Vancomycin Hcl (vancomycin HCl)

Dosage of vancomycin hydrochloride is expressed in terms of vancomycin.

Vancomycin hydrochloride is administered by IV infusion for the treatment of systemic infections.

Vancomycin hydrochloride is administered orally as capsules or solution for the treatment of Clostridioides difficile (formerly known as Clostridium difficile-associated diarrhea or enterocolitis caused by Staphylococcus aureus (including MRSA). If necessary, the parenteral form of vancomycin hydrochloride may be diluted and administered orally by mouth or nasogastric tube for these indications. Orally administered vancomycin is not effective for and should not be used for the treatment of systemic infections.

Vancomycin has been administered rectally+ in the treatment of fulminant CDI in adults.

Safety and efficacy of intrathecal (intralumbar or intraventricular), intracameral, intravitreal, or intraperitoneal administration of vancomycin have not been established.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Antibiotics/Fecal Microbiota

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota.

Antibiotics/Fecal Microbiota Spores

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.

Antimicrobials/Live Typhoid Vaccine

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1)

CLINICAL EFFECTS: Vaccination may be ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3)

DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

Selected Nephrotoxic Agents/Bacitracin

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3)

CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3)

PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1)

PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3)

DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3)

Selected Nephrotoxic Agents/Cidofovir

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Cidofovir is nephrotoxic. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1-3)

CLINICAL EFFECTS: Concurrent use of cidofovir with nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, tenofovir, vancomycin, voclosporin and non-steroidal anti-inflammatory agents may result in renal toxicity.(1-3) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Australian,(1) UK,(2) and US(3) manufacturers of cidofovir state that concurrent administration of potentially nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, tenofovir, vancomycin, voclosporin and non-steroidal anti-inflammatory agents may result in renal toxicity.(1-3) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin. These agents should be discontinued at least 7 days before the administration of cidofovir.

DISCUSSION: The safety of cidofovir has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is the major toxicity of cidofovir.(1-3)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

Selected Nephrotoxic Agents/Foscarnet

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Foscarnet is nephrotoxic. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1) Concurrent intravenous pentamidine may also result in hypocalcemia.(1)

CLINICAL EFFECTS: Concurrent use of foscarnet with nephrotoxic agents such as acyclovir, adefovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, non-steroidal anti-inflammatory agents, intravenous pentamidine, tacrolimus, tenofovir, vancomycin and voclosporin may result in renal toxicity.(1) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of foscarnet state that concurrent administration of potentially nephrotoxic agents such as acyclovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, tacrolimus, and intravenous pentamidine should be avoided.(1) Other nephrotoxic agents include adefovir, capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, non-steroidal anti-inflammatory agents, streptozocin, tenofovir, vancomycin and voclosporin. If concurrent therapy is warranted, monitor renal function closely. In patients receiving concurrent foscarnet and pentamidine, also monitor serum calcium levels and instruct patients to report severe muscle spasms, mental/mood changes, and/or seizures.(1)

DISCUSSION: The safety of foscarnet has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is the major toxicity of foscarnet.(1)

Selected Nephrotoxic Agents/Inotersen

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Inotersen can cause glomerulonephritis and renal toxicity. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1)

CLINICAL EFFECTS: Concurrent use of inotersen with nephrotoxic agents such as acyclovir, adefovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, non-steroidal anti-inflammatory agents, intravenous pentamidine, tacrolimus, tenofovir, vancomycin and voclosporin may result in renal toxicity.(1) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin.

PREDISPOSING FACTORS: Patients with pre-existing renal impairment.

