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Bumetanide

Prescription loop diuretic · oral and IV/IM products

Short-acting loop diuretic for selected edema, with route-specific dosing and a boxed warning for profound fluid/electrolyte depletion.

Routes
Oral tablets or selected IV/IM injection
Oral usual total
0.5–2 mg/day; individualized
Injection concentration
0.25 mg/mL
Essential safety

Supervise fluid and electrolyte losses

Potent diuresis can cause dehydration, circulatory collapse and electrolyte depletion. Individualize oral or IV/IM dose and interval, with renal, urine-output and electrolyte monitoring.

Warnings and precautions
01

Indications

Prescription loop diuretic for edema associated with selected cardiac, hepatic and renal disease.

Labeled edema and route choice

Treats edema associated with congestive heart failure, hepatic disease and renal disease including nephrotic syndrome. Use IV/IM injection when GI absorption is impaired or oral treatment is impractical, then return to oral therapy as soon as possible. This is symptomatic edema treatment, not proof of disease-modifying heart-failure survival benefit or a general hypertension indication.

Population and scope

Both selected products are prescription medicines; safety/effectiveness under age eighteen is not established. Label neonatal PK observations are not an approved neonatal dosing protocol. This review covers selected tablets and IV/IM injection, not an unverified outpatient infusion or compounded formulation.

02

Dosage and administration

Individualize dose, interval and route to response and safety.

Oral dosing

Usual total daily tablet dose is 0.5–2 mg, generally once daily. If response is insufficient, a second or third dose may be prescribed 4–5 hours apart, with maximum 10 mg/day. The oral label favors intermittent maintenance schedules, such as alternate days or 3–4 treatment days followed by 1–2 rest days; this requires a clinician’s response-based plan, not independent skipped-dose decisions.

Tablet regimenSelected adult label
Usual daily total0.5–2 mg, usually one dose
Additional doses if inadequate responseSecond/third dose at 4–5-hour intervals
Daily ceiling10 mg/day; individual monitoring remains required

IV or IM dosing

Usual initial injection dose is 0.5–1 mg IV or IM; give IV over 1–2 minutes. If insufficient, a second or third dose may follow at 2–3-hour intervals; total must not exceed 10 mg/day. Terminate parenteral treatment and use oral treatment as soon as practical. Verify concentration, mg and route before injection.

Selected injectionAdult label instruction
Initial dose0.5–1 mg IV or IM
IV administrationOver 1–2 minutes
Repeat and daily ceilingIf needed, second/third doses 2–3 hours apart; maximum 10 mg/day

Renal, hepatic and conversion boundaries

No validated eGFR/CrCl reduction table is supplied. Anuria is contraindicated; marked BUN/creatinine increase or new oliguria during treatment of progressive renal disease calls for discontinuation. Hepatic failure requires minimum dosing; cirrhosis/ascites treatment is best initiated in hospital with small doses and close observation. Label approximate furosemide potency comparisons are not an automatic route-independent conversion algorithm.

Injection preparation

Selected Sagent injection is 0.25 mg/mL; 1 mg corresponds to 4 mL. Label compatibility is documented with 5% dextrose, 0.9% sodium chloride and lactated Ringer’s in specified glass/PVC containers. Prepare solutions freshly and use within 24 hours; inspect for particles/discoloration and follow sterile handling and the actual vial’s single- or multidose instructions.

03

Safety

Profound diuresis, electrolyte loss and renal or hearing toxicity can be serious.

Warnings and precautions

Excessive dose/frequency can cause dehydration, hypotension, circulatory collapse and thrombosis/embolism, especially in older patients. Potassium loss can worsen arrhythmia/digoxin risk; calcium and magnesium losses also occur. Abrupt electrolyte shifts in cirrhosis can precipitate encephalopathy/coma.

IV high/repeated dosing with impaired renal excretion increases concern about ototoxicity. Sulfonamide-allergic patients may react; rare thrombocytopenia is reported. Oral labeling also reports serious skin reactions including SJS/TEN. Seek urgent assessment for severe dehydration/fainting, hearing change, major rash or allergy.

Contraindications

Contraindicated with anuria, ingredient/drug hypersensitivity, hepatic coma or severe electrolyte depletion until corrected. Progressive renal disease with marked BUN/creatinine increase or oliguria requires stopping treatment. Renal insufficiency alone is not the same as anuria, and there is no invented numeric creatinine stop threshold.

Boxed-warning status

Both selected labels carry a box warning that this potent diuretic can cause profound diuresis with water/electrolyte depletion when excessive amounts are used; careful medical supervision and individualized dose/schedule are required. A printed daily maximum does not establish safety for every patient.

Adverse reactions

Reported effects include cramps, dizziness, hypotension, headache, nausea and encephalopathy in patients with preexisting liver disease. Hearing impairment, rash, weakness, dehydration and renal failure are reported; laboratory effects include low potassium/sodium/chloride, azotemia, hyperuricemia and increased creatinine. Rare thrombocytopenia and oral-label serious skin reactions merit prompt assessment. Historical trial rates are not universal individual predictions.

04

Drug interactions

Lithium, ototoxic/nephrotoxic drugs and opposing diuretic effects require review.

