vancomycin (Rx)

Brand and Other Names:Vancocin, Firvanq
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule (Vancocin)

  • 125mg
  • 250mg

injection, lyophilized powder for reconstitution (generic)

  • 500mg
  • 750mg
  • 1g
  • 5g
  • 10g

kit, powder for oral solution (Firvanq)

  • 3.75g
  • 7.5g
  • 10.5g
  • 15g

injection, single-dose flexible bag (generic)

  • 500mg/100mL
  • 1g/200mL
  • 1.5g/300mL
  • 2g/400mL

Staphylococcal Enterocolitis

Vancocin and Firvanq

Indicated for enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)

Firvanq: Indicated for treatment of enterocolitis in adults and pediatric patients <18 years

0.5-2 g/day PO divided q6-8hr for 7-10 days

Clostridium difficile-associated Diarrhea

Vancocin and Firvanq

Indicated for treatment of Clostridium difficile (C. difficile)-associated diarrhea

Firvanq: Indicated for treatment of C. difficile-associated diarrhea in adults and pediatric patients <18 years

125 mg PO q6hr for 10 days

Infective Endocarditis

Indicated for treatment of infective endocarditis due to: susceptible isolates of MRSA, viridans group streptococci Streptococcus gallolyticus, Enterococcus species, and Corynebacterium species

For enterococcal endocarditis, use in combination with an aminoglycoside

Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other therapies

Indicated for treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside

Usual dosage: 2 g divided either as 500 mg q6hr or 1 gram q12hr

Initial daily dose should be no less than 15 mg/kg

Septicemia

Indicated for treatment of septicemia due to: susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins

Usual dosage: 2 g divided either as 500 mg q6hr or 1 gram q12hr

Initial daily dose should be no less than 15 mg/kg

Skin and Skin Structure Infections

Indicated for treatment of skin and skin structure infections due to: susceptible isolates of MRSA and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or have failed to respond to other therapies

Usual dosage: 2 g divided either as 500 mg q6hr or 1 g q12hr

Initial daily dose should be no less than 15 mg/kg

Bone Infections

Indicated for treatment of bone infections due to: susceptible isolates of MRSA and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or have failed to respond to other therapies

Usual dosage: 2 gdivided either as 500 mg q6hr or 1 gram q12hr

Initial daily dose should be no less than 15 mg/kg

Lower Respiratory Tract Infections

Indicated for treatment of lower respiratory tract infections due to: susceptible isolates of MRSA and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or have failed to respond to other therapies

Usual dosage: 2 g divided either as 500 mg q6hr or 1 gram q12hr

Initial daily dose should be no less than 15 mg/kg

Preoperative Antimicrobial Prophylaxis (Off-label)

Gastrointestinal [GI] and genitourinary [GU] procedures: 1 g IV by slow infusion over 1 hour, beginning 1-2 hours before procedure (with or without gentamicin 1.5 mg/kg; not to exceed 120 mg IV or IM <30 minutes before procedure)

Surgical Prophylaxis (Off-label)

Prophylaxis of infection in cardiac, thoracic, and arterial procedures; craniotomy; joint replacement; amputation

15 mg/kg IV over 1-2 hr; begin administration within 2 hr before incision; duration of prophylaxis for most procedures should be <24 hr

Dosing Modifications

Renal impairment

  • Mild-to-severe: Initial dose should be no less than 15 mg/kg
  • Functionally anephric patients: Initial dose of 15 mg/kg of body weight to achieve prompt therapeutic serum concentration; start at 1.9 mg/kg/24 hr after the initial dose of 15 mg/kg

Dosing Considerations

Peak values 18-26 mg/L; trough values 5-10 mg/L; however, Infectious Diseases Society of America and other guidelines urge troughs 15-20 mg/L

Only treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria to reduce development of drug-resistant bacteria

Limitations of use

  • Oral vancomycin: Not effective for other types of infections
  • IV vancomycin: Not effective for treatment of staphylococcal enterocolitis and C. difficile-associated diarrhea

Dosage Forms & Strengths

capsule (Vancocin)

  • 125mg
  • 250mg

injection, lyophilized powder for reconstitution (generic)

  • 500mg
  • 750mg
  • 1g
  • 5g
  • 10g

kit, powder for oral solution (Firvanq)

  • 3.75g
  • 7.5g
  • 10.5g
  • 15g

injection, single-dose flexible bag (generic)

  • 500mg/100mL
  • 1g/200mL
  • 1.5g/300mL
  • 2g/400mL

Staphylococcal Enterocolitis

Vancocin and Firvanq

Indicated for enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)