PATIENT MANAGEMENT: The US manufacturer of inotersen state that caution should be used when administered concurrently with potentially nephrotoxic agents or agents that impair renal function.(1) If concurrent therapy is warranted, monitor renal function closely.(1)

DISCUSSION: The safety of inotersen has not been studied in patients receiving other known potentially nephrotoxic agents. Inotersen is only available through a Tegsedi REMS program because of the risk of glomerulonephritis and severe thrombocytopenia.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Polypeptide Antibiotics/Neuromuscular Blocking Agents

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Synergistic pharmacologic activity. Polymyxin B affects neuromuscular transmission by blocking acetylcholine receptors. Its action is thus post-synaptic and the neuromuscular block has no antagonists. Polymyxin B causes neostigmine resistance to d-tubocurarine blockade and calcium resistance to the blockade evoked by aminoglycoside antibiotics (1,2,3,4). A pre-synaptic mechanism may also be involved with decreased release of acetylcholine.

CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

DISCUSSION: Concomitant administration of polypeptide antibiotics and neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and apnea. This interaction has been documented with colistimethate, polymyxin B, bacitracin, and vancomycin.

Selected Nephrotoxic Agents/Adefovir

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Recommended doses of adefovir have been associated with delayed nephrotoxicity.(1-4) Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1)

CLINICAL EFFECTS: Concurrent use of adefovir with nephrotoxic agents such as intravenous aminoglycosides, amphotericin B, cyclosporine, tacrolimus,tenofovir, vancomycin, voclosporin and non-steroidal anti-inflammatory agents may result in renal toxicity.(1) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, intravenous pentamidine, and streptozocin.

PREDISPOSING FACTORS: Patients with pre-existing renal impairment(1,2) or receiving multiple nephrotoxic agents appear to be at greater risk for nephrotoxicity.

PATIENT MANAGEMENT: Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function. Weigh the risks and benefits of concurrent therapy in patients with treatment-emergent nephrotoxicity.

DISCUSSION: Because of the known risks for adefovir nephrotoxicity, particularly at higher than recommended doses, the safety of adefovir has not been studied in patients receiving other known potentially nephrotoxic agents.

Selected Nephrotoxic Agents/Immune Globulin Iv (Igiv)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, can cause renal dysfunction, acute renal failure, osmotic nephrosis, and/or death. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1-4)

CLINICAL EFFECTS: Concurrent use of Immune Globulin Intravenous (IGIV) products with nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, non-steroidal anti-inflammatory agents, tenofovir, and vancomycin may result in renal toxicity.(1-4) Other nephrotoxic agents include capreomycin, gallium nitrate, and streptozocin.

PREDISPOSING FACTORS: Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs.(1-4) Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.(3-4)

PATIENT MANAGEMENT: For patients at risk of renal dysfunction or renal failure, the US manufacturers of Immune Globulin Intravenous (IGIV) products recommends administration at the minimum dose and infusion rate practicable; ensure adequate hydration in patients before administration; and monitor renal function and urine output with assessment of blood urea nitrogen (BUN) and serum creatinine before initial infusion and at regular intervals during therapy.(1-3) Concurrent administration of potentially nephrotoxic agents should be avoided.(1) Review prescribing information for IGIV product to be administered for sucrose content. If concurrent therapy is warranted, monitor renal function closely. In high risk patients, consider selecting an IGIV product that does not contain sucrose.

DISCUSSION: The safety of Immune Globulin Intravenous (IGIV) has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is a major toxicity of IGIV products.(1-3) A review of the FDA renal adverse events (RAEs) (i.e. acute renal failure or insufficiency) from June 1985 to November 1998 identified 120 reports worldwide associated with IGIV administration. In the US, the FDA received 88 reports of cases with clinical and/or laboratory findings consistent with RAE (i.e. increased serum creatinine, oliguria, and acute renal failure). Patient cases involved a median age of 60.5 years and 55% were male. Of the 54 patients who developed acute renal failure, 65% were greater than 65 years, 56% had diabetes, and 26% had prior renal insufficiency; 59% had one, 35% had two, and 6% had three of these conditions. Upon review of the IGIV product received, 90% of cases received sucrose-containing IGIV products with the remaining patients receiving either maltose- or glucose-containing products. Approximately 40% of affected patients required dialysis and RAE may have contributed to death in 15% of patients.(4)

