HEPATASOL 8%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HEPATASOL 8% (HEPATASOL 8%).
HEPATASOL 8% (amino acid injection) provides essential and non-essential amino acids to support protein synthesis and correct nitrogen balance in hepatic encephalopathy. It reduces plasma ammonia levels by promoting urea cycle activity and decreasing aromatic amino acids.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle pathways. Specific hepatic enzymes include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and carbamoyl phosphate synthetase I. |
| Excretion | Renal: >95% of administered amino acids are reabsorbed and metabolized; negligible unchanged excretion. Biliary/fecal: <5% |
| Half-life | Approximately 30-60 minutes for individual amino acids; clinical context: rapid clearance supports continuous infusion to maintain plasma levels. |
| Protein binding | Minimal (<5%) for most amino acids; branched-chain amino acids (BCAAs) are weakly bound to albumin. |
| Volume of Distribution | 0.15-0.25 L/kg for total amino acids; clinical meaning: reflects distribution primarily in extracellular fluid and lean body mass. |
| Bioavailability | Intravenous: 100%; not administered orally for systemic effect. |
| Onset of Action | Intravenous: Nitrogen balance improvement within 24-48 hours; clinical effect on hepatic encephalopathy within 2-12 hours. |
| Duration of Action | Duration: 2-6 hours after infusion cessation; clinical notes: effects on ammonia reduction persist for 4-8 hours post-infusion. |
Intravenous infusion of 500 mL (40 g amino acids) over 3-4 hours, administered once daily or as directed by clinical response.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal failure (GFR < 25 mL/min) due to risk of nitrogen accumulation. For GFR 25-50 mL/min, reduce dose by 50% and monitor BUN/creatinine. |
| Liver impairment | Use with caution in Child-Pugh class B or C; start at 50% of standard dose and titrate based on ammonia levels and tolerability. |
| Pediatric use | Neonates and infants: 2-3 g amino acids/kg/day via continuous IV infusion over 12-24 hours. Children: 1-2 g/kg/day administered as intermittent infusion over 3-4 hours. |
| Geriatric use | Initiate at the lower end of the dosing range (e.g., 250 mL over 4-6 hours) due to age-related reduction in renal function and increased risk of volume overload; monitor renal function and electrolytes frequently. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HEPATASOL 8% (HEPATASOL 8%).
| Breastfeeding | No data on excretion in human milk. Use with caution. M/P ratio unknown. |
| Teratogenic Risk | No teratogenic effects reported. HEPATASOL 8% (amino acid injection) is considered low risk in pregnancy. No specific fetal risks documented in any trimester. |
| Fetal Monitoring | Monitor fluid balance, serum electrolytes, acid-base status, and blood glucose during prolonged infusion. Fetal monitoring not specifically required. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component","Severe acid-base disturbances","Anuria or severe oliguria"]
| Precautions | ["Use with caution in patients with severe renal impairment, fluid overload, or electrolyte imbalances","Monitor serum electrolytes, renal function, and ammonia levels","Risk of hyperglycemia or metabolic acidosis with prolonged use"] |
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| Fertility Effects | No known adverse effects on fertility. |