Furosemide (injection)

Furosemide (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. * 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.

Overview

Furosemide (injection) is a loop diuretic that is FDA approved for the {{{indicationType}}} of peripheral edema associated with congestive heart failure, cirrhosis, and renal disease, including the nephrotic syndrome. Furosemide is also indicated as adjunctive therapy in acute pulmonary edema. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hyperuricemia, hypomagnesemia, loss of appetite, and spasm of bladder.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

• 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.

• Geriatric Patients

• In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range.

Edema

• Dosing Information

• Initial Dosage: 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.
• 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

• Dosing Information

• Initial Dosage: 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Furosemide (injection) in adult patients.

Non–Guideline-Supported Use

Nocturnal Polyuria

• Dosing Information

• 40 mg 6 hours prior to bedtime

Hypoalbuminemic Chronic Kidney Disease

• Dosing Information

• 40 mg IV

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• 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.

Edema

• Dosing Information

• Initial Dosage: 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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Furosemide (injection) in pediatric patients.

Non–Guideline-Supported Use

Bronchopulmonary Dysplasia of Newborn

• Dosing Information

• 1 to 4 mg/kg given intravenously or orally for 6 to 10 days

Contraindications

• Anuria
• Hypersensitivity to furosemide

Warnings

WARNING See full prescribing information for complete Boxed Warning. * 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.

• 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).
• 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.

Precautions

• Excessive 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 2-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.

Laboratory Tests

• Serum 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Furosemide (injection) in the drug label.

Postmarketing Experience

• Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

• Adverse reactions are categorized below by organ system and listed by decreasing severity.

Central Nervous System

• Tinnitus and hearing loss
• Paresthesias
• Vertigo
• Dizziness
• Headache
• Blurred vision
• Xanthopsia

Cardiovascular

• Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.
• Increase in cholesterol and triglyceride serum levels.

Gastrointestinal

• Hepatic encephalopathy in patients with hepatocellular insufficiency
• Pancreatitis
• Jaundice (intrahepatic cholestatic jaundice)
• Increased liver enzymes
• Anorexia
• Oral and gastric irritation
• Cramping
• Diarrhea
• Constipation
• Nausea
• Vomiting

Systemic Hypersensitivity Reactions

• Severe anaphylactic or anaphylactoid reactions (e.g. with shock)
• Systemic vasculitis
• Interstitial nephritis
• Necrotizing angiitis

Dermatologic Hypersensitivity Reactions

• Exfoliative dermatitis
• Bullous pemphigoid
• Erythema multiforme
• Purpura
• Photosensitivity
• Urticaria
• Rash
• Pruritus
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Hypersensitivity

• Aplastic anemia
• Thrombocytopenia
• Agranulocytosis
• Hemolytic anemia
• Leukopenia
• Anemia
• Eosinophilia

Miscellaneous

• Hyperglycemia
• Glycosuria
• Hyperuricemia
• Muscle spasm
• Weakness
• Restlessness
• Urinary bladder spasm
• Thrombophlebitis
• Transient injection site pain following intramuscular injection
• Fever

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 the 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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category C

• 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 treated dams as compared with the incidence of fetuses from the control group.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Furosemide (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Furosemide (injection) during labor and delivery.

Nursing Mothers

• Because it appears in breast milk, caution should be exercised when furosemide is administered to a nursing mother.
• Furosemide may inhibit lactation.

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.

Geriatic 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.

Gender

There is no FDA guidance on the use of Furosemide (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Furosemide (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Furosemide (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Furosemide (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Furosemide (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Furosemide (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

• Intramuscular

Monitoring

There is limited information regarding Monitoring of Furosemide (injection) in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Furosemide (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• 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 1000 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.

Management

• 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.

Chronic Overdose

There is limited information regarding Chronic Overdose of Furosemide (injection) in the drug label.

Pharmacology

Furosemide (injection)
Systematic (IUPAC) name
4-chloro-2-(furan-2-ylmethylamino)- 5-sulfamoylbenzoic acid
Identifiers
CAS number	54-31-9
ATC code	C03CA01
PubChem	3440
DrugBank	DB00695
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	330.745 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	43-69%
Metabolism	hepatic and renal glucuronidation
Half life	up to 100 minutes
Excretion	renal 66%, biliary 33%
Therapeutic considerations
Pregnancy cat.	C(AU) C(US)
Legal status	Template:Unicode Prescription only
Routes	Oral, IV, IM

Mechanism of Action

Structure

File:Furosemide (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Furosemide (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Furosemide (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Furosemide (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Furosemide (injection) in the drug label.

Condition1

• Description

How Supplied

• Furosemide Injection, USP (10 mg/mL):

File:Furosemide (injection)02.png

This image is provided by the National Library of Medicine.

• Do not use if solution is discolored.

• Store at 20° to 25°C (68° to 77°F) ; excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]

• Protect from light.

Storage

There is limited information regarding Furosemide (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• 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.

Precautions with Alcohol

• Alcohol-Furosemide (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Lasix®

Look-Alike Drug Names

• Lasix® — Losec®

• Lasix® — Luvox®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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