Selected Nephrotoxic Agents/Tenofovir

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Tenofovir and other nephrotoxic agents may result in additive or synergistic effects on renal function and increase nephrotoxicity risk.(1)

CLINICAL EFFECTS: Concurrent use of tenofovir and other nephrotoxic agents may result in renal toxicity and acute renal failure.(1) Reports of acute renal failure and Fanconi syndrome have been reported with tenofovir use.(2,3) However, this has been reported in 3 case reports and the renal failure may have been complicated by other pre-existing conditions.(2)

PREDISPOSING FACTORS: Pre-existing renal dysfunction, long duration of use, low body weight, concomitant use of drugs that may increase tenofovir levels may increase the risk of nephrotoxicity.(1)

PATIENT MANAGEMENT: The US prescribing information for tenofovir recommends avoiding concurrent or recent use of a nephrotoxic agent.(3) Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function. Tenofovir should be avoided with high-dose or multiple NSAIDs. Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.(3) Patients receiving concurrent NSAIDs with tenofovir should be monitored for possible renal toxicity.(1,2) The dosing interval should be adjusted in patients with a baseline creatinine clearance of less than 50 ml/min.(1-3)

DISCUSSION: From March 18, 2003 to December 1, 2005, Health Canada received 10 reports of nephrotoxic reactions with tenofovir. Three of these occurred following the addition of a NSAID to tenofovir therapy. In the first report, a patient maintained on tenofovir for 29 months developed acute renal failure and acute tubular necrosis requiring dialysis 5 days after beginning indomethacin (100 mg rectally twice daily). In the second report, a patient maintained on tenofovir for 7 months developed acute renal failure and acute tubular necrosis after taking 90 tablets of naproxen (375 mg) over 2 months. The patient died. In the third report, a patient maintained on tenofovir for over a year developed acute renal failure and nephrotic syndrome after 2 months of valdecoxib (20 mg daily) therapy. Symptoms subsided following discontinuation of valdecoxib.(1)

Vancomycin/Gentamicin, Amikacin, Tobramycin

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive with those of vancomycin.

CLINICAL EFFECTS: The concurrent administration of gentamicin, amikacin, or tobramycin with vancomycin may result in additive ototoxic or nephrotoxic effects.(1)

PREDISPOSING FACTORS: Preexisting renal impairment, sepsis, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, or concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin appear to increase the risk for nephrotoxicity and ototoxicity.(1-5). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides.

PATIENT MANAGEMENT: The Australian manufacturer of gentamicin, amikacin, and tobramycin state that the concurrent use of gentamicin, amikacin, or tobramycin and vancomycin should be avoided.(1,4,5)

DISCUSSION: The Australian and U.K. manufacturers of gentamicin, amikacin, and tobramycin state that since the ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including vancomycin.(1,3,4,5)

Vancomycin/Piperacillin-Tazobactam

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The nephrotoxic effects of piperacillin-tazobactam may be additive with those of vancomycin.(1-5)

CLINICAL EFFECTS: The concurrent administration of piperacillin-tazobactam with vancomycin may result in additive nephrotoxic effects.(1-5)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of piperacillin-tazobactam states that the concurrent use of piperacillin-tazobactam and vancomycin warrants routine monitoring of kidney function.(1) The manufacturer of vancomycin states renal function monitoring is warranted when used concurrently and/or sequentially with other potentially nephrotoxic drugs.(2) Area-under-the curve (AUC) based dosing of vancomycin when used concurrently with piperacillin-tazobactam may reduce the risk of acute kidney injury (AKI). Routine monitoring of kidney function is warranted.(3)

