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

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 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

Condition1
  • Dosing Information
  • Dosage
Condition2

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

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

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

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.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

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

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


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

There is no FDA guidance on the use of Furosemide (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Furosemide (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Furosemide (injection) with respect to geriatric patients.

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

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

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)10.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

There is limited information regarding Patient Counseling Information of Furosemide (injection) in the drug label.

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

Look-Alike Drug Names

  • Lasix® — Losec®[2]
  • Lasix® — Luvox®[2]

Drug Shortage Status

Price

References

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

  1. ↑ "FUROSEMIDE injection, solution".
  2. ↑ 2.0 2.1 "http://www.ismp.org". External link in |title= (help)


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