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Vancomycin

Pronunciation

(van koe MYE sin)

Index Terms

  • Vancocin
  • Vancomycin HCl
  • Vancomycin Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Vancocin HCl: 125 mg, 250 mg [contains fd&c blue #2 (indigotine)]

Generic: 125 mg, 250 mg

Solution, Intravenous:

Generic: 1000 mg/100 mL in Dextrose 5% (100 mL); 1000 mg/150 mL in NaCl 0.9% (150 mL); 1000 mg/200 mL in Dextrose 5% (200 mL); 1000 mg/200 mL in NaCl 0.9% (200 mL); 1000 mg/250 mL in Dextrose 5% (250 mL); 1000 mg/250 mL in NaCl 0.9% (250 mL); 1250 mg/250 mL in Dextrose 5% (250 mL); 1250 mg/250 mL in NaCl 0.9% (250 mL); 1500 mg/150 mL in NaCl 0.9% (150 mL); 1500 mg/250 mL in Dextrose 5% (250 mL); 1500 mg/250 mL in NaCl 0.9% (250 mL); 1500 mg/500 mL in Dextrose 5% (500 mL); 1500 mg/500 mL in NaCl 0.9% (500 mL); 1750 mg/250 mL in NaCl 0.9% (250 mL); 1750 mg/300 mL in NaCl 0.9% (300 mL); 1750 mg/500 mL in Dextrose 5% (500 mL); 1750 mg/500 mL in NaCl 0.9% (500 mL); 2000 mg/250 mL in NaCl 0.9% (250 mL); 2000 mg/500 mL in Dextrose 5% (500 mL); 2000 mg/500 mL in NaCl 0.9% (500 mL); 2500 mg/500 mL in NaCl 0.9% (500 mL); 500 mg/100 mL in Dextrose 5% (100 mL); 750 mg/150 mL in Dextrose 5% (150 mL); 750 mg/150 mL in NaCl 0.9% (150 mL); 750 mg/250 mL in NaCl 0.9% (250 mL)

Solution, Intravenous [preservative free]:

Generic: 750 mg/250 mL in NaCl 0.9% (250 mL)

Solution, Oral:

First-Vancomycin 25: 25 mg/mL (150 mL, 300 mL) [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), sodium benzoate; white grape flavor]

First-Vancomycin 50: 50 mg/mL (150 mL, 210 mL, 300 mL) [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), sodium benzoate; white grape flavor]

Solution Reconstituted, Intravenous:

Generic: 500 mg (1 ea [DSC]); 1000 mg (1 ea [DSC]); 5000 mg (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Generic: 500 mg (1 ea); 750 mg (1 ea); 1000 mg (1 ea); 5000 mg (1 ea); 10 g (1 ea)

Suspension, Oral:

Vancomycin+SyrSpend SF PH4: 50 mg/mL (120 mL, 240 mL)

Brand Names: U.S.

  • First-Vancomycin 25
  • First-Vancomycin 50
  • Vancocin HCl
  • Vancomycin+SyrSpend SF PH4

Pharmacologic Category

  • Glycopeptide

Pharmacology

Inhibits bacterial cell wall synthesis by blocking glycopeptide polymerization through binding tightly to D-alanyl-D-alanine portion of cell wall precursor

Absorption

Oral: Poor; Intraperitoneal (IP): 60% of an IP dose absorbed in 6 hours; Rectal: significant absorption through inflamed colonic mucosa may occur

Distribution

Distributes widely in body tissue and fluids, except for CSF

Vd:

Neonate, term: 0.57 to 0.69 L/kg (de Hoog 2004)

Neonates, receiving ECMO (mean age: ~39 weeks): Variable; 1.1 L/kg (range: 0.6 to 2.1 L/kg) (Amaker 1996); others have reported lower values: 0.45 ± 0.18 L/kg (Buck 1998), 0.67 ± 0.15 L/kg (Mulla 2005)

Pediatric patients: Median: 0.57 L/kg (range: 0.26 to 1.05 L/kg) (Marsot 2012)

Adults: 0.4 to 1 L/kg (ASHP/IDSA/SIDP [Rybak 2009])

Relative diffusion from blood into CSF: Good only with inflammation (exceeds usual MICs)

Children:

CSF concentrations: 0.2 to 17.3 mcg/mL (de Hoog 2004)

CSF:blood level ratio: Normal meninges: Nil; Inflamed meninges: 7.1% to 68% (de Hoog 2004)

Adults:

Uninflamed meninges: 0 to 4 mcg/mL; serum concentration dependent (ASHP/IDSA/SIDP [Rybak 2009])

Inflamed meninges: 6 to 11 mcg/mL; serum concentration dependent (ASHP/IDSA/SIDP [Rybak 2009])

CSF:serum level ratio: Normal meninges: Nil; Inflamed meninges: ~80% (Shokouhi 2014)

Metabolism

No apparent metabolism

Excretion

Primarily via glomerular filtration; IV: Urine (75% as unchanged drug in the first 24 hours); Oral: Primarily feces

Clearance: presence of malignancy in children is associated with an increase in vancomycin clearance

Neonates: 0.63 to 1.5 mL/minute/kg; dependent on GA and/or PMA (de Hoog 2004)

Neonates, receiving ECMO: ~0.79 mL/minute/kg (Amaker 1996; Buck 1998); others have reported a slightly slower rate: 0.67 mL/minute/kg (Mulla 2005)

Pediatric patients: Median: 1.1 mL/minute/kg (range: 0.33 to 1.87 mL/minute/kg) (Marsot 2012)

Adults: 0.71 to 1.31 mL/minute/kg (de Hoog 2004)

Time to Peak

Serum: IV: Immediately after completion of infusion

Half-Life Elimination

Biphasic: Terminal:

Newborns: 6 to 10 hours

Neonates receiving ECMO: 6.53 ± 2.1 hours (Buck 1998); others have reported longer: 10.4 ± 6.7 hours (Mulla 2005)

Infants and Children 3 months to 4 years: 4 hours

Children and Adolescents >3 years: 2.2 to 3 hours

Adults: 4 to 6 hours; significantly prolonged with renal impairment

End-stage renal disease (ESRD): 7.5 days

Protein Binding

~55%

Special Populations: Elderly

Total systemic and renal clearance may be reduced.

