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VANCOMYCIN HYDROCHLORIDE 5.13 g/g Injection, Powder, For Solution, 1 vial

by HIKMA PHARMACEUTICALS USA INC. · 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE

NDC 00143-9163-01

🏷️ FDA NDC (as labeled) 0143-9163-01 billing pads the labeler segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

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) 0143-9163-01

Product NDC 0143-9163

11-digit billing NDC 00143916301

NCPDP billing unit EA — each (per item)

RxCUI 239209

UNII 71WO621TJD

UPC 0301439163015, 0301439164012

Application # NDA210274

SPL Set ID e4ce7b87-fab4-4b7a-b121-eba136c464ce

Established class (EPC) Glycopeptide Antibacterial

Chemical class Glycopeptides

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-02-03

Route INTRAVENOUS, ORAL

Dosage form INJECTION, POWDER, FOR SOLUTION

Substance VANCOMYCIN HYDROCHLORIDE

GPI-14 16280080102125

GCN Seq No 009330

GCN 41283

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 HCL 5 GM VIAL

FDB brand name Vancomycin Hcl

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 0143-9163-01 — a 4-4-2 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 labeler segment → 00143-9163-01. 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

LabelerHIKMA PHARMACEUTICALS USA INC.

Application holderZHEJIANG NOVUS PHARMACEUTICALS CO LTD

FDA applicationNDA210274 (NDA)

Labeler code00143

First marketedFeb 2023

Product typeHuman Prescription Drug

Portfolio726 products on file

🔎 All NDCs from HIKMA PHARMACEUTICALS USA INC.

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 HCL 5 GM VIAL Ingredient Vancomycin Hcl

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Vancomycin Hydrochloride — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Vancomycin Hydrochloride (50 interactions) — ranked by severity →

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.

BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion +2 more

🧪 Full Vancomycin Hydrochloride nutrient depletion report →

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.
0.5 mg / 1 g UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
1.25 g / 1 g UNII B8WCK70T7I
Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.

3 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 DailyMed — ingredient 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$6.03	—
Medicare drug plans payPart D · Q2 2026	$57.21	—
Medicare Part B allowsASP · J3376	$0.017 / J3376 unit	—

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)0143-9163-01

11-digit billing NDC00143-9163-01

Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)

HCPCS J-codeJ3376

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Vancomycin Hydrochloride 5.13 g/gthis 00143-9163-01	HIKMA	1 vial	—	—	FDA listed	—
Vancomycin Hydrochloride 10.25 g/g 00143-9164-01	HIKMA	1 vial	—	—	FDA listed	—
Vancomycin Hydrochloride 10 g 00143-9359-01	Hikma	1 injection	—	AP	FDA listed	—
Vancomycin Hydrochloride 500 mg/5mL 00409-1319-01	Hospira,	1 vial	—	AP	FDA listed	—
Vancomycin Hydrochloride 500 mg/5mL 00409-5017-01	Hospira,	1 vial	—	AP	Discontinued	—
Vancomycin 10 g/100mL 25021-0158-99	Sagent	1 bottle	—	AP	FDA listed	—
Vancomycin Hydrochloride 10 g 55150-0206-99	Eugia	1 vial	—	AP	FDA listed	—
Vancomycin Hydrochloride 10 g/100mL 63323-0314-61	Fresenius	1 bottle	—	AP	FDA listed	—
Vancomycin Hydrochloride 100 g 66288-7100-01	SAMSON	1 injection	—	—	FDA listed	—
Vancomycin Hydrochloride 10 g/100mL 67457-0342-10	Mylan	1 vial	—	AP	FDA listed	—
Vancomycin Hydrochloride 10 g 68001-0407-75	BluePoint	1 vial	—	AP	FDA listed	—
Vancomycin Hydrochloride 10 g/100mL 68083-0570-01	Gland	1 bottle	—	AP	FDA listed	—
Vancomycin Hydrochloride 10 g 70436-0023-82	Slate	1 vial	—	AP	FDA listed	—
Vancomycin Hydrochloride 10 g/95mL 71288-0026-75	Meitheal	1 vial	—	AP	FDA listed	—
Vancomycin Hydrochloride 500 mg/5mL 72572-0207-01	Civica,	1 vial	—	AP	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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

