FDA label 2a7d33df-e362-d1e4-e063-6294a90a6d1c

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 4mg 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 6. oral and gastric irritation 2. pancreatitis 7. cramping 3. jaundice (intrahepatic cholestatic jaundice) 8. diarrhea 4. increased liver enzymes 9. constipation 5. anorexia 10. nausea 11. vomiting Systemic Hypersensitivity Reactions 1. severe anaphylactic or anaphylactoid reactions (eg., 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 2. stevens-johnson syndrome 3. erythema multiforme 4. drug rash with eosinophilia and systemic symptoms 5. acute generalized exanthematous pustulosis 6. exfoliative dermatitis 7. bullous pemphigoid 8. purpura 9. photosensitivity 10. rash 11. pruritis 12. urticaria Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics. 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 5. weakness 9. fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

<table ID="ID19" width="100%" styleCode="Noautorules"><caption/><col/><col/><tbody><tr><td align="left" valign="top"> 1.hepatic encephalopathy in patients with hepatocellular insufficiency </td><td align="left" valign="top"> 6. oral and gastric irritation </td></tr><tr><td align="left" valign="top"> 2. pancreatitis </td><td align="left" valign="top"> 7. cramping </td></tr><tr><td align="left" valign="top"> 3. jaundice (intrahepatic cholestatic jaundice) </td><td align="left" valign="top"> 8. diarrhea </td></tr><tr><td align="left" valign="top"> 4. increased liver enzymes </td><td align="left" valign="top"> 9. constipation </td></tr><tr><td align="left" valign="top"> 5. anorexia </td><td align="left" valign="top"> 10. nausea </td></tr><tr><td valign="top"/><td align="left" valign="top"> 11. vomiting </td></tr></tbody></table>

<table ID="ID21" width="555" styleCode="Noautorules"><caption/><col width="312"/><col width="37"/><col width="206"/><tbody><tr><td align="left" valign="top"> 1. severe anaphylactic or anaphylactoid reactions (eg., with shock) </td><td valign="top"/><td align="left" valign="top"> 3. interstitial nephritis </td></tr><tr><td align="left" valign="top"> 2. systemic vasculitis </td><td valign="top"/><td align="left" valign="top"> 4. necrotizing angiitis </td></tr></tbody></table>

<table ID="ID23" width="100%" styleCode="Noautorules"><caption/><col/><col/><col/><tbody><tr><td align="left" valign="top"> 1. tinnitus and hearing loss </td><td valign="top"/><td align="left" valign="top"> 5. headache </td></tr><tr><td align="left" valign="top"> 2. paresthesias </td><td valign="top"/><td align="left" valign="top"> 6. blurred vision </td></tr><tr><td align="left" valign="top"> 3. vertigo </td><td valign="top"/><td align="left" valign="top"> 7. xanthopsia </td></tr><tr><td align="left" valign="top"> 4. dizziness </td><td valign="top"/><td valign="top"/></tr></tbody></table>