HomeNDC LookupIngredientsVancomycin Hydrochloride › 67457-0339-50
Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution — NDC 67457-0339-50 package photo

Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution

by Mylan Institutional LLC · 10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00)
NDC 67457-0339-50
🏷️ FDA NDC (as labeled) 67457-339-50 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Vancomycin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0820-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0805-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 67457-339-50
Product NDC 67457-339
11-digit billing NDC 67457033950
NCPDP billing unit EA — each (per item)
RxCUI 1807513, 1807516
UNII 71WO621TJD
Application # ANDA065397
SPL Set ID 2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf
Established class (EPC) Glycopeptide Antibacterial
Chemical class Glycopeptides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-12-05
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance VANCOMYCIN HYDROCHLORIDE
GCN Seq No 009331
GCN 41280
HICL code 004042
Ingredient (HICL) Vancomycin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1J
Therapeutic class — specific (HIC3) Vancomycin Antibiotics And Derivatives
AHFS code 08:12.28.16
AHFS class Glycopeptide Antibiotics
FDB label name VANCOMYCIN 500 MG VIAL
FDB brand name Vancomycin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 67457-339-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 67457-0339-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Glycopeptide Antibacterial class.

Pharmacologic class Glycopeptide Antibacterial
Drug family (ATC) Antibiotics, Glycopeptide antibacterials, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMylan Institutional LLC
Application holderMYLAN LABORATORIES LTD
FDA applicationANDA065397 (ANDA)
Labeler code67457
First marketedDec 2013
Product typeHuman Prescription Drug
Portfolio167 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name VANCOMYCIN 500 MG VIAL Ingredient Vancomycin Hcl
📖 What it is MedlinePlus · NLM

Vancomycin injection is used to treat certain serious infections caused by bacteria. Vancomycin injection is in a class of medications called glycopeptide antibiotics. It works by killing bacteria that cause infections. Antibiotics such as vancomycin injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on what you're being treated for. If you have a serious infection like a bloodstream infection, heart valve infection, or bone infection, the oral form of vancomycin sim...
  • Why do I need an IV antibiotic — can't I just take a pill?
  • The two biggest things to watch for are changes in your hearing and changes in your urination. If you notice ringing in your ears, muffled hearing, or dizziness, let your doctor kn...
  • What should I watch out for while taking vancomycin?
📖 Read our full Vancomycin guide →
7
Nutrient depletion considerations

