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Vancomycin Hydrochloride

Pronunciation

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

Introduction

Antibacterial; tricyclic glycopeptide antibiotic.266 267

Uses for Vancomycin Hydrochloride

Endocarditis

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

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

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

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

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

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

Meningitis

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

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

Osteomyelitis

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

Respiratory Tract Infections

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

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

Septicemia

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

Skin and Skin Structure Infections

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

Bacillus Infections

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

Capnocytophaga Infections

Treatment of infections caused by Capnocytophaga.149

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

Clostridium difficile-associated Diarrhea and Colitis

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

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

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

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

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

Rhodococcus Infections

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

Staphylococcal Enterocolitis

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

Prevention of Perinatal Group B Streptococcal (GBS) Infection

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

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

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

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

Perioperative Prophylaxis

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

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

Empiric Therapy in Febrile Neutropenic Patients

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

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

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

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

Vancomycin Hydrochloride Dosage and Administration

Administration

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

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

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

Oral Administration

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

Reconstitution

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

IV Infusion

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

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

Reconstitution and Dilution

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

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

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

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

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

Rate of Administration

Administer by IV infusion over ≥1 hour.266 267

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

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

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

Dosage

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

Pediatric Patients

General Dosage for Neonates
Systemic Infections
IV

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

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

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

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

General Pediatric Dosage
Systemic Infections
IV

10 mg/kg every 6 hours.266 267

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

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

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

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

Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis
IV

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

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

Treatment of Enterococcal Endocarditis
IV

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

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

Culture-negative Endocarditis
IV

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

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

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

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

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

Meningitis
IV

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

Clostridium difficile-associated Diarrhea and Colitis
Oral

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

Staphylococcal Enterocolitis
Oral

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

Adults

General Adult Dosage
Treatment of Life-threatening Systemic Infections
IV

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

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

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

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

Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis
IV

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

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

Treatment of Enterococcal Endocarditis
IV

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

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

Culture-negative Endocarditis
IV

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

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

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

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

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

Meningitis
IV

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

Osteomyelitis
IV

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

Respiratory Tract Infections
IV

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

Septicemia
IV

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

Skin and Skin Structure Infections
IV

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

Clostridium difficile-associated Diarrhea and Colitis
Oral

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

Staphylococcal Enterocolitis
Oral

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

Prevention of Perinatal Group B Streptococcal (GBS) Infection
IV

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

Perioperative Prophylaxis
Cardiac, Neurosurgical, Orthopedic, Thoracic (Noncardiac), or Vascular Surgery
IV

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

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

Prescribing Limits

Pediatric Patients

Maximum 2 g daily.122 235 197 236 237

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

Adults

Maximum 2 g daily.265

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

Special Populations

Hepatic Impairment

Limited data suggest dosage adjustments not necessary.264

Renal Impairment

Treatment of Systemic Infections
IV

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

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

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

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

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

Geriatric Patients

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

Cautions for Vancomycin Hydrochloride

Contraindications

  • Hypersensitivity to vancomycin.197 266 267

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

Warnings/Precautions

Warnings

Ototoxicity

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

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

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

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

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

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

If tinnitus occurs, discontinue vancomycin.c

Nephrotoxicity

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

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

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

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

Infusion Reactions

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

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

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

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

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

Sensitivity Reactions

Hypersensitivity Reactions

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

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

General Precautions

Hematologic Effects

Neutropenia, eosinophilia, and thrombocytopenia have been reported rarely.155 266 267 c Neutropenia may occur ≥7 days after initiation of therapy or after a total dose of >25 g and may be rapidly reversible following discontinuance of the drug.266

Monitor leukocyte counts periodically in patients receiving prolonged therapy and in those receiving concomitant therapy with drugs that may cause neutropenia.155 266 267

Local Reactions

Vancomycin is very irritating to tissues and can cause pain, tenderness, and necrosis if inadvertent extravasation occurs during IV administration.266 267 Thrombophlebitis may occur.266 267 Do not administer by IM injection.266 267

Increased Systemic Absorption

Although not usually appreciably absorbed from GI tract,101 117 266 267 clinically important serum vancomycin concentrations may occur following multiple enteral or oral doses in patients with active C. difficile-associated diarrhea and colitis, particularly those with renal impairment.101 117 266 267 (See Renal Impairment under Cautions.)

Clinically important systemic absorption of vancomycin may occur in some patients receiving oral vancomycin who have inflammatory disorders of intestinal mucosa; this may increase risk of adverse reactions, particularly in those with renal impairment.197 (See Renal Impairment under Cautions.)

