Pronunciation: VAN-koe-MYE-sin HYE-droe-KLOR-ide
Class: Anti-infective agent

Trade Names

Vancocin
- Capsules, oral 125 mg
- Capsules, oral 250 mg

Vancomycin
- Injection, lyophilized powder for solution 500 mg
- Injection, lyophilized powder for solution 750 mg
- Injection, lyophilized powder for solution 1 g
- Injection, lyophilized powder for solution 5 g
- Injection, lyophilized powder for solution 10 g
- Injection, frozen, premixed solution 500 mg per 100 mL
- Injection, frozen, premixed solution 750 mg per 150 mL
- Injection, frozen, premixed solution 1 g per 200 mL

Pharmacology

Inhibits bacterial cell wall synthesis and alters cell-membrane permeability and RNA synthesis.

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Pharmacokinetics

Absorption

Poorly absorbed (orally). C _max is 63 mcg/mL and T _max is 1 h (injection).

Distribution

55% protein bound. Vd is 0.3 to 0.43 L/kg. Distributes in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue.

Metabolism

No apparent metabolism of the drug.

Elimination

Mean half-life is 4 to 6 h. About 75% is excreted in the urine by glomerular filtration (in the first 24 h). Mean plasma Cl is 0.058 L/kg/h. Renal Cl is 0.048 L/kg/h.

Special Populations

Renal Function Impairment

Renal impairment slows excretion of vancomycin; in anephric patients, half-life is 7.5 days. Dosage adjustment is required.

Elderly

Total systemic and renal Cl may be reduced.

Indications and Usage

Oral

Treatment of Clostridium difficile –associated diarrhea; treatment of staphylococcal enterocolitis.

Parenteral

Treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam–resistant) staphylococci; treatment of staphylococcal, streptococcal, enterococcal, or diphtheroid endocarditis.

Unlabeled Uses

Aerosolization; central venous catheter infection; preoperative prophylaxis; rectal administration; ventricular shunt infections.

Contraindications

Hypersensitivity to vancomycin; hypersensitivity to corn or corn products ( Galaxy containers only).

Dosage and Administration

Endocarditis (staphylococcal, streptococcal, enterococcal, diphtheroid), staphylococcal infections
Adults

IV 500 mg every 6 h or 1 g every 12 h at a rate no faster than 10 mg/min or over at least 60 min, whichever is longer.

Children

IV 10 mg/kg per dose given every 6 h over at least 60 min.

Neonates (1 mo or younger)

IV An initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 h for neonates in the first week of life and every 8 h thereafter up to 1 mo of age.

C. difficile –associated diarrhea
Adults

PO 125 mg 4 times daily for 10 days.

Children

PO 40 mg/kg/day in 3 or 4 divided doses for 7 to 10 days; max dosage is 2 g/day.

Staphylococcal enterocolitis
Adults

PO 500 mg to 2 g in 3 or 4 divided doses for 7 to 10 days.

Children

PO 40 mg/kg/day in 3 or 4 divided doses for 7 to 10 days; max dosage is 2 g/day.

Off-Label Dosing
Aerosolization Adults

120 mg (1 mL) every 6 h via face mask.

Children

250 mg per 4 mL per 10 min every 12 h, 40 mg 3 times a day for 72 h, 4 mg/kg per dose 4 times a day for 5 days.

Alternative dosing Adults

IV Daily doses of 15 to 20 mg/kg (as actual body weight) every 8 to 12 h when the minimum inhibitory concentration is 1 mg/L or less; in complicated infections, loading dose of 25 to 30 mg/kg (based on actual body weight) to rapidly achieve target trough serum concentrations.

Central venous catheter infection Children

Add 25 mg/mL to the parenteral nutrition solution and administer as a continuous infusion or as a flush/lock.

Hospital-acquired pneumonia Adults

IV 15 mg/kg every 12 h.

Preoperative antimicrobial prophylaxis

For cardiac surgery (prosthetic valve or pacemaker), neurosurgery (craniotomy), and orthopedic surgery (internal fixation of fractures or prosthetic joints), the preoperative dose in children is 10 mg/kg IV if the likely pathogens include methicillin-resistant Staphylococcus aureus or methicillin-resistant Staphylococcus epidermidis .