Use: Labeled Indications

Clostridium difficile infection (oral): Treatment of C. difficile infection (CDI)

Endocarditis (injection):

Corynebacteria (diphtheroids): Treatment of diphtheroid endocarditis in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by diphtheroids

Enterococcal: Treatment of endocarditis caused by enterococci (eg, Enterococcus faecalis), in combination with an aminoglycoside

Staphylococcal: Treatment of staphylococcal endocarditis

Streptococcal: Treatment of endocarditis due to Streptococcus viridans or Streptococcus bovis, as monotherapy or in combination with an aminoglycoside

Staphylococcal infections (injection): Treatment of serious or severe infections (eg, septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections) caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci; empiric therapy of infections when methicillin-resistant staphylococci are suspected

Off Label Uses

Catheter-related infections

Based on The Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection, vancomycin antibiotic lock therapy is recommended for patients for whom catheter salvage is the goal, in combination with systemic antimicrobial therapy, especially when peripheral cultures are positive.

Cerebrospinal fluid (CSF) shunt infection

Based on the Infectious Diseases Society of America (IDSA) guidelines for health care-associated ventriculitis and meningitis, vancomycin is an effective and recommended systemic therapy (as part of an empiric combination regimen) for treatment of health care-associated ventriculitis and meningitis. Intraventricular administration of vancomycin, as an adjunct to systemic therapy, may be considered in patients with poor response to systemic antimicrobial therapy alone.

Community-acquired pneumonia (children)

Following management recommendations of clinical guidelines reduces the incidence of morbidity and mortality related to pneumonia. Vancomycin is the preferred parenteral option for treatment of CAP caused by MRSA and should be added to empiric beta-lactam therapy when S. aureus is suspected. It can be used for pathogen-directed therapy aimed at S. pneumoniae, GAS, or MSSA in children >3 months of age.

Clostridium difficile infection (adults; rectal administration)

Rectal administration of vancomycin is recommended in national practice guidelines for the management of severe, complicated cases of C. difficile infection despite evidence based on case reports/series.

Endophthalmitis, treatment

Data from a limited number of patients studied suggest that intravitreal vancomycin may be beneficial for the treatment of postoperative endophthalmitis [Gan 2001]. Clinical experience based on data from peer-reviewed scientific literature also suggests the utility of vancomycin in the management of bacterial endophthalmitis [Packer 2011]. Additional data may be necessary to further define the role of vancomycin in this condition.

Group B Streptococcus, maternal use (neonatal prophylaxis)

Based on the Centers for Disease Control and Prevention (CDC) Prevention of Perinatal Group B Streptococcal Disease, vancomycin is effective and recommended at the time of delivery in mothers colonized with group B streptococcus (neonatal prophylaxis) when patients have multiple antibiotic allergies.

Intra-abdominal infections

Based on the Surgical Infection Society and Infectious Diseases Society of America (IDSA) guidelines for diagnosis and management of complicated intra-abdominal infection in adults and children, vancomycin is effective and recommend in patients with intra-abdominal infections due to MRSA or ampicillin-resistant enterococci.

Meningitis, bacterial

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of bacterial meningitis and for health care-associated ventriculitis and meningitis, vancomycin is an effective and recommended systemic therapy as part of an empiric regimen for treatment of bacterial meningitis when Streptococcus pneumoniae or MRSA is a presumptive pathogen.

Perioperative prophylaxis

Based on the American Society of Health-System Pharmacists (ASHP) Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery, vancomycin given as an alternative antibiotic in patients with beta-lactam allergy requiring surgical prophylaxis is effective and recommended for a number of surgical procedures.

Peritonitis, treatment (continuous ambulatory peritoneal dialysis [CAPD] patients)

Based on the International Society for Peritoneal Dialysis (ISPD) Peritonitis Recommendations: Update on Prevention and Treatment, intraperitoneal vancomycin in continuous ambulatory peritoneal dialysis (CAPD) is effective and recommended for empiric treatment of peritonitis in CAPD patients caused by gram-positive organisms.

Prosthetic joint infection

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of prosthetic joint infection, vancomycin is effective and recommended for treatment of prosthetic joints infected with Staphylococci or Enterococcus spp.

Surgical-site infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), vancomycin is an effective and recommended option for treatment of surgical-site infections. Systemic antibacterials are not routinely indicated for surgical-site infections, but may be beneficial (in conjunction with suture removal plus incision and drainage) in patients with significant systemic response (eg, temperature >38.5°C, heart rate >110 beats per minute, erythema/induration extending >5 cm from incision, WBC >12,000/mm3).

Contraindications

Hypersensitivity to vancomycin or any component of the formulation

Dosing: Adult

Usual dosage range: Note: Initial IV dosing in nonobese patients should be based on actual body weight; subsequent dosing should generally be adjusted based on serum trough vancomycin concentrations and renal function. Patient-specific pharmacokinetic calculations may be needed to determine appropriate dose and interval in patients expected to have altered pharmacokinetics (eg, morbid obesity, burns, critical illness, unstable renal function, pregnancy, cystic fibrosis). For patients with uncomplicated skin and soft tissue infections who are not obese and have normal renal function, serum trough monitoring is generally not needed (IDSA [Liu 2011]).

IV: Note: Ineffective for treating C. difficile infections (CDIs): 15 to 20 mg/kg/dose (rounded to the nearest 250 mg; usual maximum: 2 g/dose initially) every 8 to 12 hours (ASHP/IDSA/SIDP [Rybak 2009]). Note: 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours is a usual starting dose in most nonobese patients with normal renal function; refer to infection-specific dosing (Drew 2017; IDSA [Liu 2011]; Murray 2015).

