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Lasix FUROSEMIDE 20 mg Tablet, 1,000-count — NDC 30698-0067-10 package photo

Lasix FUROSEMIDE 20 mg Tablet, 1,000-count

by Validus Pharmaceuticals LLC · 1000 TABLET in 1 BOTTLE (30698-067-10)
NDC 30698-0067-10
🏷️ FDA NDC (as labeled) 30698-067-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Also comes in: 100 tablets 30698-0067-01
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) 30698-067-10
Product NDC 30698-067
11-digit billing NDC 30698006710
RxCUI 197732, 200801, 200809, 205732, 310429, 313988
UNII 7LXU5N7ZO5
UPC 0330698060018, 0330698066058, 0330698067017
Application # NDA016273
SPL Set ID 2c9b4d8f-0770-482d-a9e6-9c616a440b1a
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 1978-04-24
Route ORAL
Dosage form TABLET
Substance FUROSEMIDE
GPI-14 37200030000305
GPI class Lasix
GCN Seq No 008208
GCN 34961
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 LASIX 20 MG TABLET
FDB brand name Lasix
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 30698-067-10 — 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 → 30698-0067-10. 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

LabelerValidus Pharmaceuticals LLC
Application holderVALIDUS PHARMACEUTICALS LLC
FDA applicationNDA016273 (NDA)
Labeler code30698
First marketedApr 1978
Product typeHuman Prescription Drug
Portfolio27 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 LASIX 20 MG TABLET Ingredient Furosemide
📗 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
ShapeRound
ImprintLasix;80
Size1 mm
ScoringNot scored
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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

5 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 eachPer 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: 100 tablets
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
Furosemide 20 mg 00054-4297-25 Hikma 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 00054-8297-25 Hikma 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 00904-7177-61 Major 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 43547-0401-10 Solco 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 62135-0753-90 Chartwell 90 tablets $0.027 — Availability likely —
Furosemide 20 mg 64980-0562-01 Rising 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 69315-0116-01 Leading 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 83980-0002-01 Ipca 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 00615-8368-05 NCS 15 tablets — AB FDA listed —
Furosemide 20 mg 10135-0832-01 Marlex 100 tablets — AB FDA listed —
Furosemide 20 mg 17224-0178-21 Calvin 21 tablets — AB FDA listed —
Lasix 20 mgthis 30698-0067-10 Validus 1000 tablets — — FDA listed —
Furosemide 20 mg 42291-0468-01 AvKARE 100 tablets — AB FDA listed —
Furosemide 20 mg 43063-0702-21 PD-Rx 21 tablets — AB FDA listed —
Furosemide 20 mg 43063-0849-21 PD-Rx 21 tablets — AB FDA listed —
Furosemide 20 mg 43353-0747-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-5429-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-6219-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-6642-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-6942-00 A-S 90 tablets — AB FDA listed —
Furosemide 20 mg 50090-7706-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-7708-00 A-S 90 tablets — AB FDA listed —
Furosemide 20 mg 51655-0269-25 Northwind 60 tablets — AB FDA listed —
Furosemide 20 mg 51655-0310-53 Northwind 10 tablets — AB FDA listed —
Furosemide 20 mg 51655-0481-52 Northwind 30 tablets — AB FDA listed —
Furosemide 20 mg 55154-2349-00 Cardinal 10 tablets — AB FDA listed —
Furosemide 20 mg 59651-0796-91 Aurobindo 100000 tablets — AB FDA listed —
Furosemide 20 mg 61919-0242-30 DIRECT 30 tablets — AB FDA listed —
Furosemide 20 mg 63187-0517-30 Proficient 30 tablets — AB FDA listed —
Furosemide 20 mg 63187-0739-10 Proficient 10 tablets — AB FDA listed —
Furosemide 20 mg 63561-0164-01 Granulation 100 tablets — AB FDA listed —
Furosemide 20 mg 63629-1214-01 Bryant 1000 tablets — AB FDA listed —
Furosemide 20 mg 63629-1215-01 Bryant 100 tablets — AB FDA listed —
Furosemide 20 mg 67046-0768-03 Coupler 30 tablets — AB FDA listed —
Furosemide 20 mg 67046-1589-03 Coupler 30 tablets — AB FDA listed —
Furosemide 20 mg 67296-2136-01 Redpharm 3 tablets — AB FDA listed —
Furosemide 20 mg 68071-1708-01 NuCare 100 tablets — AB FDA listed —
Furosemide 20 mg 68071-3673-03 NuCare 30 tablets — AB FDA listed —
Furosemide 20 mg 68071-4534-01 NuCare 100 tablets — AB FDA listed —
Furosemide 20 mg 68788-6948-01 Preferred 100 tablets — AB FDA listed —
Furosemide 20 mg 68788-8870-01 Prefferred 100 tablets — AB FDA listed —
Furosemide 20 mg 70518-0050-00 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 70518-2528-01 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 70518-3061-00 REMEDYREPACK 5 tablets — AB Discontinued —
Furosemide 20 mg 70518-3757-00 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 70518-4679-00 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 71335-0384-01 Bryant 30 tablets — AB Discontinued —
Furosemide 20 mg 71335-0852-01 Bryant 30 tablets — AB FDA listed —
Furosemide 20 mg 71335-2319-01 Bryant 30 tablets — AB FDA listed —
Furosemide 20 mg 71610-0096-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 71610-0635-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 71610-0843-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 72162-1360-00 Bryant 1000 tablets — AB FDA listed —
Furosemide 20 mg 72789-0030-30 PD-Rx 30 tablets — AB FDA listed —
Furosemide 20 mg 82868-0050-30 Northwind 30 tablets — AB FDA listed —
Furosemide 20 mg 87441-0033-01 Unit 30 tablets — AB 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

