range. Higher doses may be
necessary to produce troughs ≥15 mcg/mL.(3) Some authors have recommended up to 85 mg/kg/day in
children to reach these higher concentrations.(4)
Vancomycin HCl: Pediatric Injectable Drugs
Dose obese individuals using actual or total body weight.(5-8) Shorter dosing intervals may be needed to
maintain trough serum vancomycin concentration above 5 mg/L.(7,8)
Neonates: Some advocate a loading dose of 15 mg/kg.(2,9)
Although a variety of neonatal dosing recommendations have been published,(10-14) the following continue to
be the most common and are based on postnatal age (PNA) and weight.
Based on weight and PNA
<1200 g
15 mg/kg q 24 hr*
1200-2000 g
≥2000 g
20-30 mg/kg/day divided q 12-18
30-45 mg/kg/day divided q 8-12
30-45 mg/kg/day divided q 8-12 hr*(15) 40-60 mg/kg/day divided q 6-8
Until 4 weeks of age.
Infants and children
Mild-to-moderate infections: 40 mg/kg/day divided q 6-8 hr up to 2 g/day.(15)
Severe infections (including meningitis and bacteremia): 60 mg/kg/day divided q 6 hr up to 4 g/day.
In adults, give loading dose of 25-30 mg/kg over at least 60 minutes followed by 45-60 mg/kg/day
divided q 8-12 hr.(17)
Each dose should be administered no faster than 10 mg/min or over a period of at least 60 minutes,
whichever is longer.(2)
Bacterial endocarditis (prophylaxis): A single dose of vancomycin 30-60 minutes before the procedure may
be indicated in the highest risk patients.(18) (See Comments section.)
Bacterial endocarditis (treatment): Current guidelines recommend 60 mg/kg/day divided q 6 hr for 2-6
weeks depending on the source of infection.(3) However, other guidelines have recommended 40 mg/kg/day
divided q 8-12 hr for 4-6 weeks for endocarditis with native or prosthetic valves in combination with other
Central venous catheter infection: 25 mg/L of vancomycin added to PN solution as a continuous
infusion(20-22) or as a flush/lock.(23,24) Although this dose has been used for prophylaxis to decrease
catheter-related, coagulase-negative staphylococcal sepsis, the Centers for Disease Control and Prevention
discourage this practice.(21) An antibiotic lock regimen using 2 mg/mL had limited efficacy.(25)
Ventricular shunt infection: ISMP lists intraventricularly administered medications as high-alert and have an
increased risk of causing significant patient harm if it is used in error.(26)
60 mg/kg/day divided q 6 hr by IV administration. 5-20 mg/dose (50 mg/mL diluted with preservative-free NS
to a final concentration of 1-5 mg/mL) directly into the ventricle (if the shunt is not externalized) or via the
externalized shunt, which is then clamped for 1 hour after administration.(27-29)
Vancomycin HCl: Pediatric Injectable Drugs
Dosage adjustment in organ dysfunction
Adjust dosage in renal dysfunction.(30) If CrCl is 30-50 mL/min, give a normal dose q 12 hr; if CrCl is 10-29
mL/min, give normal dose q 18-24 hr; and if CrCl is <10 mL/min, adjust dosage based on serum
Patients on extracorporeal membrane oxygenation have an increased circulating volume and transiently
altered renal function; therefore, a suggested dose is 20 mg/kg q 24 hr.(31) Patients with malignancy may
have increased clearance and require larger doses (i.e., mean dose of 71.5 mg/kg/day).(32,33) Although serum
vancomycin concentration should not be routinely monitored, trough concentration may be helpful in patients
who are not clinically responding.
Maximum dosage
Although higher doses have been used, 60 mg/kg/day, not to exceed the adult dose of 4g/day, is still
Suitable diluents
NS, LR, D5W, D5NS, D5LR.(2,34)
Maximum concentration
<5 mg/mL.(2,34) May use 10 mg/mL in fluid-restricted patients, but the risk of infusion reactions increase.(2)
Preparation and delivery
Delivery system issues: The potential for toxic effects from chemicals that may leach from the plastic
containers into the single-dose, premixed IV preparation has not been determined.(35) Leaching has been
reported to produce less than detectable concentrations for vancomycin PVC containers.(34)
Compatibility: See Appendix D for PN compatibility information.(36)
IV push
Not recommended.(2)
Intermittent infusion
Over ≥60 minutes or ≤10 mg/min in adults.(2) (See Infusion-Related Cautions section; see Rare Adverse
Effects in the Comments section.)