DISCUSSION: A systematic review and metaanalysis found the concomitant use of vancomycin and piperacillin-tazobactam was associated with acute kidney injury in unadjusted odds ratio (OR 3.12; 95% confidence interval (CI) 2.04 - 4.78, p<0.001) and in adjusted OR (aOR 3.11; 95% CI 1.77 - 5.47, p<0.001) analysis. For adults only, results were similar for unadjusted (OR 2.71; 95% CI 1.72 - 4.27, p<0.001) and adjusted (aOR 3.15; 95% CI 1.72 - 5.76, p<0.001) analysis. For children only, concurrent use was associated with increased risk in unadjusted (OR 5.26; 95% CI 2.71 - 10.21, p<0.001) analysis.(4) A retrospective matched cohort study in patients receiving concurrent vancomycin and piperacillin-tazobactam for a minimum of 48 hours had significantly higher rates of acute kidney injury than patients receiving vancomycin and cefepime (29% vs 11%, respectively; hazard ratio (HR) = 4, p<0.001). Results of a multivariate analysis found vancomycin and piperacillin-tazobactam combination therapy was an independent risk factor for RIFLE (Risk, Injury, Failure, Loss, End Stage Renal Disease) -defined acute kidney injury (HR = 4.3; 95% CI 2.7 - 6.7; p<0.0001). The onset of acute kidney injury was more rapid in patients receiving vancomycin and piperacillin-tazobactam than in patients receiving vancomycin and cefepime (3 days vs 5 days, p<0.001).(5) A retrospective cohort analysis evaluated RIFLE-defined acute kidney injury in patients receiving combination vancomycin and piperacillin-tazobactam, vancomycin monotherapy, and piperacillin-tazobactam monotherapy. RIFLE-defined acute kidney injury occurred in 14.1% of patients across the cohort. The therapy specific acute kidney injury occurred in combination vancomycin and piperacillin-tazobactam, vancomycin monotherapy and piperacillin-tazobactam monotherapy in 21%, 8.3%, and 7.8% of patients (p<0.0001), respectively. In a multivariate analysis, vancomycin monotherapy and piperacillin-tazobactam monotherapy were associated with decreased odds of acute kidney injury compared to combination vancomycin and piperacillin-tazobactam therapy (Vancomycin Monotherapy - aOR 0.48; 95% CI 0.41 - 0.57; Piperacillin-Tazobactam Monotherapy - aOR 0.43; 95% CI 0.37 - 0.5). In a univariate analysis the following factors were associated with acute kidney injury: combination vancomycin and piperacillin-tazobactam therapy, days of therapy, baseline creatinine clearance, transfer from outside hospitals, Charlson Comorbidity Index, admission type, length of hospitalization, dehydration exposure, and hypotension exposure.(6) A retrospective cohort study evaluated the incidence of AKI with Vancomycin AUC based dosing with concomitant piperacillin-tazobactam (VPT) compared to meropenem or cefepime (VMC). AKI occurred in 13.68% of patients with VPT compared to 4.8% of patients who received VMC. Patients in other VPT studies utilizing traditional trough based vancomycin dosing experienced AKI 21.4 to 34.8%.(3)

*Hypersensitivity to vancomycin.

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

There are no contraindication contraindications for this drug.

• Hearing loss
• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Systemic mastocytosis

• Neutropenic disorder

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

Oral solution: Nausea, abdominal pain, and hypokalemia.

Less Frequent

• Hearing loss
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Nephrotoxicity
• Neutropenic disorder

Rare or Very Rare

• Acute generalized exanthematous pustulosis
• Acute renal failure
• Agranulocytosis
• Anaphylaxis
• Cardiac arrest
• Clostridioides difficile infection
• DRESS syndrome
• Dyspnea
• Erythema
• Exfoliative dermatitis
• Hemolytic anemia
• Hypersensitivity angiitis
• Hypersensitivity drug reaction
• Hypotension
• Interstitial nephritis
• Kounis syndrome
• Leukopenia
• Linear immunoglobulin A bullous dermatosis
• Maculopapular rash
• Ototoxicity
• Pancytopenia
• Shock
• Stevens-johnson syndrome
• Thrombocytopenic disorder
• Thrombophlebitis
• Tinnitus
• Toxic epidermal necrolysis
• Urticaria