🏛️

2023

On the market since

Feb 2023

📍

2026

Currently FDA-listed

3 years listed

🔒

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 00143-9163-01, 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

465

Units reimbursed last 4 qtrs

4.2K

Gross reimbursed last 4 qtrs

$25.1K

Avg / prescription

$53.89

Avg / unit

$6.0352

Latest quarter Q1 2026

136Rx

Fee-for-service vs managed care ⓘ

29% FFS 71% MCO

Fee-for-service · 135 Rx Managed care · 330 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.053.5

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 Massachusetts 53.5 /100k

2 Kentucky 1.6 /100k

3 Illinois 1.2 /100k

4 Utah 0.8 /100k

5 Ohio 0.5 /100k

6 Arizona 0.5 /100k

7 Pennsylvania 0.3 /100k

8 Missouri 0.1 /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

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

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 NDC	Description	Marketing start	Status
00143-9163-01 You're viewing this	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE	2023-02-03	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 0143-9163-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00143-9163-01, written without dashes as 00143916301. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00143-9163-01, the first segment (00143) is the labeler code FDA assigned to HIKMA PHARMACEUTICALS USA INC.; the middle segment (9163) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HIKMA PHARMACEUTICALS USA INC.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

HIKMA PHARMACEUTICALS USA INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J3376 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of: o Septicemia ( 1.1 ) o Infective Endocarditis ( 1.2 ) o Skin and Skin Structure Infections ( 1.3 ) o Bone Infections ( 1.4 ) o Lower Respiratory Tract Infections ( 1.5 ) Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of: o Clostridioides difficile -associated diarrhea ( 1.6 ) o Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) ( 1.7 ) Limitations of Use ( 1.8 ) Vancomycin Hydrochloride for Injection administered intravenously is not approved for the treatment of C. difficile -associated diarrhea and enterocolitis caused by susceptible isolates of Staphylococcus aureus because it is not effective.

Vancomycin Hydrochloride for Injection administered orally is not approved for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections because it is not effective. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

( 1.9 )

1.1Septicemia Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of septicemia due to: Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

1.2Infective Endocarditis Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of infective endocarditis due to: Susceptible isolates of MRSA. Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use Vancomycin Hydrochloride for Injection in combination with an aminoglycoside.

Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside.

1.3Skin and Skin Structure Infections Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of skin and skin structure infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

1.4Bone Infections Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of bone infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosp…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Pharmacy Bulk Package. Not for direct intravenous infusion See full prescribing information for important information on intravenous and oral administration, preparation and storage instructions ( 2.1 , 2.5 , 2.8 ). Recommended Dosage and Administration Intravenous Use: o Administer Vancomycin Hydrochloride for Injection in a diluted solution by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions. o Adult Patients: 2 grams (g) divided either as 0.5 g every 6 hours or 1 g every 12 hours ( 2.2 ) o Pediatric Patients (1 month and older): 10 mg/kg per dose given every 6 hours ( 2.2 ) o Pediatric Patients (younger than 1 month of age): See full prescribing information for recommended dosage ( 2.2 ) o Patients with Renal Impairment: See full prescribing information for recommended dosage in patients with renal impairment ( 2.4 ) Oral use: Adult Patients (18 years of age or greater): o C. difficile Associated Diarrhea: 125 mg administered orally 4 times daily for 10 days ( 2.3 ). o Staphylococcal enterocolitis: 500 mg to 2 grams administered orally in 3 or 4 divided doses for 7 to 10 days ( 2.3 ) Pediatric Patients (less than 18 years of age): o For both C. difficile -associated diarrhea and staphylococcal enterocolitis: 40 mg/kg in 3 or 4 divided doses for 7 days to 10 days.

