Bumex Bumetanide 1 mg Tablet, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Loop Diuretic class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Bumetanide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease. Bumetanide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.
Read the full MedlinePlus article ↗- Think of it as a very efficient 'water pill.' Your kidneys normally recycle most of the salt that flows through them, and water follows that salt back into your bloodstream. Bumeta...
- What is bumetanide actually doing in my body?
- Bumetanide works fast. If you take a tablet, you'll usually feel the urge to urinate within 30 to 60 minutes, with the strongest effect around 1 to 2 hours. Most of the diuretic ac...
- When will I notice it working, and how long does it last?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bumetanide — tap one for details:
Bumetanide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bumetanide 1 mg 00185-0129-01 | Sandoz | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 00904-7016-04 | Major | 30 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 16571-0678-01 | Rising | 100 tablets | $0.108 | AB | Availability likely | — |
| bumetanide 1 mg 23155-0901-01 | Heritage | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 42799-0120-01 | Edenbridge | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 43547-0897-10 | Solco | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 50268-0131-15 | AvPAK | 50 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 51672-4224-01 | Sun | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 60687-0384-01 | American | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 69238-1490-01 | Amneal | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 70756-0080-11 | Lifestar | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 72603-0900-01 | NorthStar | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 72888-0020-01 | Advagen | 100 tablets | $0.108 | AB | Availability likely | — |
| Bumetanide 1 mg 76282-0798-01 | Exelan | 100 tablets | $0.108 | AB | Availability likely | — |
| bumetanide 1 mg 68382-0526-01 | Zydus | 100 tablets | $0.177 | AB | FDA listed | — |
| Bumetanide 1 mg 00615-8615-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 00781-8113-01 | Sandoz | 100 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 00832-0541-10 | Upsher-Smith | 1000 tablets | — | AB | FDA listed | — |
| Bumex 1 mgthis 30698-0631-01 | Validus | 100 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 43353-0288-09 | Aphena | 9000 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 50090-5666-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| bumetanide 1 mg 50090-6138-02 | A-S | 90 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 50090-6345-02 | A-S | 90 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 50090-7965-02 | A-S | 90 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 55154-3572-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 55154-4345-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 63629-4968-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 70518-4385-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| bumetanide 1 mg 70771-1025-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| bumetanide 1 mg 71335-1692-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 71335-2670-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 71335-2920-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 72162-2196-05 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 72205-0057-05 | Novadoz | 500 tablets | — | AB | FDA listed | — |
| bumetanide 1 mg 72603-0298-01 | NorthStar | 100 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 81469-0222-01 | First | 100 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 82804-0119-90 | Proficient | 90 tablets | — | AB | FDA listed | — |
| Bumetanide 1 mg 82804-0287-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 30698-0631-01 You're viewing this | 100 TABLET in 1 BOTTLE (30698-631-01) | 1983-02-28 | Active |
| 30698-0631-05 | 500 TABLET in 1 BOTTLE (30698-631-05) | 2024-01-17 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 30698-0631-01?
What is the difference between NDC 30698-0631-01 and NDC 30698-0631-05?
What NDC number is used to bill for this package of Bumex Bumetanide 1 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 ) .
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Bumex tablets 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 Bumex tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Individualize dosage with careful monitoring of patient response. Oral Administration The usual total daily dosage of Bumex tablets 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 tablets 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 tablets are 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, keep the dosage to a minimum. Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide in proportion to furosemide in patients allergic to furosemide.
Parenteral Administration Bumetanide injection may be administered parenterally (intravenously and intramuscularly) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical. Terminate parenteral treatment and institute oral treatment as soon as possible.
⛔ Contraindications ▾
CONTRAINDICATIONS Bumex is contraindicated in anuria. Although Bumex 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. Bumex is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected.
Bumex is contraindicated in patients hypersensitive to this drug.
⚠️ Warnings ▾
WARNINGS Volume and Electrolyte Depletion The dose of Bumex should be adjusted to the patient's need. Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients. Hypokalemia Hypokalemia can occur as a consequence of Bumex administration.
Prevention of hypokalemia requires particular attention in the following conditions: patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, 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 Bumex. Thrombocytopenia Since there have been rare spontaneous reports of thrombocytopenia from postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequent clinical adverse reactions considered probably or possibly related to Bumex 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 pre-existing liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with Bumex. 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 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. 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, 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 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.
To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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 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) 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. This antagonistic effect of probenecid on Bumex 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. 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 is thus not recommended.
Antihypertensives Bumex 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 to have no effect on warfarin metabolism or on plasma prothrombin activity.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Bumex is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose. Bumex 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 Bumex parallels the marked pharmacologic and toxicologic effects of the drug in this species.
Bumex 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 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 should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
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 ▾
Geriatric Use Clinical studies of Bumex 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.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Bumex is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg Bumex has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of Bumex 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 inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH 2 O) during hydration and tubular free-water reabsorption (T C H 2 O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by Bumex, and Bumex is somewhat more chloruretic than natriuretic.
Potassium excretion is also increased by Bumex, in a dose-related fashion. Bumex may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during Bumex induced diuresis is indicative of this additional action.
This is further supported by the reduction in the renal clearance of Bumex 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 does not appear to have a noticeable action on the distal tubule.
Bumex decreases uric acid excretion and increases serum uric acid. Following oral administration of Bumex 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 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 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 mL/min/kg to 1.1 mL/min/kg.
In a population of neonates receiving bumetanide for volume overload, mean serum clearance rates were 2.2 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 μg/L at 1 hour to 57 μg/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
0.39L/kg. The degree of protein binding of bumetanide in cord sera from healthy neonates was approxi…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Bumex Tablets for oral administration are elliptical, flat-faced, and bevel-edged, available as: Dosage Color Engraving NDC 30698-xxx-xx Bottle of 100 Bottle of 500 0.5 mg Light Green BUMEX 0.5 630-01 — 1 mg Yellow BUMEX 1 631-01 631-05 2 mg Peach BUMEX 2 632-01 632-05 Store at 68° to 77°F (20° to 25°C); excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
Manufactured for and Distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 [email protected] www.validuspharma.com 1-866-982-5438 Product of Italy © 2023 Validus Pharmaceuticals LLC 60018-05 November 2023
📋 Description ▾
DESCRIPTION Bumex ® (bumetanide) is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No.
10 aluminum lake; 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 364.42, and the following structural formula: FDA-approved impurity specifications differ from the USP. structural formula