Continuous infusion
May be given by continuous IV infusion.(34) Vancomycin has a slow bactericidal activity and exhibits timedependent killing. Some have proposed that administration by continuous infusion would maximize the time
that vancomycin serum concentrations exceed the minimum inhibitory concentration (MIC) for the suspected
organism and thereby enhance efficacy, prevent bacterial regrowth, and perhaps decrease toxicity.(37-39) Data
for the administration of vancomycin by continuous infusion are extremely limited and have focused on
adults (37,38,40-42) and neonates.(39,43) Neonates have received 10-40 mg/kg/day by continuous infusion.
A higher rate of nephrotoxicity occurred in adult patients receiving continuous infusions producing
Vancomycin HCl: Pediatric Injectable Drugs
steady state concentrations ≥28 mg/mL.(42)
Other routes of administration
IM administration is not recommended because it may cause local tissue necrosis and has erratic absorption.
Has been given by inhalation(45,46) and intraventricular routes (27-29) for the treatment of methicillinresistant Staphylococcus aureus. No information available to support administration by other routes.
Chemical peritonitis (abdominal pain, fever, and changes in dialysate fluid) has been reported following IP
delivery of vancomycin during continuous ambulatory peritoneal dialysis.(2) Discontinuation of IP
vancomycin has shown to reverse the chemical peritonitis.
Rare adverse effects: Rapid IV administration may result in red man syndrome.(2) This syndrome may be
accompanied by flushing and/or a maculopapular rash or erythematous rash on the face, neck, chest, and
upper extremities. Symptoms usually begin minutes after start of the infusion. Symptoms usually resolve
spontaneously after discontinuation of the infusion. Lengthen the infusion time to 2 hours and/or
pretreatment with an antihistamine or H2 antagonist may prevent the syndrome.(47,48)
Although extremely rare, nephrotoxicity may occur in patients with underlying kidney dysfunction, those
receiving large doses, or in patients receiving concurrent nephrotoxic medications.(2) When vancomycin is
discontinued, azotemia resolves in most patients.(2) Although most of these have occurred in patients who
were given aminoglycosides concomitantly, the literature does not support the contention that the
combination is more nephrotoxic in the pediatric population.(49-51)
Vancomycin-associated hearing loss has been reported in patients with kidney dysfunction, preexisting
hearing loss, and/or those receiving other ototoxic agents.(2) Vertigo, dizziness, and tinnitus have been
reported rarely. An increased risk for hearing loss has been reported in neonates receiving vancomycin.(52)
Hearing loss has been reported in adults receiving high doses.(53)
DRESS syndrome has been reported.(54)
Monitoring: Studies have shown,(55,56) and the American Academy of Pediatrics (15) recommends, that routine
monitoring of serum vancomycin concentrations is unnecessary. Although not validated in pediatric patients,
an AUC/MIC ratio of >400 may be a better indicator of treatment success than trough concentrations.(17,57)
Trough concentrations of 15-20 mcg/mL have recently been recommended for children with serious infections.
This higher concentration has also not been validated in the pediatric population.
Drug interactions: Combination with other nephrotoxic or neurotoxic drugs requires close monitoring.(2)
Consult appropriate resources for dosing recommendations before combining any drug with vancomycin.
Other: Cardiac conditions associated with the highest risk of adverse outcome from endocarditis for which
prophylaxis with dental procedures is reasonable: (1) prosthetic cardiac valve or prosthetic material used for
cardiac valve repair; (2) previous infective endocarditis; (3) congenital heart disease (CHD) in a person with
a) unrepaired cyanotic CHD, including palliative shunts and conduits, b) completely repaired congenital heart
defect with prosthetic material or device, whether placed by surgery or by catheter intervention, during the
first 6 months after the procedure, c) repaired CHD with residual defects at the site or adjacent to the site of
a prosthetic patch or prosthetic device (which inhibit endothelialization); and (4) cardiac transplantation
recipients who develop cardiac valvulopathy.(18)
Vancomycin HCl: Pediatric Injectable Drugs
1. Hicks RW, Becker SC, Cousins DD, eds. MEDMARX Data Report. A Report on the Relationship of Drug
Names and Medication Errors in Response to the Institute of Medicine’s Call for Action. Rockville, MD:
Center for the Advancement of Patient Safety, US Pharmacopeia; 2008.
2. Vancomycin Hydrochloride [prescribing information]. Princeton, NJ: Sandoz Inc; March 2010.
3. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of
America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and
children: executive summary. Clin Infect Dis. 2011;52(3):285-292.
4. Eiland LS, English TM, Eiland EH 3rd. Assessment of vancomycin dosing and subsequent serum
concentrations in pediatric patients. Ann Pharmacother. 2011;45(5):582-589.
5. Miller M, Miller JL, Hagemann TM, et al. Vancomycin dosage in overweight and obese children. Am J
Health Syst Pharm. 2011;68(21):2062-2068.