Loading dose: Complicated infections in seriously ill patients: A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations (ASHP/IDSA/SIDP [Rybak 2009]; Reardon 2015).

Oral: Note: Ineffective for treating systemic infections: 125 to 500 mg 4 times daily

Indication-specific dosing:

Bacteremia (off-label dose):

Empiric therapy or pathogen-specific therapy for methicillin-resistant S. aureus: IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL. A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]). For catheter-related bloodstream infections, consider antibiotic lock therapy for catheter salvage, in addition to systemic therapy (IDSA [Mermel 2009]).

Empiric therapy or pathogen-specific therapy for methicillin-resistant coagulase-negative staphylococci: IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours (most patients with normal renal function can be started with 15 mg/kg/dose every 12 hours); adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (Drew 2017). For catheter-related bloodstream infections, consider antibiotic lock therapy for catheter salvage, in addition to systemic therapy (IDSA [Mermel 2009]).

Antibiotic lock technique (catheter salvage strategy (off-label use): Prepare lock solution to final concentration of vancomycin 5 mg/mL (may be combined with heparin 5,000 units/mL). Instill into each lumen of the catheter access port using a volume sufficient to fill the catheter (2 to 5 mL) with a dwell time of 48 to 72 hours. Dwell times will depend on frequency of catheter use. Withdraw lock solution prior to catheter use; replace with fresh vancomycin lock solution after catheter use. For catheter-related bloodstream infections consider antibiotic lock technique, in addition to systemic antibiotics. Duration of lock therapy should be 10 to 14 days (IDSA [Mermel 2009]; LaPlante 2007).

Brain abscess, intracranial or spinal epidural abscess (off-label dose): As a component of empiric therapy or pathogen specific therapy for methicillin-resistant S. aureus: IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL. A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Cerebrospinal fluid (CSF) shunt infection (off-label use): As a component of empiric therapy or pathogen-specific therapy (eg, methicillin-resistant S. aureus or coagulase-negative staphylococci):

IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (IDSA [Tunkel 2017]). A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]).

Intraventricular (adjunct to systemic therapy; use a preservative-free preparation): 5 to 20 mg; adjust dosage and administration interval based on CSF vancomycin concentrations (goal: 10 to 20 times MIC of causative organism), ventricular size, and daily output from ventricular drain. When intraventricular vancomycin is administered via a ventricular drain, clamp drain for 15 to 60 minutes after administration (allows solution to equilibrate in CSF) (IDSA [Tunkel 2004; Tunkel 2017]). Note: Intraventricular administration is generally reserved for use in patients who fail parenteral therapy despite removal of CSF shunt or when CSF shunt cannot be removed (Baddour 2017).

Clostridium difficile infection (CDI):

Oral:

Mild or moderate CDI:

Initial episode or first relapse: 125 mg 4 times daily for 10 to 14 days (AHRQ [Butler 2016]; Kelly 2017)

Second relapse: Pulsed and/or tapered therapy over 6 to 7 weeks (Kelly 2017; SHEA/IDSA [Cohen 2010])

Severe, complicated CDI: 125 to 500 mg 4 times daily (ACG [Surawicz 2013]; ESCMID [Debast 2014]; SHEA/IDSA [Cohen 2010])]; with or without IV metronidazole (Rokas 2015). Vancomycin retention enema may be added if there is concern that orally administered vancomycin may not reach colon (ACG [Surawicz 2013]).

Rectal (intracolonic) (off-label route): Retention enema: Note: Institution-specific protocols vary; optimal regimen not established. Consider assessing serum concentration as absorption may occur through inflamed mucosa (SHEA/IDSA [Cohen 2010]).

Severe, complicated infection in patients with a condition that may prevent oral vancomycin from reaching the colon (eg, ileus, megacolon, ileostomy) or unable to tolerate oral therapy: 500 mg every 6 hours (in 100 mL NS) (SHEA/IDSA [Cohen 2010]) retained for 1 hour (Apisarnthanarak 2002), with oral vancomycin (if tolerated) with or without concurrent IV metronidazole; dose adjustment and/or altered volume (eg, up to 500 mL NS) may be needed based upon extent of disease and patient weight (ACG [Surawicz 2013]; SHEA/IDSA [Cohen 2010]).

Endocarditis, treatment (off-label dose):

Enterococcus (native or prosthetic valve; penicillin-resistant strains or patients unable to tolerate beta-lactams): IV: 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours in combination with gentamicin for 6 weeks; adjust dose to obtain a trough concentration of 10 to 20 mcg/mL (AHA [Baddour 2015]); some experts favor a trough of 15 to 20 mcg/mL (BSAC [Gould 2012]; ESC [Habib 2015]).

S. aureus, methicillin-resistant or methicillin-susceptible (severe-beta lactam hypersensitivity; alternative agent): IV:

Native valve: 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours for 6 weeks; dose adjusted to obtain a serum trough concentration of 10 to 20 mcg/mL (AHA [Baddour 2015]) or 15 to 20 mg/kg/dose (usual maximum dose: 2 g/dose initially) every 8 to 12 hours for 6 weeks; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (IDSA [Lui 2011]).

Prosthetic valve: 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours; adjust dose to obtain a trough concentration of 10 to 20 mcg/mL (AHA [Baddour 2015]) or 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (IDSA [Lui 2011]). Duration of therapy: At least 6 weeks (combine with rifampin for the entire duration of therapy and gentamicin for the first 2 weeks) (AHA [Baddour 2015]; IDSA [Lui 2011]).

Viridans group Streptococcus and S. bovis (native or prosthetic valve; penicillin or ceftriaxone intolerance): IV: 15 mg/kg/dose (usual maximum dose: 2 g/dose initially) every 12 hours for 4 weeks (native valve) or 6 weeks (prosthetic valve); adjust dose to obtain a trough concentration of 10 to 15 mcg/mL (AHA [Baddour 2015]).

