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bumetanide
Overview
What is bumetanide?
Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula:
What does bumetanide look like?
What are the available doses of bumetanide?
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What should I talk to my health care provider before I take bumetanide?
Sorry No records found
How should I use bumetanide?
Bumetanide tablets USP are 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 bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
Individualize dosage with careful monitoring of patient response.
What interacts with bumetanide?
Sorry No Records found
What are the warnings of bumetanide?
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 postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.
What are the precautions of bumetanide?
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. 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 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 bumetanide use is not certain.
Drug Interactions
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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 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 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 bumetanide. This antagonistic effect of probenecid on 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 bumetanide.
Indomethacin
Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide is thus not recommended.
Antihypertensives
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 bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.
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Bumetanide was devoid of mutagenic activity in various strains of when tested in the presence or absence of an 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 mg/kg/day, 30 mg/kg/day, 60 mg/kg/day 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
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Bumetanide is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose.
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 mg/kg/day 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 bumetanide parallels the marked pharmacologic and toxicologic effects of the drug in this species.
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. 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 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
Geriatric Use
Clinical studies of 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.
What are the side effects of bumetanide?
The most frequent clinical adverse reactions considered probably or possibly related to 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 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 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 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 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 bumetanide may also rarely be accompanied by changes in LDH (1%), 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.
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using bumetanide?
What might happen if I take too much bumetanide?
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.
How should I store and handle bumetanide?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18Bumetanide Tablets USP, 0.5 mg are light green, round, biconvex, uncoated tablet debossed with '525' on one side separating '5' & '25' with breakline and plain on the other side and are supplied as follows:NDC 70771-1024-3 in bottles of 30 tabletsNDC 70771-1024-9 in bottles of 90 tabletsNDC 70771-1024-1 in bottles of 100 tabletsNDC 70771-1024-5 in bottles of 500 tabletsNDC 70771-1024-0 in bottles of 1000 tabletsBumetanide Tablets USP, 1 mg are light yellow, round, biconvex, uncoated tablet debossed with '526' on one side separating '5' & '26' with breakline and plain on the other side and are supplied as follows:NDC 70771-1025-3 in bottles of 30 tabletsNDC 70771-1025-9 in bottles of 90 tabletsNDC 70771-1025-1 in bottles of 100 tabletsNDC 70771-1025-5 in bottles of 500 tabletsNDC 70771-1025-0 in bottles of 1000 tabletsBumetanide Tablets USP, 2 mg are light orange, round, biconvex, uncoated tablet debossed with '527' on one side separating '5' & '27' with breakline and plain on the other side and are supplied as follows:NDC 70771-1026-3 in bottles of 30 tabletsNDC 70771-1026-9 in bottles of 90 tabletsNDC 70771-1026-1 in bottles of 100 tabletsNDC 70771-1026-5 in bottles of 500 tabletsNDC 70771-1026-0 in bottles of 1000 tabletsStorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).Manufacturedby:Cadila Healthcare Ltd.Baddi, IndiaRev.: 04/18
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Bumetanide is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg bumetanide has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of 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. Bumetanide inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CHO) during hydration and tubular free-water reabsorption (THO) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by bumetanide, and bumetanide is somewhat more chloruretic than natriuretic.
Potassium excretion is also increased by bumetanide, in a dose-related fashion.
Bumetanide may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during bumetanide-induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of 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. Bumetanide does not appear to have a noticeable action on the distal tubule.
Bumetanide decreases uric acid excretion and increases serum uric acid. Following oral administration of 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 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 bumetanide amounted to only 2% of the administered dose.
Non-Clinical Toxicology
Bumetanide was devoid of mutagenic activity in various strains of when tested in the presence or absence of an 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 mg/kg/day, 30 mg/kg/day, 60 mg/kg/day or 100 mg/kg/day. The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant.
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. 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.
The most frequent clinical adverse reactions considered probably or possibly related to 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 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 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 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 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 bumetanide may also rarely be accompanied by changes in LDH (1%), 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.
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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