Monday, October 24, 2016

Vancomycin Hydrochloride



Class: Glycopeptides
VA Class: AM900
CAS Number: 1404-93-9
Brands: Vancocin

Introduction

Antibacterial; tricyclic glycopeptide antibiotic.266 267


Uses for Vancomycin Hydrochloride


Endocarditis


Treatment of native valve or prosthetic valve endocarditis caused by susceptible Staphylococcus aureus or S. epidermidis, including oxacillin-resistant (methicillin-resistant) strains.155 265 266 267 AHA and IDSA recommend vancomycin as drug of choice for treatment of endocarditis caused by oxacillin-resistant staphylococci.265 Also recommended as alternative to nafcillin (or oxacillin) or cefazolin for treatment of endocarditis caused by oxacillin-susceptible staphylococci in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.265 May be used alone for native valve endocarditis caused by oxacillin-susceptible staphylococci; used in conjunction with rifampin and gentamicin for endocarditis caused by oxacillin-resistant staphylococci and for prosthetic valve staphylococcal endocarditis.265


Treatment of native valve or prosthetic valve endocarditis caused by viridans streptococci or Streptococcus bovis.155 265 266 267 Recommended by AHA and IDSA as an alternative to penicillin G or ceftriaxone for treatment of streptococcal endocarditis in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.265


Treatment of native valve or prosthetic valve enterococcal endocarditis; used in conjunction with gentamicin or streptomycin.155 265 266 267 Recommended by AHA and IDSA as an alternative to penicillin G or ampicillin for treatment of enterococcal endocarditis in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.265


Empiric treatment of culture-negative endocarditis.265 For culture-negative native valve endocarditis, regimen of ampicillin-sulbactam and gentamicin recommended by AHA and IDSA; regimen of vancomycin, gentamicin, and ciprofloxacin recommended for those unable to tolerate penicillin.265 For culture-negative prosthetic valve endocarditis occurring ≤1 year after valve replacement, regimen of vancomycin, gentamicin, and rifampin recommended; this regimen also should include cefepime if onset of infection is within 2 months of valve replacement.265 Selection of the most appropriate anti-infective regimen is difficult and should be guided by epidemiologic features and clinical course of the infection.265 Consultation with an infectious diseases specialist is recommended.265


Treatment of early-onset prosthetic valve endocarditis caused by Corynebacterium jeikeium (JK group);149 266 267 c used in conjunction with rifampin and/or an aminoglycoside.c


Prevention of bacterial endocarditis in patients undergoing certain genitourinary and GI (except esophageal) procedures who have cardiac conditions that put them at moderate or high risk.145 AHA recommends ampicillin as a drug of choice; vancomycin recommended in those hypersensitive to penicillins.145 Used alone in penicillin-allergic individuals at moderate risk or in conjunction with gentamicin in those at high risk.145 Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.145


Meningitis


Treatment of meningitis caused by S. pneumoniae that are highly resistant to penicillins.122 149 235 236 237 .122 149 203 204 205 206 235 236 237 For empiric treatment, usually used in conjunction with a third generation cephalosporin (ceftriaxone, cefotaxime) with or without rifampin;122 203 204 205 206 235 236 237 vancomycin should be discontinued if the causative organism is found to be susceptible to the cephalosporin.235 236 237


Should not be used alone for treatment of meningitis since effective CSF concentrations may not be attained.122 148 235 237


Osteomyelitis


Treatment of osteomyelitis caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.266 267


Respiratory Tract Infections


Treatment of pneumonia caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.266 267


Treatment of pneumonia caused by S. pneumonia highly resistant to penicillins.122 149 235 236 237 266 267 Used alone or in conjunction with a third generation cephalosporin (ceftriaxone, cefotaxime) with or without rifampin.122 149 235 236 237


Septicemia


Treatment of septicemia caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.149 155 266 267 Used alone or in conjunction with gentamicin and/or rifampin.149


Skin and Skin Structure Infections


Treatment of skin and skin structure infections caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.155 266 267


Bacillus Infections


Treatment of infections caused by Bacillus cereus or B. subtilis.149 Drug of choice.149


