EDECRIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EDECRIN (EDECRIN).
Ethacrynic acid inhibits the Na-K-Cl cotransporter (NKCC2) in the thick ascending limb of the loop of Henle, reducing reabsorption of sodium, chloride, and potassium, leading to diuresis.
| Metabolism | Metabolized primarily in the liver, with approximately 30% excreted unchanged in urine and the remainder as metabolites, including the cysteine conjugate. |
| Excretion | Approximately 60-70% excreted unchanged in urine via glomerular filtration and tubular secretion; remaining 30-40% eliminated via biliary/fecal route. |
| Half-life | Terminal elimination half-life is 2-4 hours; prolonged in renal impairment (up to 30 hours) and in heart failure. |
| Protein binding | Approximately 95-98% bound, primarily to albumin. |
| Volume of Distribution | 0.4-0.8 L/kg; reflects distribution primarily into extracellular fluid. |
| Bioavailability | Oral: approximately 50-70% due to first-pass metabolism; Intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-15 minutes. |
| Duration of Action | Oral: 6-8 hours; Intravenous: 2-4 hours; diuresis may persist up to 12 hours with dehydration risk. |
Oral: 50-100 mg once or twice daily, maximum 400 mg/day. IV: 50 mg (0.5 mg/kg) once, may repeat once at 2-hour intervals if needed.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 10-50 mL/min: 50% of normal dose. GFR <10 mL/min: not recommended or use with extreme caution. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated. |
| Pediatric use | Oral: 1-3 mg/kg/day in 1-2 divided doses. IV: 1 mg/kg/dose, maximum 50 mg/dose. |
| Geriatric use | Start at lowest dose (25-50 mg oral daily) due to increased risk of electrolyte disturbances and hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EDECRIN (EDECRIN).
| Breastfeeding | It is not known if ethacrynic acid is excreted in human milk. Due to potential adverse effects in the nursing infant, such as electrolyte imbalance, caution is advised. The manufacturer recommends discontinuing nursing or the drug, taking into account the importance of the drug to the mother. M/P ratio is unknown. |
| Teratogenic Risk | EDECRIN (ethacrynic acid) is classified as FDA Pregnancy Category B. Limited human data; animal studies have not demonstrated teratogenic effects. However, diuretic use during pregnancy may reduce placental perfusion. Fetal risks include electrolyte disturbances, volume depletion, and possible growth restriction. Use only if clearly needed. |
■ FDA Black Box Warning
WARNING: EDECRIN is a potent diuretic which, if given in excessive amounts, can lead to profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dose schedule must be adjusted to the individual patient's needs.
| Serious Effects |
["Anuria","Hypersensitivity to ethacrynic acid or any component of the formulation","Severe electrolyte depletion (e.g., hypokalemia, hyponatremia) until corrected","Concurrent use with other ototoxic agents (relative contraindication)"]
| Precautions | ["Ototoxicity: Risk of hearing loss, especially with rapid IV administration or in patients with renal impairment; avoid concurrent use with other ototoxic drugs.","Volume and electrolyte depletion: Profound diuresis leading to dehydration, hypokalemia, hyponatremia, hypochloremia, and metabolic alkalosis.","Hypersensitivity reactions: Rash, eosinophilia, and anaphylaxis.","Gastrointestinal disturbances: Nausea, vomiting, diarrhea, and gastrointestinal bleeding (rare).","Hyperuricemia may precipitate gout.","Use with caution in patients with hepatic cirrhosis due to risk of hepatic encephalopathy."] |
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| Fetal Monitoring | Monitor maternal electrolytes (sodium, potassium, chloride), BUN, creatinine, and uric acid. Assess maternal weight, blood pressure, and signs of volume depletion. Fetal monitoring includes ultrasound for growth and amniotic fluid volume due to potential reduced placental perfusion. |
| Fertility Effects | No specific studies on fertility effects in humans. In animal studies, ethacrynic acid did not demonstrate adverse effects on fertility. However, diuretic-induced electrolyte disturbances may theoretically affect reproductive function. |