The total daily dosage should not exceed 2 g ( 2.3 )

2.1Important Administration Instructions for Intravenous Use Vancomycin Hydrochloride for Injection is supplied in pharmacy bulk packages. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents of Vancomycin Hydrochloride for Injection pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion.

The Pharmacy Bulk Package is NOT for direct infusion. Further dilution is required before use [see Dosage and Administration ( 2.4 )] . To reduce the risk of infusion related adverse reactions, administer diluted Vancomycin Hydrochloride for Injection by intravenous infusion over 60 minutes or greater [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 )] .

Diluted Vancomycin Hydrochloride for Injection concentrations of no more than 5 mg/mL are recommended in adults [see Dosage and Administration ( 2.2 )] . See also age-specific recommendations [see Dosage and Administration ( 2.2 , 2.3 )] . In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used.

Infusion related events may occur, however, at any rate or concentration [see Warnings and Precautions ( 5.5 )] . Other drugs should not be added to the Vancomycin Hydrochloride for Injection Pharmacy Bulk Package or the diluted Vancomycin Hydrochloride for Injection [see Dosage and Administration ( 2.7 )] . Administer diluted Vancomycin Hydrochloride for Injection prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions ( 5.5 )] .

Administer diluted Vancomycin Hydrochloride for Injection by a secure intravenous route of administration to avoid local irritation and phlebitis reactions [see Warnings and Precautions ( 5.6 )] .

2.2Intravenous Dosage in Adult and Pediatric Patients with Normal Renal Function Dosage in Adult Patients The usual daily intravenous dose is 2 grams (g) divided either as 500 mg every 6 hours or 1 g every 12 hours. Administer each dose by intravenous infusion over a period of 60 minutes or greater. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

Dosage in Pediatric Patients Aged 1 Month and Older 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.

Dosage in Pediatric…

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Vancomycin Hydrochloride for Injection, in a Pharmacy Bulk Package is a sterile white, almost white to tan to brown spray-dried powder in vials each containing vancomycin hydrochloride equivalent to 5 g or 10 g vancomycin base. Vancomycin Hydrochloride for Injection: Pharmacy Bulk Package vial containing vancomycin hydrochloride equivalent to 5 gram or 10 gram of vancomycin base ( 3 )

⛔ Contraindications 27 words ▾

4 CONTRAINDICATIONS Vancomycin Hydrochloride for Injection is contraindicated in patients with known hypersensitivity to vancomycin and polysorbate 80. Hypersensitivity to vancomycin, and polysorbate 80 ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Nephrotoxicity : Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. Monitor serum vancomycin concentrations and renal function in patients receiving Vancomycin Hydrochloride for Injection intravenously. Monitor renal function in patients over 65 years of age receiving Vancomycin Hydrochloride for Injection orally.

( 5.1 ) Ototoxicity : Ototoxicity has occurred in patients administered vancomycin intravenously or orally. Monitor for signs and symptoms of ototoxicity during oral or intravenous therapy. Assessment of auditory function may be appropriate in some instances.

( 5.2 ) Severe Dermatologic Reactions: Discontinue Vancomycin Hydrochloride for Injection at the first appearance of skin rashes, mucosal lesions, or blisters ( 5.3 ). Neutropenia: This has been reported in patients administered vancomycin intravenously or orally. Periodically monitor leukocyte count.

( 5.4 ) Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular, chest pain and vancomycin infusion reaction which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Hydrochloride for Injection in a diluted solution over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1 , 5.5 ) Phlebitis : To reduce the risk of local irritation and phlebitis administer Vancomycin Hydrochloride for Injection by a secure intravenous route of administration.

( 5.6 ) Clostridioides difficile -Associated Diarrhea : Evaluate patients if diarrhea occurs. ( 5.7 ) Development of Drug-Resistant Bacteria : Prescribing Vancomycin Hydrochloride for Injection 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. ( 5.9 )

5.1Nephrotoxicity Vancomycin Hydrochloride for Injection administered intravenously or orally can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifested by increasing blood urea nitrogen (BUN) and serum creatinine (Cr). The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions ( 7.2 )] , volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment.