6. Kendrick JG, Carr RR, Ensom MH. Pharmacokinetics and drug dosing in obese children. J Pediatr
Pharmacol Ther. 2010;15(2):94-109.
7. Pai MP, Bearden DT. Antimicrobial dosing considerations in obese adult patients. Pharmacotherapy.
8. Bauer LA, Black DJ, Lill JS. Vancomycin dosing in morbidly obese patients. Eur J Clin Pharmacol.
9. Asbury WH, Darsey EH, Rose WB, et al. Vancomycin pharmacokinetics in neonates and infants: a
retrospective evaluation. Ann Pharmacother. 1993;27(4):490-496.
10. Mehrotra N, Tang L, Phelps SJ, et al. Evaluation of vancomycin dosing regimens in preterm and term
neonates using Monte Carlo simulations. Pharmacotherapy. 2012;32(5):408-419.
11. McDougal A, Ling EW, Levine M. Vancomycin pharmacokinetics and dosing in premature neonates. Ther
Drug Monit. 1995;17(4):319-326.
12. Grimsley C, Thomson AH. Pharmacokinetics and dose requirements of vancomycin in neonates. Arch Dis
Child Fetal Neonatal Ed. 1999;81(3):F221-F227.
13. Lo YL, van Hasselt JG, Heng SC, et al. Population pharmacokinetics of vancomycin in premature
Malaysian neonates: identification of predictors for dosing determination. Antimicrob Agents Chemother.
14. Marques-Minana MR, Saadeddin A, Peris JE. Population pharmacokinetic analysis of vancomycin in
neonates. A new proposal of initial dosage guideline. Br J Clin Pharmacol. 2010;70(5):713-720.
15. American Academy of Pediatrics; Pickering LK. Red Book: 2009 Report of the Committee on Infectious
Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009.
16. Prober CG, Stevenson DK, Benitz WE. The use of antibiotics in neonates weighing less than 1200 grams.
Pediatr Infect Dis J. 1990;9(2):111-121.
17. Rybak M, Lomaestro B, Rotschafer JC, et al. Therapeutic monitoring of vancomycin in adult patients: a
consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society
of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009;66(1):8298.
18. Wilson W, Taubert KA, Gewitz M, et al. Prevention of infective endocarditis: guidelines from the
American Heart Association: a guideline from the American Heart Association Rheumatic Fever,
Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the
Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care
and Outcomes Research Interdisciplinary Working Group. Circulation. 2007;116(15):1736-1754.
19. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis: diagnosis, antimicrobial therapy, and
management of complications: a statement for healthcare professionals from the Committee on
Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young,
and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American
Heart Association: endorsed by the Infectious Diseases Society of America. Circulation.
20. Spafford PS, Sinkin RA, Cox C, et al. Prevention of central venous catheter-related coagulase-negative
staphylococcal sepsis in neonates. J Pediatr. 1994;125(2):259-263.
21. Preventing the Spread of Vancomycin Resistance—A Report from the Hospital Infection Control Practices
Advisory Committee prepared by the Subcommittee on Prevention and Control of Antimicrobial-Resistant
Microorganisms in Hospitals; comment period and public meeting—CDC. Notice. Fed Regist.
Vancomycin HCl: Pediatric Injectable Drugs
Baier RJ, Bocchini JA Jr, Brown EG. Selective use of vancomycin to prevent coagulase-negative
staphylococcal nosocomial bacteremia in high risk very low birth weight infants. Pediatr Infect Dis J.
Ocete E, Ruiz-Extremera A, Goicoechea A, et al. Low-dosage prophylactic vancomycin in central-venous
catheters for neonates. Early Hum Dev. 1998;53 Suppl:S181-S186.
Henrickson KJ, Axtell RA, Hoover SM, et al. Prevention of central venous catheter-related infections and
thrombotic events in immunocompromised children by the use of vancomycin/ciprofloxacin/heparin flush
solution: A randomized, multicenter, double-blind trial. J Clin Oncol. 2000;18(6):1269-1278.
Megged O, Shalit I, Yaniv I, et al. Outcome of antibiotic lock technique for persistent central venous
catheter-associated coagulase-negative Staphylococcus bacteremia in children. Eur J Clin Microbiol Infect
Dis. 2010;29(2):157-161.
Institute for Safe Medication Practices. List of high-alert medications. Accessed May 6, 2012.
Pfausler B, Haring HP, Kampfl A, et al. Cerebrospinal fluid (CSF) pharmacokinetics of intraventricular
vancomycin in patients with staphylococcal ventriculitis associated with external CSF drainage. Clin
Infect Dis. 1997;25(3):733-735.
Al-Jeraisy MA, Einhaus S, Christensen ML, et al. Intraventricular vancomycin in pediatric patients with
cerebrospinal fluid shunt infection. J Pediatr Pharmacol Ther. 2004:9.
