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FUROSEMIDE 10 mg/mL Injection, Solution — NDC 51662-1574-03 package photo

FUROSEMIDE 10 mg/mL Injection, Solution

by HF Acquisition Co LLC, DBA HealthFirst · 25 POUCH in 1 CASE (51662-1574-3) / 1 VIAL in 1 POUCH (51662-1574-2) / 4 mL in 1 VIAL
NDC 51662-1574-03
🏷️ FDA NDC (as labeled) 51662-1574-3 billing pads the package segment with a zero
This package
Contains4 mL in 1 vial Pack sizes2 compare ↓
Also priced by: Part D plans $0.3524/unit — full pricing hub ↓
Also comes in: 4 ml 51662-1574-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Furosemide (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. (Leading Pharma, LLC) · FDA recall D-0486-2026
Class II · Jan 10, 2026 — Presence of Foreign Substance (Graviti Pharmaceuticals Private Limited) · FDA recall D-0293-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51662-1574-3
Product NDC 51662-1574
11-digit billing NDC 51662157403
RxCUI 1719291
UNII 7LXU5N7ZO5
UPC 0363323280031
Application # NDA018902
SPL Set ID c5db4434-0b47-038c-e053-2995a90ad7fe
Established class (EPC) Loop Diuretic
Physiologic effect Increased Diuresis at Loop of Henle
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-28
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FUROSEMIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 51662-1574-3 — 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 → 51662-1574-03. 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 Loop Diuretic class.

Pharmacologic class Loop Diuretic
Drug family (ATC) Sulfonamides, plain
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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA018902 (NDA)
Labeler code51662
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio333 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

📖 What it is MedlinePlus · NLM

Furosemide injection is used to treat edema (excess fluid held in body tissues) caused by various medical problems in persons who cannot take medications by mouth or in emergency situations. Furosemide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Furosemide is a strong 'water pill' that tells your kidneys to flush out excess sodium and water through your urine. If your legs are swollen or you're short of breath from fluid b...
  • Why did my doctor prescribe furosemide — what is it actually doing for me?
  • Yes, that's exactly what furosemide is supposed to do. The whole point is to increase urine output so your body can shed excess fluid. Many people notice it kicks in within an hour...
  • I'm going to the bathroom a lot more — is that normal?
📖 Read our full Furosemide guide →
9
Nutrient depletion considerations

Furosemide may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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

🧪 Inactive Ingredients / Excipients

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

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price 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 $0.3524 $35.24 / 100 ml
Medicare Part B allowsASP · J1938 $0.018 / J1938 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)51662-1574-3
11-digit billing NDC51662-1574-03
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1938
Descriptor1 MG
Billing units / pkg1,000 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Furosemide 10 mg/mL 31722-0310-32 Camber 25 vials $0.266 AP Availability likely —
Furosemide 10 mg/mL 36000-0283-25 Baxter 25 vials $0.266 AP Availability likely —
Furosemide 40 mg/4mL 55150-0323-25 Eugia 25 vials $0.266 AP Availability likely —
Furosemide 10 mg/mL 72572-0190-25 Civica, 25 vials $0.266 AP Availability likely —
Furosemide 10 mg/mL 72603-0251-25 NorthStar 25 vials $0.266 AP Availability likely —
Furosemide 10 mg/mL 73043-0023-01 Devatis 25 vials $0.266 AP Availability likely —
Furosemide 10 mg/mL 00143-9159-01 Hikma 1 vial $0.266 AP Availability likely —
Furosemide 10 mg/mL 00143-9157-10 Hikma 10 vials $0.266 AP Availability likely —
Furosemide 10 mg/mL 16729-0502-43 Accord 10 vials $0.342 AP Availability likely —
Furosemide 10 mg/mL 16729-0500-08 Accord 25 vials $0.415 AP Availability likely —
Furosemide 10 mg/mL 00409-6102-02 Hospira, 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 23155-0473-41 Heritage 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 25021-0311-02 Sagent 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 25021-0320-02 Sagent 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 63323-0280-02 Fresenius 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 71288-0203-03 Meitheal 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 83634-0302-02 Avenacy 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 81565-0201-02 Phlow 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 00143-9158-01 Hikma 1 vial $0.462 AP Availability likely —
Furosemide 10 mg/mL 00143-9155-25 Hikma 25 vials $0.462 AP Availability likely —
Furosemide 10 mg/mL 00143-9156-10 Hikma 10 vials — AP FDA listed —
Furosemide 10 mg/mL 00404-9863-04 Henry 1 vial — AP FDA listed —
Furosemide 10 mg/mL 16729-0501-43 Accord 10 vials — AP FDA listed —
Furosemide 10 mg/mL 36000-0064-05 Baxter 5 vials — AP FDA listed —
Furosemide 40 mg/4mL 42571-0437-66 Micro 25 vials — AP FDA listed —
Furosemide 10 mg/mL 51662-1336-01 HF 4 ml — AP FDA listed —
Furosemide 10 mg/mLthis 51662-1574-03 HF 25 pouches — AP FDA listed —
Furosemide 10 mg/mL 55154-2365-05 Cardinal 5 vials — AP Discontinued —
Furosemide 10 mg/mL 55154-4452-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 55154-9582-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 68083-0433-05 Gland 5 vials — AP FDA listed —
Furosemide 40 mg/4mL 70121-1164-05 Amneal 25 vials — — FDA listed —
Furosemide 10 mg/mL 70518-4444-00 REMEDYREPACK 25 vials — AP FDA listed —
Furosemide 10 mg/mL 70756-0619-05 Lifestar 5 vials — AP FDA listed —
Furosemide 10 mg/mL 71872-7127-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7278-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7314-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 72572-0275-10 Civica, 10 vials — AP FDA listed —
Furosemide 10 mg/mL 73542-0102-25 Maiva 25 vials — AP FDA listed —
Furosemide 10 mg/mL 84549-0251-25 ProPharma 4 ml — AP FDA listed —
Furosemide 10 mg/mL 51662-1575-01 HF 10 ml — AP FDA listed —
Furosemide 10 mg/mL 68083-0432-05 Gland 5 vials — AP FDA listed —
Furosemide 10 mg/mL 68083-0434-05 Gland 5 vials — AP FDA listed —
Furosemide 10 mg/mL 51662-1226-01 HF 10 ml — AP FDA listed —
Furosemide 10 mg/mL 51662-1572-01 HF 2 ml — AP FDA listed —
Furosemide 10 mg/mL 71872-7350-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 55154-2364-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 55154-9581-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 51662-1227-01 HF 2 ml — AP FDA listed —
Furosemide 10 mg/mL 71872-7380-01 Medical 1 vial — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Furosemide — the program that covers self-administered drugs. 22 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 Furosemide. 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
$31.03M
Claims incl. refills
5.6M
Beneficiaries
3.6M
Spend / beneficiary
$8.60
Spend / claim
$5.52
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51662-1574-01 4 mL in 1 VIAL (51662-1574-1) 2021-06-28 Active
51662-1574-03 You're viewing this 25 POUCH in 1 CASE (51662-1574-3) / 1 VIAL in 1 POUCH (51662-1574-2) / 4 mL in 1 VIAL 2021-06-28 Active

