NDC 51662-1574 Furosemide

Furosemide

NDC Product Code 51662-1574

NDC CODE: 51662-1574

Proprietary Name: Furosemide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Furosemide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Furosemide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This can lessen symptoms such as shortness of breath and swelling in your arms, legs, and abdomen. This drug is also used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Furosemide is a "water pill" (diuretic) that causes you to make more urine. This helps your body get rid of extra water and salt.

NDC Code Structure

NDC 51662-1574-1

Package Description: 4 mL in 1 VIAL

NDC 51662-1574-3

Package Description: 25 POUCH in 1 CASE > 1 VIAL in 1 POUCH (51662-1574-2) > 4 mL in 1 VIAL

NDC Product Information

Furosemide with NDC 51662-1574 is a a human prescription drug product labeled by Hf Acquisition Co Llc, Dba Healthfirst. The generic name of Furosemide is furosemide. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1719291.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Furosemide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Increased Diuresis at Loop of Henle - [PE] (Physiologic Effect)
  • Loop Diuretic - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Labeler Code: 51662
FDA Application Number: NDA018902 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-28-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Furosemide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx only

WARNINGFurosemide 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 (see DOSAGE AND ADMINISTRATION).

Lake Zurich, IL 60047

www.fresenius-kabi.us
45788FRevised: March 2016

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.

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 PopulationFurosemide 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).

Indications & Usage

Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.EdemaFurosemide 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.

Contraindications

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

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 UseIn 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).

Precautions

GeneralExcessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. As with any effective diuretic, electrolyte depletion may occur during furosemide therapy, especially in patients receiving higher doses and a restricted salt intake. Hypokalemia may develop with furosemide, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives. Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects.All patients receiving furosemide therapy should be observed for these signs or symptoms of fluid or electrolyte imbalance (hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia or hypocalcemia): dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia, or gastrointestinal disturbances such as nausea and vomiting. Increases in blood glucose and alterations in glucose tolerance tests (with abnormalities of the fasting and two-hour postprandial sugar) have been observed, and rarely, precipitation of diabetes mellitus has been reported.In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment.In patients at high risk for radiocontrast nephropathy, furosemide can lead to a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast.In patients with hypoproteinemia (e.g., associated with nephrotic syndrome) the effect of furosemide may be weakened and its ototoxicity potentiated.Asymptomatic hyperuricemia can occur and gout may rarely be precipitated.Patients allergic to sulfonamides may also be allergic to furosemide. The possibility exists of exacerbation or activation of systemic lupus erythematosus.As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions.Information for PatientsPatients 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.Laboratory TestsSerum electrolytes (particularly potassium), CO2, creatinine and BUN should be determined frequently during the first few months of furosemide therapy and periodically thereafter. Serum and urine electrolyte determinations are particularly important when the patient is vomiting profusely or receiving parenteral fluids. Abnormalities should be corrected or the drug temporarily withdrawn. Other medications may also influence serum electrolytes.Reversible elevations of BUN may occur and are associated with dehydration, which should be avoided, particularly in patients with renal insufficiency.Urine and blood glucose should be checked periodically in diabetics receiving furosemide, even in those suspected of latent diabetes.Furosemide may lower serum levels of calcium (rarely cases of tetany have been reported) and magnesium. Accordingly, serum levels of these electrolytes should be determined periodically.In premature infants furosemide may precipitate nephrocalcinosis/nephrolithiasis, therefore renal function must be monitored and renal ultrasonography performed (see
PRECAUTIONS, PEDIATRIC USE).
Drug InteractionsFurosemide 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 disease, 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.Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.Simultaneous administration of sucralfate and Furosemide Injection may reduce the natriuretic and antihypertensive effects of furosemide. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved. The intake of furosemide and sucralfate should be separated by at least two hours.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. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of furosemide, and consequently to lower peak serum furosemide concentrations.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.High doses (> 80 mg) 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 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.Carcinogenesis, Mutagenesis, Impairment of FertilityFurosemide was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. A small but significantly increased incidence of mammary gland carcinomas occurred in female mice at a dose 17.5 times the maximum human dose of 600 mg. There were marginal increases in uncommon tumors in male rats at a dose of 15 mg/kg (slightly greater than the maximum human dose) but not at 30 mg/kg.Furosemide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system, and questionably positive for gene mutation in mouse lymphoma cells in the presence of rat liver S9 at the highest dose tested. Furosemide did not induce sister chromatid exchange in human cells in vitro, but other studies on chromosomal aberrations in human cells in vitro gave conflicting results. In Chinese hamster cells it induced chromosomal damage but was questionably positive for sister chromatid exchange. Studies on the induction by furosemide of chromosomal aberrations in mice were inconclusive. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.Furosemide produced no impairment of fertility in male or female rats, at 100 mg/kg/day (the maximum effective diuretic dose in the rat and 8 times the maximal human dose of 600 mg/day).Pregnancy-Teratogenic EffectsPregnancy Category C—Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at two, four and eight 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 (two times the maximal recommended human oral dose of 600 mg/day). In another study, a dose of 50 mg/kg (four 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 treated dams as compared with the incidence in fetuses from the control group.Nursing MothersBecause it appears in breast milk, caution should be exercised when furosemide is administered to a nursing mother. Furosemide may inhibit lactation.Pediatric UseRenal calcifications (from barely visible on x-ray to staghorn) have occurred in some severely premature infants treated with IV 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.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.Geriatric UseControlled 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).

Adverse Reactions

Adverse reactions are categorized below by organ system and listed by decreasing severity.Gastrointestinal System ReactionsHepatic 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 ReactionsSevere anaphylactic or anaphylactoid reactions (e.g., with shock)

Systemic vasculitis

Interstitial nephritis

Necrotizing angiitis
Central Nervous System ReactionsTinnitus and hearing loss

Paresthesias

Vertigo

Dizziness

Headache

Blurred vision

Xanthopsia
Hematologic ReactionsAplastic anemia

Thrombocytopenia

Agranulocytosis

Hemolytic anemia

Leukopenia

Anemia

Eosinophilia
Dermatologic-Hypersensitivity ReactionsToxic 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 ReactionsOrthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics

Increase in cholesterol and triglyceride serum levels
Other ReactionsHyperglycemia

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

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.

Dosage & Administration

AdultsParenteral 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 PatientsIn 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 PatientsParenteral 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.

How Supplied

Furosemide injection, USP2 mL, 4 mL and 10 mL sizes are single dose vials, packaged 25 vials per tray.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].

* Please review the disclaimer below.