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Context, anatomy, and key evidence

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glycopeptide antibiotic

Vancomycin

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

The stated antibacterial mechanism includes primary inhibition of cell-wall biosynthesis plus additional effects on membrane permeability and RNA synthesis. Vancomycin lacks in vitro antimicrobial activity against gram-negative bacilli, mycobacteria, and fungi. A dose-/exposure-related nephrotoxicity statement is provided: systemic exposure may cause AKI, with risk increasing as exposure/serum levels increase. The adult dosing schedule provided totals 2 g/day and can be administered as 500 mg q6h or 1 g q12h.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

How does it work?

Target, response, and disposition.

Mechanism

The stated antibacterial mechanism includes primary inhibition of cell-wall biosynthesis plus additional effects on membrane permeability and RNA synthesis.

Sources[3]dailymedVancomycin Hydrochloride for Oral Solution, USPThe bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.[4]dailymedVancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous UseThe bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyThe bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.
Source records
3
Regulatory records
3

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.”

    Vancomycin Hydrochloride for Oral Solution, USP · CLINICAL PHARMACOLOGY

    dailymed:3c47d5c4-8cdb-4701-8d7a-8a6e79025b53:2d093bfc7f04:2d093bfc7f04
  2. supports · Source-backed record
    “The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.”

    Vancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous Use · Microbiology

    dailymed:4983e3c8-e0f2-b366-e063-6394a90a9557:dc2bc21b707e:dc2bc21b707e
  3. supports · Source-backed record
    “The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · CLINICAL PHARMACOLOGY

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

Mechanism

Vancomycin’s primary bactericidal mechanism is inhibition of bacterial cell-wall biosynthesis.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · CLINICAL PHARMACOLOGY

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284

Mechanism

Vancomycin’s stated primary bactericidal mechanism is inhibition of cell-wall biosynthesis, with additional described effects on membrane permeability and RNA synthesis.

Sources[5]dailymedSterile Vancomycin Hydrochloride USP 500 mg & 1 gThe bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.[7]dailymeddailymed-lead-f604d399The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.
Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis.”

    Sterile Vancomycin Hydrochloride USP 500 mg & 1 g · Microbiology

    dailymed:6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168:f26b3efc38ab:f26b3efc38ab
  2. supports · Source-backed record
    “The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.”

    dailymed-lead-f604d399 · MICROBIOLOGY

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Pharmacokinetics

Renal elimination is described as predominantly glomerular filtration, with ~75% of a dose excreted in urine within 24 hours.

Sources[7]dailymeddailymed-lead-f604d399In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration.
Reported result
about 75%
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration.”

    dailymed-lead-f604d399 · CLINICAL PHARMACOLOGY

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Pharmacokinetics

After oral dosing, vancomycin generally shows low gastrointestinal absorption.

Sources[3]dailymedVancomycin Hydrochloride for Oral Solution, USPVancomycin is poorly absorbed after oral administration.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is poorly absorbed after oral administration.”

    Vancomycin Hydrochloride for Oral Solution, USP · CLINICAL PHARMACOLOGY

    dailymed:3c47d5c4-8cdb-4701-8d7a-8a6e79025b53:2d093bfc7f04:2d093bfc7f04

Pharmacokinetics

The labeled pharmacokinetic parameter for vancomycin elimination in normal renal function is a mean plasma half-life of 4–6 hours.

Sources[7]dailymeddailymed-lead-f604d399The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.
Reported result
4 to 6 hours
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.”

    dailymed-lead-f604d399 · CLINICAL PHARMACOLOGY

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Pharmacokinetics

Oral administration results in poor absorption of vancomycin, per the provided pharmacology statement.

Sources[7]dailymeddailymed-lead-f604d399Vancomycin is poorly absorbed after oral administration.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is poorly absorbed after oral administration.”

    dailymed-lead-f604d399 · CLINICAL PHARMACOLOGY

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Pharmacokinetics

Protein binding is stated as ~55% using ultrafiltration, with the noted measurement range of serum concentrations (10 to 100 mcg/mL).

Sources[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyVancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL.
Reported result
approximately 55%
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · CLINICAL PHARMACOLOGY

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

Pharmacokinetics

With normal renal function, vancomycin shows a mean plasma elimination half-life in the 4 to 6 hour range.

Sources[4]dailymedVancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous UseThe mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.
Reported result
4 to 6 hours
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.”

    Vancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous Use · CLINICAL PHARMACOLOGY

    dailymed:4983e3c8-e0f2-b366-e063-6394a90a9557:dc2bc21b707e:dc2bc21b707e

Pharmacokinetics

In individuals with normal renal function, vancomycin exhibits a mean plasma elimination half-life in the 4 to 6 hour range.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.
Reported result
4 to 6 hours
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · CLINICAL PHARMACOLOGY

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284

Pharmacokinetics

Oral dosing results in limited gastrointestinal absorption of vancomycin, per the pharmacokinetic statement provided.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.Vancomycin is poorly absorbed after oral administration.[4]dailymedVancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous UseVancomycin is poorly absorbed after oral administration.[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyVancomycin is poorly absorbed after oral administration.
Source records
3
Regulatory records
3

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is poorly absorbed after oral administration.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · CLINICAL PHARMACOLOGY

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284
  2. supports · Source-backed record
    “Vancomycin is poorly absorbed after oral administration.”

    Vancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous Use · CLINICAL PHARMACOLOGY

    dailymed:4983e3c8-e0f2-b366-e063-6394a90a9557:dc2bc21b707e:dc2bc21b707e
  3. supports · Source-backed record
    “Vancomycin is poorly absorbed after oral administration.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · CLINICAL PHARMACOLOGY

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

What has been studied?

What the evidence says.

Study findings

In vitro, vancomycin lacks activity against gram-negative bacilli and also against mycobacteria and fungi.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.Vancomycin is not activein vitroagainst gram-negative bacilli, mycobacteria, or fungi.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is not activein vitroagainst gram-negative bacilli, mycobacteria, or fungi.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · CLINICAL PHARMACOLOGY

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284

Study findings

Cross-resistance refers to shared resistance mechanisms affecting multiple drugs; the source states vancomycin has no cross-resistance with other antibiotics.

Sources[5]dailymedSterile Vancomycin Hydrochloride USP 500 mg & 1 gThere is no cross-resistance between vancomycin and other antibiotics.
Reported result
no cross-resistance
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “There is no cross-resistance between vancomycin and other antibiotics.”

    Sterile Vancomycin Hydrochloride USP 500 mg & 1 g · Microbiology

    dailymed:6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168:f26b3efc38ab:f26b3efc38ab

Study findings

The stated spectrum limitation is that vancomycin lacks in vitro activity against gram-negative bacilli, mycobacteria, and fungi.

Sources[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyVancomycin is not activein vitroagainst gram-negative bacilli, mycobacteria, or fungi.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is not activein vitroagainst gram-negative bacilli, mycobacteria, or fungi.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · CLINICAL PHARMACOLOGY

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

Study findings

Vancomycin lacks in vitro antimicrobial activity against gram-negative bacilli, mycobacteria, and fungi.

Sources[4]dailymedVancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous UseVancomycin is not activein vitroagainst gram-negative bacilli, mycobacteria, or fungi.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is not activein vitroagainst gram-negative bacilli, mycobacteria, or fungi.”

    Vancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous Use · Microbiology

    dailymed:4983e3c8-e0f2-b366-e063-6394a90a9557:dc2bc21b707e:dc2bc21b707e

Risks and interactions

Risks, organized for scanning.

Contraindications

Known hypersensitivity to vancomycin is a contraindication to vancomycin hydrochloride for injection.

Sources[4]dailymedVancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous UseVancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.”

    Vancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous Use · CONTRAINDICATIONS

    dailymed:4983e3c8-e0f2-b366-e063-6394a90a9557:dc2bc21b707e:dc2bc21b707e

Contraindications

A labeled contraindication for oral vancomycin hydrochloride capsules is a known hypersensitivity to vancomycin.

Sources[2]dailymedThese highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986Vancomycin Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to vancomycin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to vancomycin.”

    These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986 · 4 CONTRAINDICATIONS

    dailymed:3707ad2e-5c82-4111-a370-e518e5e7e4c5:15f1c414826d:15f1c414826d

Contraindications

A known vancomycin hypersensitivity is listed as a contraindication for Vancomycin Hydrochloride for Oral Solution.

Sources[3]dailymedVancomycin Hydrochloride for Oral Solution, USPVancomycin Hydrochloride for Oral Solution is contraindicated in patients with known hypersensitivity to vancomycin.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin Hydrochloride for Oral Solution is contraindicated in patients with known hypersensitivity to vancomycin.”

    Vancomycin Hydrochloride for Oral Solution, USP · CONTRAINDICATIONS

    dailymed:3c47d5c4-8cdb-4701-8d7a-8a6e79025b53:2d093bfc7f04:2d093bfc7f04

Contraindications

The contraindication is stated as known hypersensitivity to vancomycin hydrochloride for injection.

