Enbumyst

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults. ENBUMYST is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including nephrotic syndrome in adults. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION ENBUMYST is for nasal route only. ( 2 ) Individualize dosage based on patient response. The recommended total daily dosage of ENBUMYST is 0.5 mg to 2 mg administered once daily. ( 2.1 ) ENBUMYST is not intended for chronic use; replace with oral diuretics as soon as practical. ( 2.1 ) 2.1 Recommended Dosage Each unit-dose nasal spray contains 0.5 mg of bumetanide. The usual total daily dosage of ENBUMYST is 0.5 mg to 2 mg once daily. The number of nasal spray devices needed for a single dose depends upon the prescribed dose. Individualize dosage based on patient response up to a maximum dose of 2 mg/day. ENBUMYST is not intended for chronic use and should be replaced with oral diuretics as soon as practical. ENBUMYST can be substituted at approximately a 1:40 ratio to oral furosemide and a 1:20 ratio to intravenous furosemide. 2.2 Administration Instructions ENBUMYST is for nasal use only. Each ENBUMYST unit is for single use and delivers 0.5 mg bumetanide upon actuation. Do not prime or attempt to reuse ENBUMYST for more than one administration. Administer ENBUMYST directly into the nose and not against the wall of the nose. If prescribed dose requires more than one nasal spray, alternate between right and left nostrils. Refer patients and caregivers to the Instructions for Use for detailed administration instructions. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Fluid, Electrolyte, and Metabolic Abnormalities: Monitor serum electrolytes, CO 2 , BUN, creatinine, glucose and uric acid. ( 5.1 ) Worsening Renal Function: Monitor for dehydration and azotemia. ( 5.2 ) Ototoxicity: Avoid higher than recommended doses. ( 5.3 ) Potential Altered Absorption in Patients with Nasal Mucosal or Structural Abnormalities: Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause. ( 5.4 ) 5.1 Fluid, Electrolyte, and Metabolic Abnormalities Bumetanide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during bumetanide therapy. 5.2 Worsening Renal Function Bumetanide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide [see Clinical Pharmacology (12.3) ]. 5.3 Ototoxicity Tinnitus and hearing loss (usually reversible) have been reported with loop diuretics, including bumetanide. Reports indicate that 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. 5.4 Potential Altered Absorption in Patients with Nasal Mucosal or Structural Abnormalities ENBUMYST has not been assessed in individuals with nasal mucosal or structural abnormalities. Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause. Consider alternative products or therapies in such patients. Drug interactions 7 DRUG INTERACTIONS Lithium may reduce renal clearance of bumetanide and add a high risk of lithium toxicity. ( 7 ) Probenecid reduces both the natriuresis and hyperreninemia. ( 7 ) Indomethacin blunts the increase in urine volume and sodium excretion. ( 7 ) Drugs with ototoxic potential: avoid parenteral bumetanide in patients receiving aminoglycoside antibiotics. ( 7 ) Drugs with nephrotoxic potential: the simultaneous administration of ENBUMYST with drugs of nephrotoxic potential should be avoided. ( 7 ) Antihypertensive effects may be potentiated by bumetanide. ( 7 ) 7.1 Effects of Other Drugs on Bumetanide Lithium Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity. Probenecid Probenecid should not be administered concurrently with bumetanide. Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produce