Furosemide: uses, appearance and warnings

Edema 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. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Hypertension 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.

Furosemide tablets, USP, for oral administration, are available as: 20 mg : White to off-white, round, flat face, radius edge, debossed “G 164” on one side and plain on the other side, and supplied as: NDC 63561-0164-09 bottles of 90 NDC 63561-0164-01 bottles of 100 NDC 63561-0164-02 bottles of 1,000 40 mg: White to off-white, round, flat face, radius edge, scored tablet debossed “G” above the score and “165” below the score on one side and plain on the other side, and supplied as: NDC 63561-0165-09 bottles of 90 NDC 63561-0165-01 bottles of 100 NDC 63561-0165-02 bottles of 1,000 80 mg: White to off-white, round, flat face, radius edge, scored tablet debossed “G” above the score and “166” below the score on one side and plain on the other side, and supplied as: NDC 63561-0166-09 bottles of 90 NDC 63561-0166-01 bottles of 100 NDC 63561-0166-05 bottles of 500 Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Store at 68º to 77ºF (20º to 25ºC) [See USP Controlled Room Temperature]. Dispense and store in a tight, light-resistant container. Manufactured by Granulation Technology, Inc. Fairfield, NJ 07004 Rev. June 2026

Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

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 [ s ee DOSAGE AND ADMINISTRATION ] . WARNINGS In patients with hepatic cirrhosis and ascites, Furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, Furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that Furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg Furosemide per minute has been used) [see PRECAUTIONS: Drug Interactions ].

Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions hepatic encephalopathy in patients with hepatocellular insufficiency pancreatitis jaundice (intrahepatic cholestatic jaundice) increased liver enzymes anorexia oral and gastric irritation cramping diarrhea constipation nausea vomiting Systemic Hypersensitivity Reactions severe anaphylactic or anaphylactoid reactions (e.g., with shock) systemic vasculitis interstitial nephritis necrotizing angiitis Central Nervous System Reactions tinnitus and hearing loss paresthesias vertigo dizziness headache blurred vision xanthopsia Hematologic Reactions aplastic anemia thrombocytopenia agranulocytosis hemolytic anemia leukopenia anemia eosinophilia Dermatologic-Hypersensitivity Reactions toxic epidermal necrolysis Stevens-Johnson Syndrome erythema multiforme drug rash with eos …

Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this 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 disease, 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. …