Sources[7]dailymeddailymed-lead-f604d399Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.”

    dailymed-lead-f604d399 · CONTRAINDICATIONS

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Contraindications

Known hypersensitivity to vancomycin is a contraindication for vancomycin hydrochloride for injection.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · CONTRAINDICATIONS

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284

Contraindications

A contraindication is a situation where a drug should not be used; the source lists known hypersensitivity to vancomycin as a contraindication.

Sources[5]dailymedSterile Vancomycin Hydrochloride USP 500 mg & 1 gVancomycin is contraindicated in patients with known hypersensitivity to this antibiotic.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic.”

    Sterile Vancomycin Hydrochloride USP 500 mg & 1 g · CONTRAINDICATIONS

    dailymed:6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168:f26b3efc38ab:f26b3efc38ab

Safety findings

A dose-/exposure-related nephrotoxicity statement is provided: systemic exposure may cause AKI, with risk increasing as exposure/serum levels increase.

Sources[7]dailymeddailymed-lead-f604d399Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase.”

    dailymed-lead-f604d399 · Nephrotoxicity

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Safety findings

Randomized controlled clinical studies reported nephrotoxicity with oral vancomycin capsules, with onset possible during therapy or post-therapy.

Sources[2]dailymedThese highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral Vancomycin Hydrochloride Capsules therapy in randomized controlled clinical studies, and can occur either during or after completion of therapy.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral Vancomycin Hydrochloride Capsules therapy in randomized controlled clinical studies, and can occur either during or after completion of therapy.”

    These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986 · 5.3 Nephrotoxicity

    dailymed:3707ad2e-5c82-4111-a370-e518e5e7e4c5:15f1c414826d:15f1c414826d

Products and regulatory status

Same ingredient. Different records.

Regulatory status

The oral administration section specifies the oral-use cases (C. difficile antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis) and states lack of effectiveness orally for other infection types.

Sources[7]dailymeddailymed-lead-f604d399Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused byC. difficileand for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused byC. difficileand for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections.”

    dailymed-lead-f604d399 · For Oral Administration

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Regulatory status

The text states that vancomycin hydrochloride parenteral formulation may be administered orally for C. difficile–associated pseudomembranous colitis and for staphylococcal enterocolitis.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced byC. difficileand for staphylococcal enterocolitis.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced byC. difficileand for staphylococcal enterocolitis.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · INDICATIONS AND USAGE

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284

Regulatory status

The labeled indication includes treatment of serious or severe infections due to susceptible methicillin-resistant (β-lactam-resistant) staphylococcal strains.

Sources[1]dailymedVancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.”

    Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. · INDICATIONS AND USAGE

    dailymed:00946db3-d6c5-4534-a870-1ec6e63eda43:2ba166392284:2ba166392284

Regulatory status

The labeled oral indications include S. aureus enterocolitis (including methicillin-resistant strains) and C. difficile antibiotic-associated pseudomembranous colitis.

Sources[3]dailymedVancomycin Hydrochloride for Oral Solution, USPVancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused byStaphylococcus aureus(including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused byC. difficile.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused byStaphylococcus aureus(including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused byC. difficile.”

    Vancomycin Hydrochloride for Oral Solution, USP · INDICATIONS AND USAGE

    dailymed:3c47d5c4-8cdb-4701-8d7a-8a6e79025b53:2d093bfc7f04:2d093bfc7f04

Regulatory status

The contraindication is a known hypersensitivity to the antibiotic.

Sources[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyVancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · CONTRAINDICATIONS

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

Regulatory status

The indication statement specifies use for serious/severe infections due to susceptible methicillin-resistant (β-lactam-resistant) staphylococci.

Sources[7]dailymeddailymed-lead-f604d399Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.”

    dailymed-lead-f604d399 · INDICATIONS AND USAGE

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Administration context

The practical clinical context.

Administration

To reduce rapid-infusion-related adverse reactions, the infusion should be diluted and administered over ≥60 minutes per the warning.

Sources[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyVancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · WARNINGS

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

Administration

Because vancomycin has poor oral absorption, the source states it is administered intravenously for systemic infection therapy.

Sources[5]dailymedSterile Vancomycin Hydrochloride USP 500 mg & 1 gVancomycin is poorly absorbed after oral administration; it is given intravenously for therapy of systemic infections.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin is poorly absorbed after oral administration; it is given intravenously for therapy of systemic infections.”

    Sterile Vancomycin Hydrochloride USP 500 mg & 1 g · CLINICAL PHARMACOLOGY

    dailymed:6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168:f26b3efc38ab:f26b3efc38ab

Administration

The warnings specify an infusion administration constraint: diluted solution and infusion duration ≥60 minutes to avoid rapid-infusion-related reactions.

