Bumex

Before taking Bumex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have liver disease
• have kidney disease
• have diabetes
• have gout
• have electrolyte imbalances
• are allergic to any medications
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bumex falls into category C. In animals studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with Bumex, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

• Store at room temperaure between 59° and 86°F (15° and 30°C).
• Keep this and all medications out of the reach of children.

Bumetanide is sometimes used only once, so you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Bumex is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route.

Successful treatment with Bumex following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Volume and Electrolyte Depletion

The dose of Bumex 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 Bumex 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, ie, 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 Bumex.

Thrombocytopenia

Since there have been rare spontaneous reports of thrombocytopenia from postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.

Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.

Applies to bumetanide: compounding powder, injectable solution, oral tablet

Metabolic

Metabolic side effects associated with bumetanide (the active ingredient contained in Bumex) as with other loop diuretics, occur in 7% to 20% of patients, and include hyponatremia, hypokalemia, hypochloremia, and hyperuricemia. These side effects may be more likely in patients with renal insufficiency. Glucose intolerance is reported in up to 14% of elderly patients. Hypokalemia may lead to increased renal tubular bicarbonate reabsorption, resulting in metabolic alkalosis.[Ref]

Besides acting on the loop of Henle, bumetanide also inhibits phosphate reabsorption in the proximal tubule, resulting in phosphaturia. Since phosphorous is abundant in most diets, bumetanide-induced phosphaturia may not be significant except in malnourished patients, patients on life support, and patients with significant muscle weakness.

Calcium balance appears to remain neutral during treatment with a loop diuretic (i.e., furosemide, bumetanide). Although loop diuretics cause an increase in renal calcium excretion, this appears to be compensated for by a parathyroid-dependent increase in 1,25-dihydroxyvitamin D levels, which increases intestinal calcium absorption. Bone metabolism does not appear to be significantly affected by loop diuretics.[Ref]

Musculoskeletal

Musculoskeletal side effects have included muscle cramps in 1.1% and weakness in 0.2% of patients.[Ref]

Renal

Renal insufficiency, manifested as a rise in serum creatinine and BUN, may occur in up to 7% of patients. It is usually due to extracellular fluid volume depletion and is readily reversible.[Ref]

Cardiovascular

Cardiovascular side effects include hypotension in less than 2% of patients. Patients with a history of cardiac arrhythmias should be monitored closely because of the risk of hypokalemia.[Ref]

Gastrointestinal

Gastrointestinal side effects were reported in less than 2% of patients and included nausea, vomiting, loose stools, and constipation. There have been rare reports of hyperamylasemia and pancreatitis associated with bumetanide (the active ingredient contained in Bumex) use.[Ref]

Nervous system

Nervous system side effects, such as headache, dizziness, deafness, tinnitus, vertigo, and decreased hearing, are reported in less than 2% of patients. Encephalopathy after bumetanide (the active ingredient contained in Bumex) administration is reported in patients with severe liver disease.[Ref]

Hypersensitivity

Severe hypersensitivity reactions such as Stevens-Johnson syndrome and recurrent urticaria have been reported in rare cases.[Ref]

Hypersensitivity reactions are rare. Rash is reported in less than 1% of treated patients. Because cross-reactivity with furosemide is rare, bumetanide can be substituted at about a 1:40 dose ratio of bumetanide to furosemide in patients allergic to furosemide.[Ref]

Dermatologic

Dermatologic side effects have included pseudoporphyria, Stevens-Johnson syndrome, and toxic epidermal necrolysis.[Ref]

Hematologic

Hematologic side effects are extremely rare. Cases of thrombocytopenia, mild anemia, and leukopenia have been reported.[Ref]

Some side effects of Bumex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.