Home › NDC Lookup › Ingredients › Cefoxitin › 66288-4100-01
💉image loading
(from DailyMed)

Cefoxitin 100 g Injection, Powder, For Solution, 1 injection

by SAMSON MEDICAL TECHNOLOGIES LLC · 1 BAG in 1 BAG (66288-4100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG
NDC 66288-4100-01
🏷️ FDA NDC (as labeled) 66288-4100-1 billing pads the package segment with a zero
Rx only Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 66288-4100-1
Product NDC 66288-4100
11-digit billing NDC 66288410001
RxCUI 1739890
UNII Q68050H03T
Application # ANDA200938
SPL Set ID ea6dba56-5d9c-463a-b1d9-f7af5b602ed9
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-03-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance CEFOXITIN SODIUM
GCN Seq No 053126
GCN 20476
HICL code 003979
Ingredient (HICL) Cefoxitin Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1X
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 2Nd Generation
AHFS code 08:12.06.08
AHFS class 2Nd Generation Cephalosporin Antibiotics
FDB label name CEFOXITIN 100 GM BULK BAG
FDB brand name Cefoxitin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 66288-4100-1 — a 5-4-1 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 package segment → 66288-4100-01. 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 Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) Second-generation cephalosporins
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

LabelerSAMSON MEDICAL TECHNOLOGIES LLC
Application holderSAMSON MEDICAL TECHNOLOGIES LLC
FDA applicationANDA200938 (ANDA)
Labeler code66288
First marketedMar 2016
Product typeHuman Prescription Drug
Portfolio3 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 CEFOXITIN 100 GM BULK BAG Ingredient Cefoxitin Sodium
📗 Our plain-language guide HelloPharmacist
  • Cefoxitin is used for serious bacterial infections in several parts of the body — including the lungs, urinary tract, abdomen, female reproductive system, bloodstream, bones and jo...
  • What kinds of infections does cefoxitin treat?
  • Cefoxitin is given through an IV — directly into a vein — by a nurse or other healthcare professional. It's not a pill or something you take at home on your own. You'll receive it...
  • How will I receive this medication? Do I take it at home?
📖 Read our full Cefoxitin Injection guide →
7
Nutrient depletion considerations

Cefoxitin 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cefoxitin 100 gthis 66288-4100-01 SAMSON 1 injection — — 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

🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 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.

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

Medicare Part D (outpatient prescription) spending for Cefoxitin — the program that covers self-administered drugs. 5 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 Cefoxitin. 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
$98.8K
Claims incl. refills
507
Beneficiaries
114
Spend / beneficiary
$866.98
Spend / claim
$194.94
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 Cefoxitin — the ingredient across all brands.

Top reported reactions

Drug Resistance90
Nausea80
Drug Reaction With Eosinophilia And Systemic Symptoms79
Rash77
Thrombocytopenia62
Condition Aggravated56
Dyspnoea51

Age at onset

Neonate16
Infant1
Child15
Adolescent2
Adult93
Elderly53

Reporter sex

1,373 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization541
Life-threatening176
Death126
Disabling24
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 132 35
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
66288-4100-01 You're viewing this 1 BAG in 1 BAG (66288-4100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG 2016-03-01 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 66288-4100-1, 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: 66288-4100-01, written without dashes as 66288410001. 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 66288-4100-01, the first segment (66288) is the labeler code FDA assigned to SAMSON MEDICAL TECHNOLOGIES LLC; the middle segment (4100) 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 SAMSON MEDICAL TECHNOLOGIES LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SAMSON MEDICAL TECHNOLOGIES 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.
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.
🚨 Boxed Warning 19 words ▾

PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefoxitin and other antibacterial drugs, Cefoxitin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Treatment Cefoxitin for Injection, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species.

Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri ). Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species. Gynecological infections, including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli , Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger , Peptostreptococcus species, and Streptococcus agalactiae .

Cefoxitin for Injection, USP, like cephalosporins, has no activity against Chlamydia trachomatis . Therefore, when Cefoxitin for Injection, USP is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. Septicemia caused by Streptococcus pneumoniae , Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.

Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains). Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species including B. fragilis , Clostridium species, Peptococcus niger , and Peptostreptococcus species.

Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to cefoxitin. Therapy may be started while awaiting the results of these studies. In randomized comparative studies, cefoxitin and cephalothin were comparably safe and effective in the management of infections caused by gram-positive cocci and gram-negative rods susceptible to the cephalosporins.

Cefoxitin has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases. Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to cefoxitin. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with cefoxitin.

Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with cefoxitin. Prevention Cefoxitin for Injection, USP is indicated for the prophylaxis of infection in…

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than the 1 gram dose of cefoxitin. THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF SOLUTIONS FOR INTRAVENOUS INFUSION ONLY.

BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 100 MG/ML AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION. THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION USE THIS FORMULATION OF CEFOXITIN ONLY IN PATIENTS WHO REQUIRE A 1 GRAM DOSE. Treatment Adults Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin. The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism. This formulation of Cefoxitin for Injection USP, Pharmacy Bulk Package SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin. Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments: In adults with renal insufficiency , Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients with renal impairment who require less than the 1 gram dose of cefoxitin. An initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage ( Table 2 ) may be used as a guide.

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function. Males: Weight (kg) x (140-age) 72 x serum creatinine (mg/100 mL) Females: 0.85 x above value In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2 .

Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated. Pediatric Patients Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in pediatric patients who require less than the 1 gram dose of cefoxitin. The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections.

The total daily dosage should not exceed 12 grams. At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS ). In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2 ).

Prevention Cefox…

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS: Cefoxitin for Injection is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.

⚠️ Warnings ~1 min read ▾

WARNINGS: BEFORE THERAPY WITH CEFOXITIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS.

IF AN ALLERGIC REACTION TO CEFOXITIN OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefoxitin, 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: Cefoxitin is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently.

Local Reactions Thrombophlebitis has occurred with intravenous administration. Allergic Reactions Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted. Cardiovascula r Hypotension.

Gastrointestinal Diarrhea, including documented pseudomembranous colitis, which can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely. Neuromuscular Possible exacerbation of myasthenia gravis.

Blood Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia, including hemolytic anemia, thrombocytopenia, and bone marrow depression. A positive direct Coombs test may develop in some individuals, especially those with azotemia. Liver Function Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported.

Renal Function Cefoxitin for Injection USP, Pharmacy Bulk Package bag, SmartPak ® should not be used in patients with renal impairment who require less than the 1 gram adult dose of cefoxitin. Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely.

The role of cefoxitin in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present. In addition to the adverse reactions listed above which have been observed in patients treated with Cefoxitin for Injection, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics: Urticaria, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions, abdominal pain, colitis, renal dysfunction, toxic nephropathy, false-positive test for urinary glucose, hepatic dysfunction including cholestasis, elevated bilirubin, aplastic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis, superinfection, vaginitis including vaginal candidiasis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

🔄 Drug Interactions 15 words ▾

Drug Interactions Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

🔄 Drug / Laboratory Test Interactions 108 words ▾

Drug/Laboratory Test Interactions As with cephalothin, high concentrations of cefoxitin (>100 mcg/mL) may interfere with measurement of serum and urine creatinine levels by the Jaffé reaction, and produce false increases of modest degree in the levels of creatinine reported. Serum samples from patients treated with cefoxitin should not be analyzed for creatinine if withdrawn within 2 hours of drug administration. High concentrations of cefoxitin in the urine may interfere with measurement of urinary 17-hydroxy-corticosteroids by the Porter-Silber reaction, and produce false increases of modest degree in the levels reported.

A false-positive reaction for glucose in the urine may occur. This has been observed with CLINITEST † reagent tablets.

🤰 Pregnancy 122 words ▾

Pregnancy Pregnancy Category B. Reproduction studies performed in rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. In the rabbit, cefoxitin was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit's unusual sensitivity to antibiotic-induced changes in the population of the microflora of the intestine.

🧒 Pediatric Use 72 words ▾

Pediatric Use Cefoxitin for Injection USP, Pharmacy Bulk Package bag, SmartPak® should not be used in pediatric patients who require less than the 1 gram adult dose of cefoxitin. Safety and efficacy in pediatric patients from birth to three months of age have not yet been established. In pediatric patients three months of age and older, higher doses of cefoxitin have been associated with an increased incidence of eosinophilia and elevated SGOT.

🧓 Geriatric Use 135 words ▾

Geriatric Use Of the 1,775 subjects who received cefoxitin in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see CLINICAL PHARMACOLOGY ). This drug is known to be substantially excreted by the kidney, and the risk of toxic 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, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION and PRECAUTIONS ).

