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Furosemide 10 mg/mL Injection — NDC 16729-0502-43 package photo

Furosemide 10 mg/mL Injection

by Accord Healthcare, Inc. · 10 VIAL, SINGLE-DOSE in 1 CARTON (16729-502-43) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-502-03)
NDC 16729-0502-43
🏷️ FDA NDC (as labeled) 16729-502-43 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage
🗂️ 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

⚠️
Active FDA shortage. Furosemide Injection is currently reported in shortage by the FDA (Requirements related to complying with good manufacturing practices). Unavailable Shortage details →
⚠️
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) 16729-502-43
Product NDC 16729-502
11-digit billing NDC 16729050243
NCPDP billing unit ML — per mL (volume)
RxCUI 1719286, 1719290, 1719291
UNII 7LXU5N7ZO5
UPC 0316729500302, 0316729500081, 0316729501644
Application # ANDA070017
SPL Set ID f6f64972-714c-4ee9-8a5e-9ffcab41a73b
Established class (EPC) Loop Diuretic
Physiologic effect Increased Diuresis at Loop of Henle
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-21
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance FUROSEMIDE
GPI-14 37200030002005
GPI class Furosemide
GCN Seq No 008205
GCN 34940
HICL code 003660
Ingredient (HICL) Furosemide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1M
Therapeutic class — specific (HIC3) Loop Diuretics
AHFS code 24:36.08.00
AHFS class Loop Diuretics (24:36)
FDB label name FUROSEMIDE 100 MG/10 ML VIAL
FDB brand name Furosemide
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 16729-502-43 — 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 → 16729-0502-43. 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

LabelerAccord Healthcare, Inc.
Application holderACCORD HEALTHCARE INC
FDA applicationANDA070017 (ANDA)
Labeler code16729
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio67 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 FUROSEMIDE 100 MG/10 ML VIAL Ingredient Furosemide
📖 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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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 $0.342 $34.17 / 100 ml
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 —
NADAC price history (per mL) — tap or hover for the price & month
Nov 2023 Jul 2025 Mar 2026 May 2026 $0.594 $0.223
▼ Down 42% over the last 6 months.
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)16729-502-43
11-digit billing NDC16729-0502-43
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1938
DescriptorINJECTION, FUROSEMIDE, 1 MG
Billing units / pkg10 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Furosemide 10 mg/mL 00143-9157-10 Hikma 10 vials $0.266 AP Availability likely save 22%
Furosemide 10 mg/mL 00143-9159-01 Hikma 1 vial $0.266 AP Availability likely save 22%
Furosemide 10 mg/mLthis 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 +22%
Furosemide 10 mg/mL 00409-6102-02 Hospira, 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 23155-0473-41 Heritage 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 25021-0311-02 Sagent 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 25021-0320-02 Sagent 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 63323-0280-02 Fresenius 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 71288-0203-03 Meitheal 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 83634-0302-02 Avenacy 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 81565-0201-02 Phlow 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 00143-9158-01 Hikma 1 vial $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 00143-9155-25 Hikma 25 vials $0.462 AP Availability likely +35%
Furosemide 10 mg/mL 00404-9862-10 Henry 1 vial — AP FDA listed —
Furosemide 10 mg/mL 31722-0311-31 Camber 25 vials — AP FDA listed —
Furosemide 10 mg/mL 36000-0065-05 Baxter 5 vials — AP FDA listed —
Furosemide 10 mg/mL 36000-0284-25 Baxter 25 vials — AP FDA listed —
Furosemide 100 mg/10mL 42571-0438-85 Micro 25 vials — AP FDA listed —
Furosemide 10 mg/mL 51662-1226-01 HF 10 ml — AP FDA listed —
Furosemide 10 mg/mL 51662-1575-01 HF 10 ml — AP FDA listed —
Furosemide 100 mg/10mL 55150-0324-25 Eugia 25 vials — AP FDA listed —
Furosemide 10 mg/mL 68083-0434-05 Gland 5 vials — AP FDA listed —
Furosemide 100 mg/10mL 70121-1076-05 Amneal 25 vials — — FDA listed —
Furosemide 10 mg/mL 70756-0620-10 Lifestar 10 vials — AP FDA listed —
Furosemide 10 mg/mL 71872-7308-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7350-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 72603-0474-25 NorthStar 25 vials — AP FDA listed —
Furosemide 10 mg/mL 73043-0024-01 Devatis 25 vials — AP FDA listed —
Furosemide 10 mg/mL 73542-0103-25 Maiva 25 vials — AP FDA listed —
Furosemide 10 mg/mL 84549-0474-25 ProPharma 10 ml — AP FDA listed —
Furosemide 10 mg/mL 68083-0432-05 Gland 5 vials — AP FDA listed —
Furosemide 10 mg/mL 68083-0433-05 Gland 5 vials — AP FDA listed —
Furosemide 10 mg/mL 71872-7278-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 55154-9582-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 00143-9156-10 Hikma 10 vials — AP FDA listed —
Furosemide 10 mg/mL 55154-2365-05 Cardinal 5 vials — AP Discontinued —
Furosemide 10 mg/mL 51662-1572-01 HF 2 ml — AP FDA listed —
Furosemide 10 mg/mL 72572-0275-10 Civica, 10 vials — AP FDA listed —
Furosemide 10 mg/mL 55154-2364-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 16729-0501-43 Accord 10 vials — AP FDA listed —
Furosemide 10 mg/mL 51662-1574-01 HF 4 ml — AP FDA listed —
Furosemide 10 mg/mL 51662-1336-01 HF 4 ml — 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 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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 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
16729-0502-43 You're viewing this 10 VIAL, SINGLE-DOSE in 1 CARTON (16729-502-43) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-502-03) 2021-04-21 Active

