FDA Approves Furosemide for Edema and Hypertension
The FDA has approved furosemide, a loop diuretic, for the treatment of edema in adults and pediatric patients with congestive heart failure, cirrhosis of the liver, and renal disease including nephrotic syndrome. It is also approved for hypertension in adults, alone or with other antihypertensives. Furosemide is particularly useful when greater diuretic potential is needed. The approval underscores the drug's role in managing fluid overload and hypertension, but clinicians must be vigilant about its potent diuretic effects, which can lead to water and electrolyte depletion if not dosed carefully. The label emphasizes individualized therapy to achieve maximal response with minimal effective dose.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
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. It is particularly useful when an agent with greater diuretic potential is desired. Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
Edema: Adults: initial dose 20 mg to 80 mg as a single dose; may repeat same dose 6 to 8 hours later or increase by 20 mg or 40 mg. Maximum 600 mg/day in severe edematous states. Pediatric: initial 2 mg/kg as a single dose; may increase by 1 or 2 mg/kg no sooner than 6 to 8 hours; maximum 6 mg/kg. Hypertension: Adults: initial 80 mg, usually divided as 40 mg twice daily; adjust according to response. When adding furosemide to other antihypertensives, reduce other agents by at least 50% to prevent excessive blood pressure drop. Geriatric patients: start at low end of dosing range.
Trial data not available in label.
Contraindicated in anuria and history of hypersensitivity. Furosemide is a potent diuretic; excessive doses can cause profound diuresis with water and electrolyte depletion. In hepatic cirrhosis and ascites, initiate therapy in hospital. Discontinue if increasing azotemia and oliguria occur in severe progressive renal disease. Ototoxicity (tinnitus, hearing impairment) reported, associated with rapid injection, severe renal impairment, high doses, hypoproteinemia, or concomitant ototoxic drugs. Avoid concomitant use with aminoglycosides (except life-threatening) and ethacrynic acid. Salicylate toxicity may occur at lower doses with high-dose salicylates. Risk of ototoxicity with cisplatin.
Furosemide is a potent loop diuretic used for edema in heart failure, cirrhosis, and renal disease, and as an antihypertensive. It is reserved for cases requiring greater diuretic effect. Dosing must be individualized to avoid electrolyte depletion. It is not first-line for hypertension if thiazides fail.
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