Capnocytophaga Infections


Treatment of infections caused by Capnocytophaga.149


Optimum regimens for treatment of infections caused by Capnocytophaga not identified; some clinicians recommend use of penicillin G or, alternatively, a third generation cephalosporin (cefotaxime, ceftizoxime, ceftriaxone), a carbapenem (imipenem or meropenem), vancomycin, a fluoroquinolone, or clindamycin.149


Clostridium difficile-associated Diarrhea andColitis


Treatment of Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis, and pseudomembranous colitis) in seriously ill patients (i.e., with severe or potentially life-threatening colitis) or those who cannot tolerate or do not respond to oral metronidazole.122 149 197 198 199 200 211 212 213 214 215 266 267


Oral metronidazole appears to be as effective as oral vancomycin for treatment of Clostridium difficile-associated diarrhea and colitis.172 178 179 180 181 182 183 184 185 193 211 212 213 214 215


Because of cost considerations122 172 178 179 180 181 182 183 184 185 211 212 213 214 215 and concerns about increasing resistance to vancomycin in enterococci and other bacteria (e.g., staphylococci) and the risk of selection of such strains secondary to widespread and/or injudicious use of the drug,115 122 169 172 173 174 175 176 189 190 191 192 200 most experts state that oral metronidazole is preferred (unless a resistant strain of C. difficile is suspected or therapy with metronidazole is contraindicated or not tolerated) when anti-infective therapy is indicated for most cases of Clostridium difficile-associated diarrhea and colitis.122 149 172 178 179 180 181 182 183 184 185 198 200 211 212 213 214 215


Oral vancomycin is the drug of choice when anti-infective therapy is indicated for critically ill patients or those who cannot tolerate or do not respond to oral metronidazole.122 149 180 181 182 184 193 198 199 200 211 212 213 214 215 (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)


Has been used to prevent nosocomial outbreaks of Clostridium difficile-associated diarrhea and colitis in institutionalized patients who asymptomatically harbor the organism.186 187 188 194 However, current evidence suggests that the risks of such prophylaxis (e.g., in selecting potentially resistant organisms such as enterococci) outweigh any possible benefit.172 177 181 186 188 189 190 192 194 Most experts currently recommend that appropriate enteric and barrier precautions (e.g., isolation of patients, private bathroom facilities, strict hygiene) rather than prophylactic anti-infective therapy be implemented to prevent nosocomial transmission of the organisms.177 180 187 188 190 192 193 194 212 213


Rhodococcus Infections


Treatment of infections caused by Rhodococcus equi.149 240 241 242 243 Optimum regimens not identified; combination regimens usually recommended, including vancomycin given with a fluoroquinolone, rifampin, a carbapenem (imipenem or meropenem), or amikacin.149 240 241 242 243


Staphylococcal Enterocolitis


Treatment of enterocolitis caused by S. aureus (including oxacillin-resistant strains).199 Considered the drug of choice for staphylococcal enterocolitis because it does not affect the normal coliform bacteria present in the GI tract.c


Prevention of Perinatal Group B Streptococcal (GBS) Infection


Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease in penicillin-allergic pregnant women at risk for anaphylaxis with a β-lactam anti-infective when clindamycin or erythromycin cannot be used.158 159


Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.158 159


Penicillin G is the regimen of choice and ampicillin is the preferred alternative.158 159 Cefazolin can be used in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity, but clindamycin or erythromycin are the drugs of choice in penicillin-allergic women at high risk for anaphylaxis.158


Because S. agalactiae (group B streptococci) with in vitro resistance to clindamycin and erythromycin has been reported with increasing frequency,158 in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening is necessary.158 If in vitro susceptibility testing is not possible, results are unknown, or isolates are found to be resistant to erythromycin or clindamycin, vancomycin should be used for intrapartum prophylaxis in penicillin-allergic women at high risk for anaphylaxis with β-lactams.158


