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Cautions

Contraindications

• Anuria.
• Known hypersensitivity to furosemide or any ingredient in the formulation.

Warnings/Precautions

Warnings

Hepatic Effects

Sudden alterations of electrolyte balance in patients with cirrhosis may precipitate hepatic coma; use with caution in patients with hepatic cirrhosis and ascites.

Do not inititiate therapy in patients with hepatic coma or electrolyte depletion until the basic condition is improved. Therapy in such patients is best initiated in the hospital with careful monitoring of clinical status and electrolyte balance.

Renal Effects

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue the drug.

Sensitivity Reactions

Anaphylaxis

Anaphylaxis (e.g., urticaria, angioedema, hypotension) within 5 minutes after IV administration reported.

Systemic Lupus Erythematosus

Possible exacerbation or activation of systemic lupus erythematosus.

Sulfonamide Sensitivity

Patients sensitive to sulfonamides may show allergic reactions to furosemide.

Photosensitivity

Photosensitivity may occur.

Major Toxicities

Ototoxicity

Risk of tinnitus, reversible or permanent hearing impairment increased following IV or IM administration, especially at high dosages, after too-rapid administration, in patients with severely impaired renal function, and/or in patients receiving other ototoxic drugs (e.g., aminoglycosides). (See Specific Drugs under Interactions.)

If high-dose IV therapy is indicated, administer by slow IV infusion (e.g., at a rate not exceeding 4 mg/minute in adults).

General Precautions

Fluid, Electrolyte, and Cardiovascular Effects

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. (See Boxed Warning.)

Risk of orthostatic hypotension, especially with brisk diuresis. May be aggravated by concomitant use with alcohol, barbiturates, or narcotics.

Risk of hypokalemia, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids or ACTH. Concomitant therapy with digitalis may exaggerate metabolic effects of hypokalemia, especially myocardial effects.

Observe carefully for manifestations of fluid and electrolyte depletion (e.g., dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia, nausea, vomiting).

Endocrine Effects

Possible increased blood glucose and alterations in glucose tolerance tests (with abnormalities of the fasting and 2-hour postprandial sugar); precipitation of diabetes mellitus rarely reported. Monitor urine and blood glucose concentrations periodically in patients with diabetes and those suspected of latent diabetes.

Possible hyperuricemia and precipitation of gout; use with caution in patients with a history of gout or elevated serum uric acid concentrations.

Patient Monitoring

Monitor regularly for the possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions.

Serum electrolytes (particularly potassium), CO₂, creatinine and BUN should be determined frequently during the first few months of therapy and periodically thereafter.

Elective Surgery

Discontinue therapy 1 week (oral furosemide) or 2 days (parenteral furosemide) before elective surgery.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk. Use with caution.

Pediatric Use

Risk of persistent patent ductus arteriosus (PDA) may be increased in premature neonates with respiratory distress syndrome (RDS) who receive furosemide during the first weeks of life.

Do not exceed dosage of 1 mg/kg per 24 hours in premature neonates with <31 weeks’ postconception age (gestational age at birth plus postnatal age); risk of potentially toxic furosemide plasma concentrations with higher dosages.

Renal calcification reported in severely premature infants treated with IV furosemide for edema due to PDA and hyaline membrane disease; concomitant chlorothiazide therapy may decrease hypercalciuria and dissolve some calculi.

Hearing loss reported in neonates; possibly secondary to renal immaturity.

Oral solutions contain sorbitol; high dosages may cause diarrhea in children.

Hepatic Impairment

Use with caution.

Renal Impairment

Use with caution.

Common Adverse Effects

Orthostatic hypotension, dizziness, electrolyte imbalance (hyponatremia, hypokalemia, hypochloremia) tinnitus, photosensitivity.