Bumex (Bumetanide)
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Bumex (Bumetanide)

BUMEX
(bumetanide) Tablets

WARNING

Bumex (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).

DRUG DESCRIPTION

Bumex (bumetanide) is a loop diuretic, available as scored tablets, 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) for oral administration; each tablet also contains lactose, magnesium stearate, microcrystalline cellulose, cornstarch and talc, with the following dye systems: 0.5 mg-D&C Yellow No. 10 and FD&C Blue No. 1; 1 mg-D&C Yellow No. 10; 2 mg-red iron oxide.

Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.41, and the following structural formula:

Bumex (bumetanide) Structural Formula Illustration

What are the possible side effects of bumetanide

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using bumetanide and call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, hallucinations, seizure, shallow breathing or breathing...

Read All Potential Side Effects and See Pictures of Bumex »

What are the precautions when taking bumetanide (Bumex)?

Before taking bumetanide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, inability to make urine, gout.

If you have diabetes, bumetanide may affect your blood sugar level. Check your blood sugar level regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication or diet.

Bumetanide may reduce the potassium level in your blood. Your doctor may instruct you to add potassium-rich foods to your diet...

Read All Potential Precautions of Bumex »

Last reviewed on RxList: 3/20/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bumex (bumetanide) 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 (bumetanide) following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

DOSAGE AND ADMINISTRATION

Dosage should be individualized with careful monitoring of patient response.

Oral Administration

The usual total daily dosage of Bumex (bumetanide) is 0.5 mg to 2 mg and in most patients is given as a single dose.

If the diuretic response to an initial dose of Bumex (bumetanide) is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5-hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby Bumex (bumetanide) is given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, the dosage should be kept to a minimum and, if necessary, dosage increased very carefully.

Because cross-sensitivity with furosemide has rarely been observed, Bumex (bumetanide) can be substituted at approximately a 1:40 ratio of Bumex (bumetanide) to furosemide in patients allergic to furosemide.

Parenteral Administration

Bumetanide injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.

Parenteral treatment should be terminated and oral treatment instituted as soon as possible.

HOW SUPPLIED

Tablets, 0.5 mg (light green), bottles of 100 (NDC 0004-0125-01) and 5000 (NDC 0004-012511); 1 mg (yellow), bottles of 100 (NDC 0004-0121-01), 500 (NDC 0004-0121-14) and 5000 (NDC 0004-0121-11); 2 mg (peach), bottles of 100 (NDC 0004-0162-01) and 5000 (NDC 00040162-11).

Imprint on tablets: 0.5 mg–ROCHE BUMEX (bumetanide) 0.5; 1 mg–ROCHE BUMEX (bumetanide) 1; 2 mg–ROCHE BUMEX (bumetanide) 2.

Store tablets at 59° to 86°F (15° to 30°C).

Validus Pharmaceuticals LLC, 19 Cherry Hill Road, Suite 310, Parsippany, NJ 07054. 1-866-9VALIDUS. (1-866-982-5438), info@validuspharma.com. (Rev 9/2009).

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most frequent clinical adverse reactions considered probably or possibly related to Bumex (bumetanide) are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with preexisting liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with Bumex (bumetanide) .

Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use.

Less frequent clinical adverse reactions to Bumex (bumetanide) are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%). One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with Bumex (bumetanide) .

Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, premature ejaculation and difficulty maintaining an erection.

Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients tested), hypochloremia (14.9%), hypokalemia (14.7%), azotemia (10.6%), hyponatremia (9.2%), increased serum creatinine (7.4%), hyperglycemia (6.6%), and variations in phosphorus (4.5%), CO content (4.3%), bicarbonate (3.1%) and calcium (2.4%). Although manifestations of the pharmacologic action of Bumex (bumetanide) , these conditions may become more pronounced by intensive therapy.

Also reported have been thrombocytopenia (0.2%) and deviations in hemoglobin (0.8%), prothrombin time (0.8%), hematocrit (0.6%), WBC (0.3%) and differential counts (0.1%). There have been rare spontaneous reports of thrombocytopenia from postmarketing experience.