🏛️
1978
On the market since
Apr 1978
📍
2026
Currently FDA-listed
48 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 Lasix — 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 Lasix. 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
$88.8K
Claims incl. refills
1.6K
Beneficiaries
1.1K
Spend / beneficiary
$80.04
Spend / claim
$56.70
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 Lasix (this brand).

Top reported reactions

Dyspnoea29,956
Fatigue21,046
Diarrhoea20,617
Nausea19,253
Acute Kidney Injury19,010
Death18,736
Fall16,514

Age at onset

Neonate474
Infant432
Child576
Adolescent401
Adult21,066
Elderly40,019

Reporter sex

398,101 reports
Male · 44%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization195,201
Death61,832
Life-threatening25,863
Disabling10,272
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 30,538 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 Per unit Per pack Marketing startStatus
30698-0067-01 100 TABLET in 1 BOTTLE (30698-067-01) $0.7487 / ea $74.87 1978-04-24 Active
30698-0067-10 You're viewing this 1000 TABLET in 1 BOTTLE (30698-067-10) — — 1978-04-24 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 30698-0067-10?
NDC 30698-0067-10 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 30698-0067-10 and NDC 30698-0067-01?
Both are Lasix FUROSEMIDE 20 mg Tablet — the drug itself is identical. NDC 30698-0067-10 is the 1,000-count package, while NDC 30698-0067-01 is the 100 tablets package.
What NDC number is used to bill for this package of Lasix FUROSEMIDE 20 mg Tablet?
Bill NDC 30698-0067-10 — the 11-digit billing format is 30698006710. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 30698-067-10, 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: 30698-0067-10, written without dashes as 30698006710. 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 30698-0067-10, the first segment (30698) is the labeler code FDA assigned to Validus Pharmaceuticals LLC; the middle segment (0067) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Validus Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (30698-0067-01). 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?
Validus Pharmaceuticals 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.
🎯 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 86 words ▾

INDICATIONS AND USAGE Edema LASIX 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. LASIX is particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral LASIX may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents.

Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with LASIX alone.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Edema Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Adults -- The usual initial dose of LASIX is 20 mg to 80mg given as a single dose. Ordinarily a prompt diuresis ensues.

If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 mg or 40mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm).

The dose of LASIX may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states. Edema may be most efficiently and safely mobilized by giving LASIX on 2 to 4 consecutive days each week. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable ( s ee PRECAUTIONS: Laboratory Test ) .

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 -- The usual initial dose of oral LASIX in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose.

Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level. Hypertension Therapy should be individualized according to the patient’s response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.

Adults -- The usual initial dose of LASIX for hypertension is 80mg, usually divided into 40mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when LASIX is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when LASIX is added to the regimen. As the blood pressure falls under the potentiating effect of LASIX, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

Geriatric patients -- In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use ).

⛔ Contraindications 18 words ▾

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

⚠️ Warnings ~1 min read ▾

WARNING LASIX ® (furosemide) is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient’s needs ( s ee DOSAGE AND ADMINISTRATION ) .

WARNINGS In patients with hepatic cirrhosis and ascites, LASIX 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, LASIX should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported.

Reports usually indicate that LASIX 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 4mg LASIX per minute has been used) ( s ee PRECAUTIONS: Drug Interactions ) .

🤒 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 7. cramping 2. pancreatitis 8. diarrhea 3. jaundice (intrahepatic cholestatic jaundice) 9. constipation 4. increased liver enzymes 10. nausea 5. anorexia 11. vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) 3. interstitial nephritis 4. necrotizing angiitis 2. systemic vasculitis 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. toxic epidermal necrolysis 7. bullous pemphigoid 2.

