Bumetanide - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Bumetanide. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule have to be adjusted to the individual patient’s needs (see DOSAGE AND ADMINISTRATION ).
WARNINGS Volume and Electrolyte Depletion The dose of bumetanide should be adjusted to the patient's need.
Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients.
Hypokalemia Hypokalemia can occur as a consequence of bumetanide administration.
Prevention of hypokalemia requires particular attention in the following conditions: patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, i.e., history of ventricular arrhythmias.
In patients with hepatic cirrhosis and ascites, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma.
Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient's clinical status and electrolyte balance.
Supplemental potassium and/or spironolactone may prevent hypokalemia and metabolic alkalosis in these patients.
Ototoxicity In cats, dogs and guinea pigs, bumetanide has been shown to produce ototoxicity.
In these test animals bumetanide was 5 to 6 times more potent than furosemide and, since the diuretic potency of bumetanide is about 40 to 60 times furosemide, it is anticipated that blood levels necessary to produce ototoxicity will rarely be achieved.
The potential exists, however, and must be considered a risk of intravenous therapy, especially at high doses, repeated frequently in the face of renal excretory function impairment Potentiation of aminoglycoside ototoxicity has not been tested for bumetanide.
Like other members of this class of diuretics, bumetanide probably shares this risk.
Allergy to Sulfonamides Patients allergic to sulfonamides may show hypersensitivity to bumetanide.
Thrombocytopenia Since there have been rare spontaneous reports of thrombocytopenia from post marketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.
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