Endophthalmitis, treatment (off-label use): Intravitreal: Usual dose: 1 mg/0.1 mL NS or sterile water injected into vitreum, usually in combination with ceftazidime (Durand 2017; Kelsey 1995). May repeat after 48 hours if needed based on culture result (Durand 2017).

Group B streptococcus (neonatal prophylaxis) (off-label use; alternative agent): IV: 20 mg/kg (maximum: 2 g/dose) every 8 hours from onset of labor until delivery (Onwuchuruba 2014). Note: Reserved for penicillin allergic patients at high risk for anaphylaxis and if organism is resistant to clindamycin or when no susceptibility data are available (CDC 2010).

Intra-abdominal infection (off-label use): As a component of empiric therapy or pathogen-specific therapy (eg, methicillin-resistant S. aureus): IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Solomkin 2010]).

Meningitis, bacterial (off-label use): As a component of empiric therapy or pathogen-specific therapy (eg, methicillin-resistant S. aureus or penicillin- and cephalosporin-resistant S. pneumoniae): IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (IDSA [Tunkel 2004; 2017]) A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Osteomyelitis (off-label dose): As a component of empiric therapy or pathogen-specific therapy (eg, methicillin-resistant S. aureus): IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours (IDSA [Liu 2011]) or 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours (IDSA [Berbari 2015]); adjust dose to obtain a trough concentration of 15 to 20 mcg/mL. A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]).

Perioperative prophylaxis (in combination with other appropriate agents when coverage for methicillin-resistant S. aureus is indicated or for gram-positive coverage in patients unable to tolerate beta-lactams) (off-label use): IV: 15 mg/kg (usual maximum: 2 g/dose initially) started within 60 to 120 minutes prior to initial surgical incision. Vancomycin doses may be repeated intraoperatively in 2 half-lives (approximately 8 to 12 hours in patients with normal renal function) if procedure is lengthy or if there is excessive blood loss (ASHP/IDSA/SIS/SHEA [Bratzler 2013]). In cases where an extension of prophylaxis is warranted post-operatively, total duration should be ≤24 hours (Anderson 2014). Postoperative prophylaxis is not recommended in clean and clean-contaminated surgeries (CDC [Berrios-Torres 2017]).

Peritonitis, treatment (continuous ambulatory dialysis [CAPD] patients) (off-label use): Intraperitoneal: Note: Intraperitoneal administration is preferred to IV administration. Adjust dose to obtain a trough concentration between 15 and 20 mcg/mL (ISPD [Li 2016])

Intermittent (preferred): 15 to 30 mg/kg added to one exchange of CAPD solution every 5 to 7 days (allow to dwell for ≥6 hours); supplemental doses and more frequent monitoring of serum levels may be needed for patients receiving automated peritoneal dialysis (APD) or with significant residual renal function (ISPD [Li 2016]).

Continuous (all exchanges): Loading dose: 30 mg/kg added to first exchange of CAPD solution; maintenance dose: 1.5 mg/kg/bag for each subsequent exchange of CAPD solution (Bunke 1983; ISPD [Li 2016])

Pneumonia, S. aureus (methicillin-resistant): IV:

Community-acquired pneumonia (CAP) (hospitalized patient): As a component of empiric therapy or pathogen-specific therapy for community-acquired methicillin-resistant S. aureus: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]; IDSA [Mandell 2007]); most patients with normal renal function can be started with 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours. Adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (File 2017). A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]; IDSA [Mandell 2007]).

Hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP): As a component of empiric therapy or pathogen-specific therapy for methicillin-resistant S. aureus: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL. A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; ATS/IDSA [Kalil 2016]).

Prosthetic joint infection (off-label use): IV:

Pathogen-specific therapy for methicillin-resistant or susceptible S. aureus (alternative agent in beta-lactam intolerance): IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours (Berbari 2017; IDSA [Liu 2011]) or 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours (IDSA [Osmon 2013]); adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (ASHP/IDSA/SIDP [Rybak 2009]). Note: May be combined with oral rifampin in selected cases (eg, debridement and retention of prosthesis or one-stage arthroplasty).

Pathogen-specific therapy for Enterococcus spp (penicillin susceptible [alternative agent] or penicillin resistant): 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours (Berbari 2017; IDSA [Osmon 2013]).

Sepsis/septic shock (off-label dose): As a component of empiric therapy or pathogen-specific therapy of methicillin-resistant S. aureus: IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (ASHP/IDSA/SIDP [Rybak 2009]). Administer within 1 hour of identifying sepsis (Rhodes 2017). A loading dose may be considered in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; Rhodes 2017). A duration of therapy of 7 to 10 days is generally adequate for serious infections; a variety of factors play a role in determining optimal duration of therapy (Rhodes 2017).

Septic arthritis, without prosthetic material (off-label dose): As a component of empiric therapy or pathogen-specific therapy of methicillin-resistant S. aureus or coagulase-negative staphylococci: IV: 15 to 20 mg/kg/dose (usual maximum: 2 g/dose initially) every 8 to 12 hours; adjust dose to obtain a trough concentration of 15 to 20 mcg/mL (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]). Most patients with normal renal function can be started with 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours (Goldenberg 2017).

Skin and soft tissue infections (hospitalized patient) (off-label dose): As a component of empiric therapy or pathogen-specific therapy of methicillin-resistant S. aureus: IV: 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours (IDSA [Stevens 2014]); adjust dose to obtain a trough concentration of 10 to 15 mcg/mL (uncomplicated infection) or 15 to 20 mcg/mL (complicated infection or seriously ill) (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]; IDSA [Stevens 2014]). Note: For empiric therapy of necrotizing infection, must be used in combination with other agents (IDSA [Stevens 2014]).

Surgical site infections (off-label use): As a component of empiric therapy or pathogen-specific therapy of methicillin-resistant S.aureus: IV: 15 mg/kg/dose (usual maximum: 2 g/dose initially) every 12 hours; adjust dose to obtain trough concentrations of 10 to 15 mcg/mL (uncomplicated infection) or 15 to 20 mcg/mL (complicated infections or seriously ill) (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Stevens 2014]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Usual dosage range: Note: Initial IV dosing should be based on actual body weight; subsequent dosing adjusted based on serum trough vancomycin concentrations.