Diuresis induced by Bumex (bumetanide) may also rarely be accompanied by changes in LDH (1.0%), total serum bilirubin (0.8%), serum proteins (0.7%), SGOT (0.6%), SGPT (0.5%), alkaline phosphatase (0.4%), cholesterol (0.4%) and creatinine clearance (0.3%). Increases in urinary glucose (0.7%) and urinary protein (0.3%) have also been seen.

Read the Bumex (bumetanide) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Drugs With Ototoxic Potential (see WARNINGS)

Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.

Drugs With Nephrotoxic Potential There has been no experience with the concurrent use of Bumex (bumetanide) with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.

Lithium

Lithium should generally not be given with diuretics (such as Bumex (bumetanide) ) because they reduce its renal clearance and add a high risk of lithium toxicity.

Probenecid

Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by Bumex (bumetanide) . This antagonistic effect of probenecid on Bumex (bumetanide) natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with Bumex (bumetanide) .

Indomethacin

Indomethacin blunts the increases in urine volume and sodium excretion seen during Bumex treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with Bumex (bumetanide) is thus not recommended.

Antihypertensives

Bumex (bumetanide) may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.

Digoxin

Interaction studies in humans have shown no effect on digoxin blood levels.

Anticoagulants

Interaction studies in humans have shown Bumex (bumetanide) to have no effect on warfarin metabolism or on plasma prothrombin activity.

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Volume and Electrolyte Depletion

The dose of Bumex (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 Bumex (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, 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 (bumetanide) .

Thrombocytopenia

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

PRECAUTIONS

General

Serum potassium should be measured periodically and potassium supplements or potassium-sparing diuretics added if necessary. Periodic determinations of other electrolytes are advised in patients treated with high doses or for prolonged periods, particularly in those on low-salt diets.

Hyperuricemia may occur; it has been asymptomatic in cases reported to date. Reversible elevations of the BUN and creatinine may also occur, especially in association with dehydration and particularly in patients with renal insufficiency. Bumex (bumetanide) may increase urinary calcium excretion with resultant hypocalcemia.

Diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Laboratory Tests

Studies in normal subjects receiving Bumex (bumetanide) revealed no adverse effects on glucose tolerance, plasma insulin, glucagon and growth hormone levels, but the possibility of an effect on glucose metabolism exists. Periodic determinations of blood sugar should be done, particularly in patients with diabetes or suspected latent diabetes.

Patients under treatment should be observed regularly for possible occurrence of blood dyscrasias, liver damage or idiosyncratic reactions, which have been reported occasionally in foreign marketing experience. The relationship of these occurrences to Bumex (bumetanide) use is not certain.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Bumex (bumetanide) was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system. An 18-month study showed an increase in mammary adenomas of questionable significance in female rats receiving oral doses of 60 mg/kg/day (2000 times a 2-mg human dose). A repeat study at the same doses failed to duplicate this finding.

Reproduction studies were performed to evaluate general reproductive performance and fertility in rats at oral dose levels of 10, 30, 60 or 100 mg/kg/day. The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Bumex (bumetanide) is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose.

Bumex (bumetanide) has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given in doses of 3400 times the maximum human therapeutic dose and in rabbits at doses of 3.4 times the maximum human therapeutic dose. In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, 3400 times the maximum human therapeutic dose. These effects were associated with maternal weight reductions noted during dosing. No such adverse effects were observed at 30 mg/kg/day (1000 times the maximum human therapeutic dose). No fetotoxicity was observed at 1000 to 2000 times the human therapeutic dose.

In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 and 0.3 mg/kg/day (3.4 and 10 times the maximum human therapeutic dose). A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day. The sensitivity of the rabbit to Bumex (bumetanide) parallels the marked pharmacologic and toxicologic effects of the drug in this species.

Bumex (bumetanide) was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (17 times the maximum human therapeutic dose). Bumetanide was not teratogenic when given intravenously to mice and rats at doses up to 140 times the maximum human therapeutic dose.

There are no adequate and well-controlled studies in pregnant women. A small investigational experience in the United States and marketing experience in other countries to date have not indicated any evidence of adverse effects on the fetus, but these data do not rule out the possibility of harmful effects. Bumex (bumetanide) should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while the patient is on Bumex (bumetanide) since it may be excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

In vitro studies using pooled sera from critically ill neonates have shown bumetanide to be a potent displacer of bilirubin (see CLINICAL PHARMACOLOGY: Pediatric Pharmacology). The administration of bumetanide could present a particular concern if given to critically ill or jaundiced neonates at risk for kernicterus.