Perioperative Prophylaxis


Perioperative prophylaxis to reduce the risk of infection in patients undergoing cardiac surgery (e.g., placement of electrophysiologic devices, ventricular assist devices, ventriculoatrial shunts, arterial patches), neurosurgery (e.g., craniotomy, spinal surgery), orthopedic surgery (e.g., joint replacement, internal fixation of compound or open fractures with nails, plates, screws, or wires), noncardiac thoracic surgery (pulmonary resection, closed-tube thoracostomy for chest trauma with hemothorax or pneumothorax), or vascular surgery (arterial reconstructive surgery involving the abdominal aorta, leg procedures that include a groin incision, lower extremity amputation for ischemia) at institutions where oxacillin-resistant S. epidermidis are frequent causes of postoperative wound infection.208 Also used in these procedures when drugs of first choice (cefazolin, cefuroxime) cannot be used because patient is hypersensitive to β-lactams.208


Routine use of vancomycin for perioperative prophylaxis is not recommended since such use may promote emergence of vancomycin-resistant enterococci or staphylococci.200 208 224 (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)


Empiric Therapy in Febrile Neutropenic Patients


Has been used in conjunction with 1 or 2 other anti-infectives for empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients.256


Some clinicians suggest that it may be prudent to include vancomycin in an initial empiric regimen in selected patients with clinically suspected serious catheter-related infections (e.g., bacteremia, cellulitis); known colonization with penicillin- and cephalosporin-resistant S. pneumoniae or oxacillin-resistant (methicillin-resistant) S. aureus; initial blood culture results indicating presence of gram-positive bacteria; or hypotension or other evidence of cardiovascular impairment.256


If vancomycin is included in an initial empiric regimen, it should be discontinued within 24–48 hours if results of cultures do not identify gram-positive bacteria susceptible to the drug.256 (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)


Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.256 Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.256


Vancomycin Hydrochloride Dosage and Administration


Administration


Administer orally197 or by slow IV infusion.155 266 267 Should not be given IM;266 267 safety and efficacy of intrathecal (intralumbar or intraventricular) or intraperitoneal administration have not been determined.266 267


Given orally as capsules for treatment Clostridium difficile-associated diarrhea and colitis or for treatment of staphylococcal enterocolitis;197 if necessary, the parenteral formulation (500-mg single-use vial) may be diluted and administered orally or by NG tube for treatment of these infections.267


Oral vancomycin is not effective for treatment of systemic infections197 266 267


Oral Administration


Administer orally as capsules.197 Alternatively, an oral solution prepared using the IV preparation of the drug can be given orally or via NG tube.267


Reconstitution

When necessary, an oral solution can be prepared by diluting the appropriate dose of vancomycin powder for IV infusion in 30 mL of water.267 The 500-mg single-use vial should be used to prepare these oral solutions;267 ADD-Vantage vials should not be used.266


IV Infusion


For solution and drug compatibility information, see Compatibility under Stability.


Usually administered by intermittent IV infusion.266 267 Has been administered by continuous IV infusion when intermittent infusions were not feasible.c


Reconstitution and Dilution

Reconstitute powder for IV infusion by adding 10 or 20 mL of sterile water for injection to a vial containing 500 mg or 1 g of vancomycin.267 Further dilute reconstituted solutions containing 500 mg or 1 g with at least 100 mL or at least 200 mL, respectively, of a compatible IV solution.267


Alternatively, ADD-Vantage vials containing 500 mg or 1 g of vancomycin may be reconstituted according to the manufacturer’s directions using 5% dextrose injection or 0.9% sodium chloride injection.266 ADD-Vantage vials should be used only when actual doses of 500 mg or 1 g are appropriate and should not be used in neonates, infants, or young children who require doses <500 mg.266


The pharmacy bulk package is not intended for direct IV infusion; doses of the drug from the reconstituted bulk package must be further diluted in a compatible IV infusion solution prior to administration.157


Thaw the commercially available injection (frozen) at room temperature or in a refrigerator; do not force thaw by immersion in a water bath or by exposure to microwave radiation.155 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.155 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.155


The thawed injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.155


Rate of Administration

Administer by IV infusion over ≥1 hour.266 267


Rapid IV infusion should be avoided and patients monitored closely to detect a hypotensive reaction if it occurs.266 267


Adverse effects may be minimized if infusion rate is ≤10 mg/minute,266 267 but consider that adverse effects associated with vancomycin infusions could occur with any infusion rate.155 247 266 267 (See Infusion Reactions under Cautions.)


