Furosemide (injection)

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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

For patient information regarding Furosemide, click here.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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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 treatment 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 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[1]
Hypoalbuminemic Chronic Kidney Disease
  • Dosing Information

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[3][4][5][6]

Contraindications

Warnings

  • 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

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
Cardiovascular
Gastrointestinal
Systemic Hypersensitivity Reactions
Dermatologic Hypersensitivity Reactions
Hypersensitivity
Miscellaneous

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 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.

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

Prolonged Use
  • When furosemide is given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
Urinary Retention
  • 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.
Premature Infants
Pregnancy
  • Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher fetal birth weights.
Pediatric
Geriatric
  • 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.

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

Chronic Overdose

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

Pharmacology

Template:Px
Template:Px
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

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

Structure

  • Furosemide is a diuretic which is an anthranilic acid derivative.
  • Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.
  • Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection.
  • 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 structural formula is as follows:
This image is provided by the National Library of Medicine.
  • Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.

Pharmacodynamics

  • Recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. Furosemide is extensively bound to plasma proteins, mainly to albumin. Plasma concentrations ranging from 1 to 400 μg/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations.
  • The onset of diuresis following intravenous administration is within 5 minutes and somewhat later after intramuscular administration. The peak effect occurs within the first half hour. The duration of diuretic effect is approximately 2 hours.

Pharmacokinetics

  • In fasted normal men, the mean bioavailability of furosemide from furosemide tablets and furosemide oral solution is 64 % and 60%, respectively, of that from an intravenous injection of the drug. Although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. Peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. The terminal half-life of furosemide is approximately 2 hours.
  • Significantly more furosemide is excreted in urine following the intravenous injection than after the tablet or oral solution. There are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine.

Nonclinical Toxicology

  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Furosemide 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).

Clinical Studies

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

How Supplied

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

Images

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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

Brand Names

Look-Alike Drug Names

  • Lasix® — Losec®[8]
  • Lasix® — Luvox®[8]

Drug Shortage Status

References

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

  1. ↑ Reynard, J. M. (1998-02). "A novel therapy for nocturnal polyuria: a double-blind randomized trial of frusemide against placebo". British Journal of Urology. 81 (2): 215–218. ISSN 0007-1331. PMID 9488061. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  2. ↑ Phakdeekitcharoen, Bunyong (2012). "The added-up albumin enhances the diuretic effect of furosemide in patients with hypoalbuminemic chronic kidney disease: a randomized controlled study". BMC nephrology. 13: 92. doi:10.1186/1471-2369-13-92. ISSN 1471-2369. PMC 3538583. PMID 22931630. Unknown parameter |coauthors= ignored (help)
  3. ↑ Kao, L. C. (1983-10). "Furosemide acutely decreases airways resistance in chronic bronchopulmonary dysplasia". The Journal of Pediatrics. 103 (4): 624–629. ISSN 0022-3476. PMID 6620024. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  4. ↑ Rush, M. G. (1990-07). "Double-blind, placebo-controlled trial of alternate-day furosemide therapy in infants with chronic bronchopulmonary dysplasia". The Journal of Pediatrics. 117 (1 Pt 1): 112–118. ISSN 0022-3476. PMID 2196353. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  5. ↑ McCann, E. M. (1985-06). "Controlled trial of furosemide therapy in infants with chronic lung disease". The Journal of Pediatrics. 106 (6): 957–962. ISSN 0022-3476. PMID 3889258. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  6. ↑ Engelhardt, B. (1986-12). "Short- and long-term effects of furosemide on lung function in infants with bronchopulmonary dysplasia". The Journal of Pediatrics. 109 (6): 1034–1039. ISSN 0022-3476. PMID 3537245. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  7. ↑ "FUROSEMIDE injection, solution".
  8. ↑ 8.0 8.1 "http://www.ismp.org". External link in |title= (help)

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