Thompson JB, Einhaus S, Buckingham S, et al. Vancomycin for treating cereborspinal fluid infections in
pediatric patients. J Pediatr Pharmacol Ther. 2005;10:14-25.
Aronoff GR, Berns JS, Brier ME, et al. Drug prescribing in renal failure. Accessed May 7, 2012.
Amaker RD, DiPiro JT, Bhatia J. Pharmacokinetics of vancomycin in critically ill infants undergoing
extracorporeal membrane oxygenation. Antimicrob Agents Chemother. 1996;40(5):1139-1142.
Chang D. Influence of malignancy on the pharmacokinetics of vancomycin in infants and children.
Pediatr Infect Dis J. 1995;14(8):667-673.
Chang D, Liem L, Malogolowkin M. A prospective study of vancomycin pharmacokinetics and dosage
requirements in pediatric cancer patients. Pediatr Infect Dis J. 1994;13(11):969-974.
Trissel LA. Handbook on Injectable Drugs [database]. Bethesda, MD: American Society of Health-System
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Strauss AA. Di(2-ethlhexyl)phthalate (DEHP). J Pediatr Pharmacol Ther. 2004;9:89-95.
Robinson C. Y-site compatibility of medications with parenteral nutrition. J Pediatr Pharmacol Ther.
Wysocki M, Delatour F, Faurisson F, et al. Continuous versus intermittent infusion of vancomycin in
severe Staphylococcal infections: prospective multicenter randomized study. Antimicrob Agents
Chemother. 2001;45(9):2460-2467.
James JK, Palmer SM, Levine DP, et al. Comparison of conventional dosing versus continuous-infusion
vancomycin therapy for patients with suspected or documented gram-positive infections. Antimicrob
Agents Chemother. 1996;40(3):696-700.
Pawlotsky F, Thomas A, Kergueris MF, et al. Constant rate infusion of vancomycin in premature
neonates: a new dosage schedule. Br J Clin Pharmacol. 1998;46(2):163-167.
Albanese J, Leone M, Bruguerolle B, et al. Cerebrospinal fluid penetration and pharmacokinetics of
vancomycin administered by continuous infusion to mechanically ventilated patients in an intensive care
unit. Antimicrob Agents Chemother. 2000;44(5):1356-1358.
Byl B, Jacobs F, Wallemacq P, et al. Vancomycin penetration of uninfected pleural fluid exudate after
continuous or intermittent infusion. Antimicrob Agents Chemother. 2003;47(6):2015-2017.
Ingram PR, Lye DC, Tambyah PA, et al. Risk factors for nephrotoxicity associated with continuous
vancomycin infusion in outpatient parenteral antibiotic therapy. J Antimicrob Chemother.
Plan O, Cambonie G, Barbotte E, et al. Continuous-infusion vancomycin therapy for preterm neonates
with suspected or documented Gram-positive infections: a new dosage schedule. Arch Dis Child Fetal
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Vancomycin HCl: Pediatric Injectable Drugs
simplified dosage. Arch Dis Child Fetal Neonatal Ed. 2011;96(5):F365-F370.
Weathers L, Riggs D, Santeiro M, et al. Aerosolized vancomycin for treatment of airway colonization by
methicillin-resistant Staphylococcus aureus. Pediatr Infect Dis J. 1990;9(3):220-221.
Maiz L, Canton R, Mir N, et al. Aerosolized vancomycin for the treatment of methicillin-resistant
Staphylococcus aureus infection in cystic fibrosis. Pediatr Pulmonol. 1998;26(4):287-289.
Healy DP, Sahai JV, Fuller SH, et al. Vancomycin-induced histamine release and “red man syndrome”:
comparison of 1- and 2-hour infusions. Antimicrob Agents Chemother. 1990;34(4):550-554.
Renz CL, Thurn JD, Finn HA, et al. Antihistamine prophylaxis permits rapid vancomycin infusion. Crit
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Bhatt-Mehta V, Schumacher RE, Faix RG, et al. Lack of vancomycin-associated nephrotoxicity in newborn
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Nahata MC. Lack of nephrotoxicity in pediatric patients receiving concurrent vancomycin and
aminoglycoside therapy. Chemotherapy. 1987;33(4):302-304.
Timpe EM. Nephrotoxicity with combination vancomycin-aminoglycoside therapy. J Pediatr Pharmacol
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ototoxicity in the neonate? A retrospective audit. Neonatology. 2011;100(2):186-193.
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Vinson AE, Dufort EM, Willis MD, et al. Drug rash, eosinophilia, and systemic symptoms syndrome: Two
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Vancomycin HCl: Pediatric Injectable Drugs
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