FDA label 593a25eb-05bc-42e1-ac91-57afb6bdf01c

WARNING 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).

ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. hepatic encephalopathy in patients 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 6. oral and gastric irritation Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) 3. interstitial nephritis 2. systemic vasculitis 4. necrotizing angiitis 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. toxic epidermal necrolysis 7. bullous pemphigoid 2. Stevens-Johnson Syndrome 8. purpura 3. erythema multiforme 9. photosensitivity 4. drug rash with eosinophilia and systemic 10. rash symptoms 5. acute generalized exanthematous pustulosis 11. pruritis 6. exfoliative dermatitis 12. urticaria Cardiovascular Reaction 1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics. 2. Increase in cholesterol and triglyceride serum levels Other Reactions 1. hyperglycemia 6. restlessness 2. glycosuria 7. urinary bladder spasm 3. hyperuricemia 8. thrombophlebitis 4. muscle spasm 9. fever 5. weakness Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Esjay Pharma LLC at 1-800-239-9339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

<table cellspacing="0" cellpadding="0" border="0"><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">1. hepatic encephalopathy in patients with hepatocellular insufficiency </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">7. cramping </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">2. pancreatitis</td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">8. diarrhea </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">3. jaundice (intrahepatic cholestatic jaundice) </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">9. constipation</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">4. increased liver enzymes </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">10. nausea </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">5. anorexia </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">11. vomiting</td></tr><tr><td styleCode="Lrule Rrule" valign="middle">6. oral and gastric irritation </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr></tbody></table>

<table cellspacing="0" cellpadding="0" border="0"><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">3. interstitial nephritis </td></tr><tr><td styleCode="Lrule Rrule" valign="middle">2. systemic vasculitis</td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">4. necrotizing angiitis</td></tr></tbody></table>

<table cellspacing="0" cellpadding="0" border="0"><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold"/>1. tinnitus and hearing loss </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">5. headache </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">2. paresthesias </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">6. blurred vision </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">3. vertigo </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle">7. xanthopsia</td></tr><tr><td styleCode="Lrule Rrule" valign="middle">4. dizziness </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr></tbody></table>