Geriatric Use

Clinical studies of Bumex (bumetanide) did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

CONTRAINDICATIONS

Bumex (bumetanide) is contraindicated in anuria. Although Bumex (bumetanide) can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with Bumex (bumetanide) . Bumex (bumetanide) is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumex (bumetanide) is contraindicated in patients hypersensitive to this drug.

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Bumex (bumetanide) is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg Bumex (bumetanide) has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of Bumex (bumetanide) action is the ascending limb of the loop of Henle.

The mode of action has been determined through various clearance studies in both humans and experimental animals. Bumex (bumetanide) inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH O) during hydration and tubular free-water reabsorption (T H O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by Bumex (bumetanide) , and Bumex (bumetanide) is somewhat more chloruretic than natriuretic.

Potassium excretion is also increased by Bumex (bumetanide) , in a dose-related fashion.

Bumex (bumetanide) may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during Bumex (bumetanide) induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of Bumex (bumetanide) by probenecid, associated with diminution in the natriuretic response. This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumex (bumetanide) does not appear to have a noticeable action on the distal tubule.

Bumex (bumetanide) decreases uric acid excretion and increases serum uric acid. Following oral administration of Bumex (bumetanide) the onset of diuresis occurs in 30 to 60 minutes. Peak activity is reached between 1 and 2 hours. At usual doses (1 mg to 2 mg) diuresis is largely complete within 4 hours; with higher doses, the diuretic action lasts for 4 to 6 hours. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes.

Several pharmacokinetic studies have shown that bumetanide, administered orally or parenterally, is eliminated rapidly in humans, with a half-life of between 1 and 1½ hours. Plasma protein-binding is in the range of 94% to 96%.

Oral administration of carbon-14 labeled Bumex (bumetanide) to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. Biliary excretion of Bumex (bumetanide) amounted to only 2% of the administered dose.

Pediatric Pharmacology

Elimination of bumetanide appears to be considerably slower in neonatal patients compared with adults, possibly because of immature renal and hepatobiliary function in this population. Small pharmacokinetic studies of intravenous bumetanide in preterm and full-term neonates with respiratory disorders have reported an apparent half-life of approximately 6 hours, with a range up to 15 hours and a serum clearance ranging from 0.2 to 1.1 mL/min/kg. In a population of neonates receiving bumetanide for volume overload, mean serum clearance rates were 2.17 mL/min/kg in patients less than 2 months of age and 3.8 mL/min/kg in patients aged 2 to 6 months. Mean serum half-life of bumetanide was 2.5 hours and 1.5 hours in patients aged less than 2 months and those aged 2 to 6 months, respectively. Elimination half-life decreased considerably during the first month of life, from a mean of approximately 6 hours at birth to approximately 2.4 hours at 1 month of age.

In preterm neonates, mean serum concentrations following a single 0.05 mg/kg dose ranged from 126 mcg/L at 1 hour to 57 mcg/L at 8 hours. In another study, mean serum concentrations following a single 0.05 mg/kg dose were 338 ng/mL at 30 minutes and 176 ng/mL after 4 hours. A single dose of 0.1 mg/kg produced mean serum levels of 314 ng/mL at 1 hour, and 195 ng/mL at 6 hours. Mean volume of distribution in neonates and infants has been reported to range from 0.26 L/kg to 0.39 L/kg.

The degree of protein binding of bumetanide in cord sera from healthy neonates was approximately 97%, suggesting the potential for bilirubin displacement. A study using pooled sera from critically ill neonates found that bumetanide at concentrations of 0.5 to 50 mcg/mL, but not 0.25 mcg/mL, caused a linear increase in unbound bilirubin concentrations.

In 56 infants aged 4 days to 6 months, bumetanide doses ranging from 0.005 mg/kg to 0.1 mg/kg were studied for pharmacodynamic effect. Peak bumetanide excretion rates increased linearly with increasing doses of drug. Maximal diuretic effect was observed at a bumetanide excretion rate of about 7 mcg/kg/hr, corresponding to doses of 0.035 to 0.040 mg/kg. Higher doses produced a higher bumetanide excretion rate but no increase in diuretic effect. Urine flow rate peaked during the first hour after drug administration in 80% of patients and by 3 hours in all patients.