Rare or Very Rare

• Anticholinergic toxicity
• Chest pain
• Chills
• Diarrhea
• Dizziness
• Drug fever
• Eosinophilia
• Fever
• Flushing
• Injection site sequelae
• Myalgia
• Nausea
• Phlebitis after infusion
• Pruritus of skin
• Skin rash
• Vertigo
• Wheezing

No enhanced messaging available.

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

IV vancomycin should be used with caution in premature neonates and young infants because of the renal immaturity of these patients and the potential for increased serum concentrations of the drug. Close monitoring of serum vancomycin concentrations may be warranted in pediatric patients, especially neonates and young infants.

Safety of the chemical components that may leach out of the plastic containers of commercially available frozen vancomycin injections has not been established in children.

There was no evidence of teratogenicity when vancomycin was administered IV to rats in dosages up to 200 mg/kg daily (1180 mg/m2 or equivalent to the recommended maximum human dosage based on mg/m2) or to rabbits in dosages up to 120 mg/kg daily (1320 mg/m2 or 1.1 times the recommended maximum human dosage based on mg/m2). There were no effects on fetal weight or development in rats at the highest dosage tested or in rabbits given 80 mg/kg daily (880 mg/m2 or 0.74 times the maximum recommended human dosage based on mg/m2).

In one study, no sensorineural hearing loss or nephrotoxicity was reported in neonates born to women who received IV vancomycin for severe staphylococcal infections associated with injection drug abuse- during pregnancy. In one infant whose mother received IV vancomycin in the third trimester of pregnancy, conductive hearing loss was reported; however, a causal relationship to vancomycin has not been established. Because the number of pregnant women in this study was limited and vancomycin was only administered during the second and third trimester of pregnancy, it is not known whether the drug can cause fetal harm when administered to pregnant women.

In a prospective study, no major adverse effects were observed in mothers or their newborns when IV vancomycin was administered at the time of delivery. This study included 55 pregnant women with positive group B Streptococcus culture with resistance to clindamycin or unknown sensitivity and a high-risk penicillin allergy. Vancomycin dosage ranged from 1 g every 12 hours to 20 mg/kg (maximum individual dose 2 g) every 8 hours. None of the newborns had sensorineural hearing loss; although renal function of the neonates was not assessed, all neonates were discharged in good condition.

Vancomycin should be used during pregnancy only when clearly needed.

Vancomycin is distributed into milk following IV administration. Systemic absorption of oral vancomycin is very low and it is not known whether the drug distributes into human milk following oral administration. However, IV and oral vancomycin should be used with caution in nursing women. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of vancomycin to the woman.

Vancomycin dosage should be adjusted accordingly in geriatric patients; consider the greater frequency of renal impairment in this age group.

In clinical studies of oral vancomycin, 54% of patients were >65 years of age; of these, 40% were >65-75 years of age and 60% were >75 years of age. In these studies, geriatric patients treated with oral vancomycin capsules for diarrhea associated with CDI were more likely to develop nephrotoxicity during or after completion of therapy. Renal function should be monitored during and after treatment with oral vancomycin in all geriatric patients, including those with normal renal function.

Geriatric patients >65 years of age may take longer to respond to oral vancomycin therapy compared with younger patients. Clinicians should be aware of the appropriate duration of oral vancomycin treatment in geriatric patients and therapy should not be prematurely discontinued or prematurely switched to an alternate therapy.

IV vancomycin dosage in geriatric patients should be adjusted based on the degree of renal impairment. Because geriatric patients may have decreasing glomerular filtration with increasing age, increased serum vancomycin concentrations may occur if dosage is not adjusted in these patients.