Consider monitoring serum vancomycin concentrations in patients with renal impairment and/or colitis.197

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of vancomycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.155 197

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.155 197 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.155 197

Vancomycin-resistant Enterococci and Staphylococci

Vancomycin-resistant enterococci have been reported with increasing frequency and there are concerns regarding the increased possibility of vancomycin-resistant strains of other gram-positive bacteria (e.g., S. aureus).115 200 217 256 Because vancomycin use is a consistent risk factor for colonization and infection with vancomycin-resistant enterococci, prudent use of the drug is recommended.115 200

CDC recommends that vancomycin be reserved for use in the treatment of serious infections caused by gram-positive bacteria resistant to β-lactam anti-infectives; treatment of gram-positive bacterial infections in patients with severe hypersensitivity to β-lactam anti-infectives; prophylaxis in certain patients at high risk for bacterial endocarditis as recommended by AHA; treatment of C. difficile-associated diarrhea and colitis that is severe or potentially life-threatening or that fails to respond to oral metronidazole; and for perioperative prophylaxis for major surgical procedures involving implantation of prosthetic materials or devices (e.g., cardiac and vascular procedures and total hip replacement) at institutions with a high rate of oxacillin-resistant (methicillin-resistant) S. aureus or S. epidermidis.200

CDC discourages use of vancomycin in all other situations, including treatment of C. difficile-associated colitis when metronidazole would be effective; routine empiric therapy for febrile neutropenic patients; selective decontamination of the GI tract; eradication of colonization with MRSA; routine prophylaxis in patients undergoing surgery; routine prophylaxis in patients undergoing CAPD or hemodialysis; systemic or local (e.g., antibiotic lock) prophylaxis for infection or colonization of indwelling central or peripheral intravascular catheters; routine prophylaxis in very low birthweight neonates; use for topical application or irrigation; use for treatment of infections caused by gram-positive organisms susceptible to β-lactam anti-infectives; and use in response to a single blood culture positive for coagulase-negative staphylococci if other blood cultures drawn in the same time frame are negative (i.e., contamination of the blood culture with skin flora is likely).200

Specific Populations

Pregnancy

Category B with oral administration.197 Category C with IV administration.266 267

Lactation

Distributed in milk following IV administration;266 267 not known whether distributed into milk following oral administration.197 Discontinue nursing or the drug.266 267

Pediatric Use

Safety and efficacy of oral vancomycin not established in pediatric patients.197

Use IV vancomycin with caution in premature neonates and young infants because of renal immaturity and potential for increased serum vancomycin concentrations; close monitoring of serum concentrations recommended.266 267

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.197

Select dosage with caution, usually starting at low end of dosing range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.197 (See Geriatric Patients under Dosage and Administration.)

Risk of increased systemic absorption of vancomycin.197 (See Increased Systemic Absorption under Cautions.)

Serial tests of auditory function and regular determination of serum or blood vancomycin concentrations recommended in patients with borderline renal function and those >60 years of age.c

Renal Impairment

Increased half-life and decreased clearance.104 105 106 155 264 Increased risk of toxicity.266 267 Use with caution and reduce dosage.155 266 267 (See Renal Impairment under Dosage and Administration.)

Careful monitoring of renal function and serum vancomycin concentrations recommended.155 256 (See Renal Impairment under Dosage and Administration.)

Some clinicians recommend monitoring Scr every 3 days in those with stable renal function and as frequently as once daily in those with unstable renal function or when other nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, loop diuretics) are used concomitantly.264 (See Ototoxic and Nephrotoxic Drugs under Interactions.)

Common Adverse Effects

Local effects (pain and thrombophlebitis); infusion reactions; hypersensitivity reactions.c

Interactions for Vancomycin Hydrochloride

Ototoxic and Nephrotoxic Drugs

Concurrent or sequential use with other ototoxic and/or nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, bacitracin, cisplatin, colistin, furosemide, polymyxin B) may result in additive toxicity and should be avoided, if possible.155 264 266 267 Monitor renal and auditory function intensely if used concomitantly with an ototoxic and/or nephrotoxic agent.155 266 267

Specific Drugs

Drug

Interaction

Comments

Aminoglycosides

In vitro evidence of synergistic antibacterial activity against S. aureus, nonenterococcal group D streptococci (S. bovis), enterococci, and viridans streptococci155 266 267

Increased risk of ototoxicity and/or nephrotoxicity155 266 267

Used to therapeutic advantage, but consider possible increased risk of ototoxicity and/or nephrotoxicity266 267

Anesthetics

Possible increased risk of anaphylactoid reactions and increased risk of vancomycin infusion reactions in patients receiving anesthetic agents;155 266 267 erythema and histamine-like flushing reported155 266 267

Risk of infusion-related adverse effects may be minimized if vancomycin is given by IV infusion (over ≥1 hour) prior to induction of anesthesia155 266 267

Vancomycin Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from GI tract in most patients; must be given parenterally for treatment of systemic infections.101 117 197 264 266 267

Oral bioavailability usually <5%;264 bioavailability increased in C. difficile-associated diarrhea and colitis and/or in severe renal impairment.101 117 264 266 267

Clinically important serum vancomycin concentrations may occur following multiple enteral or oral doses in some patients being treated for active C. difficile-associated diarrhea and colitis, particularly those with renal impairment.101 117 197 266 267 (See Increased Systemic Absorption under Cautions.)