If intermittent IV infusion is not feasible, 1–2 g of reconstituted vancomycin may be added to a sufficient volume of 0.9% sodium chloride or 5% dextrose injection to permit administration of the desired daily dosage over a 24-hour period.c


Dosage


Available as vancomycin hydrochloride; dosage expressed in terms of vancomycin.197 266 267


Pediatric Patients


General Dosage for Neonates

Systemic Infections

IV

AAP states optimal dosage in neonates should be based on serum vancomycin concentrations, especially in those with low birthweight (i.e., <1.5 kg).122


Manufacturer recommends 15 mg/kg initially, followed by 10 mg/kg every 12 hours in neonates <1 week of age and 10 mg/kg every 8 hours in neonates 1 week to 1 month of age.266 267


Neonates <1 week of age: AAP recommends 15 mg/kg every 24 hours in those weighing <1.2 kg, 10–15 mg/kg every 12–18 hours in those weighing 1.2–2 kg, or 10–15 mg/kg every 8–12 hours for those weighing > 2 kg.122


Neonates ≥1 week of age: AAP recommends 15 mg/kg every 24 hours in those weighing <1.2 kg, 10–15 mg/kg every 8–12 hours in those weighing 1.2–2 kg, or 10–15 mg/kg every 6–8 hours in those weighing >2 kg.122


General Pediatric Dosage

Systemic Infections

IV

10 mg/kg every 6 hours.266 267


Children ≥1 month of age: AAP recommends 40 mg/kg daily given in 3–4 divided doses for mild to moderate infections or 40–60 mg/kg daily given in 4 divided doses for severe infections.122


Endocarditis

Treatment of Endocarditis Caused by Staphylococci (Including Oxacillin-resistant Staphylococci)

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265


Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for ≥6 weeks.265 Given in conjunction with oral or IV rifampin (20 mg/kg daily given in 3 equally divided doses for ≥6 weeks) and IM or IV gentamicin (3 mg/kg daily given in 3 divided doses during first 2 weeks of treatment).265


Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 4 weeks.265


Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265


Treatment of Enterococcal Endocarditis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265 Used in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (20–30 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265 Used in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (20–30 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Culture-negative Endocarditis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses in conjunction with oral or IV ciprofloxacin (20–30 mg/kg daily given in 2 equally divided doses) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses).265 All 3 drugs should be given for 4–6 weeks.265


Prosthetic valve (≤1 year after valve replacement): 40 mg/kg daily given in 2 or 3 equally divided doses in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses) and oral or IV rifampin (20 mg/kg daily given in 3 equally divided doses).265 Cefepime (150 mg/kg daily given IV in 3 equally divided doses) also may be included.265 Vancomycin, rifampin, and cefepime should be given for 6 weeks; gentamicin should be given only during first 2 weeks of treatment.265


Prevention of Bacterial Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures

IV

For moderate-risk patients, 20 mg/kg given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure.145


For high-risk patients, 20 mg/kg given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure; given in conjunction with IV or IM gentamicin (1.5 mg/kg given within 30 minutes prior to start of the procedure).145


Meningitis

IV

Children ≥1 month of age: AAP and other clinicians recommend 60 mg/kg daily given in 4 divided doses.122 235 236 237


Clostridium difficile-associated Diarrhea and Colitis

Oral

40 mg/kg given in 3 or 4 divided doses for 7–10 days.122 156 197


Staphylococcal Enterocolitis

Oral

40 mg/kg given in 3 or 4 divided doses for 7–10 days.122 156 197


Adults


General Adult Dosage

Treatment of Life-threatening Systemic Infections

IV

500 mg every 6 hours or 1 g every 12 hours.266 267


Endocarditis

Treatment of Endocarditis Caused by Staphylococci (Including Oxacillin-resistant Staphylococci)

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265


Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for ≥6 weeks.265 Given in conjunction with oral or IV rifampin (900 mg daily given in 3 equally divided doses every 8 hours for ≥6 weeks) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses during first 2 weeks of treatment).265


Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 4 weeks.265


Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265


Treatment of Enterococcal Endocarditis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265 Given in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (15 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265 Given in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (15 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Culture-negative Endocarditis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses in conjunction with ciprofloxacin (1 g daily given orally in 2 equally divided doses or 800 mg daily given IV in 2 equally divided doses) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses).265 All 3 drugs should be given for 4–6 weeks.265


Prosthetic valve (≤1 year after valve replacement): 30 mg/kg daily given in 2 equally divided doses in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses) and oral or IV rifampin (900 mg daily given in 3 equally divided doses).265 Cefepime (6 g daily given IV in 3 equally divided doses) also may be included.265 Vancomycin, rifampin, and cefepime should be given for 6 weeks; gentamicin should be given only during first 2 weeks of treatment.265


Prevention of Bacterial Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures

IV

For moderate-risk patients, 1 g given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure.145


For high-risk patients, 1 g given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure; given in conjunction with IV or IM gentamicin (1.5 mg/kg given within 30 minutes prior to start of the procedure).145


Meningitis

IV

500 mg every 6 hours or 1 g every 12 hours.266


Osteomyelitis

IV

500 mg every 6 hours or 1 g every 12 hours.266


Respiratory Tract Infections

IV

500 mg every 6 hours or 1 g every 12 hours.266


Septicemia

IV

500 mg every 6 hours or 1 g every 12 hours.266


Skin and Skin Structure Infections

IV

500 mg every 6 hours or 1 g every 12 hours.266


Clostridium difficile-associated Diarrhea and Colitis

Oral

0.5–2 g daily given in 3 or 4 divided doses for 7–10 days.156 197 Many clinicians recommend 125 mg 4 times daily for 7–10 days.212 215 c


Staphylococcal Enterocolitis

Oral

0.5–2 g daily given in 3 or 4 divided doses for 7–10 days.156 197


Prevention of Perinatal Group B Streptococcal (GBS) Infection

IV

1 g every 12 hours beginning at time of labor or rupture of membranes and continued until delivery.158


Perioperative Prophylaxis

Cardiac, Neurosurgical, Orthopedic, Thoracic (Noncardiac), or Vascular Surgery

IV

A single 1-g dose given just prior to the procedure.208


Start infusion 1–2 hours prior to incision to minimize risk of adverse reaction occurring at time of induction of anesthesia and to ensure adequate tissue concentrations at time of incision.208 If surgery is prolonged (>4 hours), additional intraoperative doses may be given every 6–12 hours for duration of the procedure; additional doses also are advisable if substantial blood loss occurs.208 Postoperative doses generally unnecessary and should not be used.208


Prescribing Limits


Pediatric Patients


Maximum 2 g daily.122 235 197 236 237


For treatment of endocarditis, AHA and IDSA state pediatric dosage should not exceed recommended adult dosage.265


Adults


Maximum 2 g daily.265


For treatment of endocarditis, AHA and IDSA recommend maximum 2 g daily unless serum concentrations are inappropriately low.265 These experts recommend dosage be adjusted to obtain peak serum concentrations (1 hour after completion of IV infusion) of 30–45 mcg/mL and trough concentrations of 10–15 mcg/mL.265


Special Populations


Hepatic Impairment


Limited data suggest dosage adjustments not necessary.264


Renal Impairment


Treatment of Systemic Infections

IV

Doses and/or frequency of administration must be modified in response to the degree of renal impairment.266 267 c


Various methods of calculating vancomycin dosage for patients with impaired renal function have been proposed and specialized references should be consulted.c


If possible, dosage should be based on serum vancomycin concentrations, especially in seriously ill patients with changing renal function.105 106 266 267 Peak serum concentrations of 30–40 mg/L and trough concentrations <10–20 mg/L generally have been recommended.264 To ensure efficacy and avoid toxicity, trough serum concentrations may be more useful than peak serum concentrations.264


Some clinicians have recommended that 1 g of vancomycin be administered at 12-hour intervals in patients with Scr of <1.5 mg/dL, at 3- to 6-day intervals in patients with Scr of 1.5–5 mg/dL, and at 10- to 14-day intervals in patients with Scr >5 mg/dL.c


Others have recommended that the usual individual dose be administered every 3–10 days in patients with GFR 10–50 mL/minute and every 10 days in patients with GFR <10 mL/minute.116


Geriatric Patients


Cautious dosage selection (usually starting at the low end of the dosing range) because of age-related decreases in renal function.197 266 267 (See Renal Impairment under Dosage and Administration.)


