Vancomycin HCl
Transcription
Vancomycin HCl
22/4/2015 Vancomycin HCl: Pediatric Injectable Drugs Pediatric Injecta… ▼ vancomycin Dashboard Publications Product Updates Drug Interactions Help My Account Dashboard > The Teddy Bear Book > Monographs > V Search Results | Hide Highlighting Next Result ► Vancomycin HCl Brand names Generic 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 arrest.(2) 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. (2) Extravasation should be avoided.(2) (See Appendix E for information regarding infiltration.) Dosage 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) https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 1/8 22/4/2015 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 PNA <1200 g <7 days 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 hr(15,16) hr(15) (15,16) ≥7 days * 30-45 mg/kg/day divided q 8-12 hr*(15) 40-60 mg/kg/day divided q 6-8 hr(15) 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. (3,15) 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 antibiotics.(19) 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) https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 2/8 22/4/2015 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 concentrations.(30) 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 recommended.(15) Additives None. 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. (39,43,44) A higher rate of nephrotoxicity occurred in adult patients receiving continuous infusions producing https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 3/8 22/4/2015 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. (2,34) 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. Comments 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) Comments 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. (3) 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) References https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 4/8 22/4/2015 Vancomycin HCl: Pediatric Injectable Drugs 1. 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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. 2007;27(8):1081-1091. 8. Bauer LA, Black DJ, Lill JS. Vancomycin dosing in morbidly obese patients. Eur J Clin Pharmacol. 1998;54(8):621-625. 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. 2010;54(6):2626-2632. 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. 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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. 2008;62(1):168-171. 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 Neonatal Ed. 2008;93(6):F418-F421. Oudin C, Vialet R, Boulamery A, et al. Vancomycin prescription in neonates and young infants: toward a https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 6/8 22/4/2015 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 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 Care Med. 1999;27(9):1732-1737. Bhatt-Mehta V, Schumacher RE, Faix RG, et al. Lack of vancomycin-associated nephrotoxicity in newborn infants: a case-control study. Pediatrics. 1999;103(4):e48. 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 Ther. 2005;10:174-182. Vella-Brincat JW, Begg EJ, Robertshawe BJ, et al. Are gentamicin and/or vancomycin associated with ototoxicity in the neonate? A retrospective audit. Neonatology. 2011;100(2):186-193. Forouzesh A, Moise PA, Sakoulas G. Vancomycin ototoxicity: a reevaluation in an era of increasing doses. Antimicrob Agents Chemother. 2009;53(2):483-486. Vinson AE, Dufort EM, Willis MD, et al. Drug rash, eosinophilia, and systemic symptoms syndrome: Two pediatric cases demonstrating the range of severity in presentation—a case of vancomycin-induced drug hypersensitivity mimicking toxic shock syndrome and a milder case induced by minocycline. Pediatr Crit Care Med. 2010;11(4):e38-e43. Chicella M, Adkins J, Mancao MY, et al. Impact of pediatric specific guidelines for vancomycin serum concentration monitoring on patient care. J Pediatr Pharmacol Ther. 1999;4:146-151. Lee KR, Phelps SJ. Implementation of vancomycin monitoring criteria in a pediatric hospital. J Pediatr Pharmacol Ther. 2004;9:179-186. Dehority W. Use of vancomycin in pediatrics. Pediatr Infect Dis J. 2010;29(5):462-464. ◄ Previous: Valproate Sodium | Top | Next: Vasopressin ► Back to top Dashboard Publications Search MedicinesComplete Search Product Updates Contact Us You can contact our Support Team anytime Monday to Friday between 9am and 5pm (UK time). Drug Interactions Telephone: +44 (0) 207 572 2266 Help My Account Accessibility Cookie and Privacy Policy Site Map Terms and Conditions Our other sites: Pharmaceutical Press and The Royal Pharmaceutical Society Your IP address is 190.116.28.2 Shop at Pharmaceutical Press Subscribe to our email newsletter Follow us on Twitter Find us on Facebook https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 7/8 22/4/2015 Vancomycin HCl: Pediatric Injectable Drugs Pediatric Injectable Drugs © American Society of Health-System Pharmacists 2015 MedicinesComplete © 2015 Royal Pharmaceutical Society. All Rights Reserved. https://www.medicinescomplete.com/mc/pid/current/Vancomycin_HCl.htm?q=vancomycin&t=search&ss=text&p=1#_hit 8/8