Vancomycin

Pregnancy category: C (injection); B (oral)

Lactation: Drug enters breast milk; not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Vancomycin may be found in some form under the following brand names:

• Lyphocin

• Vancocin

• Vancoled

Tell your doctor if you are breastfeeding or plan to breastfeed.

Vancomycin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from vancomycin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Oral:

• Store vancomycin capsules at room temperature.
• Keep this and all medicines out of the reach of children.

Injectable:

• Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to vancomycin.

(van koe MYE sin)

• Vancocin
• Vancomycin HCl
• Vancomycin Hydrochloride

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

Catheter-related infections

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

Community-acquired pneumonia (children)

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

Clostridium difficile infection (adults; rectal administration)

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

Endophthalmitis

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

Group B Streptococcus, maternal use (neonatal prophylaxis)

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

Intra-abdominal infections

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

Meningitis, bacterial

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of bacterial meningitis, vancomycin is an effective and recommended systemic therapy as part of an empiric regimen for treatment of bacterial meningitis when Streptococcus pneumoniae or MRSA is a presumptive pathogen. Intraventricular vancomycin administration (with or without concomitant IV therapy) [Luer 1993] may occasionally be necessary in patients who have difficult to eradicate shunt infections or who cannot undergo surgical components of therapy.

Osteomyelitis, native vertebral

Based on the Infectious Diseases Society of America (IDSA) guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults, vancomycin is an effective and recommended treatment for native vertebral osteomyelitis due to Enterococcus spp (penicillin-resistant), or as an alternative treatment option for beta-hemolytic streptococci, penicillin-susceptible Enterococcus spp, Cutibacterium acnes, or oxacillin-susceptible staphylococci, in patients with type-1 or documented delayed beta-lactam allergy.

Peritonitis, treatment

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

Prosthetic joint infection

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of prosthetic joint infection, vancomycin is effective and is the preferred agent for treatment of prosthetic joints infected with Staphylococci (oxacillin-resistant), Enterococcus spp (penicillin-resistant), as an alternative agent for prosthetic joints infected with Staphylococci (oxacillin-susceptible), and only in the case of beta-lactam allergy for infections caused by Enterococcus (penicillin-susceptible), beta-hemolytic streptococci, or Cutibacterium acnes.

Skin and soft tissue necrotizing infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), vancomycin is an effective and recommended treatment for necrotizing infections of the skin, fascia, and muscle due to Staphylococcus aureus (resistant strains) or in combination with piperacillin-tazobactam for empiric therapy of polymicrobial [mixed] infections.

Surgical prophylaxis

Based on the American Society of Health-System Pharmacists (ASHP) Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery, The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part I: Duration guidelines and The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part II: Antibiotic Choice guidelines, vancomycin given as an alternative antibiotic in patients with beta-lactam allergy requiring surgical prophylaxis is effective and recommended for a number of surgical procedures.

Surgical-site infections

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

Hypersensitivity to vancomycin or any component of the formulation

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.

Injection:

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

1% to 10%:

Cardiovascular: Local phlebitis

Central nervous system: Chills, drug fever

Dermatologic: Skin rash

Hematologic & oncologic: Eosinophilia, neutropenia (reversible)

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

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

Oral:

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

1% to 10%:

Cardiovascular: Peripheral edema

Central nervous system: Fatigue, headache

Gastrointestinal: Diarrhea, flatulence, vomiting

Genitourinary: Urinary tract infection

Neuromuscular & skeletal: Back pain

Miscellaneous: Fever

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

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.

Oral vancomycin works only in the intestines and will not treat infections in other parts of the body. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Taking more of this medicine will not make it more effective, and may cause serious or life-threatening side effects.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Vancomycin will not treat a viral infection such as the common cold or flu.

If you use this medication long-term, you may need frequent medical tests at your doctor's office.

Shake the oral suspension (liquid) well just before you measure a dose.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store vancomycin capsules at room temperature, away from heat and moisture.