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Vancomycin

Pronunciation

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.

Capsule, Oral:

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

Generic: 125 mg, 250 mg

Solution, Intravenous:

Generic: 500 mg/100 mL (100 mL); 750 mg/150 mL (150 mL); 1 g/200 mL (200 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); 750 mg (1 ea); 1000 mg (1 ea); 5000 mg (1 ea); 10 g (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Generic: 500 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

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 (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 (Rybak 2009)

Inflamed meninges: 6 to 11 mcg/mL; serum concentration dependent (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-associated diarrhea/staphylococcal enterocolitis (oral): Treatment of C. difficile-associated diarrhea (CDAD), pseudomembranous colitis, and staphylococcal enterocolitis

Endocarditis (injection):

Diphtheroid: Treatment of diphtheroid endocarditis in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis or 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

Use: Unlabeled

Bacterial endophthalmitis; treatment of infections caused by gram-positive organisms in patients who have serious allergies to beta-lactam agents; treatment of beta-lactam resistant gram-positive infections; surgical (perioperative) prophylaxis; treatment of prosthetic joint infection; group B streptococcus maternal use for neonatal prophylaxis; rectal administration for treatment of Clostridium difficile infection

Contraindications

Hypersensitivity to vancomycin or any component of the formulation

Dosing: Adult

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

IV:

Manufacturer’s labeling: Usual dose: 500 mg every 6 hours or 1,000 mg every 12 hours

Alternate recommendations:

15 to 20 mg/kg/dose every 8 to 12 hours (ASHP/IDSA/SIDP [Rybak 2009])

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]).

Oral: 500 to 2,000 mg daily in divided doses every 6 hours. Note: Not appropriate for systemic infections due to low absorption.

Indication-specific dosing:

Bacteremia (S. aureus [methicillin-resistant]) (off-label dose): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for 2 to 6 weeks depending on severity. A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Brain abscess, subdural empyema, spinal epidural abscess (S. aureus [methicillin-resistant]) (off-label dose): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for 4 to 6 weeks (with or without rifampin). A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Catheter-related infections: Antibiotic lock technique (off-label use) (Mermel 2009): 2 mg/mL ± 10 units heparin/mL or 2.5 mg/mL ± 2,500 or 5,000 units heparin/mL or 5 mg/mL ± 5,000 units heparin/mL (preferred regimen); instill into catheter port with a volume sufficient to fill the catheter (2 to 5 mL). Note: May use SWFI/NS or D5W as diluents. Do not mix with any other solutions. Dwell times generally should not exceed 48 hours before renewal of lock solution. Remove lock solution prior to catheter use, then replace.

C. difficile-associated diarrhea (CDAD): Oral:

Manufacturer’s labeling: 125 mg 4 times daily for 10 days

Alternate dosing:

HIV-infected patients: 125 mg 4 times daily for 10 to 14 days (HHS [OI adult 2015])

Mild to moderate disease unresponsive to metronidazole: 125 mg 4 times daily for 10 days (ACG [Surawicz 2013])

Severe disease (defined as serum albumin <3 g/dL and either WBC ≥15,000 or abdominal tenderness): 125 mg 4 times daily for 10 days (ACG [Surawicz 2013])

Severe, complicated infection without abdominal distention: 125 mg 4 times daily with IV metronidazole (ACG [Surawicz 2013])

Severe, complicated infection: 500 mg 4 times daily for 10 to 14 days with or without concurrent IV metronidazole. May consider vancomycin retention enema (in patients with complete ileus) (SHEA/IDSA [Cohen 2010])

Severe, complicated infection with significant abdominal distention, ileus, and/or toxic colon: 500 mg 4 times daily plus rectal vancomycin in combination with IV metronidazole (ACG [Surawicz 2013])

Recurrent, severe infection (if initial regimen did not include vancomycin): 125 mg 4 times daily for 10 days (ACG [Surawicz 2013])

