Vancomycin Hydrochloride

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

Trade Names: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 1 g per 200 mL

Trade Names:Vancocin- Capsules 125 mg- Capsules 250 mg

Pharmacology

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

Pharmacokinetics

Absorption

Poorly absorbed (orally). C max is 63 mcg/mL; 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. 75% is excreted in 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 required.

Elderly

Total systemic and renal Cl may be reduced.

Indications and Usage

Parenteral

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

Oral

Treatment of pseudomembranous colitis caused by Clostridium difficile ; treatment of staphylococcal enterocolitis.

Unlabeled Uses

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

Contraindications

Standard considerations.

Dosage and Administration

ParenteralEndocarditis (Staphylococcal, Streptococcal, 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 of age 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.

OralPseudomembranous Colitis/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 DosingAerosolization 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)

IV 10 to 15 mg/kg every 6 h. For meningitis, the dosage is 15 mg/kg every 6 h; max, 1 g per dose or 4 g/day.

Mild to Moderate Infections

IV 40 mg/kg/day in divided doses every 6 to 8 h; max, 1 g per dose or 2 g/day.

Neonates

IV Base optimal dosage on serum concentrations, especially in neonates with low birth weight (less than 1.5 kg). For neonates with very low birth weight (less than 1.2 kg), dosing every 18 to 24 h may be appropriate for the first 7 days of life.

0 to 4 wk of age and weighing less than 1.2 kg

15 mg/kg IV every 24 h.

Younger than 1 wk of age
  • Body weight 1.2 to 2 kg: 10 to 15 mg/kg IV every 12 to 18 h.
  • Body weight more than 2 kg: 10 to 15 mg/kg IV every 8 to 12 h.
1 wk of age and older
  • Body weight 1.2 to 2 kg: 10 to 15 mg/kg IV every 8 to 12 h.
  • Body weight more than 2 kg: 10 to 15 mg/kg IV every 6 to 8 h.
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 containers at room temperature or under refrigeration. Do not thaw by water bath immersion or by microwave.

Storage/Stability

Parenteral

Store 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.

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.

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.

Methotrexate

May increase methotrexate toxicity.

Nondepolarizing muscle relaxants

Neuromuscular blockade may be enhanced.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension.

Dermatologic

Exfoliative dermatitis, inflammation at site of injection, pruritus, rash, Stevens-Johnson syndrome, TEN, urticaria, vasculitis; drug rash with eosinophilia and systemic symptoms (postmarketing)

EENT

Hearing loss.

GI

Antibiotic-associated colitis, nausea.

Genitourinary

Increased serum creatinine and BUN; interstitial nephritis, renal failure (rare).

Hematologic

Eosinophilia, reversible agranulocytosis, reversible neutropenia; thrombocytopenia (rare).

Respiratory

Dyspnea, wheezing.

Miscellaneous

Anaphylaxis, chills, drug fever, hypotension, red man syndrome (flushing of the face, neck, upper chest, and extremities).

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.

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.

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 face, neck, upper chest, and extremities (red man or red neck syndrome). Reaction has been rarely associated with slow infusion or oral or intraperitoneal administration.

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 patient to report hearing loss, ringing in ears, or vertigo to health care provider.
  • Explain signs of superinfection (eg, vaginitis).
  • Identify symptoms of potential adverse reactions.
  • Tell patient to maintain adequate fluid intake.
  • Tell patients not to stop taking vancomycin, even if they start to feel better.

Copyright © 2009 Wolters Kluwer Health.

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