Schedule H

Oral, Intravenous

• Tablet: 1 mg

• Injection: 0.25 mg/mL (2 mL ampoule = 0.5 mg total)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Pulmonary Oedema

Parameter Recommendation

Starting dose 0.5–1 mg IV push over 1–2 minutes

Titration May repeat after 2–3 hours if response inadequate; double dose if needed

Usual maintenance dose 0.5–2 mg IV as required

Maximum dose 10 mg IV per single dose

Key Clinical Notes:

• Onset of action: within 5 minutes IV

• Peak diuretic effect: approximately 30 minutes

• Potency equivalent: 1 mg bumetanide ≈ 40 mg furosemide

• Ensure adequate monitoring of BP and urine output

1. Oedema in Congestive Heart Failure

Parameter Recommendation

Starting dose 0.5–1 mg orally once daily

Titration Increase after 4–6 hours if diuretic response inadequate

Usual maintenance dose 1–2 mg once daily or in 2 divided doses

Maximum dose 10 mg/day

Key Clinical Notes:

• Higher oral bioavailability than furosemide (~80% vs ~50%)

• Preferred when oral furosemide response is poor due to gut oedema

• Monitor daily weight, fluid balance, and electrolytes

1. Oedema in Chronic Kidney Disease

Parameter Recommendation

Starting dose 1 mg orally once or twice daily

Titration Increase gradually based on urine output and electrolyte status

Usual maintenance dose 2–5 mg/day in divided doses

Maximum dose 10 mg/day

Key Clinical Notes:

• Higher doses may be required in advanced CKD (reduced GFR)

• Response diminishes as GFR declines

• Monitor closely for volume depletion and electrolyte imbalance

Secondary Indications — Adults Only (Off-label)

Indication Refractory Ascites in Cirrhosis

Dose Starting: 0.5–1 mg once daily; combine with spironolactone

Duration As per clinical response and ascites control

Status OFF-LABEL; Specialist only (Hepatologist/Gastroenterologist)

Evidence Indian hepatology practice; used when furosemide-spironolactone combination inadequate

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Oedema due to Cardiac or Renal Causes

Neonates 0.015 mg/kg/dose IV or oral once daily Titrate cautiously under specialist supervision 0.05 mg/kg/dose

Infants (1–12 months) 0.015–0.05 mg/kg/dose once or twice daily May increase based on response 0.1 mg/kg/dose

Children (>1 year) 0.015–0.1 mg/kg/dose once or twice daily Adjust based on urine output and electrolytes 0.1 mg/kg/dose or 1 mg (whichever is lower)

Key Clinical Notes:

• Short duration of action; may require twice daily dosing

• Not first-line — preferred when furosemide resistance or allergy exists

• Monitor closely for dehydration and electrolyte depletion

Safety Monitoring:

• Serum electrolytes (K⁺, Na⁺, Mg²⁺)

• Renal function

• Daily weight and fluid balance

• Hearing assessment if prolonged high-dose IV use

Secondary Indications — Paediatric Doses (Off-label)

Indication Refractory Oedema in Nephrotic Syndrome

Dose 0.03–0.1 mg/kg/dose IV or oral twice daily

Duration As per clinical response and specialist guidance

Status OFF-LABEL; Specialist only (Paediatric Nephrologist)

Evidence Indian paediatric nephrology protocols; tertiary hospital experience

⚠️ Not recommended below 6 months of age except under specialist supervision in NICU/PICU settings

Mild to moderate CKD No dose reduction required; higher doses may be needed for adequate response

Severe CKD (eGFR <15) Higher doses often required; monitor closely for electrolyte imbalance

Note: Use the lowest effective dose in early CKD to minimise electrolyte disturbances

• Anuria or severe oliguria unresponsive to initial test dose

• Known hypersensitivity to bumetanide

• Sulfonamide allergy (cross-reactivity possible, though rare)

• Severe uncorrected electrolyte depletion (hypokalaemia, hyponatraemia)

• Hepatic coma or pre-coma

• Addison's disease (untreated)

• Gout or hyperuricaemia — may precipitate acute gout

• Diabetes mellitus — may worsen glycaemic control

• Pre-existing hypotension or hypovolaemia

• Elderly patients — increased risk of orthostatic hypotension and acute kidney injury

• Concurrent use of ototoxic drugs (aminoglycosides, cisplatin)

• Electrolyte monitoring essential — particularly K⁺, Na⁺, Mg²⁺

• Prostatic hypertrophy or urinary retention — acute retention may occur

• SLE — may exacerbate or activate

Parameter Information

Risk category Avoid in routine pregnancy; potential fetal risk (crosses placenta)

Preferred alternatives Furosemide is more commonly used if loop diuretic essential