Infants >2 months (60 days), Children, and Adolescents (Red Book [AAP 2015]): Note: Every 6 hour dosing recommended as initial dosage regimen if targeting trough serum concentrations >10 mcg/mL (Benner 2009; Frymoyer 2009) in patients with normal renal function. Close monitoring of serum concentrations and assurance of adequate hydration status is recommended; utilize local antibiogram and protocols for further guidance.

Mild to moderate infection: IV: 40 to 45 mg/kg/day divided every 6 to 8 hours; dose and frequency should be individualized based on serum concentrations; usual maximum daily dose: 2,000 mg/day

Severe infection: IV: 45 to 60 mg/kg/day divided every 6 to 8 hours; dose and frequency should be individualized based on serum concentrations; usual maximum daily dose: 4,000 mg/day

Indication-specific dosing:

Bacteremia (off-label use): Empiric therapy or pathogen-specific therapy (eg, methicillin-resistant S. aureus): Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for 2 to 6 weeks depending on severity (IDSA [Liu 2011])

Brain abscess, intracranial epidural abscess, spinal epidural abscess (S. aureus [methicillin-resistant]) (off-label use): As a component of empiric therapy or pathogen specific therapy for methicillin-resistant S. aureus: Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for 4 to 6 weeks (with or without rifampin) (IDSA [Liu 2011])

C. difficile infection (CDI): Infants >1 month, Children, and Adolescents:

Manufacturer’s labeling: Oral: 40 mg/kg/day in 3 to 4 divided doses for 7 to 10 days (maximum: 2,000 mg/day)

HIV-exposed/-positive patients: Adolescents: Oral: 125 mg 4 times daily for 10 to 14 days (HHS [OI adult 2017])

Endocarditis, treatment (off-label dose):

S. aureus (methicillin-resistant):

Native valve: Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for 6 weeks (IDSA [Liu 2011])

Prosthetic valve: Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for at least 6 weeks (combine with rifampin for the entire duration of therapy and gentamicin for the first 2 weeks) (IDSA [Liu 2011]).

Meningitis, bacterial: Infants >1 month, Children, and Adolescents: IV: 15 mg/kg/dose every 6 hours (for empiric therapy, use in combination with a third-generation cephalosporin); duration of therapy should be individualized based upon clinical response (in general, 10 to 21 days) (IDSA [Tunkel 2004]). For methicillin-resistant S. aureus, treat for 2 weeks (with or without rifampin) (IDSA [Liu 2011]).

Osteomyelitis (off-label use): As a component of empiric therapy or pathogen-specific therapy (eg, methicillin-resistant S. aureus): Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for 4 to 6 weeks (IDSA [Liu 2011]).

Perioperative prophylaxis (off-label use): Children and Adolescents: IV: 15 mg/kg/dose within 120 minutes prior to surgical incision. May be administered in combination with other antibiotics depending upon the surgical procedure (ASHP/IDSA/SIS/SHEA [Bratzler 2013]).

Note: For patients known to be colonized with methicillin-resistant S. aureus, a single 15 mg/kg preoperative dose may be added to other recommended agents for the specific procedure (ASHP/IDSA/SIS/SHEA [Bratzler 2013]).

Pneumonia:

Community-acquired pneumonia (CAP) (IDSA/PIDS, 2011): Infants >3 months, Children, and Adolescents: IV: Note: In children ≥5 years, a macrolide antibiotic should be added if atypical pneumonia cannot be ruled out. Also consider if community-acquired MRSA suspected.

Group A Streptococcus (alternative to ampicillin or penicillin in beta-lactam allergic patients): 40 to 60 mg/kg/day divided every 6 to 8 hours

Presumed bacterial (in addition to recommended antibiotic therapy), S. pneumoniae, moderate to severe infection (MICs to penicillin ≤2.0 mcg/mL) (alternative to ampicillin or penicillin): 40 to 60 mg/kg/day divided every 6 to 8 hours

S. aureus (methicillin-susceptible) (alternative to cefazolin/oxacillin): 40 to 60 mg/kg/day divided every 6 to 8 hours

S. aureus, moderate to severe infection (methicillin-resistant +/- clindamycin susceptible) (preferred): 40 to 60 mg/kg/day divided every 6 to 8 hours or dosing to achieve AUC/MIC >400

Alternate regimen: 60 mg/kg/day divided every 6 hours for 7 to 21 days, depending on severity (Liu 2011)

S. pneumoniae, moderate to severe infection (MICs to penicillin ≥4.0 mcg/mL) (alternative to ceftriaxone in beta-lactam allergic patients): 40 to 60 mg/kg/day divided every 6 to 8 hours

Health care–associated pneumonia (HAP): As a component of empiric therapy or pathogen-specific therapy for methicillin-resistantS.aureus: Infants, Children, and Adolescents: IV: 60 mg/kg/day divided every 6 hours for 7 to 21 days depending on severity (IDSA [Liu 2011])

Prophylaxis against infective endocarditis: Children and Adolescents: IV:

Dental, oral, or upper respiratory tract surgery: 20 mg/kg/dose administered 1 hour prior to the procedure. Note: American Heart Association (AHA) guidelines recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur.

GI/GU procedure: 20 mg/kg (plus gentamicin 1.5 mg/kg) administered 1 hour prior to surgery. Note: Routine prophylaxis no longer recommended by the AHA.