Firvanq: Indicated for treatment of enterocolitis in adults and pediatric patients <18 years

0.5-2 g/day PO divided q6-8hr for 7-10 days

Clostridium difficile-associated Diarrhea

Vancocin and Firvanq

Firvanq: Indicated for treatment of C. difficile-associated diarrhea in adults and pediatric patients <18 years

125 mg PO q6hr for 10 days

Preoperative Antimicrobial Prophylaxis

GI and GU procedures: 20 mg/kg IV by slow infusion over 1 hour, beginning 1 hour before procedure (with or without gentamicin 1.5 mg/kg; not to exceed 120 mg IV or IM <30 minutes before procedure)

Infective Endocarditis

Indicated for treatment of infective endocarditis due to: susceptible isolates of MRSA, viridans group streptococci Streptococcus gallolyticus, Enterococcus species, and Corynebacterium species

For enterococcal endocarditis, use in combination with an aminoglycoside

Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other therapies

Indicated for treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside

<1 month: See dosing considerations

≥1 month: 10 mg/kg/dose q6hr

Current AHA guidelines recommend using only for high-risk patients

Septicemia

Indicated for treatment of septicemia due to: susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins

<1 month: See dosing considerations

≥1 month: 10 mg/kg/dose q6hr  

Skin and Skin Structure Infections

Indicated for treatment of skin and skin structure infections due to: susceptible isolates of MRSA and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or have failed to respond to other therapies

<1 month: See dosing considerations

≥1 month: 10 mg/kg/dose q6hr  

Bone Infections

Indicated for treatment of bone infections due to: susceptible isolates of MRSA and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or have failed to respond to other therapies

<1 month: See dosing considerations

≥1 month: 10 mg/kg/dose q6hr  

Lower Respiratory Tract Infections

Indicated for treatment of lower respiratory tract infections due to: susceptible isolates of MRSA and coagulase negative staphylococci, methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or have failed to respond to other therapies

<1 month: See dosing considerations

≥1 month: 10 mg/kg/dose q6hr  

Bacterial Meningitis

15-20 mg/kg IV q6hr  

Other Infections

40 mg/kg/day IV divided q6hr  

Dosing Considerations

Neonatal dosing

  • After 20 mg/kg IV loading dose, give maintenance dose according to gestational age (GA) and serum creatinine (Scr)
  • GA ≤28 wk
    • Scr <0.5: 15 mg/kg q12hr
    • Scr 0.5-0.7: 20 mg/kg q24hr
    • Scr 0.8-1: 15 mg/kg q24hr
    • Scr 1.1-1.4: 10 mg/kg q24hr
    • Scr >1.4: 15 mg/kg q48hr
  • GA >28 wk
    • Scr <0.7: 15 mg/kg q12hr
    • Scr 0.7-0.9: 20 mg/kg q24hr
    • Scr 1-1.2: 15 mg/kg q24hr
    • Scr 1.3-1.6: 10 mg/kg q24hr
    • Scr >1.6: 15 mg/kg q48hr

Vancomycin is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and monitor renal function

Patients >65 years: Monitor during and following treatment to detect potential vancomycin induced nephrotoxicity; may take longer to respond to therapy compared to patients ≤65 years

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Interactions

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            Adverse Effects

            10% (Oral)

            capsule

            • Nausea (17%)
            • Abdominal pain (15%)
            • Hypokalemia (13%)

            1-10% (Oral)

            capsule

            • Vomiting (9%)
            • Diarrhea (9%)
            • Pyrexia (9%)
            • Flatulence (8%)
            • Urinary tract infection (8%)
            • Headache (7%)
            • Peripheral edema (6%)
            • Back pain (6%)
            • Fatigue (5%)
            • Nephrotoxicity (5%)

            Frequency Not Defined (IV)

            Immune system disorders: Hypersensitivity reactions (eg, anaphylaxis, “red man syndrome”)

            Skin and subcutaneous tissue disorders: Erythema and pruritus which are manifestations of rashes including exfoliative dermatitis, linear IgA bullous dermatosis, Stevens-Johnson syndrome, toxic epidermal necrolysis

            Renal and urinary disorders: Acute kidney injury and interstitial nephritis

            Ear and labyrinth disorders: Tinnitus, hearing loss, vertigo

            Blood and lymphatic system disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia

            Gastrointestinal disorders: Pseudomembranous colitis Cardiac disorders: Cardiac arrest, chest pain

