HomeNDC LookupIngredientsNafcillin Sodium › 63323-0328-22
Nafcillin 2 g/8mL Injection, Powder, Lyophilized, For Solution — NDC 63323-0328-22 package photo

Nafcillin 2 g/8mL Injection, Powder, Lyophilized, For Solution

by Fresenius Kabi USA, LLC · 10 VIAL in 1 CARTON (63323-328-22) / 8 mL in 1 VIAL
NDC 63323-0328-22
🏷️ FDA NDC (as labeled) 63323-328-22 billing pads the product segment with a zero
This package
Contains8 mL in 1 vial Pack sizes2 compare ↓
Also priced by: Part D plans $9.11/unit — full pricing hub ↓
Also comes in: 10 vials 63323-0328-20
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 63323-328-22
Product NDC 63323-328
11-digit billing NDC 63323032822
NCPDP billing unit EA — each (per item)
RxCUI 1721460
UNII 49G3001BCK
Application # ANDA090002
SPL Set ID c39721a3-7b22-4720-9dbd-bc82f03d2af7
Established class (EPC) Penicillin-class Antibacterial
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-30
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance NAFCILLIN SODIUM
GPI-14 01300040102115
GPI class Nafcillin Sodium
GCN Seq No 008968
GCN 39462
HICL code 003957
Ingredient (HICL) Nafcillin Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.12
AHFS class Penicillinase-Resistant Penicillins
FDB label name NAFCILLIN 2 GM VIAL
FDB brand name Nafcillin Sodium
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 63323-328-22 — 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 → 63323-0328-22. 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 Penicillin-class Antibacterial class.

Pharmacologic class Penicillin-class Antibacterial
Drug family (ATC) Beta-lactamase resistant penicillins
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

LabelerFresenius Kabi USA, LLC
Application holderISTITUTO BIOCHIMICO ITALIANO SPA
FDA applicationANDA090002 (ANDA)
Labeler code63323
First marketedJun 2011
Product typeHuman Prescription Drug
Portfolio554 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 NAFCILLIN 2 GM VIAL Ingredient Nafcillin Sodium
📖 What it is MedlinePlus · NLM

Nafcillin injection is used to treat infections caused by certain types of bacteria. Nafcillin injection is in a class of medications called penicillins. It works by killing bacteria. Antibiotics such as nafcillin injection will not work for colds, flu, or other viral infections. Taking 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
  • Nafcillin is used specifically for infections caused by staphylococci — a type of bacteria — that have become resistant to regular penicillin. These 'penicillinase-producing' staph...
  • What kind of infection is nafcillin used for?
  • NAFCILLIN Injection is formulated to be given directly into a vein (IV) or into a muscle (IM). This route allows the medication to get into your bloodstream quickly and reach effec...
  • Why is it given as an injection instead of a pill?
📖 Read our full Nafcillin Injection guide →
7
Nutrient depletion considerations

Nafcillin Sodium 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.

  • 40 mg / 8 mL UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.

1 inactive ingredient 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $9.11 $728.87 / 80 ml
Medicare Part B allowsASP · J2290 $0.047 / J2290 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)63323-328-22
11-digit billing NDC63323-0328-22
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2290
DescriptorINJECTION, NAFCILLIN SODIUM, 20 MG
Billing units / pkg100 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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
Nafcillin 2 g/100mL 00338-1019-48 Baxter 100 ml FDA listed
Nafcillin 2 g/8mL 23155-0907-41 Heritage 10 vials AP FDA listed
Nafcillin 2 g 44567-0222-10 WG 10 vials AP FDA listed
Nafcillin 2 g/8mL 55150-0123-16 Eugia 10 vials AP FDA listed
Nafcillin 2 g/8mLthis 63323-0328-22 Fresenius 10 vials AP FDA listed
Nafcillin Sodium 2 g 72485-0406-10 Armas 10 vials AP FDA listed
Nafcillin 2 g/8mL 72603-0453-01 NorthStar 1 vial AP FDA listed
Nafcillin Sodium 2 g 83270-0310-10 ONESOURCE 10 vials 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

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 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 by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials63323-0328-20 50 Rx · $37,139
Drug total (last 4 qtrs): 50 Rx · 529 units · $37,139 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nafcillin Sodium (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nafcillin Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$479.9K
Claims incl. refills
673
Beneficiaries
203
Spend / beneficiary
$2,363.82
Spend / claim
$713.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Nafcillin (this brand).