Rectal (off-label route): Retention enema:

Severe, complicated infection in patients with ileus: 500 mg every 6 hours (in 100 mL 0.9% sodium chloride) with oral vancomycin with or without concurrent IV metronidazole (SHEA/IDSA [Cohen 2010])

Severe and complicated disease with abdominal distention, ileus, and/or toxic colon: 500 mg 4 times daily (in 500 mL NS) in combination with oral vancomycin and IV metronidazole (ACG [Surawicz 2013])

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 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])

S. aureus (methicillin-resistant): IV:

Native valve: 15 mg/kg/dose 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 (based on actual body weight) every 8 to 12 hours for 6 weeks (IDSA [Lui 2011]) .

Prosthetic valve: 15 mg/kg/dose 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 (based on actual body weight) every 8 to 12 hours (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 (VGS) and S. bovis (native or prosthetic valve; patients intolerant to penicillin or ceftriaxone): IV: 15 mg/kg/dose 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 (off-label use): Intravitreal (off-label): Usual dose: 1 mg/0.1 mL NS instilled into vitreum; may repeat administration, if necessary, in 2 to 3 days, usually in combination with ceftazidime or an aminoglycoside (Kelsey 1995). Note: Based on concerns for retinotoxicity, some clinicians have recommended using a lower dose of 0.2 mg/0.1mL; may repeat in 3 to 4 days, if necessary (Gan 2001).

Enterocolitis (S. aureus): Oral: 500 to 2,000 mg/day in 3 to 4 divided doses for 7 to 10 days (usual dose: 125 to 500 mg every 6 hours)

Group B streptococcus (neonatal prophylaxis) (off-label use): IV: 1,000 mg every 12 hours until delivery. Note: Reserved for penicillin allergic patients at high risk for anaphylaxis if organism is resistant to clindamycin or where no susceptibility data are available (CDC 2010).

Intra-abdominal infection (off-label use): IV: 15 to 20 mg/kg/dose every 8 to 12 hours (Solomkin 2010)

Meningitis, bacterial (off-label use): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours (for empiric therapy, use in combination with a third-generation cephalosporin; for patients >50 years, include ampicillin); duration of therapy should be individualized based upon clinical response (in general, 10 to 21 days). A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentration in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Tunkel 2004]). Note: For PCN-resistant Streptococcus pneumoniae (MIC ≥2 mcg/mL), combine with a third-generation cephalosporin (IDSA [Tunkel 2004]). For methicillin-resistant S. aureus, treat for 2 weeks (with or without rifampin) (IDSA [Liu 2011]).

Osteomyelitis (S. aureus [methicillin-resistant]) (off-label dose): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for a minimum of 8 weeks (with or without rifampin). A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Osteomyelitis, native vertebral: IV:

Staphylococci (oxacillin-resistant) (off-label dose): 15 to 20 mg/kg/dose (based on actual body weight) every 12 hours for 6 weeks. A loading dose may be considered (IDSA [Berbari 2015]).

Enterococcus spp (penicillin-susceptible or -resistant), beta-hemolytic streptococci, Propionibacterium acnes, or staphylococci (oxacillin-susceptible) (off-label use): 15 to 20 mg/kg/dose (based on actual body weight) every 12 hours for 6 weeks. A loading dose may be considered. Note: In patients with infective endocarditis due to Enterococcus spp, adjunctive aminoglycoside therapy for 4 to 6 weeks is recommended (IDSA [Berbari 2015])

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

Community-acquired pneumonia (CAP): 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for 7 to 21 days depending on severity. A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Hospital-acquired pneumonia or ventilator-associated pneumonia: 15 mg/kg/dose every 8 to 12 hours for 7 days; may consider shorter or longer duration depending on rate of clinical improvement. A loading dose of 25 to 30 mg/kg/ dose may be used in seriously ill patients. When used as empiric therapy, use in combination with an antipseudomonal agent (one or two antipseudomonal agents depending on patient and institution specific risk factors) (Kalil 2016).