Vancomycin Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.305 $23.05 / 10 vials
Medicaid paysCMS SDUD · 12 mo $18.97 $189.72 / 10 vials
Medicare drug plans payPart D · Q2 2026 $4.68 $46.81 / 10 vials
Medicare Part B allowsASP · J3373 $0.033 / J3373 unit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 $2.305 $2.305
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)67457-339-50
11-digit billing NDC67457-0339-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3373
Descriptor10 MG
Billing units / pkg500 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vancomycin Hydrochloride 500 mg 00409-4332-01 Hospira, 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 500 mg/10mL 25021-0150-10 Sagent 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 500 mg/10mL 31722-0210-10 Camber 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 500 mg/10mLthis 67457-0339-50 Mylan 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 500 mg 70436-0020-82 Slate 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 500 mg 70594-0122-02 Xellia 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 500 mg/10mL 71288-0022-11 Meitheal 10 vials $2.305 AP Availability likely
Vancomycin Hydrochloride 513 mg/mg 00143-9161-25 HIKMA 25 vials FDA listed
Vancomycin Hydrochloride 500 mg 00143-9356-25 Hikma 25 vials AP FDA listed
Vancomycin Hydrochloride 500 mg 00404-9965-99 Henry 1 vial AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 43538-0805-10 Eurofarma, 10 vials AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 55150-0203-10 Eugia 10 vials AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 63323-0221-38 Fresenius 25 vials AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 68083-0143-25 Gland 25 vials AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 68462-0955-51 GLENMARK 10 vials AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 00409-6509-49 Hospira, 1 vial AP FDA listed
Vancomycin Hydrochloride 500 mg/10mL 72572-0105-01 Civica, 1 vial AP FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Dec 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 67457-0339-50, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
3.2K
Gross reimbursed last 4 qtrs
$61.6K
Avg / prescription
$56.10
Avg / unit
$18.9731
Latest quarter Q1 2026
236Rx
Medicaid pays / ea
$18.9731
gross reimbursed
vs
NADAC / ea
$2.3054
acquisition cost
=
Spread
+$16.6677
+723% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
45% FFS 55% MCO
Fee-for-service · 494 Rx Managed care · 604 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 38 units · 1.9 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 34 units · 0.3 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 138 units · 3.3 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 248 units · 2.0 per 100k residents IL Indiana: no data reported IN Ohio: 48 units · 0.4 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 13 units · 0.1 per 100k residents NJ Massachusetts: no data reported MA California: 552 units · 1.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 68 units · 1.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 83 units · 3.9 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 110 units · 1.5 per 100k residents TN North Carolina: 97 units · 0.9 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 27 units · 0.6 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,791 units · 5.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.15.9
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Texas 5.9 /100k
2 New Mexico 3.9 /100k
3 Oregon 3.3 /100k
4 Illinois 2.0 /100k
5 Idaho 1.9 /100k
6 Tennessee 1.5 /100k
7 Kentucky 1.5 /100k
8 California 1.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Vancomycin Hydrochloride — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury4,892
Pyrexia4,046
Drug Reaction With Eosinophilia And Systemic Symptoms2,695
Renal Failure2,468
Diarrhoea2,392
Sepsis2,383
Pneumonia2,235

Age at onset

Neonate412
Infant290
Child601
Adolescent347
Adult4,320
Elderly2,570

Reporter sex

65,520 reports
Male · 54%
Female · 45%
Unknown · 1%

Serious outcomes

Hospitalization34,799
Life-threatening9,326
Disabling1,408
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 5,210 2,096
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
67457-0339-50 You're viewing this 10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00) 2013-12-05 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE 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. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.

Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.

Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis . For endocarditis caused by enterococci (e.g., E. faecalis ), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis.

Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To 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 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis.

Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min, are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events.

An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS ). Infusion-related events may occur, however, at any rate or concentration. Patients With Normal Renal Function Adults The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours.

Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. Pediatric patients The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.

Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients. Neonates In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower.

In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases.

Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients. Patients With Impaired Renal Function and Elderly Patients Dosage adjustment must be made in patients with impaired renal function.

In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table). DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al.

1 ) Creatinine Clearance mL/min Vancomycin Dose mg/24 hr 100 1,545 90 1,390 80 1,235 70 1,080 60 925 50 770 40 620 30 465 20 310 10 155 The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations.

The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

When only serum creatinine is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

Men: [ Weight (kg) x (140 - age in years)] 72 x serum cr…

Contraindications 15 words

CONTRAINDICATIONS Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.

⚠️ Warnings ~2 min read

WARNINGS Infusion Reactions Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest. 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. Stopping the infusion usually results in prompt cessation of these reactions.

Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients, especially patients with underlying renal impairment, patients with co-morbidities that predispose to renal impairment, and patients receiving concomitant therapy with a drug known to be nephrotoxic.

Ototoxicity Ototoxicity has occurred in patients receiving vancomycin hydrochloride for injection. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside.

Vancomycin should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations. Dosage of vancomycin hydrochloride for injection must be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ). Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin.

Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin hydrochloride for injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. Clostridium Difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including vancomycin hydrochloride for injection, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Hemorrhagic Occlusive Retinal Vasculitis (HORV) Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials.

