furosemide injection, USP VIAL Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use FUROSEMIDE INJECTION safely and effectively. See full prescribing information for FUROSEMIDE INJECTION.

FUROSEMIDE INJECTION (furosemide), for intravenous or intramuscular use
Initial U.S. Approval: 1982

INDICATIONS AND USAGE

FUROSEMIDE INJECTION is a loop diuretic indicated for:

The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease (1.1)
Acute pulmonary edema as adjunctive therapy (1.2)

DOSAGE AND ADMINISTRATION

Edema:

Initial dose is 20 mg to 40 mg once given intramuscularly or intravenously. The intravenous dose should be administered slowly over 1 minute to 2 minutes (2.2)
If needed, a second dose may be administered 2 hours after the first dose (2.2)

Acute Pulmonary Edema:

Initial dose is 40 mg injected slowly intravenously over 1 minute to 2 minutes (2.2)
If needed, a second dose is 80 mg injected intravenously slowly in 1 minute to 2 minutes (2.2)

Pediatric Dosage:

The initial dose in pediatric patients is 1 mg/kg body weight once given slowly intramuscularly or intravenously. If needed, 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 (2.3)

DOSAGE FORMS AND STRENGTHS

Injection: Furosemide Injection, USP is supplied as a sterile, colorless solution as

20 mg/2 mL (10 mg/mL) in a single-dose vial (3)
40 mg/4 mL (10 mg/mL) in a single-dose vial (3)
100 mg/10 mL (10 mg/mL) in a single-dose vial (3)

CONTRAINDICATIONS

Anuria (4)
Hypersensitivity to furosemide (4)

WARNINGS AND PRECAUTIONS

Fluid, Electrolyte, and Metabolic Abnormalities: Monitor serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid (5.1)
Worsening Renal Function: Monitor for dehydration and azotemia. (5.2)
Ototoxicity: Avoid rapid injection and higher than recommended doses. (5.3, 7.1)
Acute Urinary Retention: Monitor patients with symptoms of urinary retention. (5.4)

ADVERSE REACTIONS

Most common adverse reactions are related to fluid and electrolyte imbalance (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Aminoglycoside antibiotics: Increased potential ototoxicity of the antibiotics. Avoid combination (7.1)
Ethacrynic acid: Risk of ototoxicity. Avoid combination (7.1)
Salicylates: Risk of salicylate toxicity (7.1)
Cisplatin and nephrotoxic drugs: Risk of ototoxicity and nephrotoxicity (7.1)
Lithium: Risk of lithium toxicity (7.1)
Renin-angiotensin inhibitors: Increased risk of hypotension and renal failure.(7.1)
Adrenergic blocking drugs: Risk of potentiation (7.1)
Drugs undergoing renal tubular secretion: Risk of toxicity potentiation (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use FUROSEMIDE INJECTION safely and effectively. See full prescribing information for FUROSEMIDE INJECTION.

FUROSEMIDE INJECTION (furosemide), for intravenous or intramuscular use
Initial U.S. Approval: 1982

INDICATIONS AND USAGE

FUROSEMIDE INJECTION is a loop diuretic indicated for:

The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease (1.1)
Acute pulmonary edema as adjunctive therapy (1.2)

DOSAGE AND ADMINISTRATION

Edema:

Initial dose is 20 mg to 40 mg once given intramuscularly or intravenously. The intravenous dose should be administered slowly over 1 minute to 2 minutes (2.2)
If needed, a second dose may be administered 2 hours after the first dose (2.2)

Acute Pulmonary Edema:

Initial dose is 40 mg injected slowly intravenously over 1 minute to 2 minutes (2.2)
If needed, a second dose is 80 mg injected intravenously slowly in 1 minute to 2 minutes (2.2)

Pediatric Dosage:

The initial dose in pediatric patients is 1 mg/kg body weight once given slowly intramuscularly or intravenously. If needed, 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 (2.3)

DOSAGE FORMS AND STRENGTHS

Injection: Furosemide Injection, USP is supplied as a sterile, colorless solution as

20 mg/2 mL (10 mg/mL) in a single-dose vial (3)
40 mg/4 mL (10 mg/mL) in a single-dose vial (3)
100 mg/10 mL (10 mg/mL) in a single-dose vial (3)

CONTRAINDICATIONS

Anuria (4)
Hypersensitivity to furosemide (4)

WARNINGS AND PRECAUTIONS

Fluid, Electrolyte, and Metabolic Abnormalities: Monitor serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid (5.1)
Worsening Renal Function: Monitor for dehydration and azotemia. (5.2)
Ototoxicity: Avoid rapid injection and higher than recommended doses. (5.3, 7.1)
Acute Urinary Retention: Monitor patients with symptoms of urinary retention. (5.4)

ADVERSE REACTIONS

Most common adverse reactions are related to fluid and electrolyte imbalance (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Aminoglycoside antibiotics: Increased potential ototoxicity of the antibiotics. Avoid combination (7.1)
Ethacrynic acid: Risk of ototoxicity. Avoid combination (7.1)
Salicylates: Risk of salicylate toxicity (7.1)
Cisplatin and nephrotoxic drugs: Risk of ototoxicity and nephrotoxicity (7.1)
Lithium: Risk of lithium toxicity (7.1)
Renin-angiotensin inhibitors: Increased risk of hypotension and renal failure.(7.1)
Adrenergic blocking drugs: Risk of potentiation (7.1)
Drugs undergoing renal tubular secretion: Risk of toxicity potentiation (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2023

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