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

Enterococcus spp (penicillin-susceptible or –resistant), Propionibacterium acnes, streptococci (beta-hemolytic): 15 mg/kg every 12 hours for 4 to 6 weeks, followed by an oral antibiotic suppressive regimen (IDSA [Osman 2013]).

Note: For penicillin-susceptible or -resistant Enterococcus spp, consider addition of an aminoglycoside; in penicillin-susceptible Enterococcus, beta-hemolytic streptococcus or Propionibacterium acnes infections, only use vancomycin if patient has penicillin allergy (IDSA [Osman 2013]).

Staphylococci (oxacillin-susceptible or –resistant): 15 mg/kg every 12 hours for 2 to 6 weeks in combination with rifampin followed by oral antibiotic treatment and suppressive regimens (IDSA [Osman 2013]).

Sepsis/Septic shock (empiric treatment or treatment for specific sensitive organism): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours. A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]). The Society of Critical Care Medicine recommends administration of empiric antibiotics within 1 hour of identifying severe sepsis (SCCM [Dellinger 2013]).

Septic arthritis (S. aureus [methicillin-resistant]) (off-label dose): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for 3 to 4 weeks. A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Septic thrombosis of cavernous or dural venous sinus (S. aureus [methicillin-resistant]) (off-label dose): IV: 15 to 20 mg/kg/dose (based on actual body weight) every 8 to 12 hours for 4 to 6 weeks (with or without rifampin). A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Skin and skin structure infections (S. aureus [methicillin-resistant]) (off-label dose): IV: 15 to 20 mg/kg/dose every 8 to 12 hours for 7 to 14 days (IDSA [Liu 2011; Stevens 2014]). A loading dose of 25 to 30 mg/kg (based on actual body weight) may be used to rapidly achieve target concentrations in seriously ill patients (ASHP/IDSA/SIDP [Rybak 2009]; IDSA [Liu 2011]).

Skin and soft tissue necrotizing infections due to S. aureus (resistant strains) or polymicrobial (mixed) (off-label use): IV: 15 mg/kg/dose every 12 hours. Note: Give in combination with piperacillin/tazobactam for empiric therapy of polymicrobial [mixed] infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Surgical (perioperative) prophylaxis (off-label use): IV: 15 mg/kg 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]).

The Society of Thoracic Surgeons recommends 1,000 to 1,500 mg or 15 mg/kg over 60 minutes with completion within 1 hour of skin incision. Although not well established, a second dose of 7.5 mg/kg may be considered during cardiopulmonary bypass (STS [Engelman 2007]).

Surgical site infections (trunk or extremity [away from axilla or perineum]) (off-label use): IV: 15 mg/kg/dose every 12 hours (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 >1 month, Children, and Adolescents: IV:

Manufacturer’s labeling: 10 mg/kg/dose every 6 hours

Alternate recommendations: 15 mg/kg/dose (maximum: 2,000 mg/dose) every 6 hours (IDSA [Liu 2011])

Indication-specific dosing:

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

Brain abscess, subdural empyema, spinal epidural abscess (S. aureus [methicillin-resistant]) (off-label use): 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-associated diarrhea (CDAD): Infants >1 month, Children, and Adolescents: Oral:

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

Alternate dosing: Adolescents: HIV-infected patients: 125 mg 4 times daily for 10 to 14 days (HHS [OI adult 2015])

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]).

Enterocolitis (S. aureus): Infants >1 months, Children, and Adolescents: Oral: 40 mg/kg/day in 3 to 4 divided doses for 7 to 10 days (maximum: 2,000 mg/day)

Meningitis: 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 (S. aureus [methicillin-resistant]) (off-label use): Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for 4 to 6 weeks (IDSA [Liu 2011]).

