Label Changes for:
Lasix (furosemide) tablets
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that Lasix 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 Lasix per minute has been used)
- In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment.
- In patients at high risk for radiocontrast nephropathy, Lasix can lead to a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast.
- In patients with hypoproteinemia (e.g., associated with nephrotic syndrome) the effect of Lasix may be weakened and its ototoxicity potentiated.
- ...Hypokalemia may develop with Lasix, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives. Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects.
- In premature infants Lasix may precipitate nephrocalcinosis/nephrolithiasis, therefore renal function must be monitored and renal ultrasonography performed
entire section revised
- Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher fetal birth weights.
- Lasix may inhibit lactation.
- In premature infants Lasix may precipitate nephrocalcinosis/nephrolithiasis. Nephrocalcinosis/nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with Lasix. Monitor renal function, and renal ultrasonography should be considered, in pediatric patients receiving Lasix.
- If Lasix is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.
Gastrointestinal System Reactions
- increased liverenzymes
Systemic Hypersensitivity Reactions
- severe anaphylactic or anaphylactoid reactions (e.g., with shock)
Dermatologic Hypersensitivity Reactions
- Stevens-Johnson Syndrome
- toxic epidermal necrolysis
- Increase in cholesterol and triglyceride serum levels