Bumetanide
Regulatory sources consulted
- AEMPS CIMA FT 52047
- CredibleMeds.org
- Clinical Pharmacology Knowledge Base
- AEMPS CIMA · nº registro 52047 ↗
- RxNorm rxcui 1808 ↗
Approved indications
- Edema associated with congestive heart failure, liver cirrhosis, and renal disease, including nephrotic syndrome.
Contraindications
Absolute
- Hypersensitivity to bumetanide or sulfonamides.
- Persistent anuria.
- Hepatic coma and precoma.
- Severe hypokalemia or hyponatremia.
- Hypovolemia or dehydration.
Clinical warnings
- Major warning · Risk of profound diuresis with water and electrolyte depletion. Requires medical supervision and periodic monitoring of serum electrolytes. — AEMPS CIMA
- Risk of ototoxicity, especially with high doses, rapid IV administration, or concomitant use of other ototoxic drugs. — AEMPS CIMA
Drug interactions
- HighLithiumN05AN01
Mechanism: Decreased renal clearance of lithium, increasing the risk of toxicity.
Recommendation: Avoid concomitant use. If necessary, monitor lithium levels closely and adjust dosage.
AEMPS CIMA FT 52047
- HighAminoglycosidesJ01G
Mechanism: Increased potential for ototoxicity and nephrotoxicity.
Recommendation: Avoid concomitant use. If the combination is unavoidable, monitor auditory and renal function.
AEMPS CIMA FT 52047
- ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: May reduce the diuretic and antihypertensive effect by inhibiting renal prostaglandin synthesis. Increases risk of renal failure.
Recommendation: Monitor blood pressure, diuresis, and renal function. Avoid in patients with pre-existing heart or renal failure.
AEMPS CIMA FT 52047
Adverse events
Common (≥1%)
hypokalemia · hyponatremia · hyperuricemia · muscle cramps · dizziness · hypotension · headache
Rare but serious
ototoxicity · acute renal failure · thrombocytopenia · agranulocytosis · hepatic encephalopathy
Pregnancy and lactation
FDA category: C
Contraindicated during pregnancy and lactation according to the Spanish summary of product characteristics.