Septic arthritis (off-label use): As a component of empiric therapy or pathogen-specific therapy of methicillin-resistant S. aureus: Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for minimum of 3 to 4 weeks (IDSA [Liu 2011])

Skin and soft tissue infections, complicated (off-label use): As a component of empiric therapy or pathogen-specific therapy of methicillin-resistant S. aureus: Infants, Children, and Adolescents: IV:

Non-necrotizing infection: 10 mg/kg/dose every 6 hours (IDSA [Stevens 2014])

Necrotizing infection: 15 mg/kg/dose every 6 hours (IDSA [Stevens 2014])

Alternate dosing: S. aureus (methicillin-resistant): 60 mg/kg/day divided every 6 hours for 7 to 14 days (IDSA [Liu 2011])

Dosing: Renal Impairment

Oral: There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

IV: Note: Vancomycin levels should be monitored in patients with any renal impairment: In critically ill patients with renal insufficiency, the initial loading dose (~25 mg/kg) should not be reduced. However, subsequent dosage adjustments should be made based on renal function and trough serum concentrations (Wang 2001).

Vancomycin Initial Dosage Regimens for Patients With Impaired Renal Function (Golightly 2013)

eGFR (mL/minute per 1.73 m2)

Actual Body Weight

<60 kg

60 to 80 kg

81 to 100 kg

>100 kg

aCheck a random vancomycin level in 24 hours after the dose. If random level is ≤20 mcg/mL, repeat the dose. If random level is >20 mcg/mL, do not re-dose; repeat random level in 12 hours.

>90

750 mg every 8 hours

1,000 mg every 8 hours

1,250 mg every 8 hours

1,500 mg every 8 hours

50 to 90

750 mg every 12 hours

1,000 mg every 12 hours

1,250 mg every 12 hours

1,000 mg every 8 hours

15 to 49

750 mg every 24 hours

1,000 mg every 24 hours

1,250 mg every 24 hours

1,500 mg every 24 hours

<15a

750 mg

1,000 mg

1,250 mg

1,500 mg

Vancomycin Initial Dosage Regimens for Patients with Impaired Renal Function (Golightly 2013)

eGFR >90 mL/minute/1.73 m2:

Actual body weight >100 kg: 1,500 mg every 8 hours

Actual body weight 81 to 100 kg: 1,250 mg every 8 hours

Actual body weight 60 to 80 kg: 1,000 mg every 8 hours

Actual body weight <60 kg: 750 mg every 8 hours

eGFR 50 to 90 mL/minute/1.73 m2:

Actual body weight >100 kg: 1,000 mg every 8 hours

Actual body weight 81 to 100 kg: 1,250 mg every 12 hours

Actual body weight 60 to 80 kg: 1,000 mg every 12 hours

Actual body weight <60 kg: 750 mg every 12 hours

eGFR 15 to 49 mL/minute/1.73 m2:

Actual body weight >100 kg: 1,500 mg every 24 hours

Actual body weight 81 to 100 kg: 1,250 mg every 24 hours

Actual body weight 60 to 80 kg: 1,000 mg every 24 hours

Actual body weight <60 kg: 750 mg every 24 hours

eGFR <15 mL/minute/1.73 m2:

Actual body weight >100 kg: 1,500 mg as a single dose

Actual body weight 81 to 100 kg: 1,250 mg as a single dose

Actual body weight 60 to 80 kg: 1,000 mg as a single dose

Actual body weight <60 kg: 750 mg as a single dose

Note: Obtain a random vancomycin level 24 hours after the dose: if random level is ≤20 mcg/mL, repeat dose; if random level is >20 mcg/mL, do not re-dose and repeat random level in 12 hours.

Dialysis: Poorly dialyzable by intermittent hemodialysis; however, use of high-flux membranes and continuous renal replacement therapy (CRRT) increases vancomycin clearance, and generally requires replacement dosing (Launay-Vacher 2002).

End stage renal disease (ESRD) on intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Following loading dose of 15 to 25 mg/kg, give either 500 to 1,000 mg or 5 to 10 mg/kg after each dialysis session (Heintz 2009). Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions.

Redosing based on pre-HD concentrations:

<10 mg/L: Administer 1,000 mg after HD

10 to 25 mg/L: Administer 500 to 750 mg after HD

>25 mg/L: Hold vancomycin

Redosing based on post-HD concentrations: <10 to 15 mg/L: Administer 500 to 1,000 mg

Peritoneal dialysis (PD): 1 g every 4 to 7 days (Aronoff 2007)

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH: Loading dose of 15 to 25 mg/kg, followed by either 1,000 mg every 48 hours or 10 to 15 mg/kg every 24 to 48 hours

CVVHD: Loading dose of 15 to 25 mg/kg, followed by either 1,000 mg every 24 hours or 10 to 15 mg/kg every 24 hours

CVVHDF: Loading dose of 15 to 25 mg/kg, followed by either 1,000 mg every 24 hours or 7.5 to 10 mg/kg every 12 hours

Note: Consider redosing patients receiving CRRT for vancomycin concentrations <10 to 15 mg/L.

Dosing: Hepatic Impairment

Oral: There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

IV: There are no dosage adjustments provided in the manufacturer’s labeling. However, degrees of hepatic dysfunction do not affect the pharmacokinetics of vancomycin (Marti, 1996).

Reconstitution

IV: Reconstitute 500 mg, 750 mg, and 1 g vials and 5 g bulk vials with SWFI to a final concentration of 50 mg/ml (10 g bulk vials may be reconstituted to a final concentration of 100 mg/mL). Reconstituted solution must be further diluted with at least 100 mL of a compatible diluent per 500 mg of vancomycin prior to parenteral administration.

Intrathecal, intraventricular (off-label route): Vancomycin powder for injection may be diluted to a 2.5, 5, or 10 mg/mL concentration in preservative free 0.9% sodium chloride for administration into the CSF (Ng 2014).

Extemporaneously Prepared

Note: A vancomycin (25 mg/mL or 50 mg/mL) suspension is commercially available as a compounding kit (First-Vancomycin).

Using a vial of vancomycin powder for injection (reconstituted to 50 mg/mL), add the appropriate volume for the dose to 30 mL of water and administer orally or via NG tube. For oral administration, common flavoring syrups may be added to improve taste.

Vancomycin Hydrochloride for Injection, USP (prescribing information), Schaumburg, Il, APP Pharmaceuticals, LLC, 2011.