Geriatric Pharmacology

In a group of ten geriatric subjects between the ages of 65 and 73 years, total bumetanide clearance was significantly lower (1.8 ± 0.3 mL/min·kg) compared with younger subjects (2.9 ± 0.2 mL/min·kg) after a single oral bumetanide 0.5 mg dose. Maximum plasma concentrations were higher in geriatric subjects (16.9 ± 1.8 ng/mL) compared with younger subjects (10.3 ± 1.5 ng/mL). Urine flow rate and total excretion of sodium and potassium were increased less in the geriatric subjects compared with younger subjects, although potassium excretion and fractional sodium excretion were similar between the two age groups. Nonrenal clearance, bioavailability, and volume of distribution were not significantly different between the two groups.

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 2/16/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Bumex Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BUMETANIDE - ORAL

(bue-MET-a-nide)

COMMON BRAND NAME(S): Bumex

WARNING: Bumetanide is a very potent medication. Using too much of this drug can lead to serious water and salt/mineral loss. Therefore, it is important that you are closely monitored by your doctor while taking this medication. Tell your doctor right away if you become very thirsty or confused, or develop muscle cramps/weakness. See also Side Effects section.

USES: Bumetanide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This can lessen symptoms such as shortness of breath and swelling in your arms, legs, and abdomen. Bumetanide is a "water pill" (diuretic) that causes you to make more urine. This helps your body get rid of extra water and salt.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat high blood pressure, especially in people who have heart failure, too much fluid in the lungs, or kidney disease. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

HOW TO USE: Take this medication by mouth as directed by your doctor, usually once or twice daily. It is best to avoid taking this medication within 4 hours of your bedtime to prevent having to get up to urinate.

Dosage is based on your medical condition and response to treatment. Older adults usually start with a lower dose to decrease the risk of side effects. Do not increase your dose or take it more often than directed.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) of the day as directed. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Tell your doctor if your condition does not improve or if it worsens. If you are taking this medication to control high blood pressure, tell your doctor if your blood pressure readings remain high or increase.

Disclaimer

Bumex Consumer (continued)

SIDE EFFECTS: Dizziness may occur as your body adjusts to the medication. If this effect persists or worsens, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause a serious loss of body water (dehydration) and salt/minerals. Tell your doctor right away if you have any of these unlikely but serious side effects: muscle cramps, weakness, unusual tiredness, confusion, severe dizziness, fainting, drowsiness, unusual dry mouth/thirst, nausea, vomiting, fast/irregular heartbeat, unusual decrease in the amount of urine.

Tell your doctor right away if any of these rare but serious side effects occur: numbness/tingling/pain/redness/swelling of the arms/legs, hearing changes (such as ringing in the ears, temporary or permanent decreased hearing/deafness), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Bumex (bumetanide) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking bumetanide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, inability to make urine, gout.

If you have diabetes, bumetanide may affect your blood sugar level. Check your blood sugar level regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication or diet.

Bumetanide may reduce the potassium level in your blood. Your doctor may instruct you to add potassium-rich foods to your diet (such as bananas, orange juice) or prescribe potassium supplements to prevent potassium loss. Ask your doctor for more details.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk of dehydration. Report prolonged diarrhea or vomiting to your doctor. Follow your doctor's instructions about the amount of fluids you can drink.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness and water/mineral loss.

During pregnancy, this drug should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Bumex Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: indomethacin, lithium, probenecid, other drugs that can affect your hearing (including aminoglycoside antibiotics such as gentamicin, tobramycin).

Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or worsen swelling (edema). Ask your pharmacist for more details.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fainting, severe weakness, a severe decrease in the amount of urine.

NOTES: Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, reducing stress, and changing your diet. Consult your doctor for more details.

Laboratory and/or medical tests (such as kidney tests, blood mineral levels such as potassium) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Bumex Patient Information Including Side Effects

Brand Names: Bumex

Generic Name: bumetanide (Pronunciation: byoo MET a nide)

What is bumetanide (Bumex)?

Bumetanide is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine.