Vancomycin is not indicated for the prophylaxis of endophthalmitis.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Infusion-Related Events During or soon after rapid infusion of vancomycin hydrochloride for injection, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY ), wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

Such events are infrequent if vancomycin hydrochloride for injection is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride for injection was administered at a rate of 10 mg/min or less. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI).

The risk of AKI increases as systemic exposure/serum levels increase. Additional risk factors for AKI in patients receiving vancomycin include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-exiting renal impairment, or with co-morbidities that predispose to renal impairment. Interstitial nephritis has also been reported in patients receiving vancomycin.

Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ). Ototoxicity A few dozen cases of hearing loss associated with vancomycin have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug.

Vertigo, dizziness, and tinnitus have been reported rarely. Hematopoietic Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued.

Thrombocytopenia has rarely been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm 3 ) has been reported rarely. Phlebitis Inflammation at the injection site has been reported.

Miscellaneous Patients have been reported to have had anaphylaxis, drug fever, nausea, chills, eosinophilia, rashes including exfoliative dermatitis, Stevens-Johnson syndrome (see WARNINGS, Severe Dermatologic Reactions ), and vasculitis in association with the administration of vancomycin. Chemical peritonitis has been reported following intraperitoneal administration (see PRECAUTIONS ) Post Marketing Reports 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 possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) (see WARNINGS, Severe Dermatologic Reactions ). To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov.

🆘 Overdosage 101 words

OVERDOSAGE Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice. 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 in your patient.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Vancomycin is poorly absorbed after oral administration. In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL 2 hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL 2 hours after infusion, and mean plasma concentrations of about 10 mcg/mL 6 hours after infusion.

The plasma concentrations during multiple dosing are similar to those after a single dose. The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration.

Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days.

The distribution coefficient is from 0.3 to

0.43L/kg. There is no apparent metabolism of the drug. About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in 6 hours.

Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials (see PRECAUTIONS ). Total systemic and renal clearance of vancomycin may be reduced in the elderly.

Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After IV administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.

MICROBIOLOGY The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics.

Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi. Synergy The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many strains of Staphylococcus aureus , Streptococcus bovis, enterococci, and the viridans group streptococci . Vancomycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic gram-positive microorganisms Diphtheroids Enterococci (e.g., Enterococcus faecalis ) Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains) Streptococcus bovis Viridans group streptococci The following in vitro data are available, but their clinical significance is unknown . Vancomycin exhibits in vitro MIC's of 1 mcg/mL or less against most (≥ 90%) strains of streptococci listed below and MIC's of 4 mcg/mL or less against most (≥ 90%) strains of other listed microorganisms; however, the safety and effectiveness of vancomycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Aerobic gram-positive microorganisms Listeria monocytogenes Streptococcus pyogenes Streptococcus pneumoniae (…

📦 How Supplied / Storage and Handling 99 words

HOW SUPPLIED/STORAGE AND HANDLING Vancomycin Hydrochloride for Injection, USP is supplied as a sterile powder in single-dose flip top vials that contain the vancomycin equivalent of either 500 mg or 1 g. 67457-339-50 - Vancomycin Hydrochloride for Injection, USP equivalent to 500 mg vancomycin in a 10 mL flip top vial in packages of 10 vials. 67457-340-01 - Vancomycin Hydrochloride for Injection, USP equivalent to 1 g vancomycin in a 20 mL flip top vial in packages of 10 vials.

Storage: Prior to reconstitution, store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

📋 Description 209 words

DESCRIPTION Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5.

It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION ), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ) .

The chemical name for vancomycin hydrochloride is (S a )-(3 S ,6 R ,7 R ,22 R ,23 S ,26 S ,36 R ,38a R )-44-[[2- O -(3-Amino-2,3,6-trideoxy-3- C -methyl-α-L- lyxo -hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2 R )-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]oxadiazacyclohexadecino[4,5- m ] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride.

The molecular formula is C 66 H 75 Cl 2 N 9 O 24 • HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula: structural formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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