A vancomycin 25 mg/mL solution in Ora-Sweet® and water (1:1) may be prepared by reconstituting vancomycin for injection with sterile water, then dilute with a 1:1 mixture of Ora-Sweet® and distilled water to a final concentration of 25 mg/mL; transfer to amber prescription bottle. Stable for 75 days refrigerated or for 26 days at room temperature.

Ensom MH, Decarie D, and Lakhani A, “Stability of Vancomycin 25 mg/mL in Ora-Sweet and Water in Unit-Dose Cups and Plastic Bottles at 4°C and 25°C,” Can J Hosp Pharm 2010, 63(5):366-72.22479004

Administration

Intravenous: Administer vancomycin with a final concentration not to exceed 5 mg/mL by IV intermittent infusion over at least 60 minutes (recommended infusion period of ≥30 minutes for every 500 mg administered [ASHP/IDSA/SIDP (Rybak 2009)]); in adult patients in need of fluid restriction, a concentration up to 10 mg/mL may be used, but risk of infusion-related reactions is increased. Not for IM administration.

If a maculopapular rash appears on the face, neck, trunk, and/or upper extremities (red man syndrome), slow the infusion rate to over 11/2 to 2 hours and increase the dilution volume (Healy 1990; Rybak 1986; Szymusiak-Mutnick 1996). Hypotension, shock, and cardiac arrest (rare) have also been reported with too rapid of infusion. Administration of antihistamines prior to infusion may prevent or minimize this reaction (Rybak 1986; Wilhem 1999).

Irritant; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Apply dry cold compresses (Hurst 2004).

Antibiotic lock technique (off-label use): Instill prepared vancomycin lock solution into each lumen of the catheter access port using a volume sufficient to fill the catheter (2 to 5 mL) with a dwell time of 48 to 72 hours (dependent on frequency of catheter use). Withdraw lock solution prior to catheter use; replace with fresh vancomycin lock solution after catheter use (IDSA [Mermel 2009]; LaPlante 2007).

Intraventricular (off-label route): Use preservative-free preparations only. May be administered intraventricularly with a final concentration of 2.5 to 10 mg/mL for the treatment of CSF shunt infections. When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow vancomycin solution to equilibrate in the CSF (IDSA [Tunkel 2004; Tunkel 2017]; Ng 2014).

Intravitreal (off-label route): May administer vancomycin intravitreally with a final concentration of 1 mg/0.1 mL NS or sterile water (Durand 2017; Kelsey 1995).

Oral: Vancomycin powder for injection may be reconstituted and used for oral administration (SHEA/IDSA [Cohen 2010]). Reconstituted powder for injection (not premixed solution) may be administered orally by diluting the reconstituted solution in 30 mL of water; common flavoring syrups may be added to improve taste. The unflavored, diluted solution may also be administered via nasogastric tube. Also see Extemporaneously Prepared section.

Rectal (off-label route): May be administered as a retention enema per rectum (SHEA/IDSA [Cohen 2010]); 500 mg in 100 to 500 mL of NS, volume may depend on length of segment being treated. If sodium chloride causes hyperchloremia could use solution with lower chloride concentration (eg, LR) (ACG [Surawicz 2013]).

Dietary Considerations

May be taken with food.

Storage

Capsules: Store at 15°C to 30°C (59°F to 86°F).

Galaxy containers: Store Galaxy containers at or below -20°C (-4°F). Handle frozen product containers with care; may be fragile in the frozen state. Thaw frozen containers at 25°C (77°F) or 5°C (41°F). Do not immerse in water bath or microwave. Thawed solution in remains chemically stable for 72 hours at 25°C (77°F) or for 30 days when stored at 5°C (41°F). Do not refreeze thawed antibiotics.

Vials: Store at 20°C to 25°C (68°F to 77°F). After initial reconstitution with SWFI, solutions are stable for 96 hours if refrigerated. After further dilution with D5W or NS to a concentration of 5 mg/mL, the solution may be stored in a refrigerator for 63 days without significant loss of potency (Das Gupta 1986).

Pharmacy bulk packages: Store at 20°C to 25°C (68°F to 77°F). Discard pharmacy bulk packages no later than 4 hours after initial closure puncture.

Drug Interactions

Aminoglycosides: Vancomycin may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bile Acid Sequestrants: May diminish the therapeutic effect of Vancomycin. Management: Avoid concurrent administration of oral vancomycin and bile acid sequestrants when possible. If use of both agents is necessary, consider separating doses by at least 2 hours to minimize the significance of the interaction. Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Colistimethate: Vancomycin may enhance the nephrotoxic effect of Colistimethate. Consider therapy modification

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Neuromuscular-Blocking Agents: Vancomycin may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May increase the serum concentration of Vancomycin. Monitor therapy

Piperacillin: May enhance the nephrotoxic effect of Vancomycin. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Adverse Reactions

Injection:

>10%: Cardiovascular: Hypotension (accompanied by flushing)

1% to 10%:

Cardiovascular: Local phlebitis

Central nervous system: Chills, drug fever

Dermatologic: Skin rash

Hematologic & oncologic: Eosinophilia, neutropenia (reversible)

Frequency not defined: Hypersensitivity: Flushing of face and neck (Red man syndrome; may be infusion related)

<1%, postmarketing, and/or case reports: DRESS syndrome (drug rash with eosinophilia and systemic symptoms), ototoxicity (rare; use of other ototoxic agents may increase risk), renal failure (limited data suggesting direct relationship), Stevens-Johnson syndrome, thrombocytopenia, vasculitis

Oral:

>10%: Gastrointestinal: Abdominal pain, dysgeusia (with oral solution), nausea

1% to 10%:

Cardiovascular: Peripheral edema

Central nervous system: Fatigue, headache

Gastrointestinal: Diarrhea, flatulence, vomiting

Genitourinary: Urinary tract infection

Neuromuscular & skeletal: Back pain

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Increased serum creatinine, interstitial nephritis, ototoxicity, renal failure, renal insufficiency, thrombocytopenia, vasculitis

Warnings/Precautions

Concerns related to adverse effects:

• Extravasation and thrombophlebitis: IV vancomycin is an irritant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. Pain, tenderness, and necrosis may occur with extravasation. If thrombophlebitis occurs, slow infusion rates, dilute solution (eg, 2.5 to 5 g/L) and rotate infusion sites.

