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Polymyxin B 500000 [USP'U]/1 Injection, Powder, Lyophilized, For Solution, 10 vials — NDC 63323-0367-11 package photo

Polymyxin B 500000 [USP'U]/1 Injection, Powder, Lyophilized, For Solution, 10 vials

by Fresenius Kabi USA, LLC · 10 VIAL in 1 CARTON (63323-367-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01)
NDC 63323-0367-11
🏷️ FDA NDC (as labeled) 63323-367-11 billing pads the product segment with a zero
This package
Contains10 vials Pack sizes2 compare ↓
Also comes in: 10 vials 63323-0367-44
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 63323-367-11
Product NDC 63323-367
11-digit billing NDC 63323036711
NCPDP billing unit EA — each (per item)
RxCUI 204509
UNII 19371312D4
Application # ANDA202766
SPL Set ID 72dd6de6-31d6-4a8f-881b-91af91ed9314
Established class (EPC) Polymyxin-class Antibacterial
Chemical class Polymyxins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Apr 2023)
Marketing start 2015-09-09
Route INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance POLYMYXIN B SULFATE
GPI-14 16100010102105
GPI class Polymyxin B Sulfate
GCN Seq No 009354
GCN 41320
HICL code 004049
Ingredient (HICL) Polymyxin B Sulfate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1N
Therapeutic class — specific (HIC3) Polymyxin Antibiotics And Derivatives
AHFS code 08:12.28.28
AHFS class Polymyxin Antibiotics
FDB label name POLYMYXIN B SULFATE VIAL
FDB brand name Polymyxin B Sulfate
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 63323-367-11 — 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 → 63323-0367-11. 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 Polymyxin-class Antibacterial class.

Pharmacologic class Polymyxin-class Antibacterial
Drug family (ATC) Antibiotics, Polymyxins, 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

LabelerFresenius Kabi USA, LLC
Application holderXELLIA PHARMACEUTICALS APS
FDA applicationANDA202766 (ANDA)
Labeler code63323
First marketedSep 2015
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 POLYMYXIN B SULFATE VIAL Ingredient Polymyxin B Sulfate

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.
Try another pack size: 10 vials
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
Polymyxin B 500000 [USP'U] 00143-9461-01 Hikma 1 vial — AP FDA listed —
Polymyxin B 500000 [iU] 00143-9941-10 Hikma 10 vials — — FDA listed —
Polymyxin B 500000 [USP'U] 25021-0196-10 Sagent 10 vials — AP FDA listed —
Polymyxin B 500000 [USP'U] 55150-0234-10 Eugia 10 vials — AP FDA listed —
Polymyxin B 500000 [USP'U] 63323-0321-10 Fresenius 10 vials — AP FDA listed —
Polymyxin B 500000 [USP'U]this 63323-0367-11 Fresenius 10 vials — AP Discontinued —
Polymyxin B 500000 [USP'U] 68083-0174-10 Gland 10 vials — AP FDA listed —
Polymyxin B 500000 [USP'U] 70594-0049-01 Xellia 1 vial — AP FDA listed —
Polymyxin B 500000 [USP'U] 72266-0249-10 FOSUN 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 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 Polymyxin B Sulfate (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Polymyxin B Sulfate. 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
$2.3K
Claims incl. refills
17
Beneficiaries
14
Spend / beneficiary
$166.60
Spend / claim
$137.20
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 POLYMYXIN B (this brand).

Top reported reactions

Pain260
Drug Hypersensitivity250
Malaise231
Pneumonia231
Vomiting200
Oedema186
Asthma185

Age at onset

Neonate6
Infant2
Child21
Adolescent8
Adult125
Elderly131

Reporter sex

1,564 reports
Male · 40%
Female · 58%
Unknown · 1%

Serious outcomes

Hospitalization514
Death287
Life-threatening159
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 182 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
63323-0367-11 You're viewing this 10 VIAL in 1 CARTON (63323-367-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01) 2015-09-09 Discontinued by firm
63323-0367-44 10 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41) 2015-09-09 Active

Pack size FAQ

What quantity is in NDC 63323-0367-11?
NDC 63323-0367-11 contains 10 vials — 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial.
What is the difference between NDC 63323-0367-11 and NDC 63323-0367-44?
Both are Polymyxin B 500000 [USP'U]/1 Injection, Powder, Lyophilized, For Solution — the drug itself is identical. NDC 63323-0367-11 is the 10 vials package, while NDC 63323-0367-44 is the 10 vials package.
What NDC number is used to bill for this package of Polymyxin B 500000 [USP'U]/1 Injection, Powder, Lyophilized, For Solution?
Bill NDC 63323-0367-11 — the 11-digit billing format is 63323036711. 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 No longer marketed (per FDA listing data)
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) — 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 ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 63323-367-11, 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: 63323-0367-11, written without dashes as 63323036711. 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 63323-0367-11, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0367) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (63323-0367-44). 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.
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 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 184 words ▾

WARNING CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN. RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO POLYMYXIN B SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA.

DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG. NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY.

THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH POLYMYXIN B SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED. THE NEUROTOXICITY OF POLYMYXIN B SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS. USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.

🎯 Indications and Usage 200 words ▾

INDICATIONS AND USAGE Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa . Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood-stream caused by susceptible strains of Ps. aeruginosa . It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa .

It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae, specifically meningeal infections. Escherichia coli, specifically urinary tract infections. Aerobacter aerogenes, specifically bacteremia.

Klebsiella pneumoniae, specifically bacteremia. NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE. To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B 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 ~2 min read ▾

DOSAGE AND ADMINISTRATION PARENTERAL: Intravenous . Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral 5% Dextrose Injection for continuous drip. Adults and children.

15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects. Intramuscular.

Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 Polymyxin B units in 2 mL Sterile Water for Injection or 0.9 % Sodium Chloride Injection or Procaine Hydrochloride Injection 1%. Adults and children.

25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.

Infants . Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects. Note : Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.

Intrathecal . A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL 0.9 % Sodium Chloride Injection USP for 50,000 units per mL dosage unit.

Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal. Children under 2 years of age.

20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal. IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.

TOPICAL: Ophthalmic . Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration. For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.

Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva. Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.

⚠️ Warnings 163 words ▾

WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Polymyxin B 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 109 words ▾

ADVERSE REACTIONS See WARNING box. Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage. Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.

Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🧬 Clinical Pharmacology 157 words ▾

CLINICAL PHARMACOLOGY Polymyxin B sulfate has a bactericidal action against almost all gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of bacterial cell membrane leading to death of the cell. All gram positive bacteria, fungi, and gram-negative cocci are resistant to polymyxin B.

For specific information regarding susceptibility test criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: www.fda.gov/STIC. Polymyxin B sulfate is not absorbed from the normal alimentary tract. Since the drug loses 50 percent of its activity in the presence of serum, active blood levels are low.

Repeated injections may give a cumulative effect. Levels tend to be higher in infants and children. The drug is excreted slowly by the kidneys.

Tissue diffusion is poor and the drug does not pass the blood brain barrier into the cerebrospinal fluid. In therapeutic dosage, polymyxin B sulfate causes some nephrotoxicity with tubule damage to a slight degree.

📦 How Supplied / Storage and Handling 148 words ▾

HOW SUPPLIED Each vial of Polymyxin B for Injection contains polymyxin B sulfate equivalent to 500,000 polymyxin B units. It is supplied in rubber-stoppered glass vial with flip off cap, carton of 10. Product Code Unit of Sale Strength Each PRX306711 NDC 63323-367-44 Unit of 10 500,000 units per vial NDC 63323-367-41 10 mL glass vial.

Storage recommendations: Before reconstitution: Store at 20° to 25° C (68° to 77° F) (See USP controlled Room Temperature) Protect from light. Retain in carton until time of use. After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.

PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured for: Fresenius Kabi USA, LLC Lake Zurich, IL 60047 Made in India 451606 Issued: March 2019 LEA-020172-00 Code No: AP/DRUGS/103/97 PREMIER ProRx ®

📦 Storage and Handling 92 words ▾

Storage recommendations: Before reconstitution: Store at 20° to 25° C (68° to 77° F) (See USP controlled Room Temperature) Protect from light. Retain in carton until time of use. After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.

PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured for: Fresenius Kabi USA, LLC Lake Zurich, IL 60047 Made in India 451606 Issued: March 2019 LEA-020172-00 Code No: AP/DRUGS/103/97 PREMIER ProRx ®

📋 Description 219 words ▾

DESCRIPTION Polymyxin B for Injection is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous) . Polymyxin B sulfate is the sulfate salt of Polymyxins B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea).

It has a potency of not less than 6000 polymyxin B units per mg, calculated on the anhydrous basis. The structural formulae are: Each vial contains 500,000 polymyxin B units for parenteral or ophthalmic administration. Polymyxin B for Injection is in powder form suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.

In the medical literature, dosages have frequently been given in terms of equivalent weights of pure polymyxin B base. Each milligram of pure polymyxin B base is equivalent to 10,000 units of polymyxin B and each microgram of pure polymyxin B base is equivalent to 10 units of polymyxin B. Aqueous solutions of polymyxin B sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration.

In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Polymyxin B sulfate should not be stored in alkaline solutions since they are less stable. Structural Formulae

💬 Information for Patients 176 words ▾

Information for Patients. Patients should be counseled that antibacterial drugs including polymyxin B should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When polymyxin B 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 polymyxin B 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 ↗
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