Pack size FAQ

What quantity is in NDC 51662-1574-03?
NDC 51662-1574-03 is listed by the FDA — 25 pouch in 1 case / 1 vial in 1 pouch / 4 ml in 1 vial.
What NDC number is used to bill for this package of FUROSEMIDE 10 mg/mL Injection, Solution?
Bill NDC 51662-1574-03 — the 11-digit billing format is 51662157403. 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 51662-1574-3, 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: 51662-1574-03, written without dashes as 51662157403. 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 51662-1574-03, the first segment (51662) is the labeler code FDA assigned to HF Acquisition Co LLC, DBA HealthFirst; the middle segment (1574) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 HF Acquisition Co LLC, DBA HealthFirst. 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 4 ml (51662-1574-01). 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?
HF Acquisition Co LLC, DBA HealthFirst 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 J1938 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 130 words ▾

INDICATIONS & USAGE Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.

Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The IV administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the IM or IV route.

Parenteral use should be replaced with oral furosemide as soon as practical.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE & ADMINISTRATION Adults Parenteral therapy with furosemide injection should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. Edema- The usual initial dose of furosemide is 20 to 40 mg given as a single dose, injected IM or IV. The IV dose should be given slowly (one to two minutes).

Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner two hours later or the dose may be increased. The dose may be raised by 20 mg and given not sooner than two hours after the previous dose until the desired diuretic effect has been obtained.

This individually determined single dose should then be given once or twice daily. Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Close medical supervision is necessary.

If the physician elects to use high dose parenteral therapy, add the furosemide to either Sodium Chloride Injection USP, Lactated Ringer’s Injection USP, or Dextrose Injection 5% USP, after pH has been adjusted to above 5.5, and administer as a controlled IV infusion at a rate not greater than 4 mg/min. Furosemide injection is a buffered alkaline solution with a pH of about 9 and the drug may precipitate at pH values below 7. Care must be taken to ensure that the pH of the prepared infusion solution is in the weakly alkaline to neutral range.

Acid solutions, including other parenteral medications (e.g., labetalol, ciprofloxacin, amrinone, milrinone) must not be administered concurrently in the same infusion because they may cause precipitation of the furosemide. In addition, furosemide injection should not be added to a running intravenous line containing any of these acidic products. Acute Pulmonary Edema- The usual initial dose of furosemide is 40 mg injected slowly IV (over one to two minutes).

If a satisfactory response does not occur within one hour, the dose may be increased to 80 mg injected slowly IV (over one to two minutes). If necessary, additional therapy (e.g., digitalis, oxygen) may be administered concomitantly. Geriatric Patients In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS, GERIATRIC USE ).