🆘 Overdosage 37 words ▾

OVERDOSAGE: The acute intravenous LD 50 in the adult female mouse and rabbit was about 8 grams/kg and greater than 1 gram/kg, respectively. The acute intraperitoneal LD 50 in the adult rat was greater than 10 grams/kg.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY: Clinical Pharmacology Following an intravenous dose of 1 gram of cefoxitin, serum concentrations were 110 mcg/mL at 5 minutes, declining to less than 1 mcg/mL at 4 hours. The half-life after an intravenous dose is 41 to 59 minutes. Approximately 85 percent of cefoxitin is excreted unchanged by the kidneys over a 6-hour period, resulting in high urinary concentrations.

Probenecid slows tubular excretion and produces higher serum levels and increases the duration of measurable serum concentrations. Cefoxitin passes into pleural and joint fluids and is detectable in antibacterial concentrations in bile. In a published study of geriatric patients ranging in age from 64 to 88 years with normal renal function for their age (creatinine clearance ranging from 31.5 to 174 mL/min), the half-life for cefoxitin ranged from 51 to 90 minutes, resulting in higher plasma concentrations than in younger adults.

These changes were attributed to decreased renal function associated with the aging process. Microbiology Mechanism of Action Cefoxitin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefoxitin has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

Mechanism of Resistance Resistance to cefoxitin is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability. Cefoxitin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-positive bacteria Staphylococcus aureus (methicillin-susceptible isolates only) Staphylococcus epidermidis (methicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Gram-negative bacteria Escherichia coli Haemophilus influenzae Klebsiella spp.

Morganella morganii Neisseria gonorrhoeae Proteus mirabilis Proteus vulgaris Providencia spp. Anaerobic bacteria Clostridium spp. Peptococcus niger Peptostreptococcus spp.

Bacteroides distasonis Bacteroides fragilis Bacteroides ovatus Bacteroides thetaiotaomicron Bacteroides spp. The following in vitro data are available, but their clinical significance is unknown . At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for cefoxitin.

However, the efficacy of cefoxitin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled studies. Gram-negative bacteria Eikenella corrodens [non-ß-lactamase producers] Anaerobic bacteria Clostridium perfringens Prevotella bivia Susceptibility Testing For specific information regarding susceptibility test interprevtive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC

🧬 Mechanism of Action 35 words ▾

Mechanism of Action Cefoxitin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefoxitin has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

📦 How Supplied / Storage and Handling 108 words ▾

HOW SUPPLIED: Cefoxitin for Injection, USP is a dry white to off-white powder available in the following SmartPak ® Pharmacy Bulk Package: 100 grams* (1 Pharmacy Bulk Package) Product No. 4100 NDC 66288-4100-1 sold in individual bags. *Each 100 gram Pharmacy Bulk Package contains sterile cefoxitin sodium equivalent to 100 grams of cefoxitin. SmartPak ® system components are not made with natural rubber latex.

Special storage instructions Cefoxitin for Injection, USP in the dry state should be stored between 2-25°C (36-77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.

📦 Storage and Handling 44 words ▾

Special storage instructions Cefoxitin for Injection, USP in the dry state should be stored between 2-25°C (36-77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.

📋 Description ~1 min read ▾

DESCRIPTION: Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin. Cefoxitin for Injection, USP is a semi-synthetic, broad-spectrum cepha antibiotic for intravenous administration.

It is derived from cephamycin C, which is produced by Streptomyces lactamdurans . Its chemical name is sodium ( 6R,7S )-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The empirical formula is C 16 H 16 N 3 NaO 7 S 2 , and the structural formula is: Cefoxitin for Injection contains approximately 53.8 mg (2.3 mEq) of sodium per gram of cefoxitin.

Solutions of Cefoxitin for Injection, USP range from colorless to light amber in color. The pH of freshly constituted solutions usually ranges from 4.2 to 7.0. BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 50 ML OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY.

THIS PRODUCT IS NOT INTENDED TO BE USED IN PEDIATRIC AND RENALLY IMPAIRED PATIENTS WHO REQUIRE LESS THAN A 1 GRAM DOSE. Each SmartPak ® Pharmacy Bulk Package contains sterile Cefoxitin Sodium, USP equivalent to 100 grams of cefoxitin and is intended for intravenous infusion only. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses.

The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSITITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

CEFOXITIN FOR INJECTION, USP SMARTPAK ® PHARMACY BULK PACKAGE SHOULD NOT BE USED IN PATIENTS WHO REQUIRE LESS THAN A 1 GRAM DOSE OF CEFOXTIN. image description

💬 Information for Patients 175 words ▾

Information for Patients Patients should be counseled that antibacterial drugs including Cefoxitin for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefoxitin 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 cefoxitin or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic.

If this occurs, patients should contact their physician as soon as possible.

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