furosemide

FDA Drug Profile — FUROSEMIDE, Furosemide, LASIX ONYU, FUROSCIX

furosemide is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including FUROSEMIDE, Furosemide, LASIX ONYU. Available dosage forms: injection, solution, tablet, injection.

Drug Details

Generic Name
furosemide
Brand Names
FUROSEMIDE, Furosemide, LASIX ONYU, FUROSCIX
Application Number
ANDA215856
Sponsor
Devatis Inc.
NDC Codes
50
Dosage Forms
INJECTION, SOLUTION, TABLET, INJECTION
Routes
INTRAVENOUS, ORAL, INTRAMUSCULAR, SUBCUTANEOUS
Active Ingredients
FUROSEMIDE

Indications and Usage

INDICATIONS AND USAGE Edema Furosemide tablets are 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 tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral Furosemide tablets 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 tablets 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 tablets should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that Furosemide tablets 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 tablets per minute has been used). (See PRECAUTIONS: Drug Interactions)