📄 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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 130 words ▾

INDICATIONS AND 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 intravenous 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 intravenous or intramuscular route.

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

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND 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 intramuscularly or intravenously. The intravenous dose should be given slowly (1 to 2 minutes).

Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner 2 hours later or the dose may be increased. The dose may be raised by 20 mg and given not sooner than 2 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.

When furosemide is given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests ). 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 (5%) Injection USP after pH has been adjusted to above 5.5, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/min. Furosemide Injection is a buffered alkaline solution with a pH of about 9 and 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 intravenously (over 1 to 2 minutes). If a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously (over 1 to 2 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 (intravenously or intramuscularly) 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 2 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.

⛔ 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 ~1 min read ▾

ADVERSE REACTIONS: Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. Hepatic encephalopathy in patients with hepatocellular insufficiency 6.

Oral and gastric irritation 2. Pancreatitis 7. Cramping 3.

Jaundice (intrahepatic cholestatic jaundice) 8. Diarrhea 4. Increased liver enzymes 9.

Constipation 5. Anorexia 10. Nausea 11.

Vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock) 3. Interstitial nephritis 2.

Systemic vasculitis 4. Necrotizing angiitis Central Nervous System Reactions 1. Tinnitus and hearing loss 5.

Headache 2. Paresthesias 6. Blurred vision 3.

Vertigo 7. Xanthopsia 4. Dizziness Hematologic Reactions 1.

Aplastic anemia 5. Leukopenia 2. Thrombocytopenia 6.

Anemia 3. Agranulocytosis 7. Eosinophilia 4.

Hemolytic anemia Dermatologic-Hypersensitivity Reactions 1. Exfoliative dermatitis 6. Urticaria 2.

Bullous pemphigoid 7. Rash 3. Erythema multiforme 8.

Pruritus 4. Purpura 9. Stevens­Johnson Syndrome 5.

Photosensitivity 10. Toxic epidermal necrolysis Cardiovascular Reaction 1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.

2. Increase in cholesterol and triglyceride serum levels. Other Reactions 1.

Hyperglycemia 6. Restlessness 2. Glycosuria 7.

Urinary bladder spasm 3. Hyperuricemia 8. Thrombophlebitis 4.

Muscle spasms 9. Transient injection site pain following intramuscular injection 5. Weakness 10.

Fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

Drug Interactions: Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination. Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity.

Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic diseases, may experience salicylate toxicity at lower doses because of competitive renal excretory sites. There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.

Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity. Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure.

An interruption or reduction in the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary. Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively. In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia.

Use of furosemide concomitantly with chloral hydrate is therefore not recommended. Phenytoin interferes directly with renal action of furosemide. Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide.

Conversely, furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High dose treatment of both furosemide and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide. Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.

Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion. One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.

Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.

🤰 Pregnancy ~1 min read ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C . Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human oral dose. There are no adequate and well-controlled studies in pregnant women.

Furosemide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher fetal birth weights. The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits.

Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (2 times the maximal recommended human oral dose of 600 mg/day). In another study, a dose of 50 mg/kg (4 times the maximal recommended human oral dose of 600 mg/day) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg.

Data from the above studies indicate fetal lethality that can precede maternal deaths. The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses derived from the treated dams as compared with the incidence of fetuses from the control group.

🧒 Pediatric Use 117 words ▾

Pediatric Use: In premature infants furosemide may precipitate nephrocalcinosis/nephrolithiasis. Nephrocalcinosis/nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with furosemide. Monitor renal function, and renal ultrasonography should be considered, in pediatric patients receiving furosemide.

If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus. Renal calcifications (from barely visible on x-ray to staghorn) have occurred in some severely premature infants treated with intravenous furosemide for edema due to patent ductus arteriosus and hyaline membrane disease. The concurrent use of chlorothiazide has been reported to decrease hypercalcinuria and dissolve some calculi.

🧓 Geriatric Use 147 words ▾

Geriatric Use: Controlled clinical studies of furosemide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

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 PRECAUTIONS: General and DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 145 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 LD 50 exceeded 1000 mg/kg body weight, while the intravenous LD 50 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 this 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 μg/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 intravenous administration is within 5 minutes and somewhat later after intramuscular administration.

The peak effect occurs within the first half hour. The duration of diuretic effect is approximately 2 hours. In fasted normal men, the mean bioavailability of furosemide from furosemide tablets and furosemide 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 2 hours.

Significantly more furosemide is excreted in urine following the intravenous 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 188 words ▾

HOW SUPPLIED Furosemide injection USP, 10 mg/mL is supplied as follows Furosemide injection USP, 10 mg/mL, 10 mg/mL, 2 mL Single-dose vial 2 mL Single-dose vials (amber colored vials) NDC 16729–500-30 25 Vials in 1 Carton NDC 16729–500-08 Furosemide injection USP, 10 mg/mL, 10 mg/mL, 4 mL Single-dose vial 4 mL Single-dose vials (amber colored vials) NDC 16729-501-64 10 vials in 1 Carton NDC 16729-501-43 Furosemide injection USP, 10 mg/mL, 10 mg/mL, 10 mL Single-dose vial 10 mL Single-dose vials (amber colored vials) NDC 16729-502-03 10 vials in 1 Carton NDC 16729-502-43 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use If solution is discolored. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15˚C to 30˚C (59˚F to 86˚F) [see USP Controlled Room Temperature]. Protect from light.

10 3372 1 6026783 Revised: 12/2023 Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No.: 457, 458, Village – Matoda, Bavla Road, Ta. - Sanand, Dist.- Ahmedabad – 382 210. India.

📋 Description 133 words ▾

DESCRIPTION: Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N -furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection.

Furosemide USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, freely soluble in acetone, in dimethyl formamide, 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: Molecular Formula: Molecular Weight: C 12 H 11 ClN 2 O 5 S 330.74 Each mL contains: Furosemide USP 10 mg, Water for Injection q.s., Sodium Chloride 7.4 mg (for isotonicity), Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.

Structure

💬 Information for Patients 103 words ▾

Information for Patients: Patients receiving furosemide should be advised that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia.

Patients with diabetes mellitus should be told that furosemide may increase blood glucose levels and thereby affect urine glucose tests. The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide. Hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16729-0501-43 · Accord 16729-0512-43 · Accord →
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.