BUMEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BUMEX (BUMEX).
Bumetanide inhibits the Na-K-2Cl symporter (NKCC2) in the thick ascending limb of the loop of Henle, reducing reabsorption of sodium, chloride, and potassium, leading to increased diuresis.
| Metabolism | Primarily metabolized by the liver via cytochrome P450 enzymes, including CYP2C9 and CYP3A4. |
| Excretion | Renal: 80% as unchanged drug; biliary/fecal: 15% as metabolites; total renal elimination accounts for ~85% of clearance. |
| Half-life | Terminal elimination half-life: 1.5–2 hours in normal renal function; prolonged to 2.5–4 hours in severe renal impairment (CrCl <20 mL/min). |
| Protein binding | Bumetanide is 94–96% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 0.15–0.22 L/kg; indicates primarily extracellular distribution. |
| Bioavailability | Oral bioavailability: 80–100% (mean ~95%). |
| Onset of Action | Intravenous: within 5 minutes; Oral: 30–60 minutes. |
| Duration of Action | Diuresis: 4–6 hours after oral dose; 2–3 hours after IV dose. Duration may be prolonged in renal impairment. |
0.5-2 mg orally once daily; if inadequate response, may increase to 2-4 mg once daily or twice daily. Maximum 10 mg/day. IV: 0.5-1 mg IV over 1-2 minutes; may repeat every 2-3 hours up to 10 mg/day.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <20 mL/min/1.73 m²: Avoid loop diuretics; consider alternative. No adjustment for mild to moderate renal impairment, but monitor response. In severe renal failure, may require higher doses due to reduced tubular secretion. |
| Liver impairment | Child-Pugh Class B or C: Reduce initial dose by 50% due to impaired metabolism and increased risk of volume depletion. Titrate cautiously. |
| Pediatric use | Infants/Children: Oral: 0.015-0.1 mg/kg/dose once daily; maximum 10 mg/day. IV/IM: 0.015-0.1 mg/kg/dose every 12-24 hours; maximum 0.5 mg/kg/dose. Neonates: 0.01-0.05 mg/kg/dose every 24-48 hours. |
| Geriatric use | Start at 0.5 mg orally once daily; increase cautiously due to enhanced pharmacodynamic effects and higher risk of electrolyte disturbances, volume depletion, and ototoxicity. Monitor renal function and electrolytes closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BUMEX (BUMEX).
| Breastfeeding | Bumetanide is excreted into human milk in low concentrations. The milk-to-plasma (M/P) ratio is approximately 0.05-0.10. Based on limited data, amounts ingested by breastfed infants are unlikely to cause adverse effects. However, due to potential risk of hypersensitivity, electrolyte disturbances, or diuresis in the infant, caution is advised, especially in premature or renal-impaired infants. Alternative diuretics with more safety data may be preferred. |
| Teratogenic Risk | Bumetanide (BUMEX) is a loop diuretic classified as FDA Pregnancy Category C. Animal studies have shown embryocidal effects and delayed ossification at high doses. Human data are limited; no well-controlled studies exist. First trimester: theoretical risk based on animal data; avoid unless essential. Second/third trimesters: may cause maternal hypovolemia, decreased placental perfusion, and fetal oliguria; use only if clearly needed and monitor amniotic fluid volume. Neonatal risks include electrolyte imbalances and ototoxicity if used close to delivery. |
■ FDA Black Box Warning
Bumetanide is a potent diuretic; if given in excessive amounts, can lead to profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule must be adjusted to individual patient's needs.
| Serious Effects |
["Anuria","Hepatic coma or severe electrolyte depletion until condition is corrected","Hypersensitivity to bumetanide or sulfonamides (cross-sensitivity possible)"]
| Precautions | ["Electrolyte depletion (hypokalemia, hyponatremia, hypochloremia)","Dehydration and hypovolemia","Ototoxicity (especially with rapid injection or in renal impairment)","Excessive diuresis causing hypotension and thromboembolic events","May increase serum uric acid levels and precipitate gout","Risk of hypokalemia in patients with cirrhosis and ascites"] |
| Food/Dietary | Avoid excessive salt intake; no specific food interactions reported. Avoid licorice as it may worsen hypokalemia. Grapefruit juice may increase bumetanide levels; use caution. |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, urine output, serum electrolytes (especially potassium, magnesium, sodium, chloride), renal function, and fluid balance. In pregnancy, assess fetal growth and amniotic fluid volume by ultrasound periodically. If used near term, monitor neonatal electrolytes, hearing (for ototoxicity), and hydration status after delivery. |
| Fertility Effects | No specific human studies on fertility. In animal studies, high doses caused reversible effects on estrous cycles and fertility in females. No evidence of significant fertility impairment in humans, but loop diuretics may theoretically affect reproductive function through electrolyte or volume changes. BUMEX is not known to cause infertility in males. |
| Clinical Pearls | Bumetanide is a loop diuretic approximately 40 times more potent than furosemide; onset of diuresis within 30-60 minutes after oral administration. Monitor for ototoxicity, especially with rapid IV administration or concurrent use of other ototoxic drugs. Hypokalemia is a common adverse effect; consider potassium supplementation or concurrent use of potassium-sparing diuretics. Contraindicated in anuria, hepatic coma, and severe electrolyte depletion. May cause hyperuricemia and precipitate gout attacks. |
| Patient Advice | Take this medication exactly as prescribed, typically once daily in the morning to avoid nighttime urination. · Avoid sudden position changes to prevent dizziness from low blood pressure. · Do not consume grapefruit juice or alcohol while taking this drug. · Monitor for signs of electrolyte imbalance: muscle cramps, weakness, irregular heartbeat, or confusion. · Weigh yourself daily and report rapid weight gain or loss to your healthcare provider. |