Monitor serum vancomycin concentrations and renal function in all patients receiving Vancomycin Hydrochloride for Injection intravenously. Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatine increased) has occurred following oral vancomycin hydrochloride capsule therapy in randomized controlled clinical studies and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients >65 years of age [see Adverse Reactions ( 6.1 ) and Use in Specific Populations ( 8.5 )] .

In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with oral Vancomycin Hydrochloride for Injection therapy to detect potential vancomycin induced nephrotoxicity. More frequent monitoring is recommended in patients with comorbidities that predispose to impairment in renal function or are concomitantly receiving other nephrotoxic drugs, in critically ill patients, in patients with changing renal function, and in patients requiring higher therapeutic vancomycin levels.

If acute kidney injury occurs, discontinue Vancomycin Hydrochlo…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrotoxicity [see Warnings and Precautions ( 5.1 )] Ototoxicity [see Warnings and Precautions ( 5.2 )] Severe Dermatologic Reactions [see Warnings and Precautions ( 5.3 )] Neutropenia [see Warnings and Precautions ( 5.4 )] Infusion Reactions [see Warnings and Precautions ( 5.5 )] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.7 )] The common adverse reactions following i ntravenously, and orally administered vancomycin were acute kidney injury, hearing loss, neutropenia, anaphylaxis, vancomycin infusion reaction.

( 6.1 ) The most common adverse reaction of orally administered vancomycin (> 10%) were nausea, abdominal pain, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Injectables USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients Receiving Intravenously and Orally Administered Vancomycin The following adverse reactions associated with the use of intravenously and orally administered vancomycin were identified in clinical trials: Renal and urinary disorders: Acute kidney injury and interstitial nephritis [see Warnings and Precautions ( 5.1 )] Ear and labyrinth disorders: Tinnitus, hearing loss, vertigo [see Warnings and Precautions ( 5.2 )] Skin and subcutaneous tissue disorders: Erythema (especially of the face, neck and upper torso) and pruritus which are manifestations of rashes including exfoliative dermatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), Linear IgA bullous dermatosis (LABD) [see Warnings and Precautions ( 5.3 )] .

Blood and lymphatic system disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia [see Warnings and Precautions ( 5.4 )] Immune system disorders: Hypersensitivity reactions including anaphylaxis and vancomycin infusion reaction [see Warnings and Precautions ( 5.5 )] General disorders and administration site conditions: General discomfort, fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration.

Vancomycin Hydrochloride for Injection is not approved for intramuscular and intraperitoneal administration [see Warnings and Precautions ( 5.6 )] Gastrointestinal disorders: Pseudomembranous colitis [see Warnings and Precautions ( 5.7 )] Cardiac disorders: Cardiac arrest, chest pain Laboratory abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and connective tissue disorders: Muscle pain Nervous system disorders: Dizziness Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea Vascular disorders: Hypotension, shock, vasculitis Adverse Reactions in Patients Receiving Oral Administration of Vancomycin Hydrochloride Capsules The data described below reflect exposure to vancomycin hydrochloride capsules 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 hydrochloride capsules 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. Adverse reactions occurring in ≥5% of vancomycin hydrochloride capsules-treated subjects are shown in Table 2. The most common adverse reactions associated with vancomycin hydrochloride capsules (≥10%) were nausea, abdominal pain, and hypokalemia.

Table 2: Comm…

🔄 Drug Interactions 161 words ▾

7 DRUG INTERACTIONS Anesthetic Agents : Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. ( 2.1 , 7.1 ) Piperacillin/Tazobactam : Increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients ( 7.2 )

7.1Anesthetic Agents Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.4 )] .

7.2Piperacillin-Tazobactam Studies have detected an increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients receiving concomitant piperacillin/tazobactam and Vancomycin Hydrochloride for Injection. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin.

