FREAMINE III 3% W/ ELECTROLYTES
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FREAMINE III 3% W/ ELECTROLYTES (FREAMINE III 3% W/ ELECTROLYTES).
Provides essential and non-essential amino acids for protein synthesis, maintaining nitrogen balance, and supporting metabolic functions. Electrolytes help maintain acid-base balance and osmotic pressure.
| Metabolism | Amino acids are metabolized via deamination, transamination, and incorporation into proteins. Electrolytes are excreted or reabsorbed by renal and gastrointestinal pathways. |
| Excretion | Renal excretion of amino acid nitrogen as urea (85-90%) and other nitrogenous wastes; minimal biliary/fecal (<5%) |
| Half-life | Variable; based on individual amino acid components (alanine ~2.3h, glycine ~1.5h, etc.); clinical context: continuous infusion achieves steady state within 8-12h |
| Protein binding | Minimal protein binding (<5%) for most amino acids; not bound to carrier proteins |
| Volume of Distribution | Vd ~0.5-1.0 L/kg, reflecting distribution into total body water and lean body mass |
| Bioavailability | 100% intravenous; not applicable via oral route due to first-pass metabolism |
| Onset of Action | Intravenous: immediate (within minutes) as plasma amino acid levels rise |
| Duration of Action | Duration depends on infusion rate; metabolic utilization continues for hours post-infusion; clinical note: transient elevation of amino acids persists for 4-6h after infusion stops |
Administered intravenously. Typical adult dose: 500-1000 mL/day (15-30 g amino acids) infused at a rate not exceeding 0.1 g/kg/hour. Frequency: continuous or intermittent infusion as part of parenteral nutrition.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-60 mL/min: Reduce dose by 25-50%. GFR 15-29 mL/min: Reduce dose by 50-75%. GFR <15 mL/min: Avoid use or use with extreme caution, monitor electrolytes. Hemodialysis: May require dose adjustment based on amino acid losses. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50% and monitor ammonia. Child-Pugh C: Avoid use due to risk of hepatic encephalopathy. |
| Pediatric use | Weight-based dosing: Initial dose 1-2 g amino acids/kg/day (10-20 mL/kg/day of Freamine III 3%), increase gradually up to 3 g/kg/day. Infusion rate: 0.1-0.15 g/kg/hour. Monitor electrolytes and nitrogen balance. |
| Geriatric use | Elderly patients may require reduced dose due to decreased renal function. Start at lower end of adult dose (e.g., 0.8 g/kg/day amino acids) and adjust based on renal function and nutritional status. Monitor electrolytes and fluid balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FREAMINE III 3% W/ ELECTROLYTES (FREAMINE III 3% W/ ELECTROLYTES).
| Breastfeeding | Excretion into breast milk is negligible due to high molecular weight and endogenous nature; M/P ratio not determined. Considered compatible with breastfeeding. |
| Teratogenic Risk | No evidence of teratogenic risk from intravenous amino acid solutions; fetal risks are indirect secondary to maternal metabolic disturbances if improperly dosed (e.g., electrolyte imbalances, hyperammonemia). |
| Fetal Monitoring |
■ FDA Black Box Warning
Not for administration to patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization. Solutions containing amino acids should be used with caution in patients with renal insufficiency or hepatic failure. Risk of hyperammonemia, particularly in pediatric patients.
| Serious Effects |
["Hypersensitivity to any component","Inborn errors of amino acid metabolism","Hepatic coma or severe hepatic insufficiency","Severe renal failure without dialysis","Hyperammonemia","Metabolic alkalosis"]
| Precautions | ["Monitor serum electrolytes, renal and hepatic function, blood glucose, and acid-base balance","Risk of hyperammonemia, especially in neonates","Use with caution in patients with cardiac, renal, or hepatic disease","Do not administer simultaneously with blood products through same tubing"] |
Loading safety data…
| Monitor maternal serum electrolytes, acid-base status, blood urea nitrogen, ammonia, and glucose. Monitor fetal heart rate and uterine activity if administered during labor. |
| Fertility Effects | No known direct effects on fertility; correction of maternal nutritional deficiencies may indirectly improve reproductive function. |