Pediatric Patients Parenteral therapy should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. The usual initial dose of furosemide injection (IM or IV) in pediatric patients is 1 mg/kg body weight and should be given slowly under close medical supervision. If the diuretic response to the initial dose is not satisfactory, dosage may be increased by 1 mg/kg not sooner than two hours after the previous dose, until the desired diuretic effect has been obtained.

Doses greater than 6 mg/kg body weight are not recommended. Literature reports suggest that the maximum dose for premature infants should not exceed 1 mg/kg/day (see WARNINGS, PEDIATRIC USE ). Furosemide injection should be inspected visually for particulate matter and discoloration before administration.

Do not use if solution is discolored.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

⚠️ Warnings ~1 min read ▾

WARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis.

Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported.

Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) (see PRECAUTIONS, DRUG INTERACTIONS ). Pediatric Use In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process.

Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. Hearing loss in neonates has been associated with the use of furosemide injection (see WARNINGS , above).

🤒 Adverse Reactions 172 words ▾

ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions Hepatic encephalopathy in patients with hepatocellular insufficiency Pancreatitis Jaundice (intrahepatic cholestatic jaundice) Increased liver enzymes Anorexia Oral and gastric irritation Cramping Diarrhea Constipation Nausea Vomiting Systemic Hypersensitivity Reactions Severe anaphylactic or anaphylactoid reactions (e.g., with shock) Systemic vasculitis Interstitial nephritis Necrotizing angiitis Central Nervous System Reactions Tinnitus and hearing loss Paresthesias Vertigo Dizziness Headache Blurred vision Xanthopsia Hematologic Reactions Aplastic anemia Thrombocytopenia Agranulocytosis Hemolytic anemia Leukopenia Anemia Eosinophilia Dermatologic-Hypersensitivity Reactions Toxic epidermal necrolysis Stevens-Johnson Syndrome Erythema multiforme Drug rash with eosinophila and systemic symptoms Acute generalized exanthematous pustulosis Exfoliative dermatitis Bullous pemphigoid Purpura Photosensitivity Rash Pruritus Urticaria Cardiovascular Reactions Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics Increase in cholesterol and triglyceride serum levels Other Reactions Hyperglycemia Glycosuria Hyperuricemia Muscle spasm Weakness Restlessness Urinary bladder spasm Thrombophlebitis Transient injection site pain following intramuscular injection Fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

🆘 Overdosage 143 words ▾

OVERDOSAGE The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1,000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg.

The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known. Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses.

Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Hemodialysis does not accelerate furosemide elimination.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. It has been demonstrated that furosemide inhibits primarily the reabsorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of Henle. The high degree of efficacy is largely due to the unique site of action.

The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone. Recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. Furosemide is extensively bound to plasma proteins, mainly to albumin.

Plasma concentrations ranging from 1 to 400 mcg/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations. The onset of diuresis following IV administration is within five minutes and somewhat later after IM administration.

The peak effect occurs within the first half hour. The duration of diuretic effect is approximately two hours. In fasted normal men, the mean bioavailability of furosemide from tablets and oral solution is 64% and 60%, respectively, of that from an intravenous injection of the drug.

Although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. Peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. The terminal half-life of furosemide is approximately two hours.

Significantly more furosemide is excreted in urine following the IV injection than after the tablet or oral solution. There are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine. Geriatric Population Furosemide binding to albumin may be reduced in elderly patients.

Furosemide is predominantly excreted unchanged in the urine. The renal clearance of furosemide after intravenous administration in older healthy male subjects (60 to 70 years of age) is statistically significantly smaller than in younger healthy male subjects (20 to 35 years of age). The initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects (see PRECAUTIONS, GERIATRIC USE ).

📦 How Supplied / Storage and Handling 106 words ▾

HOW SUPPLIED Furosemide injection, USP NDC 51662-1574-1 FUROSEMIDE INJECTION, USP 40mg PER 4mL (10mg PER mL) 4mL VIAL NDC 51662-1574-2 FUROSEMIDE INJECTION, USP 40mg PER 4mL (10mg PER mL) 4mL VIAL, 1 VIAL PER POUCH NDC 51662-1574-2 FUROSEMIDE INJECTION, USP 40mg PER 4mL (10mg PER mL) 4mL VIAL, 1 VIAL PER POUCH, 25 POUCHES PER CASE Preservative Free. Discard unused portion. Use only if solution is clear and seal intact.

PROTECT FROM LIGHT. Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275

📋 Description 122 words ▾

DESCRIPTION Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow, odorless, crystalline powder.

Practically insoluble in water; freely soluble in acetone, in dimethylformamide, and in solutions of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; slightly soluble in ether; very slightly soluble in chloroform. The structural formula is as follows: Furosemide Injection, USP is a sterile, nonpyrogenic solution of furosemide in Water for Injection prepared with the aid of sodium hydroxide for intramuscular (IM) or intravenous (IV) use. Each mL contains: Furosemide 10 mg; Water for Injection q.s.; sodium chloride to adjust isotonicity; sodium hydroxide and if necessary hydrochloric acid to adjust pH between 8.0 and 9.3.

DESCRIPTION

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