7.3Ototoxic and/or Nephrotoxic Drugs Concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs requires more frequent monitoring of renal function.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on vancomycin use in pregnant women to inform a drug associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data) .

Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology ( 12.3 )] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin for suspected or documented methicillin-resistant Staphylococcus-aureus (MRSA) infections in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls.

No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin intravenously at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g).

No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition.

Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. 1 No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively).

Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). There were no oral embryo-fetal toxicity studies conducted in animals with this Vancomycin Injection product.

8.2Lactation Risk Summary Vancomycin is present in human milk following intravenous administration, however, there are insufficient data to inform the levels. There are no available data on vancomycin presence in milk following oral administration. Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology ( 12.3 )] .

There are no data on the effects of vancomycin on the breastfed infant or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Vancomycin Hydrochloride for Injection and any potential adverse effects on the breastfed infant from Vancomycin Hydroch…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 186 words ▾

8.4Pediatric Use Vancomycin Hydrochloride for Injection administered intravenously is indicated in pediatric patients less than 18 years of age for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections [see Indications and Usage ( 1.1 to 1.5 ) and Dosage and Administration ( 2.2 )] . Vancomycin Hydrochloride for Injection administered orally is indicated in pediatric patients less than 18 years of age for the treatment of Clostridioides difficile -associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) [see Indications and Usage ( 1.6 , 1.7 ) and Dosage and Administration ( 2.3 )] .

In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin Hydrochloride for Injection intravenously [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . More severe infusion related reactions related to Vancomycin Hydrochloride for Injection administration may occur in pediatric patients. Concomitant administration of vancomycin and intravenous anesthetic agents has been associated with erythema and histamine-like flushing in all patients including pediatric patients [see Warnings and Precautions ( 5.5 )] .

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Clinical studies with another vancomycin hydrochloride drug product in C. difficile -associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with Vancomycin Hydrochloride for Injection to detect potential vancomycin induced nephrotoxicity [see Warnings and Precautions ( 5.1 )] and Adverse Reactions ( 6.1 )] .

Patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger. Clinicians should be aware of the importance of appropriate duration of Vancomycin Hydrochloride for Injection treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely. Vancomycin Hydrochloride for Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see Dosage and Administration ( 2.4 )] , and it may be useful to monitor renal function [see Warnings and Precautions ( 5.1 )] .

🆘 Overdosage 51 words ▾

10 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. For current information on the management of overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics The pharmacodynamics of vancomycin is unknown.

12.3Pharmacokinetics General Pharmacokinetics 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 like those after a single dose. Absorption 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 eual to 0.66 mcg/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 mcg/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. diffifile -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 [see Use in Specific Populations ( 8.5 )] .

Distribution The volume of distribution ranges from 0.3 to

0.43L/kg after intravenous administration. Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After intravenous 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. Elimination Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.

In anephric patients, the mean elimination half-life is 7.5 days. Total body and renal clearance of vancomycin may be reduced in the elderly. Metabolism There is no apparent metabolism of vancomycin.

Excretion In the first 24 hours after intravenous administration, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Renal impairment slows excretion of vancomycin.

12.4Microbiology Mechanism of Action The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. Resistance Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.

There is no cross-resistance between vancomycin and other antibacterials. C. difficile Isolates of C. difficile generally have vancomycin minimal inhibitory concentrations (MICs) of < 1 mcg/mL; however, vancomycin MICs ranging from 4 mcg/mL to 16 mcg/mL have been…

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How supplied Vancomycin Hydrochloride for Injection is a white, almost white to tan to brown, sterile spray-dried powder in Pharmacy Bulk Package vials each containing vancomycin hydrochloride equivalent to 5 g or 10 g of vancomycin base. The vial stopper is not made with natural rubber latex. NDC No.

