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. |
| Molecular Weight | 302.7 |
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 | Crosses placenta; associated with increased risk of fetal wastage in animal studies; use only if clearly needed. |
| 2nd trimester | Crosses placenta; may cause fetal jaundice and thrombocytopenia; avoid if possible. |
| 3rd trimester | Crosses placenta; may cause fetal jaundice, thrombocytopenia, and electrolyte disturbances; avoid near term. |
Clinical note
Comprehensive clinical and safety monograph for EDECRIN (EDECRIN).
| Placental transfer | Crosses placenta; demonstrated in animal and human studies. |
| Breastfeeding | Excreted into breast milk in low amounts; potential for serious adverse reactions in nursing infants (diuresis, electrolyte imbalance). Use caution and consider alternative diuretics. |
| Lactation Rating |
■ 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 |
AnuriaHypersensitivity to ethacrynic acid or any componentSevere electrolyte depletionHepatic coma or precoma
| 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. |
| Food/Dietary | Avoid excessive intake of high-sodium foods as they can counteract the diuretic effect. Grapefruit juice may increase the risk of ototoxicity; consumption should be limited. Alcohol can exacerbate hypotension and dehydration. Ensure adequate potassium intake through diet (e.g., bananas, oranges) unless directed otherwise by a healthcare provider. |
Loading safety data…
| L3 (Moderately Safe) - limited data suggest risk |
| 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. |
| 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. |
| Clinical Pearls | EDECRIN (ethacrynic acid) is a potent loop diuretic that, unlike furosemide, is not a sulfonamide and can be used in patients with sulfonamide allergy. It can cause ototoxicity that is often irreversible, especially when given rapidly IV or with other ototoxic drugs like aminoglycosides. Monitor for hypokalemia, hypomagnesemia, and volume depletion. Use with caution in patients with hepatic cirrhosis due to risk of electrolyte-induced encephalopathy. |
| Patient Advice | Take this medication exactly as prescribed, usually once or twice daily. · Avoid alcohol and limit salt intake to reduce fluid retention. · Weigh yourself daily and report rapid weight gain or loss to your doctor. · Stand up slowly from sitting or lying down to prevent dizziness from low blood pressure. · Notify your doctor immediately if you experience hearing loss, ringing in the ears, or dizziness. · This drug may increase blood sugar; monitor if you have diabetes. · Avoid taking with other ototoxic medications like certain antibiotics without doctor approval. |