            General disorders and administration site conditions: General discomfort, fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (Vancomycin not approved for IM and intraperitoneal administration)

            Laboratory abnormalities: Elevated blood urea nitrogen, elevated serum creatinine

            Musculoskeletal and connective tissue disorders: Muscle pain

            Nervous system disorders: Dizziness

            Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea

            Vascular disorders: Hypotension, shock, vasculitis

            Postmarketing Reports (All Formulations)

            Ototoxicity: Hearing loss associated IV administration (most cases had coexisting renal impairment or pre-existing hearing loss, or were coadministered an ototoxic drug), vertigo, dizziness, and tinnitus

            Hematopoietic: Reversible neutropenia, thrombocytopenia

            Miscellaneous: Anaphylaxis, drug fever, chills, nausea, eosinophilia, rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, and vasculitis

            Single-dose flexible bags only

            • Skin and subcutaneous tissue disorders: Drug rash with eosinophilia and systemic symptoms (DRESS)
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            Warnings

            Black Box Warnings

            Embryo-fetal toxicity due to excipients

            • Single-dose flexible bags are not recommended for use during pregnancy because it contains the excipients polyethylene glycol (PEG) 400 and N-acetyl-D-alanine (NADA), which caused fetal malformations in animal reproduction studies
            • If vancomycin is needed during pregnancy, use other available formulations of vancomycin

            Contraindications

            Hypersensitivity

            Cautions

            Rapid IV administration may result in flushing, pruritus, hypotension, erythema, and urticaria

            Systemic vancomycin exposure may result in acute kidney injury (AKI) and interstitial nephritis; risk of AKI increases as systemic exposure increases; additional risk factors for AKI include concomitant use of nephrotoxic drugs, patients with pre-existing renal impairment, or with comorbidities that predispose to renal impairment

            Endocarditis prophylaxis: Use only for high-risk patients, per AHA guidelines

            Ototoxicity may occur; toxicity proportional to amount of drug given and duration of treatment; presence of tinnitus or vertigo may indicate vestibular injury; discontinue if signs of ototoxicity occur

            Risk of neutropenia increases with doses >25 g (reversible following discontinuation of therapy)

            Avoid extravasation; necrosis may occur

            Prolonged use may result in fungal or bacterial superinfection

            Use caution in patients with renal impairment; monitor trough concentrations if multiple oral doses administered

            Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery; safety and efficacy of vancomycin administered by intracameral or intravitreal route not established by adequate and well- controlled trials; vancomycin not indicated for prophylaxis of endophthalmitis

            Oral vancomycin only indicated for treatment of pseudomembranous colitis due to C. difficile and enterocolitis due to S. aureus; not effective for systemic infections

            Clinically significant serum concentrations reported in some patients who have taken multiple oral doses of vancomycin for active C. difficile-associated diarrhea

            Prescribe vancomycin only for a proven or strongly suspected bacterial infection to prevent the development of drug resistant bacteria

            Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain may occur with rapid IV administration; reactions may be more severe in younger patients, particularly children, and in patients receiving concomitant muscle relaxant anesthetics

            Inflammation at the site of injection reported; vancomycin is irritating to tissue and must be given by a secure IV route to reduce the risk of local irritation and phlebitis

            Drug interactions overview

            • Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing and anaphylactoid reactions
            • Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, (eg, amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin)
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            Pregnancy & Lactation

            Pregnancy

            Animal reproduction studies have not been conducted with vancomycin

            Unknown whether vancomycin can affect reproduction capacity

            In a controlled clinical study, potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when administered to pregnant women for serious staphylococcal infections complicating IV drug abuse

            Single-dose flexible bags only

            • This formulation is not recommended for use during pregnancy because it contains the excipients, PEG 400 and NADA, which caused fetal malformations in animal reproduction studies (see Contraindications)
            • Perform a pregnancy test in females of reproductive potential prior to prescribing this formulation

            Lactation

            Vancomycin is excreted in human milk

            Exercise caution when vancomycin is administered to a nursing woman

            Because of the potential for adverse events, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            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.