Stevens-Johnson Syndrome 3. erythema multiforme 8. purpura 9. photosensitivity 4. drug rash with eosinophilia and systemic symptoms 10. rash 11. pruritis 5. acute generalized exanthematous pustulosis 6. exfoliative dermatitis 12. urticaria 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 spasm 9. fever 5. weakness Whenever adverse reactions are moderate or severe, LASIX dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

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

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

LASIX 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. LASIX 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 LASIX, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers may be necessary. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs. LASIX may decrease arterial responsiveness to norepinephrine.

However, norepinephrine may still be used effectively. Simultaneous administration of sucralfate and LASIX tablets may reduce the natriuretic and antihypertensive effects of LASIX. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of LASIX is achieved.

The intake of LASIX and sucralfate should be separated by at least two hours. In isolated cases, intravenous administration of LASIX within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of LASIX concomitantly with chloral hydrate is therefore not recommended.

Phenytoin interferes directly with renal action of LASIX. There is evidence that treatment with phenytoin leads to decreased intestinal absorption of LASIX, and consequently to lower peak serum furosemide concentrations. Methotrexate and other drugs that, like LASIX, undergo significant renal tubular secretion may reduce the effect of LASIX.

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

Concomitant use of cyclosporine and LASIX is associated with increased risk of gouty arthritis secondary to LASIX-induced hyperurecemia and cyclosporine impairment of renal urate excretion. High doses (>80mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. 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 LASIX (furosemide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma r…

🤰 Pregnancy ~1 min read ▾

Pregnancy Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. There are no adequate and well-controlled studies in pregnant women. LASIX 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 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 dose of 600 mg/day).

In another study, a dose of 50 mg/kg (4 times the maximal recommended human 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 a 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 in fetuses from the control group.

🧒 Pediatric Use 71 words ▾

Pediatric Use In premature infants LASIX 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 LASIX. Monitor renal function, and renal ultrasonography should be considered, in pediatric patients receiving LASIX.

If LASIX is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.

🧓 Geriatric Use 150 words ▾

Geriatric Use Controlled clinical studies of LASIX 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 ( s ee PRECAUTIONS: General and DOSAGE AND ADMINISTRATION ) .

🆘 Overdosage 145 words ▾

OVERDOSAGE The principal signs and symptoms of overdose with LASIX are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. The acute toxicity of LASIX 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 LASIX 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 LASIX 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 LASIX inhibits primarily the absorption of sodium and chloride not only in the proximal and distal tubu 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 μg/mL 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 oral administration is within 1 hour.

The peak effect occurs within the first or second hour. The duration of diuretic effect is 6 to 8 hours. In fasted normal men, the mean bioavailability of furosemide from LASIX Tablets and LASIX 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 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 ( s ee PRECAUTIONS: Geriatric Use ) .

📦 How Supplied / Storage and Handling 178 words ▾

HOW SUPPLIED LASIX (furosemide) Tablets 20mg are supplied as white, oval, monogrammed tablets in Bottles of 100 (NDC 30698-067-01) and 1000 (NDC 30698-067-10). The 20mg tablets are imprinted with “Lasix ® ” on one side. LASIX Tablets 40mg are supplied as white, round, monogrammed, scored tablets in Bottles of 100 (NDC 30698-060-01), 500 (NDC 30698-060-50), and 1000 (NDC 30698-060-10).

The 40mg tablets are imprinted with “Lasix ® 40” on one side. LASIX Tablets 80mg are supplied as white, round, scored, monogrammed, facetted-edge tablets in Bottles of 50 (NDC 30698-066-05) and 500 (NDC 30698-066-50). The 80mg tablets are imprinted with “Lasix ® 80” on one side.

Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Tested by USP Dissolution Test 2 Store at 68º to 77ºF (20º to 25ºC); excursions permitted to 59º to 86ºF (15º to 30ºC) [See USP Controlled Room Temperature]. Manufactured for and Distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 [email protected] www.validuspharma.com 1-866-982-5438 Product of Canada © 2018 Validus Pharmaceuticals LLC 60031-05 August 2018

📋 Description 137 words ▾

DESCRIPTION LASIX ® is a diuretic which is an anthranilic acid derivative. LASIX tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose monohydrate NF, magnesium stearate NF, starch NF, talc USP, and colloidal silicon dioxide NF. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.

LASIX is available as white tablets for oral administration in dosage strengths of 20, 40 and 80mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids.

The CAS Registry Number is 54-31-9. The structural formula is as follows: The structural formula for LASIX® is a diuretic which is an anthranilic acid derivative. LASIX tablets for oral administration contain furosemide as the active ingredient and the following inactive i

💬 Information for Patients 103 words ▾

Information for Patients Patients receiving LASIX 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 ↗
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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.