Sources[7]dailymeddailymed-lead-f604d399Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.”

    dailymed-lead-f604d399 · Infusion Reactions

    dailymed:f604d399-fded-4f4f-8efe-af558ed07b9d:2d6a7db44803:2d6a7db44803

Dose records

The adult dosing regimen for oral vancomycin capsules in C. difficile-associated diarrhea is 125 mg PO QID for a 10-day course.

Sources[2]dailymedThese highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.”

    These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986 · 2.1 Adults

    dailymed:3707ad2e-5c82-4111-a370-e518e5e7e4c5:15f1c414826d:15f1c414826d

Dose records

In adults, oral vancomycin capsule dosing for staphylococcal enterocolitis is 500 mg–2 g/day PO split into 3 or 4 doses over 7–10 days.

Sources[2]dailymedThese highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.”

    These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986 · 2.1 Adults

    dailymed:3707ad2e-5c82-4111-a370-e518e5e7e4c5:15f1c414826d:15f1c414826d

Dose records

The adult dosing schedule provided totals 2 g/day and can be administered as 500 mg q6h or 1 g q12h.

Sources[6]dailymedVANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx onlyThe usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours.”

    VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only · Adults

    dailymed:93589e71-3a11-4797-9176-8abdb7674a87:90d506275832:90d506275832

Dose records

The usual pediatric (<18 years) oral dosing of vancomycin capsules for both C. difficile-associated diarrhea and staphylococcal enterocolitis is 40 mg/kg/day PO divided TID or QID for 7–10 days, capped at 2 g/day.

Sources[2]dailymedThese highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986For bothC. difficile-associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “For bothC. difficile-associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.”

    These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986 · 2.2 Pediatric Patients (less than 18 years of age)

    dailymed:3707ad2e-5c82-4111-a370-e518e5e7e4c5:15f1c414826d:15f1c414826d

Dose records

Adult oral dosing is described as a total daily dose range (500 mg to 2 g), divided into 3 or 4 doses, over 7 to 10 days.

Sources[3]dailymedVancomycin Hydrochloride for Oral Solution, USPThe usual adult total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The usual adult total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.”

    Vancomycin Hydrochloride for Oral Solution, USP · DOSAGE AND ADMINISTRATION

    dailymed:3c47d5c4-8cdb-4701-8d7a-8a6e79025b53:2d093bfc7f04:2d093bfc7f04

Dose records

Once reconstituted with water, the concentration is 250 mg of vancomycin (0.17 mmol) per 5 mL of solution.

Sources[3]dailymedVancomycin Hydrochloride for Oral Solution, USPEach 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP.”

    Vancomycin Hydrochloride for Oral Solution, USP · DESCRIPTION

    dailymed:3c47d5c4-8cdb-4701-8d7a-8a6e79025b53:2d093bfc7f04:2d093bfc7f04

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: identity, interaction
  • 26 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (8), assurance_score_below_0.72 (15), current_regulatory_source_required (9), extraction_ambiguity (29), high_risk_requires_regulatory_or_two_independent_sources (15), no_direct_support (23)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. Vancomycin Hydrochloride for Injection, USP(For Intravenous Use)Rx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ↗

    dailymed · published 2026-01-30 · retrieved 2026-09-04T22:25:27Z

  2. These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES.VANCOMYCIN HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1986 ↗

    dailymed · published 2026-03-02 · retrieved 2026-09-04T22:25:26Z

  3. Vancomycin Hydrochloride for Oral Solution, USP ↗

    dailymed · published 2023-06-23 · retrieved 2026-09-04T22:25:27Z

  4. Vancomycin Hydrochloride for Injection, USPFliptop Vial for Intravenous Use ↗

    dailymed · published 2026-03-25 · retrieved 2026-09-04T22:25:27Z

  5. Sterile Vancomycin Hydrochloride USP 500 mg & 1 g ↗

    dailymed · published 2010-12-22 · retrieved 2026-09-04T22:25:27Z

  6. VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPRx only ↗

    dailymed · published 2020-11-29 · retrieved 2026-09-04T22:25:28Z

  7. dailymed-lead-f604d399 ↗

    dailymed · published 2025-05-15 · retrieved 2026-09-04T22:25:28Z

Publication history and provenance

Version 2 · Automated assessment · 2026-09-04T22:25:28Z

4eb7fe48084ac202a1119fed17bfa4604ae6288a3593e437cca15b3cd9f5b4c4