FDA label 9c06d82b-c257-1d2e-e053-2995a90abb44

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. (See 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. ) Pediatric Use In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process. Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. Hearing loss in neonates has been associated with the use of furosemide injection (see WARNINGS , above).

ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. Hepatic encephalopathy in patients 6. Oral and gastric irritation with hepatocellular insufficiency 7. Cramping 2. Pancreatitis 8. Diarrhea 3. Jaundice (intrahepatic cholestatic jaundice) 9. Constipation 4. Increased liver enzymes 10. Nausea 5. Anorexia 11. Vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid 3. Interstitial nephritis reactions (e.g. with shock) 4. Necrotizing angiitis 2. Systemic vasculitis Central Nervous System Reactions 1. Tinnitus and hearing loss 5. Headache 2. Paresthesias 6. Blurred vision 3. Vertigo 7. Xanthopsia 4. Dizziness Hematologic Reactions 1. Aplastic anemia 5. Leukopenia 2. Thrombocytopenia 6. Anemia 3. Agranulocytosis 7. Eosinophilia 4. Hemolytic anemia Dermatologic-Hypersensitivity Reactions 1. Exfoliative dermatitis 6. Urticaria 2. Bullous pemphigoid 7. Rash 3. Erythema multiforme 8. Pruritus 4. Purpura 9. Stevens-Johnson Syndrome 5. Photosensitivity 10. Toxic epidermal necrolysis Cardiovascular Reaction 1. Ortho static hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. 2. Increase in cholesterol and triglyceride serum levels. Other Reactions 1. Hyperglycemia 7. Urinary bladder spasm 2. Glycosuria 8. Thrombophlebitis 3. Hyperuricemia 9. Transient injection site pain following 4. Muscle spasms intramuscular injection 5. Weakness 10. Fever 6. Restlessness Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

<table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td colspan="2"><paragraph><content styleCode="bold">Gastrointestinal System Reactions</content></paragraph></td></tr><tr><td><paragraph>1. Hepatic encephalopathy in patients </paragraph></td><td><paragraph>6. Oral and gastric irritation</paragraph></td></tr><tr><td><paragraph> with hepatocellular insufficiency</paragraph></td><td><paragraph>7. Cramping</paragraph></td></tr><tr><td><paragraph>2. Pancreatitis</paragraph></td><td><paragraph>8. Diarrhea</paragraph></td></tr><tr><td><paragraph>3. Jaundice (intrahepatic cholestatic jaundice)</paragraph></td><td><paragraph>9. Constipation</paragraph></td></tr><tr><td><paragraph>4. Increased liver enzymes</paragraph></td><td><paragraph>10. Nausea</paragraph></td></tr><tr><td><paragraph>5. Anorexia</paragraph></td><td><paragraph>11. Vomiting</paragraph></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">Systemic Hypersensitivity Reactions</content></paragraph></td></tr><tr><td><paragraph>1. Severe anaphylactic or anaphylactoid</paragraph></td><td><paragraph>3. Interstitial nephritis</paragraph></td></tr><tr><td><paragraph> reactions (e.g. with shock)</paragraph></td><td><paragraph>4. Necrotizing angiitis</paragraph></td></tr><tr><td><paragraph>2. Systemic vasculitis</paragraph></td><td><paragraph/></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">Central Nervous System Reactions</content></paragraph></td></tr><tr><td><paragraph>1. Tinnitus and hearing loss</paragraph></td><td><paragraph>5. Headache</paragraph></td></tr><tr><td><paragraph>2. Paresthesias</paragraph></td><td><paragraph>6. Blurred vision</paragraph></td></tr><tr><td><paragraph>3. Vertigo</paragraph></td><td><paragraph>7. Xanthopsia</paragraph></td></tr><tr><td><paragraph>4. Dizziness</paragraph></td><td><paragraph/></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">Hematologic Reactions</content></paragraph></td></tr><tr><td><paragraph>1. Aplastic anemia</paragraph></td><td><paragraph>5. Leukopenia</paragraph></td></tr><tr><td><paragraph>2. Thrombocytopenia</paragraph></td><td><paragraph>6. Anemia</paragraph></td></tr><tr><td><paragraph>3. Agranulocytosis</paragraph></td><td><paragraph>7. Eosinophilia</paragraph></td></tr><tr><td><paragraph>4. Hemolytic anemia</paragraph></td><td><paragraph/></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">Dermatologic-Hypersensitivity Reactions</content></paragraph></td></tr><tr><td><paragraph>1. Exfoliative dermatitis</paragraph></td><td><paragraph>6. Urticaria</paragraph></td></tr><tr><td><paragraph>2. Bullous pemphigoid</paragraph></td><td><paragraph>7. Rash</paragraph></td></tr><tr><td><paragraph>3. Erythema multiforme</paragraph></td><td><paragraph>8. Pruritus</paragraph></td></tr><tr><td><paragraph>4. Purpura</paragraph></td><td><paragraph>9. Stevens-Johnson Syndrome</paragraph></td></tr><tr><td><paragraph>5. Photosensitivity</paragraph></td><td><paragraph>10. Toxic epidermal necrolysis</paragraph></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">Cardiovascular Reaction</content></paragraph></td></tr><tr><td colspan="2"><paragraph>1. Ortho static hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.</paragraph></td></tr><tr><td colspan="2"><paragraph>2. Increase in cholesterol and triglyceride serum levels.</paragraph></td></tr><tr><td colspan="2"><paragraph><content styleCode="bold">Other Reactions</content></paragraph></td></tr><tr><td><paragraph>1. Hyperglycemia</paragraph></td><td><paragraph>7. Urinary bladder spasm</paragraph></td></tr><tr><td><paragraph>2. Glycosuria </paragraph></td><td><paragraph>8. Thrombophlebitis</paragraph></td></tr><tr><td><paragraph>3. Hyperuricemia</paragraph></td><td><paragraph>9. Transient injection site pain following</paragraph></td></tr><tr><td><paragraph>4. Muscle spasms</paragraph></td><td><paragraph> intramuscular injection</paragraph></td></tr><tr><td><paragraph>5. Weakness</paragraph></td><td><paragraph>10. Fever</paragraph></td></tr><tr><td><paragraph>6. Restlessness</paragraph></td><td><paragraph/></td></tr></tbody></table>