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            Pharmacology

            Mechanism of Action

            Inhibits cell-wall biosynthesis; blocks glycopeptide polymerization by binding tightly to D-alanyl-D-alanine portion of cell wall precursor

            Absorption

            Oral

            • Poorly absorbed
            • After 250-mg capsules PO q8hr for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mcg/g in majority of samples

            IV

            • Peak serum time: Immediately after completion of infusion

            Distribution

            Distributed widely in body tissues and fluid, except for cerebrospinal fluid (CSF)

            Relative diffusion from blood into CSF: Good only with inflammation (exceeds usual minimal inhibitory concentrations); CSF level nil with normal meninges, 20-30% of blood level with inflamed meninges

            Protein bound: ~50%

            Vd: 0.3-0.43 L/kg (IV)

            Metabolism

            There is no apparent metabolism of the vancomycin

            Elimination

            Half-life (IV): 4-6 hr (normal renal function); 7.5 days (anephric patients)

            Mean clearance (flexible bag): 0.058 L/kg/hr (plasma); 0.048 L/kg/hr (renal)

            Excretion: Urine (IV; 80-90% as unchanged drug); primarily feces (PO)

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            Administration

            IV Compatibilities

            Solution: D5W/0.9% NaCl, D5W, D10W, LR, sodium bicarbonate 3.75%, 0.9% NaCl, D5W and LR, Normosol and D5W, 0.9% NaCl, Isolyte

            Additive: Amikacin, atracurium, calcium gluconate, cefepime, cimetidine, corticotropin, dimenhydrinate, erythromycin, famotidine, hydrocortisone, meropenem, ofloxacin, potassium chloride, ranitidine, verapamil, vitamins B and C

            Syringe: Caffeine

            Y-site (partial list): Acyclovir, alatrofloxacin, aldesleukin, allopurinol, amifostine, amiodarone, ampicillin, ampicillin-sulbactam, cefpirome, ceftizoxime, clarithromycin, diltiazem, esmolol, fluconazole, insulin, labetalol, lorazepam, linezolid, magnesium sulfate, midazolam, morphine, nicardipine, ondansetron, paclitaxel, pancuronium, perphenazine, remifentanil, sargramostim, sodium bicarbonate, tacrolimus, teniposide

            IV Incompatibilities

            Vancomycin solution has a low pH and may cause chemical or physical instability when it is mixed with other compounds

            Mixtures of solutions of vancomycin and beta-lactam antibacterial drugs have been shown to be physically incompatible

            Likelihood of precipitation increases with higher concentrations of vancomycin; adequately flush IV lines between administering these antibacterial drugs

            IV Preparation

            Add 10 mL of SWI to 500-mg vial and 20 mL of SWI to 1-g vial to yield 50 mg/mL solution; further dilution is required, depending on method of administration

            Intermittent infusion: Dilute 500 mg with ≥100 mL of diluent and 1 g with ≥200 mL of diluent (NS or D5W)

            Continuous infusion: Dilute in sufficient amount to permit infusion over 24 hours

            Single-dose flexible bags

            • Do NOT use in series connections
            • Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete

            Oral Preparation (Firvanq)

            Tap bottom edges of bottle to loosen powder

            Shake grape-flavored diluent for a few seconds

            Open diluent and transfer about half the required volume of diluent into the vancomycin powder bottle

            Shake powder bottle vertically for ~45 seconds

            Add remaining grape-flavored diluent into powder bottle; shake bottle for ~30 seconds

            Instruct patient to shake reconstituted solution well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters

            Vancomycin concentration and volume after reconstitution

            • Reconstituted vancomycin concentration: 25 mg/mL
              • 3.75 g: Dilute with 147 mL of grape-flavored diluent; final reconstituted volume: 150 mL
              • 7.5 g: Dilute with 295 mL of grape-flavored diluent; final reconstituted volume: 300 mL
            • Reconstituted vancomycin concentration: 50 mg/mL
              • 7.5 g: Dilute with 145 mL of grape-flavored diluent; final reconstituted volume: 150 mL
              • 10.5 g: Dilute with 203 mL of grape-flavored diluent; final reconstituted volume: 210 mL
              • 15 g: Dilute with 289 mL of grape-flavored diluent; final reconstituted volume: 300 mL

            Oral Administration

            Take with food

            IV Administration

            Intermittent (preferred): Administer over 60 minutes; not to exceed 10 mg/min

            Continuous: Administer over 24 hours

            Storage

            Capsules: Store at 15-30°C (59-86°F)

            Vials

            • Store at room temperature, 15-30°C (59-86°F)
            • Reconstituted solutions stable at 2-8°C for at least 4 days

            Single-dose bags

            • Store below 25°C

            Powder for oral solution

            • Unopened kits: Refrigerate, 2-8°C (36-46°F); do not freeze; keep container tightly closed
            • Protect from light
            • Reconstituted solutions: Refrigerate at 2-8°C (36-46°F); discard reconstituted solution after 14 days
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.