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

Healthcare-associated pneumonia (HAP), S. aureus (methicillin-resistant): IV: Infants, Children, and Adolescents: 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 (S. aureus [methicillin-resistant]) (off-label use): Children and Adolescents: IV: 15 mg/kg/dose every 6 hours for minimum of 3 to 4 weeks (IDSA [Liu 2011])

Septic thrombosis of cavernous or dural venous sinus (S. aureus [methicillin-resistant]) (off-label use): Infants, Children, and Adolescents: IV: 15 mg/kg/dose every 6 hours for 4 to 6 weeks (with or without rifampin) (IDSA [Liu 2011])

Skin and skin structure infections, complicated (S. aureus [methicillin-resistant or methicillin sensitive in penicillin allergic patients]) (off-label use): 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. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 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])

Surgical (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]).

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:

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)

CrCl >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

CrCl 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

CrCl 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

CrCl <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.

Critically ill patient with renal insufficiency: 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).

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) (ISPD [Li 2010]): IP:

Continuous Ambulatory Peritoneal Dialysis (CAPD): Note: In patients with residual renal function (>100 mL/day urine output), increase recommended dose by 25%.

Intermittent (per exchange, once daily): 15 to 30 mg/kg every 5 to 7 days (allow to dwell for ≥6 hours).

Continuous (all exchanges): Loading dose: 1,000 mg/L; maintenance dose: 25 mg/L.

Automated peritoneal dialysis: Loading dose: 30 mg/kg in the long dwell; repeat dosing 15 mg/kg in long dwell every 3 to 5 days (monitor serum trough levels; redose when ≤15 mcg/mL).

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

Injection: 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 [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).

Intrathecal, intraventricular (off-label route): May be administered intrathecally/intraventricularly with a final concentration of 2.5 to 10 mg/mL for the treatment of bacterial meningitis (IDSA [Tunkel 2004]; Ng 2014).

Intravitreal: (off-label route): May administer vancomycin intravitreally with a final concentration of 1.0 mg/0.1 mL NS (Kelsey 1995). Note: Due to retinotoxicity, some clinicians recommend using a lower dose of 0.2 mg/0.1 mL NS (Gan 2001).

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.

Compatibility

See Trissel’s IV Compatibility Database

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)

Hypersensitivity: Red neck syndrome (infusion rate-related)

1% to 10%:

Cardiovascular: Local phlebitis

Central nervous system: Chills, drug fever

Dermatologic: Skin rash

Hematologic & oncologic: Eosinophilia, neutropenia (reversible)

<1% (Limited to important or life-threatening): 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% (Limited to important or life-threatening): 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 (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-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD 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 the elderly). 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 Clostridium difficile-associated diarrhea (CDAD) and enterocolitis due to S. aureus and is not effective for systemic infections; parenteral vancomycin is not effective for the treatment of colitis due to C. difficile and enterocolitis due to S. aureus. Note: The SHEA, the IDSA, and the American College of Gastroenterology (ACG) recommend the use of oral metronidazole for initial treatment of mild to moderate C. difficile infection and the use of oral vancomycin for initial treatment of severe C. difficile infection (SHEA/IDSA [Cohen 2010]; ACG [Surawicz 2013]).

• 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.

• 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, unstable renal function, concurrent nephrotoxins, prolonged courses)

Suggested frequency of trough vancomycin concentration monitoring for intermittent infusion (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.

Oral/rectal therapy: Serum sample monitoring is not typically required; consider monitoring serum trough concentrations, especially with renal insufficiency, severe colitis, concurrent rectal vancomycin administration, and/or concomitant IV aminoglycosides.

Intraventricular (off-label route): Prior to administration of the next intraventricular dose, withdraw a sample of CSF. This trough CSF concentration divided by the vancomycin MIC for the isolated bacterial pathogen (inhibitory quotient) should exceed 10 to 20. (Tunkel 2004)

Pregnancy Risk Factor

B (oral); C (injection)

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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