FDA label dbda651c-a981-4e87-a188-6594565504c2

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. Usually, reports indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, doses exceeding several times the usual recommended dose, 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 Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions hepatic encephalopathy in patients with hepatocellular insufficiency 1. pancreatitis 2. jaundice (intrahepatic cholestatic jaundice) 3. increased liver enzymes 4. anorexia 5. oral and gastric irritation 6. cramping 7. diarrhea 8. constipation 9. nausea 10. vomiting 11. Systemic Hypersensitivity Reactions severe anaphylactic or anaphylactoid reations (e.g. with shock) 1. systemic vasculitis 2. interstitial nephritis 3. necrotizing angiitis 4. Central Nervous System Reactions tinnitus and hearing loss 1. paresthesias 2. vertigo 3. dizziness 4. headache 5. blurred vision 6. xanthopsia 7. Hematologic Reactions aplastic anemia 1. thrombocytopenia 2. agranulocytosis 3. hemolytic anemia 4. leukopenia 5. anemia 6. eosinophilia 7. Dermatologic-Hypersensitivity Reactions toxic epidermal necrolysis 1. Stevens-Johnson Syndrome 2. erythema multiforme 3. drug rash with eosinophilia and systemic symptoms 4. acute generalized exanthematous pustulosis 5. exfoliative dermatitis 6. bullous pemphigoid 7. purpura 8. photosensitivity 9. rash 10. pruritus 11. urticaria 12. Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. 1. Increase in cholesterol and triglyceride serum levels 2. Other Reactions hyperglycemia 1. glycosuria 2. hyperuricemia 3. muscle spasm 4. weakness 5. restlessness 6. urinary bladder spasm 7. thrombophlebitis 8. fever 9. Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.