Special Populations

Serum vancomycin concentrations are higher in patients with renal impairment than in those with normal renal function.197 c

Distribution

Extent

Widely distributed into body tissues and diffuses following IV administration, including pericardial, pleural, ascitic, and synovial fluids.155 266 267 c Small amounts are distributed into bile.102

Does not readily distribute into CSF in the absence of inflammation unless serum concentrations are exceedingly high.155 237 266 267 Low concentrations may be attained in CSF if meninges are inflamed, but negligible amounts detected in CSF in most patients with uninflamed meninges.155 237 The relationship between CSF concentrations and clinical efficacy of vancomycin in the treatment of meningitis is unclear.237

Crosses the placenta and is distributed into cord blood.155

Distributed into milk155 following IV administration;266 267 not known whether distributed into milk following oral administration.197

Plasma Protein Binding

30–60%.103 155 264 266 267

May be decreased to 19–29% in those with hypoalbuminemia (e.g., burn patients, those with end-stage renal disease).264

Elimination

Metabolism

Does not appear to be metabolized.155 264 266 267

Elimination Route

Following oral administration, excreted mainly in feces.197

Following IV administration, 75–90% of a dose eliminated unchanged in urine by glomerular filtration;155 264 266 267 c only small amounts are excreted in bile.c

Removed by hemodialysis;107 108 264 266 267 substantially removed by hemofiltration.127

Only minimally removed by peritoneal dialysis,109 110 123 266 267 including CAPD.124 125 126

Half-life

Adults with normal renal function: 4–7 hours.155 264 266 267 Accumulation tends to occur after 2–3 days of IV administration at 6- or 12-hour intervals.c

Geriatric adults: 12.1 hours.264

Neonates and infants: 6.7 hours in full-term neonates and 4.1 hour in infants ≥1 month but <1 year of age.264

Children 2.5–11 years of age: 5.6 hours.264

Special Populations

Geriatric patients: Renal clearance may be decreased.155 266 267

Renal impairment: Elimination half-life is increased.104 105 106 155 264 266 267 Half-life averages 32.3 hours (range: 10.1–75.1 hours) in patients with Clcr 10–60 mL/minute and 146.7 hours (range: 44.1–406.4 hours) in those with Clcr <10 mL/minute.106

Burn patients: Increased clearance; half-life averages 4 hours.264

Stability

Storage

Oral

Capsules

15–30°C.197

Parenteral

Powder for Infusion

15–30°C.266 267

Following reconstitution with sterile water for injection, solutions prepared in single-use vials are stable for 2 weeks at room temperature; the manufacturers state reconstituted solutions may be stored for 96 hours at 2–8°C without substantial loss of potency.c

After further dilution to a concentration of 5 mg/mL in 5–30% dextrose injection, solutions are stable when stored in plastic syringes for 24 hours at 4°C and then subsequently for 2 hours at room temperature.129

When reconstituted as directed using 5% dextrose injection or 0.9% sodium chloride injection, solutions prepared from ADD-Vantage vials are stable for 24 hours at room temperature or 14 days in a refrigerator.266

Injection (Frozen)

-20° C or lower.155 After thawing, may be stored for 72 hours at room temperature (25°C) or up to 30 days at 5°C.155

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in Ringer's injection, lactated

Dextrose 5% in sodium chloride 0.9%

Dextrose 5 or 10% in water

Normosol M in dextrose 5%

Ringer’s injection, lactated

Sodium chloride 0.9%

Sodium lactate (1/6) M

Drug Compatibility
Admixture CompatibilityHID

Compatible

Amikacin sulfate

Atracurium besylate

Calcium gluconate

Cefepime HCl

Dimenhydrinate

Famotidine

Hydrocortisone sodium succinate

Meropenem

Potassium chloride

Ranitidine HCl

Verapamil HCl

Incompatible

Chloramphenicol sodium succinate

Variable

Aminophylline

Aztreonam

Heparin sodium

Y-Site CompatibilityHID

Compatible

Acyclovir sodium

Aldesleukin

Allopurinol sodium

Alprostadil

Amifostine

Amiodarone HCl

Anidulafungin

Atracurium besylate

Caspofungin acetate

Cefepime HCl

Cisatracurium besylate

Cyclophosphamide

Dexmedetomidine HCl

Diltiazem HCl

Docetaxel

Doripenem

Doxapram HCl

Doxorubicin HCl liposome injection

Enalaprilat

Esmolol HCl

Etoposide phosphate

Fenoldopam mesylate

Filgrastim

Fluconazole

Fludarabine phosphate

Gallium nitrate

Gemcitabine HCl

Granisetron HCl

Hetastarch in lactated electrolyte injection (Hextend)