When to use Only in life-threatening situations (e.g., acute pulmonary oedema) under specialist care

Monitoring Fetal growth, amniotic fluid volume, maternal electrolytes and BP

Parameter Information

Compatibility Avoid unless essential — may suppress lactation

Preferred alternatives Furosemide (if loop diuretic needed and compatible)

Expected levels in milk Presumed low; limited human data

Infant monitoring Weight gain, hydration status, feeding adequacy

Parameter Recommendation

Starting dose 0.5 mg once daily orally

Titration Slow; increase only after assessing response and tolerability

Extra risks Orthostatic hypotension, falls, volume depletion, acute kidney injury, electrolyte disturbances, confusion

Monitoring Renal function, electrolytes, BP (lying and standing), daily weight

Interacting Drug/Class Mechanism Clinical Effect Recommendation

Aminoglycosides (gentamicin, amikacin) Additive ototoxicity Irreversible hearing loss Avoid combination; if essential, use lowest doses and monitor hearing

Lithium Reduced renal lithium clearance Lithium toxicity Avoid combination; if unavoidable, monitor lithium levels closely

NSAIDs (ibuprofen, diclofenac) Inhibit prostaglandin-mediated renal blood flow Reduced diuretic efficacy; increased AKI risk Avoid or use with caution; monitor renal function

Digoxin Bumetanide-induced hypokalaemia Digoxin toxicity (arrhythmias) Monitor potassium; supplement or add potassium-sparing agent

Interacting Drug/Class Effect Recommendation

ACE inhibitors / ARBs Additive hypotension; risk of AKI especially in volume depletion Start at low doses; monitor BP and renal function

Corticosteroids Additive hypokalaemia Monitor potassium; consider supplementation

Antidiabetic agents Hyperglycaemic effect of bumetanide Monitor blood glucose; adjust antidiabetic doses if needed

Other antihypertensives Additive hypotensive effect Monitor BP closely

Probenecid Competes for renal tubular secretion Reduced bumetanide efficacy

Cisplatin Additive ototoxicity and nephrotoxicity Use with caution; monitor hearing and renal function

• Hypokalaemia

• Hyponatraemia

• Hypomagnesaemia

• Dizziness

• Orthostatic hypotension

• Headache

• Muscle cramps

• Hyperuricaemia

• Dehydration

• Nausea

Adverse Effect Action Required

Ototoxicity (tinnitus, hearing loss) More common with rapid IV administration (>1 mg/min) or concurrent aminoglycosides; discontinue and assess

Severe electrolyte disturbances May precipitate cardiac arrhythmias; correct electrolytes urgently

Acute kidney injury From excessive volume depletion; hold diuretic; rehydrate

Stevens-Johnson Syndrome (rare) Discontinue immediately; hospitalisation required

Pancreatitis (rare) Discontinue; supportive care

Thrombocytopenia (rare) Monitor CBC; discontinue if confirmed

Phase Parameters

Baseline Serum electrolytes (Na⁺, K⁺, Mg²⁺), renal function (creatinine, eGFR), uric acid, blood glucose, BP, weight

After initiation/dose change Recheck electrolytes and renal function within 3–7 days; assess urine output and weight

Long-term Periodic electrolytes, renal function, uric acid, blood glucose; BP and weight at each visit

• Burinex

• Bumex

• Bumasafe

• Buriwell

• Bumide

• Multiple generic formulations available

Note: Not listed in NLEM India (2022); not under NPPA price control

1. Potency advantage — 1 mg bumetanide is approximately equivalent to 40 mg furosemide; useful when converting between agents

1. Better oral bioavailability — Bumetanide has ~80% oral bioavailability compared to ~50% for furosemide; preferred in patients with gut oedema causing poor furosemide absorption

1. Useful in furosemide resistance or allergy — Consider bumetanide when patients fail to respond to adequate furosemide doses or have documented furosemide hypersensitivity

1. Prevent hypokalaemia — Add potassium supplementation or combine with aldosterone antagonist (spironolactone) to maintain potassium balance

1. Ototoxicity risk — Administer IV doses slowly (≤1 mg/min); avoid concurrent aminoglycosides; higher risk in renal impairment

1. Shorter half-life — May require twice daily dosing for sustained diuresis compared to once daily furosemide in some patients

Bumetanide; loop diuretic; heart failure; pulmonary oedema; oedema; nephrotic syndrome; renal-safe; hepatic-caution; ototoxicity; Schedule H; electrolyte monitoring

RxIndia v1.0 — 01 May 2025

• CDSCO-approved product insert

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Drug Formulary

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian Paediatric Nephrology Guidelines

• Indian tertiary hospital protocols for cardiac and renal oedema management

• NLEM India 2022 — Not listed