For GU and GI tract (excluding esophageal) procedures, the preoperative dose in adults is 1 g IV given over 1 to 2 h plus gentamicin 1.5 mg/kg (up to 120 mg) IV or IM. In children, the preoperative dose is 20 mg/kg IV given over 1 to 2 h plus gentamicin 1.5 mg/kg IV or IM. Complete the infusion/injection within 30 min of starting the procedure. This regimen is indicated for high-risk patients who are allergic to ampicillin or amoxicillin. For moderate-risk patients who are allergic to ampicillin or amoxicillin, the regimen excludes gentamicin.

Rectal administration Adults

Initial doses of 1 to 2 g and maintenance dosing of 100 to 500 mg every 6 h. Administration is recommended as an enema or with a Bardex catheter (as with a barium enema).

Ventricular shunt infection Children

IV Systemic vancomycin is generally given at a dosage of 15 mg/kg every 6 h. Also administer 10 mg/day (50 mg/mL diluted with normal saline to a final concentration of 5 mg/mL) directly into the ventricle (if the shunt is not externalized) or into the externalized shunt, which is then clamped for 1 h after administration.

Other infections in children Severe infections, including CNS infections (meningitis) Adolescents

IV 20 mg/kg every 6 to 8 h.

Infants and children

IV 15 to 20 mg/kg every 6 h.

Mild to moderate infections Adolescents

IV 15 mg/kg every 6 to 8 h.

Infants and children

IV 10 to 15 mg/kg every 6 h.

Neonates

IV 10 mg/kg/dose (bacteremia) to 15 mg/kg/dose (meningitis, pneumonia). Base interval on postmenstrual and postnatal age. For postmenstrual age 45 wk or more and any postnatal age, administer every 6 h. For postmenstrual age 37 to 44 wk, administer every 12 h (postnatal age 0 to 14 days) or 8 h (postnatal age older than 14 days). For postmenstrual age 30 to 36 wk, administer every 12 h (postnatal age 0 to 7 days) or 8 h (postnatal age older than 7 days). For postmenstrual age 29 wk or younger, administer every 18 h (postnatal age 0 to 14 days) or 12 h (postnatal age older than 14 days).

Elderly

Adjust dosage in elderly patients.

Renal function impairment Adults

Adjust dosage based on CrCl and vancomycin levels.

• CrCl 100 mL/min, give 1,545 mg per 24 h.
• CrCl 90 mL/min, give 1,390 mg per 24 h.
• CrCl 80 mL/min, give 1,235 mg per 24 h.
• CrCl 70 mL/min, give 1,080 mg per 24 h.
• CrCl 60 mL/min, give 925 mg per 24 h.
• CrCl 50 mL/min, give 770 mg per 24 h.
• CrCl 40 mL/min, give 620 mg per 24 h.
• CrCl 30 mL/min, give 465 mg per 24 h.
• CrCl 20 mL/min, give 310 mg per 24 h.
• CrCl 10 mL/min, give 155 mg per 24 h.

Hemodialysis/Peritoneal dialysis Adults

IV 1 g every 4 to 7 days.

Anephric patients Adults

IV Initial dose of 15 mg/kg followed by 1.9 mg/kg every 24 h or 250 to 1,000 mg every 7 to 10 days.

Anuria Adults

IV 1,000 mg every 7 to 10 days.

General Advice

• Reconstituted powder must be further diluted prior to administration.
• Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults.
• Administer over a period of no less than 60 min by intermittent infusion.
• Other patient factors, such as age or obesity, may call for modification of the usual IV daily dose.
• The total daily IV dosage may be lower in neonates. In premature infants, vancomycin Cl decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.
• Certain parenteral products may be administered orally. Dilute in 1 oz of water. Common flavoring syrups may be added to the solution. The diluted solution may be given via nasogastric tube.
• Thaw frozen Galaxy containers at room temperature or under refrigeration. Do not thaw by water bath immersion or by microwave.

Storage/Stability

Parenteral

Store vials at 68° to 77°F. After reconstitution, vials may be stored in a refrigerator for 14 days. Solutions diluted with dextrose 5% or sodium chloride 0.9% may be stored in a refrigerator for 14 days; solutions diluted with Ringer's lactate, dextrose 5%/sodium chloride 0.9%, Ringer's lactate/dextrose 5%, or Normosol-M and dextrose 5% may be stored in a refrigerator for 96 h. Discard pharmacy bulk packages no later than 4 h after initial closure puncture. Store Galaxy containers at or below −4°F. Thawed containers may be kept for 72 h at room temperature or 30 days under refrigeration. Do not refreeze.

Oral

Store at 59° to 86°F.