Toxic combinations

Lithium generally should not be used with diuretics because reduced renal clearance can cause toxicity. Avoid parenteral bumetanide with aminoglycosides, particularly with impaired kidneys, except life-threatening circumstances under specialist care. Selected labels advise avoiding concurrent nephrotoxic drugs.

Reduced effect and blood pressure

Do not co-administer probenecid under the selected labels: it reduces bumetanide tubular secretion/natriuresis. Indomethacin blunts diuresis and concurrent treatment is not recommended. Antihypertensive effects can be intensified, potentially requiring prescribed dose adjustment; review all NSAIDs and BP medicines rather than independently alter therapy.

Digoxin, warfarin and electrolyte context

Label interaction studies did not change digoxin levels or warfarin metabolism/prothrombin activity. That does not eliminate hypokalemia-related arrhythmia risk or the need for indicated anticoagulation monitoring. Reconcile supplements and potassium-sparing diuretics with renal function and measured electrolytes.

05

Use in specific populations

Kidney/liver status, age and reproductive circumstances guide treatment.

Children and older adults

Safety/effectiveness below eighteen is unestablished. Bilirubin displacement raises particular concern in critically ill or jaundiced neonates at kernicterus risk. Older patients should generally begin at the low end because organ impairment and polypharmacy increase risk; monitor renal function and avoid profound volume loss.

Renal and hepatic disease

Individualize against response, urine output, BUN/creatinine and electrolytes rather than use an unsourced renal-dose table. Anuria, hepatic coma and severe electrolyte depletion remain contraindications. Cirrhosis/ascites requires small initial doses, hospital initiation and close encephalopathy/electrolyte assessment. No validated dialysis supplemental-dose instruction is supplied.

Pregnancy and breastfeeding

Controlled pregnancy evidence is inadequate; use only when maternal benefit justifies fetal risk. The labels describe animal findings and limited human experience without proving fetal safety. Human milk excretion is unknown; selected labels advise that nursing generally should not be undertaken during treatment. Any individualized alternative feeding/treatment decision needs clinical assessment.

Injection excipients

The selected injection contains benzyl alcohol 10 mg/mL in both listed presentations. This is not a preservative-free neonatal product. Pediatric safety is unestablished independently of the excipient concern; do not derive a neonatal regimen from its PK examples.

06

Clinical pharmacology

Loop inhibition increases urinary sodium, chloride and potassium loss.

Mechanism and onset

Acts mainly in the ascending loop of Henle to reduce sodium/chloride reabsorption, increasing diuresis and potassium excretion; some proximal tubular effects are described. Oral onset is about 30–60 minutes, peak 1–2 hours and usual-dose diuresis largely ends within four hours. IV action begins within minutes and peaks about 15–30 minutes.

Disposition and variability

Adult elimination half-life is roughly 1–1.5 hours and protein binding about 94–96%. Urinary excretion includes unchanged drug and metabolites. Clearance can be lower in older adults; neonatal elimination can be substantially slower. Label potency comparisons with furosemide are approximate and do not substitute for clinical reassessment after route/drug changes.

07

Monitoring and counseling

Follow weight/fluid response, BP, urine output and electrolyte/renal trends.

Monitoring

Assess diuretic response and volume/BP status; follow potassium periodically and other electrolytes particularly with high or prolonged exposure. Track BUN/creatinine, urine output, calcium/magnesium risk and glucose in diabetes/suspected latent diabetes. Observe for liver injury, blood dyscrasias, hearing changes and hypersensitivity when clinically indicated. Monitoring frequency is patient-specific.

Counseling and overdose

Keep the exact prescribed dose/interval and any maintenance rest-day schedule clear. Report weakness, severe cramps, fainting, markedly reduced urine, confusion, hearing change or rash promptly. Profound diuresis/overdose requires medically supervised replacement of fluid/electrolyte losses and monitoring, not independent potassium or fluid loading. Review NSAIDs, lithium and supplements before use.

08

Product identification

Verify tablet strength versus injection concentration and vial type.

Representative product identity

Zydus 1 mg tablet is light yellow, round, scored and marked 526; bottle of thirty NDC 68382-526-06. Sagent 1 mg/4 mL injection is an amber single-dose vial, NDC 25021-321-04; 2.5 mg/10 mL is multidose, NDC 25021-321-10. Match the actual package and route rather than appearance alone.

Dosage forms and strengths

Selected tablets are 0.5, 1 and 2 mg. Selected IV/IM solution is 0.25 mg/mL in 4 or 10 mL vials and contains benzyl alcohol 10 mg/mL. Milligrams, milliliters and vial contents are different quantities; a 10 mL vial contains 2.5 mg, not 10 mg.

Storage and handling

Selected tablets: 20–25°C in tight, light-resistant containers. Selected injection: 20–25°C, allowed 15–30°C excursions, protected from light. Inspect clarity and follow sterile/vial instructions; compatible freshly prepared infusion solutions are used within 24 hours, which is not an invented multidose-vial after-opening expiry.

09

References

Original sources for the clinical and product information.

  1. Zydus / DailyMedBumetanide tablets · Current full label

    PI January 2023; current SPL 5 effective December 5, 2023; published December 6, 2023.

  2. Sagent / DailyMedBumetanide injection · Current full label

    PI January 2026; SPL 2 effective July 29, 2026; published August 3, 2026.

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