• Nephrotoxicity: May cause nephrotoxicity although limited data suggest direct causal relationship; usual risk factors include preexisting renal impairment, concomitant nephrotoxic medications, advanced age, and dehydration. If multiple sequential (≥2) serum creatinine concentrations demonstrate an increase of 0.5 mg/dL or ≥50% increase from baseline (whichever is greater) in the absence of an alternative explanation, the patient should be identified as having vancomycin-induced nephrotoxicity (ASHP/IDSA/SIDP [Rybak 2009]). Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible. Nephrotoxicity has been reported following treatment with oral vancomycin (typically in patients >65 years of age).

• Neutropenia: Prolonged therapy and use of concomitant drugs that cause neutropenia may increase the risk; monitor leukocyte counts periodically in these patients. Prompt reversal of neutropenia is expected after discontinuation of therapy.

• Ototoxicity: Ototoxicity is rarely associated with monotherapy. It has been most frequently reported in patients receiving excessive doses, those who have underlying hearing loss, or those receiving concomitant ototoxic drugs (eg, aminoglycosides). Serial auditory function testing may be helpful to minimize risk. Ototoxicity may be transient or permanent; discontinue treatment if signs of ototoxicity occur.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile infection (CDI); CDI has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Inflammatory bowel disease: Clinically significant serum concentrations have been reported in patients with inflammatory disorders of the intestinal mucosa who have taken oral vancomycin (multiple doses) for the treatment of C. difficile-associated diarrhea. Although use may be warranted, the risk for adverse reactions may be higher in this situation; consider monitoring serum trough concentrations, especially with renal insufficiency, severe colitis, concurrent rectal vancomycin administration, and/or concomitant IV aminoglycosides. The Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) suggest that it is appropriate to obtain trough concentrations when a patient is receiving long courses of ≥2 g/day in adults (SHEA/IDSA [Cohen 2010]).

• Renal impairment: Use with caution in patients with renal impairment or those receiving other nephrotoxic or ototoxic drugs; dosage modification required (especially in elderly patients). Accumulation may occur after multiple oral doses of vancomycin in patients with renal impairment; consider monitoring trough concentrations in this circumstance.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Oral vancomycin is only indicated for the treatment of CDI and is not effective for systemic infections; parenteral vancomycin is not effective for the treatment of colitis due to C. difficile.

• Infusion reactions: Rapid IV administration (eg, over <60 minutes) may result in hypotension, flushing, erythema, urticaria, pruritus and, rarely, cardiac arrest. Reactions usually cease promptly after infusion is stopped. Frequency of infusion reactions may increase with concomitant administration of anesthetics. If used in conjunction with anesthesia, complete the vancomycin infusion prior to anesthesia induction.

• Intraocular administration (off-label route): Hemorrhagic occlusive retinal vasculitis (HORV), including permanent visual loss, has been reported in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. Safety and efficacy of intraocularly administered vancomycin has not been established; vancomycin is not indicated for prophylaxis of endophthalmitis.

• Intraperitoneal administration (off-label route): Use caution when administering intraperitoneally (IP); in some continuous ambulatory peritoneal dialysis (CAPD) patients, chemical peritonitis (cloudy dialysate, fever, severe abdominal pain) has occurred. Symptoms are self-limited and usually clear after vancomycin discontinuation.

Monitoring Parameters

Intravenous: Periodic renal function tests, CBC; serum trough vancomycin concentrations in select patients (eg, aggressive dosing, life-threatening infection, seriously ill, unstable renal function, concurrent nephrotoxins, prolonged courses)

Suggested frequency of trough vancomycin concentration monitoring for intermittent infusion (ASHP/IDSA/SIDP [Rybak 2009]):

Hemodynamically stable patients: Draw trough concentrations at least once-weekly.

Hemodynamically unstable patients: Draw trough concentrations more frequently or in some instances daily.

Prolonged courses (>3 to 5 days): Draw at least one steady-state trough concentration; repeat as clinically appropriate.

Note: Drawing >1 trough concentration prior to the fourth dose for short course (<3 days) or lower intensity dosing (target trough concentrations <15 mcg/mL) is not recommended. For patients with uncomplicated skin and soft tissue infections who are not obese and have normal renal function, serum trough monitoring is generally not needed (IDSA [Liu 2011]).

Oral/rectal therapy: Serum sample monitoring is not typically required; consider monitoring serum trough concentrations, especially with renal insufficiency, severe colitis, rectal vancomycin administration (SHEA/IDSA [Cohen 2010]), and/or concomitant IV aminoglycosides.

Pregnancy Risk Factor

B (oral)

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Vancomycin crosses the placenta and can be detected in fetal serum, amniotic fluid, and cord blood (Bourget 1991; Reyes 1989). Adverse fetal effects, including sensorineural hearing loss or nephrotoxicity, have not been reported following maternal use during the second or third trimesters of pregnancy.

The pharmacokinetics of vancomycin may be altered during pregnancy and pregnant patients may need a higher dose of vancomycin. Maternal half-life is unchanged, but the volume of distribution and the total plasma clearance may be increased (Bourget 1991). Individualization of therapy through serum concentration monitoring may be warranted. Vancomycin is recommended for the treatment of mild, moderate, or severe Clostridium difficile infections in pregnant women (ACG [Surawicz 2013]). Vancomycin is recommended as an alternative agent to prevent the transmission of group B streptococcal (GBS) disease from mothers to newborns (ACOG 2011; CDC 2010).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, vomiting, or nausea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), flushing, painful urination, hearing impairment, hearing loss, dizziness, passing out, chills, pharyngitis, swelling of arms or legs, severe injection site pain or irritation, burning, edema, or blisters, rash during infusion, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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