Bumetanide treats fluid retention (edema) in people with congestive heart failure, liver disease, or a kidney disorder such as nephrotic syndrome.

Bumetanide may also be used for other purposes not listed in this medication guide.

Bumetanide 0.5 mg -ZEN

round, green, imprinted with 0.5, Z 4232

Bumetanide 0.5 mg-EON

round, green, imprinted with E 128

Bumetanide 0.5 mg-MYL

round, green, imprinted with E 128

Bumetanide 0.5 mg-TEV

round, green, imprinted with Z 4232, 0.5

Bumetanide 1 mg-EON

round, yellow, imprinted with E 129

Bumetanide 1 mg-MYL

round, yellow, imprinted with E 129

Bumetanide 1 mg-TEV

round, yellow, imprinted with Z 4233, 1

Bumetanide 1 mg-ZEN

round, yellow, imprinted with Z 4233, 1

Bumetanide 2 mg-EON

round, beige, imprinted with E 130

Bumetanide 2 mg-TEV

round, pink, imprinted with Z 4234, 2

Bumetanide 2mg-ZEN

round, peach, imprinted with Z 4234, 2

Bumex 0.5 mg

oval, green, imprinted with ROCHE, BUMEX0.5

Bumex 1 mg

elliptical, yellow, imprinted with ROCHE, BUMEX 1

Bumex 2 mg

oval, peach, imprinted with BUMEX 2, ROCHE

What are the possible side effects of bumetanide

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using bumetanide and call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, hallucinations, seizure, shallow breathing or breathing that stops;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • hearing problems.

Less serious side effects may include:

  • mild muscle pain;
  • dizziness;
  • headache;
  • stomach pain, mild nausea; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Bumex (bumetanide) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about bumetanide (Bumex)?

You should not use bumetanide if you are allergic to it, if you are unable to urinate, if you have severe kidney or liver disease, or if you are severely dehydrated.

Before you take bumetanide, tell your doctor if you have kidney or liver disease, gout, diabetes, or an allergy to sulfa drugs.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Bumetanide will make you urinate more often and you may get dehydrated easily. Follow your doctor's instructions about using potassium supplements or getting enough salt and potassium in your diet.

Avoid becoming dehydrated. Follow your doctor's instructions about the type and amount of liquids you should drink while you are taking bumetanide.

Side Effects Centers

Bumex Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking bumetanide (Bumex)?

You should not use bumetanide if you are allergic to it, or if you have:

  • severe kidney disease or are unable to urinate;
  • severe liver disease; or
  • if you are severely dehydrated.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • kidney disease;
  • liver disease;
  • a history of heart rhythm disorder;
  • gout;
  • diabetes; or
  • an allergy to sulfa drugs.

FDA pregnancy category C. It is not known whether bumetanide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether bumetanide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking bumetanide.

How should I take bumetanide (Bumex)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Bumetanide will make you urinate more often and you may get dehydrated easily. Follow your doctor's instructions about using potassium supplements or getting enough salt and potassium in your diet.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking bumetanide. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Store this medication at room temperature away from heat, light, and moisture.

Side Effects Centers

Bumex Patient Information including If I Miss a Dose

What happens if I miss a dose (Bumex)?

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.

What happens if I overdose (Bumex)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or weakness, confusion, loss of appetite, stomach cramps, and vomiting.

What should I avoid while taking bumetanide (Bumex)?

Avoid becoming dehydrated. Follow your doctor's instructions about the type and amount of liquids you should drink while you are taking bumetanide.

What other drugs will affect bumetanide (Bumex)?

Although bumetanide is used in people with kidney disease, this medication can harm the kidneys if your condition gets worse. This effect is increased when you also use other medicines harmful to the kidneys (including some over-the-counter medicines). You may need dose adjustments or special tests if you have recently used:

  • medicines to treat a bowel disorder;
  • medication to prevent organ transplant rejection;
  • antiviral medications;
  • chemotherapy;
  • pain or arthritis medicines; or
  • any injected antibiotics.

Tell your doctor about all other medicines you use, especially:

  • lithium (Lithobid);
  • digoxin (Lanoxin);
  • probenecid (Benemid);
  • indomethacin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;
  • blood pressure medication; or
  • any other diuretic.

Where can I get more information?

Your pharmacist can provide more information about bumetanide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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