Cautions for Vancomycin Hydrochloride


Contraindications



  • Hypersensitivity to vancomycin.197 266 267




  • Commercially available frozen vancomycin hydrochloride injection in 5% dextrose may be contraindicated in patients with known allergy to corn or corn products.155



Warnings/Precautions


Warnings


Ototoxicity

Ototoxicity, including damage to the auditory branch of the eighth cranial nerve and permanent deafness, vertigo, dizziness, and tinnitus, has been reported.132 134 266 267


Most cases involved patients with renal impairment, patients receiving high dose or prolonged IV therapy, patients with preexisting hearing loss, or those receiving other ototoxic drugs concomitantly.266 267


Ototoxicity usually has been associated with serum or blood vancomycin concentrations of 80–100 mcg/mL, but has occurred with concentrations as low as 25 mcg/mL.132


Ototoxicity may be transient or permanent;155 266 267 deafness may progress despite cessation of therapy.c


Not recommended in patients with previous hearing loss; if use in these patients is considered necessary, reduce dosage.c


Auditory function testing may minimize risk of ototoxicity during vancomycin therapy.155 266 267 In addition, regular determinations of serum or blood vancomycin concentrations is recommended in patients with borderline renal function and in those >60 years of age.c


If tinnitus occurs, discontinue vancomycin.c


Nephrotoxicity

Nephrotoxicity has been reported, including increased BUN or Scr concentrations, presence of hyaline and granular casts and albumin in urine, fatal uremia, and acute interstitial nephritis.132 133 134


Reported most frequently in patients with renal impairment, patients receiving high dose or prolonged IV therapy, or those receiving other nephrotoxic drugs concomitantly.256


Nephrotoxicity usually is associated with serum or blood vancomycin concentrations of 80–100 mcg/mL, but has occurred with concentrations as low as 25 mcg/mL.132


Use with caution in patients with impaired renal function.266 267 Perform urinalysis and renal function tests periodically during therapy.266 267


Infusion Reactions

Rapid IV administration may result in a potentially serious hypotensive reaction.112 118 119 120 136 137 138 139 143 238 244 247


These infusion reactions usually involve a sudden and possibly severe decrease in blood pressure and may be accompanied by flushing and/or a maculopapular or erythematous rash on the face, neck, chest, and upper extremities (“red-man syndrome” or “red-neck syndrome”).112 118 119 120 135 136 137 142 143 Latter manifestations may occur in the absence of hypotension.120 135 136 142 238 244 247 Wheezing, dyspnea, angioedema, urticaria, pruritus, and, rarely, cardiac arrest or seizures may also occur.139 121 138


The reaction usually begin a few minutes after infusion is started, but may not occur until after its completion and usually resolves spontaneously over 1 to several hours after discontinuance.118 120 135 136 143 238 If the hypotensive reaction is severe, antihistamines, corticosteroids, or IV fluids are recommended.118 120 136


To minimize risk of an infusion reaction, administer IV over a period of ≥1 hour using a rate ≤10 mg/minute and monitor patient’s blood pressure.118 119 120 136 155 266 267 Avoid rapid IV administration (e.g., over several minutes).155


Pretreatment with antihistamines may attenuate but not eliminate the risk of infusion reactions.244 136 141 144


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylaxis, urticaria, exfoliative dermatitis, macular rashes, exfoliative dermatitis, and Stevens-Johnson syndrome have been reported.131 266 267


Rapid IV administration may result in anaphylactoid reaction involving hypotension, wheezing, dyspnea, urticaria, or pruritus.266 267 (See Infusion Reactions under Cautions.)


General Precautions


Hematologic Effects

Neutropenia, eosinophilia, and thrombocytopenia have been reported rarely.

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