Top reported reactions

Renal Failure Acute64
Rash56
Acute Kidney Injury49
Pyrexia44
Tubulointerstitial Nephritis43
Hypokalaemia42
Renal Failure39

Age at onset

Neonate15
Infant5
Child3
Adolescent1
Adult32
Elderly12

Reporter sex

918 reports
Male · 64%
Female · 33%
Unknown · 3%

Serious outcomes

Hospitalization465
Life-threatening82
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 62 0
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
63323-0328-20 10 VIAL in 1 CARTON (63323-328-20) / 8 mL in 1 VIAL (63323-328-21) 2011-06-30 Active
63323-0328-22 You're viewing this 10 VIAL in 1 CARTON (63323-328-22) / 8 mL in 1 VIAL 2011-06-30 Active

Pack size FAQ

What quantity is in NDC 63323-0328-22?
NDC 63323-0328-22 is listed by the FDA — 10 vial in 1 carton / 8 ml in 1 vial.
What NDC number is used to bill for this package of Nafcillin 2 g/8mL Injection, Powder, Lyophilized, For Solution?
Bill NDC 63323-0328-22 — the 11-digit billing format is 63323032822. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 63323-328-22, 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: 63323-0328-22, written without dashes as 63323032822. 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 63323-0328-22, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0328) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) 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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (63323-0328-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 J2290 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 168 words

INDICATIONS AND USAGE: Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY , Susceptibility Testing ). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G.

If the susceptibility tests indicate that the infection is due to a methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection 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.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION: Nafcillin for Injection is available for intramuscular and intravenous use. The usual IV dosage for adults is 500 mg every 4 hours. For severe infections, 1 gram every 4 hours is recommended.

Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation. Recommended Dosage for Nafcillin for Injection, USP Drug Adults Infants and Children <40 kg (88 lbs) Other Recommendations Nafcillin 500 mg IM every 4 to 6 hours. IV every 4 hours 25 mg/kg IM twice daily Neonates 10 mg/kg IM twice daily Nafcillin 1 gram IM or IV every 4 hours (severe infections) Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed.

Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not add supplementary medication to Nafcillin for Injection, USP.

Contraindications 14 words

CONTRAINDICATIONS: A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

⚠️ Warnings ~1 min read

WARNINGS: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with nafcillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, nafcillin should be discontinued and appropriate therapy instituted. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Nafcillin 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.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS: Body as a Whole The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (see WARNINGS ). Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk or vaccines.

Two types of allergic reactions to penicillins are noted clinically, immediate and delayed. Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioedema, laryngospasm, bronchospasm, hypotension, vascular collapse, and death. Such immediate anaphylactic reactions are very rare (see WARNINGS ) and usually occur after parenteral therapy but have occurred in patients receiving oral therapy.

Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever. Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy.

Manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy. Local Reactions Pain, swelling, inflammation, phlebitis, thrombophlebitis, and occasional skin sloughing at the injection site have occurred with intravenous administration of nafcillin (see DOSAGE AND ADMINISTRATION ).

Severe tissue necrosis with sloughing secondary to subcutaneous extravasation of nafcillin has been reported. Nervous System Reactions Neurotoxic reactions similar to those observed with penicillin G could occur with large intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see PRECAUTIONS ). Nephrotoxicity Renal tubular damage and interstitial nephritis have been associated with the administration of nafcillin.

Manifestations of nephrotoxicity are hematuria, proteinuria, and acute kidney injury, and may be associated with rash, fever, and eosinophilia. The majority of cases resolve upon discontinuation of nafcillin. Some patients, however, may require dialysis treatment and may develop permanent renal damage.

Hepatic Reactions Elevation of liver transaminases and/or cholestasis may occur, especially with administration of high doses of nafcillin. Gastrointestinal Reactions Pseudomembranous colitis has been reported with the use of nafcillin. The onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ).

Metabolic Reactions Agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of nafcillin. To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov .

Nervous System Reactions Neurotoxic reactions similar to those observed with penicillin G could occur with large intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see PRECAUTIONS ).

Nephrotoxicity Renal tubular damage and interstitial nephritis have been associated with the administration of nafcillin. Manifestations of nephrotoxicity are hematuria, proteinuria, and acute kidney injury, and may be associated with rash, fever, and eosinophilia. The majority of cases resolve upon discontinuation of nafcillin. Some patients, however, may require dialysis treatment and may develop permanent renal damage.