Drug Interactions

Aminoglycosides, amphotericin B, bacitracin, cisplatin, colistin, polymyxin B, viomycin

May increase risk of nephrotoxicity and/or neurotoxicity. Monitor renal function and serum drug concentrations with coadministration.

Anesthetics

Increased risk of hypersensitivity and infusion-related reactions. Give vancomycin as a 60-min infusion prior to anesthetic induction.

Indomethacin

May increase vancomycin toxicity in neonates. Closely monitor.

Methotrexate

May increase methotrexate toxicity. Monitor renal function and adjust methotrexate dosage as needed.

Nondepolarizing muscle relaxants

Neuromuscular blockade may be enhanced. If coadministration cannot be avoided, monitor neuromuscular function closely, titrate the dose of nondepolarizing muscle relaxant, and be prepared to provide mechanical respiratory support as needed.

Adverse Reactions

Cardiovascular

Hypotension.

CNS

Headache (7%); fatigue (5%); dizziness, vertigo (rare).

Dermatologic

Drug rash with eosinophilia and systemic symptoms, exfoliative dermatitis, pruritus, rash, Stevens-Johnson syndrome, TEN, urticaria, vasculitis (postmarketing).

EENT

Hearing loss; tinnitus (rare).

GI

Nausea (17%); abdominal pain (15%); diarrhea, vomiting (9%); flatulence (8%); antibiotic-associated colitis.

Genitourinary

Urinary tract infection (8%); nephrotoxicity including increased blood creatinine, renal failure, and renal impairment (5%); increased BUN; interstitial nephritis, renal failure (rare).

Hematologic

Reversible agranulocytosis; eosinophilia, reversible neutropenia, thrombocytopenia (postmarketing).

Local

Injection-site inflammation.

Respiratory

Dyspnea, wheezing.

Miscellaneous

Hypokalemia (13%); pyrexia (9%); back pain, peripheral edema (6%); anaphylaxis, chills, drug fever, hypotension, red man syndrome (flushing of the face, neck, upper chest, and extremities) (postmarketing).

Precautions

Monitor Perform serial monitoring of renal function. Monitor auditory function. Monitor leukocyte count in patients who are on prolonged therapy or who are receiving concomitant drugs that may cause neutropenia. Monitor vancomycin trough concentrations prior to next dose at steady-state concentrations (approximately after the fourth dose) and maintain above 10 mg/L. Ensure that minimum trough concentrations are higher (at least 15 to 20 mg/L) in patients with complicated infections.

Pregnancy

Category C (injection); Category B (oral).

Lactation

Excreted in breast milk.

Children

Confirming serum levels is recommended.

Elderly

Adjust dosage schedules. Elderly patients may take longer to respond and may require a prolonged course of oral vancomycin.

Hypersensitivity

Anaphylactoid reactions may occur.

Renal Function

Dosage adjustments required; use with caution.

Special Risk Patients

Use with caution in patients with preexisting hearing loss, patients receiving ototoxic or nephrotoxic drugs, and patients receiving drugs that cause neutropenia, nephrotoxicity, and/or neurotoxicity.

Superinfection

May occur.

Administration

Give by secure IV route. May minimize thrombophlebitis by giving slowly as dilute infusion. Chemical peritonitis has been reported following intraperitoneal administration.

C. difficile –associated diarrhea

Has been reported with nearly all antibacterials, including vancomycin injection, and may range in severity from mild diarrhea to fatal colitis.

Infusion-related reactions

Too rapid IV infusion or bolus administration may be associated with exaggerated hypotension, including shock and cardiac arrest, with or without maculopapular rash over the face, neck, upper chest, and extremities (red man or red neck syndrome).

Nephrotoxicity

Has occurred and ranges from increased blood creatinine to renal failure.

Ototoxicity

Has occurred and may be transient or permanent.

Reversible neutropenia

May occur after total dose of 25 g.

Overdosage

Symptoms

Hearing loss, increased BUN, increased serum creatinine, ringing in ears, vertigo.

Patient Information

• Explain that IV medication is given at regular intervals to maintain blood levels.
• Tell patients to report hearing loss, ringing in ears, or vertigo to their health care provider.
• Explain signs of superinfection (eg, vaginitis).
• Identify symptoms of potential adverse reactions.
• Tell patients to maintain adequate fluid intake.
• Tell patients not to stop taking vancomycin, even if they start to feel better.

Copyright © 2009 Wolters Kluwer Health.