Vancomycin (oral)

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Vancomycin (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Vancomycin (oral) is a glycopeptide, antibiotics that is FDA approved for the treatment of C. difficile-associated diarrhea, enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Common adverse reactions include nausea, vomiting, abdominal pain, diarrhea, and hypokalemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Orally administered Vancomycin is not effective for other types of infections.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin CAPSULES and other antibacterial drugs, Vancomycin CAPSULES should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosing Information

Off-Label Use and Dosage (Adult)

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • 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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vancomycin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vancomycin in pediatric patients.

Contraindications

Warnings

Oral Use Only
Potential for Systemic Absorption
Nephrotoxicity
  • In patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with Vancomycin to detect potential vancomycin induced Nephrotoxicity.
Ototoxicity
  • Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.
Superinfection
  • Use of Vancomycin may result in the overgrowth of nonsusceptible bacteria. If superinfection occurs during therapy, appropriate measures should be taken.
Development of Drug-Resistant bacteria
  • Prescribing Vancomycin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.

Adverse Reactions

Clinical Trials Experience

  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
  • The data described below reflect exposure to Vancomycin in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C. difficile. In both trials, subjects received Vancomycin 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%) and 52% were male.
This image is provided by the National Library of Medicine.
  • Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with Vancomycin. The most common adverse events leading to discontinuation of Vancomycin were C. difficile colitis (<1%), nausea (<1%), and vomiting (<1%).

Postmarketing Experience

  • The following adverse reactions have been identified during post-approval use of Vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Hematopoietic:
  • Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with vancomycin or after a total dose of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported.
  • Miscellaneous:

Drug Interactions

There is limited information regarding drug interactions of vancomycin capsule in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • The highest doses of vancomycin tested were not teratogenic in rats given up to 200 mg/kg/day IV (1180 mg/m2 or 1 times the recommended maximum human dose based on body surface area) or in rabbits given up to 120 mg/kg/day IV (1320 mg/m2 or 1.1 times the recommended maximum human dose based body surface area). No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (880 mg/m2 or 0.74 times the recommended maximum human dose based on body surface area).


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vancomycin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Vancomycin during labor and delivery.

Nursing Mothers

  • Vancomycin is excreted in human milk based on information obtained with the intravenous administration of vancomycin. However, systemic absorption of vancomycin is very low following oral administration of Vancomycin. It is not known whether vancomycin is excreted in human milk, as no studies of vancomycin concentration in human milk after oral administration have been done. Caution should be exercised 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 discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

There is no FDA guidance on the use of Vancomycin with respect to pediatric patients.

Geriatic Use

  • In clinical trials, 54% of Vancomycin-treated subjects were >65 years of age. Of these, 40% were between the ages of >65 and 75, and 60% were >75 years of age.
  • Patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age. Clinicians should be aware of the importance of appropriate duration of Vancomycin treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.

Gender

There is no FDA guidance on the use of Vancomycin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Vancomycin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Vancomycin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Vancomycin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Vancomycin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Vancomycin in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

Potential for Systemic Absorption=

Nephrotoxicity
  • In patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with Vancomycin to detect potential vancomycin induced Nephrotoxicity.

IV Compatibility

There is limited information regarding IV Compatibility of Vancomycin in the drug label.

Overdosage

  • To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics.

Pharmacology

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Vancomycin (oral)
Systematic (IUPAC) name
(1S,2R,18R,19R,22S,25R,28R,40S)- 48- {[(2S,3R,4S,5S,6R)- 3- {[(2S,4S,5S,6S)- 4- amino- 5- hydroxy- 4,6- dimethyloxan- 2- yl]oxy}- 4,5- dihydroxy- 6- (hydroxymethyl)oxan- 2- yl]oxy}- 22- (carbamoylmethyl)- 5,15- dichloro- 2,18,32,35,37- pentahydroxy- 19- [(2R)- 4- methyl- 2- (methylamino)pentanamido]- 20,23,26,42,44- pentaoxo- 7,13- dioxa- 21,24,27,41,43- pentaazaoctacyclo[26.14.2.23,6.214,17.18,12.129,33.010,25.034,39]pentaconta- 3,5,8(48),9,11,14,16,29(45),30,32,34,36,38,46,49- pentadecaene- 40- carboxylic acid
Identifiers
CAS number 1404-90-6
ATC code A07AA09 J01XA01 (WHO)
PubChem 14969
DrugBank DB00512
Chemical data
Formula C66H75Cl2N9O24 
Mol. mass 1449.3 g.mol-1
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability Negligible (oral)
Metabolism Excreted unchanged
Half life 4–11 hours (adults)
6-10 days (adults, impaired renal function)
Excretion Renal
Therapeutic considerations
Licence data

US

Pregnancy cat.