Hepatic Reactions Elevation of liver transaminases and/or cholestasis may occur, especially with administration of high doses of nafcill…

🆘 Overdosage 58 words

OVERDOSAGE Neurotoxic reactions similar to those observed with penicillin G may arise with intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see PRECAUTIONS ). In the case of overdosage, discontinue nafcillin, treat symptomatically and institute supportive measures as required. Hemodialysis does not increase the rate of clearance of nafcillin from the blood.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY: In a study of five healthy adults administered a single 500 mg dose of nafcillin by intravenous injection over seven minutes, the mean plasma concentration of the drug was approximately 30 mcg/mL at 5 minutes after injection. The mean area under the plasma concentration-versus-time curve (AUC) for nafcillin in this study was 18.06 mcg • h/mL. The serum half-life of nafcillin administered by the intravenous route ranged from 33 to 61 minutes as measured in three separate studies.

In contrast to the other penicillinase-resistant penicillins, only about 30% of nafcillin is excreted as unchanged drug in the urine of normal volunteers, and most within the first six hours. Nafcillin is primarily eliminated by nonrenal routes, namely hepatic inactivation and excretion in the bile. Nafcillin binds to serum proteins, mainly albumin.

The degree of protein binding reported for nafcillin is 89.9 ± 1.5%. Reported values vary with the method of study and the investigator. The concurrent administration of probenecid with nafcillin increases and prolongs plasma concentrations of nafcillin.

Probenecid significantly reduces the total body clearance of nafcillin with renal clearance being decreased to a greater extent than nonrenal clearance. The penicillinase-resistant penicillins are widely distributed in various body fluids, including bile, pleural, amniotic and synovial fluids. With normal doses insignificant concentrations are found in the aqueous humor of the eye.

High nafcillin CSF levels have been obtained in the presence of inflamed meninges. Renal failure does not appreciably affect the serum half-life of nafcillin; therefore, no modification of the usual nafcillin dosage is necessary in renal failure with or without hemodialysis. Hemodialysis does not accelerate the rate of clearance of nafcillin from the blood.

A study which assessed the effects of cirrhosis and extrahepatic biliary obstruction in man demonstrated that the plasma clearance of nafcillin was significantly decreased in patients with hepatic dysfunction. In these patients with cirrhosis and extrahepatic obstruction, nafcillin excretion in the urine was significantly increased from about 30 to 50% of the administered dose, suggesting that renal disease superimposed on hepatic disease could further decrease nafcillin clearance. Pharmacokinetics Intramuscular injections of nafcillin sodium, USP 1 gram produced peak serum levels in 0.5 to 1 hour of 7.61 mcg/mL.

The degree of protein binding reported has been 89.9 +/-1.5%. With normal doses nafcillin is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. Insignificant concentrations are found in the cerebrospinal fluid and aqueous humor.

Blood concentrations may be tripled by the concurrent use of probenecid. Clinical studies with nafcillin sodium in infants under three days of age and prematures have revealed higher blood levels and slower rates of urinary excretion than in older children and adults. A high concentration of nafcillin sodium is excreted via the bile.

About 30% of an intramuscular dose is excreted in the urine. Microbiology Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall.

Nafcillin sodium has been shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-Positive Bacteria Staphylococcus aureus (Methicillin susceptible isolates only) Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Pharmacokinetics Intramuscular injections of nafcillin sodium, USP 1 gram produced peak serum levels in 0.5 to 1 hour of 7.61…

📦 How Supplied / Storage and Handling 64 words

HOW SUPPLIED: Nafcillin for Injection, USP contains nafcillin sodium equivalent to 1 gram or 2 grams of nafcillin and is supplied as follows: Product Code Unit of Sale Strength Each 302710 NDC 63323-327-10 Unit of 10 1 gram per vial NDC 63323-327-21 302820 NDC 63323-328-20 Unit of 10 2 grams per vial NDC 63323-328-21 The container closure is not made with natural rubber latex.

📦 Storage and Handling 18 words

STORAGE: Before reconstitution store sterile powder at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

📋 Description 152 words

DESCRIPTION: Nafcillin for Injection, USP is a semisynthetic antibiotic penicillin derived from the penicillin nucleus, 6-aminopenicillanic acid. It is the sodium salt in a parenteral dosage form. The chemical name is 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[(2-ethoxy-1-naphthalenyl)carbonyl]amino]-3,3-dimethyl-7-oxo-monosodium salt, monohydrate [2S(2α,5α,6β)].

It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows: C 21 H 21 N 2 NaO 5 S•H 2 O M.W. 454.47 Nafcillin for Injection, USP, for intramuscular or the intravenous route of administration, containing nafcillin sodium as a white crystalline powder for reconstitution.

It is soluble in water. The pH of the aqueous solution is 6.0 to 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial.

The sodium content is 65.8 mg [2.9 mEq] per gram of nafcillin. The product is buffered with 40 mg sodium citrate per gram. structure

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