Strength Unit of Sale 0143-9163-01 Vancomycin Hydrochloride for Injection, equivalent to 5 g vancomycin in a Pharmacy Bulk Package vial, packaged individually. 0143-9164-01 Vancomycin Hydrochloride for Injection, equivalent to 10 g vancomycin in a Pharmacy Bulk Package vial, packaged individually. Storage Store at 20°C to 25°C (68°F to 77°F).

Brief exposure to 15°C to 30°C (59°F to 86°F) is permitted [See USP Controlled Room Temperature]. Storage after reconstitution and dilution is described elsewhere in the labeling [see Dosage and Administration ( 2.5 , 2.8 )] .

📋 Description ~1 min read ▾

11 DESCRIPTION Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial 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-Dglucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38atetradecahydro-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-dimetheno1 H ,16 H -[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26carboxylic 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: Vancomycin Hydrochloride for Injection, 5 g and 10 g, in Pharmacy Bulk Package, is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in vials. Each 5 g vial contains 5 g vancomycin (equivalent to 5.13 g vancomycin hydrochloride), 1.25 g trehalose, 0.5 mg polysorbate 80, and hydrochloric acid used to adjust the pH.

Each 10 g vial contains 10 g vancomycin (equivalent to 10.25 g vancomycin hydrochloride), 2.5 g trehalose, 1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration ( 2.5 , 2.8 )] . A pharmacy bulk package is a sterile dosage form containing many single doses.

The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. Vancomycin Hydrochloride for Injection is for intravenous or oral administration. Vancomycin Hydrochloride for Injection must be diluted with an appropriate diluent prior to intravenous administration [see Dosage and Administration ( 2.5 )] .

Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration ( 2.8 )] . structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Acute Kidney Injury Advise patients that Vancomycin Hydrochloride for Injection can result in kidney damage and that blood tests are required to monitor vancomycin blood levels and kidney function during therapy [see Warnings and Precautions ( 5.1 )] . Hearing Loss or Balance Problems Advise patients that Vancomycin Hydrochloride for Injection may result in decreased hearing and to report hearing loss or balance problems to their health care provider [see Warnings and Precautions ( 5.2 )] .

Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Hydrochloride for Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters [see Warnings and Precautions ( 5.3 )] . Infusion Reactions During or After Intravenous Use Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during Vancomycin Hydrochloride for Injection infusion. [see Warnings and Precautions ( 5.5 )].

Diarrhea Diarrhea is a common problem caused by antibacterial drugs, including vancomycin, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs during treatment with Vancomycin Hydrochloride for Injection, patients should contact their physician as soon as possible [see Warnings and Precautions ( 5.7 )].

Antibacterial Resistance Patients should be counseled that antibacterial drugs including Vancomycin Hydrochloride for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Hydrochloride for Injection 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 Hydrochloride for Injection or other antibacterial drugs in the future. Manufactured by: Zhejiang Novus Pharmaceuticals Co., Ltd. No.

125, Yuezhong Rd, Lihai Subdistrict, Yuecheng District, Shaoxing, 312366, Zhejiang, China

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

bactericidal: Describes a medicine that kills bacteria outright.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diluent: The liquid used to dissolve or thin a medicine before it is given.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

infusion reaction: Symptoms such as fever, chills, rash, or trouble breathing that happen while or shortly after a medicine is given through a vein.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

intramuscular: An injection given deep into a muscle; often written as IM.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

nephrotoxicity: Damage to the kidneys caused by a medicine or other substance.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

ototoxicity: Harm to the ear caused by a medicine, which can affect hearing or balance.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

pseudomembranous colitis: A serious swelling of the large intestine, usually caused by C. difficile bacteria, that leads to severe diarrhea.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

septicemia: An older term for blood poisoning, meaning germs have gotten into the bloodstream and are multiplying there.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

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

← 00143-9162-10 · HIKMA 00143-9164-01 · HIKMA →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

VANCOMYCIN HYDROCHLORIDE 5.13 g/g Injection, Powder, For Solution, 1 vial

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8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

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