Furosemide
Generic: FUROSEMIDE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
813c8e9b-61bc-27c4-e053-2a91aa0a9f45
Indications & Usage
INDICATIONS AND USAGE Edema FUROSEMIDE TABLET 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 TABLET is particularly useful when an agent with greater diuretic potential is desired.
Hypertension Oral FUROSEMIDE TABLET 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 TABLETS alone.
FUROSEMIDE TABLET is particularly useful when an agent with greater diuretic potential is desired.
Hypertension Oral FUROSEMIDE TABLET 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 TABLETS alone.
Warnings
WARNINGS In patients with hepatic cirrhosis and ascites, FUROSEMIDE TABLET 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 TABLET should be discontinued.
Cases of tinnitus and reversible or irreversible hearing impairment have been reported.
Usually, reports indicate that FUROSEMIDE TABLET 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 TABLET per minute has been used).
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 TABLET should be discontinued.
Cases of tinnitus and reversible or irreversible hearing impairment have been reported.
Usually, reports indicate that FUROSEMIDE TABLET 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 TABLET per minute has been used).
Adverse Reactions
ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity.
Gastrointestinal System Reactions pancreatitis jaundice (intrahepatic cholestatic jaundice) anorexia oral and gastric irritation cramping diarrhea constipation nausea vomiting Systemic Hypersensitivity Reactions 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 (rare) thrombocytopenia agranulocytosis (rare) hemolytic anemia leukopenia anemia Dermatologic-Hypersensitivity Reactions exfoliative dermatitis erythema multiforme purpura photosensitivity urticaria rash pruritus Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.
Other Reactions hyperglycemia glycosuria hyperuricemia muscle spasm weakness restlessness urinary bladder spasm thrombophlebitis fever Whenever adverse reactions are moderate or severe, FUROSEMIDE TABLET dosage should be reduced or therapy withdrawn.
Gastrointestinal System Reactions pancreatitis jaundice (intrahepatic cholestatic jaundice) anorexia oral and gastric irritation cramping diarrhea constipation nausea vomiting Systemic Hypersensitivity Reactions 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 (rare) thrombocytopenia agranulocytosis (rare) hemolytic anemia leukopenia anemia Dermatologic-Hypersensitivity Reactions exfoliative dermatitis erythema multiforme purpura photosensitivity urticaria rash pruritus Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.
Other Reactions hyperglycemia glycosuria hyperuricemia muscle spasm weakness restlessness urinary bladder spasm thrombophlebitis fever Whenever adverse reactions are moderate or severe, FUROSEMIDE TABLET dosage should be reduced or therapy withdrawn.