Hydromorphone HCl

Insulin, regular

Labetalol HCl

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Melphalan HCl

Meperidine HCl

Meropenem

Midazolam HCl

Milrinone lactate

Morphine sulfate

Mycophenolate mofetil HCl

Nicardipine HCl

Ondansetron HCl

Paclitaxel

Palonosetron HCl

Pancuronium bromide

Pemetrexed disodium

Remifentanil HCl

Sodium bicarbonate

Tacrolimus

Teniposide

Theophylline

Thiotepa

Tigecycline

Vecuronium bromide

Vinorelbine tartrate

Zidovudine

Incompatible

Albumin human

Amphotericin B cholesteryl sulfate complex

Bivalirudin

Idarubicin HCl

Omeprazole

Pantoprazole sodium

Variable

Ampicillin sodium

Ampicillin sodium–sulbactam sodium

Aztreonam

Cefazolin sodium

Cefotaxime sodium

Cefotetan disodium

Cefoxitin sodium

Ceftazidime

Ceftriaxone sodium

Cefuroxime sodium

Foscarnet sodium

Heparin sodium

Methotrexate sodium

Nafcillin sodium

Piperacillin sodium-tazobactam sodium

Propofol

Sargramostim

Ticarcillin disodium-clavulanate potassium

Warfarin sodium

Actions and Spectrum

  • A tricyclic glycopeptide antibiotic obtained from cultures of Amycolatopsis orientalis (formerly Nocardia orientalis).155 197

  • Usually bactericidal.266 267

  • Binds to the bacterial cell wall and blocks glycopeptide polymerization; inhibits cell wall synthesis and causes damage to the cytoplasmic membrane.266 267 c

  • Spectrum of activity includes many gram-positive aerobic and anaerobic bacteria.266 267 c Inactive against gram-negative bacteria, mycobacteria, and fungi.266 267 c

  • Gram-positive bacteria: Active against Staphylococci aureus and S. epidermidis (including oxacillin-resistant [methicillin-resistant] strains), S. pyogenes (group A β-hemolytic streptococci), S. pneumoniae (including penicillin-resistant strains), S. agalactiae (group B streptococci), viridans streptococci, nonenterococcal group D streptococci (S. bovis), enterococci (e.g., Enterococcus faecalis), Corynebacterium, and Clostridium (C. difficile).155 266 267 c Also active in vitro against Actinomyces, Bacillus, Lactobacillus, and Listeria monocytogenes.155 266 267

  • Resistance reported in enterococci (e.g., E. faecalis, E. faecium, E. gallinarum)169 170 171 172 173 174 175 176 177 200 217 219 222 223 224 225 and staphylococci (e.g., S. haemolyticus, S. epidermidis).114 115 168 200 220 221 226 227 228 229 230 231

Advice to Patients

  • Advise patients that antibacterials (including vancomycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).155 197

  • Importance of completing full course of therapy, even if feeling better after a few days.155 197

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with vancomycin or other antibacterials in the future.155 197

  • Importance of reporting possible manifestations of adverse effects to the clinician, including ototoxicity, nephrotoxicity, infusion site reactions, and hypersensitivity.266 267

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.266 267

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.266 267

  • Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Vancomycin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

125 mg (of vancomycin)

Vancocin HCl Pulvules

ViroPharma

250 mg (of vancomycin)

Vancocin HCl Pulvules

ViroPharma

Parenteral

For injection

5 g (of vancomycin) pharmacy bulk package

Vancomycin Hydrochloride for Injection

10 g (of vancomycin) pharmacy bulk package

Vancomycin Hydrochloride for Injection

For injection, for IV infusion

500 mg (of vancomycin)

Vancomycin Hydrochloride for Injection

Vancomycin Hydrochloride Sterile ADD-Vantage

Hospira

1 g (of vancomycin)

Vancomycin Hydrochloride for Injection

Vancomycin Hydrochloride for Injection ADD-Vantage

Hospira

Vancomycin Hydrochloride in Dextrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection (frozen), for IV infusion

5 mg (of vancomycin) per ml (500 mg) in 5% Dextrose

Vancocin HCl in Iso-osmotic Dextrose Injection (Galaxy [Baxter])

Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vancocin HCl 125MG Capsules (VIROPHARMA): 20/$686.99 or 60/$1,990.97

Vancocin HCl 250MG Capsules (VIROPHARMA): 20/$1,194.63 or 60/$3,457.17

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 4, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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