B2(AU) B (PO) / C (IV)(US)

Legal status

Prescription Only (S4)(AU) POM(UK) -only(US)

Routes IV, oral

Mechanism of Action

Structure

  • Vancomycin hydrochloride has the structural formula:
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Vancomycin in the drug label.

Pharmacokinetics

  • Vancomycin is poorly absorbed after oral administration. During multiple dosing of 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mg/kg in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%. In anephric subjects with no inflammatory bowel disease who received vancomycin oral solution 2 g for 16 days, blood concentrations of vancomycin were less than or equal to 0.66 μg/mL in 2 of 5 subjects. No measurable blood concentrations were attained in the other 3 subjects. Following doses of 2 g daily, concentrations of drug were >3100 mg/kg in the feces and <1 μg/mL in the serum of subjects with normal renal function who had C. difficile-associated diarrhea. After multiple-dose oral administration of vancomycin, measurable serum concentrations may occur in patients with active C. difficile-associated diarrhea, and, in the presence of renal impairment, the possibility of accumulation exists. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility=

  • At concentrations up to 1000 μg/mL, vancomycin had no mutagenic effect in vitro in the mouse lymphoma forward mutation assay or the primary rat hepatocyte unscheduled DNA synthesis assay. The concentrations tested in vitro were above the peak plasma vancomycin concentrations of 20 to 40 μg/mL usually achieved in humans after slow infusion of the maximum recommended dose of 1 g. Vancomycin had no mutagenic effect in vivo in the Chinese hamster sister chromatid exchange assay (400 mg/kg IP) or the mouse micronucleus assay (800 mg/kg IP).
  • No definitive fertility studies have been conducted.

Clinical Studies

Diarrhea Associated with Clostridium difficile=

  • Efficacy analyses were performed on the Full Analysis Set (FAS), which included randomized subjects who received at least one dose of Vancomycin and had any post-dosing investigator evaluation data (N=259; 134 in Trial 1 and 125 in Trial 2).
  • The demographic profile and baseline CDAD characteristics of enrolled subjects were similar in the two trials. Vancomycin-treated subjects had a median age of 67 years, were mainly white (93%), and male (52%). CDAD was classified as severe (defined as 10 or more unformed bowel movements per day or WBC ≥15000/mm3) in 25% of subjects, and 47% were previously treated for CDAD.
  • Efficacy was assessed by using clinical success, defined as diarrhea resolution and the absence of severe abdominal discomfort due to CDAD, on Day 10. An additional efficacy endpoint was the time to resolution of diarrhea, defined as the beginning of diarrhea resolution that was sustained through the end of the prescribed active treatment period.
  • The results for clinical success for Vancomycin-treated subjects in both trials are shown in TABLE 2.
This image is provided by the National Library of Medicine.
  • The median time to resolution of diarrhea was 5 days and 4 days in Trial 1 and Trial 2, respectively. For subjects older than 65 years of age, the median time to resolution was 6 days and 4 days in Trial 1 and Trial 2, respectively. In subjects with diarrhea resolution at end-of-treatment with Vancomycin, recurrence of CDAD during the following four weeks occurred in 25 of 107 (23%) and 18 of 102 (18%) in Trial 1 and Trial 2, respectively.
  • Restriction Endonuclease Analysis (REA) was used to identify C. difficile baseline isolates in the BI group. In Trial 1, the Vancomycin-treated subjects were classified at baseline as follows 31 (23%) with BI strain, 69 (52%) with non-BI strain, and 34 (25%) with unknown strain. Clinical success rates were 87% for BI strain, 81% for non-BI strain, and 76% for unknown strain. In subjects with diarrhea resolution at end-of-treatment with Vancomycin, recurrence of CDAD during the following four weeks occurred in 7 of 26 subjects with BI strain, 12 of 56 subjects with non-BI strain, and 6 of 25 subjects with unknown strain.

How Supplied

  • Vancomycin CAPSULES are available in:
  • The 125 mg* capsules have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “Vancomycin HCL 125 MG” on the body in white ink. A carton contains 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. NDC No. 62559-310-20.
  • The 250 mg* capsules have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “Vancomycin HCL 250 MG” on the body in white ink. A carton contains 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. NDC No. 62559-311-20.

Storage

  • Store at controlled room temperature, 59° to 86°F (15° to 30°C).

Images

Drug Images

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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

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This image of the FDA label is provided by the National Library of Medicine.
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This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • Patients should be counseled that antibacterial drugs including Vancomycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin or other antibacterial drugs in the future.
  • VANCOCIN® is a registered U.S. trademark owned by ANI Pharmaceuticals, Inc.
  • Rx Only
  • Distributed by:
  • ANI Pharmaceuticals, Inc.
  • Baudette, MN 56623

Precautions with Alcohol

  • Alcohol-Vancomycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Vancocin HCl Pulvules®
  • Vancocin HCl®
  • Vancoled®

Look-Alike Drug Names

  • IV VANC® - INVANZ®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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