AMINOSYN-PF 10%
Clinical safety rating
cautionComprehensive clinical and safety monograph for AMINOSYN-PF 10% (AMINOSYN-PF 10%).
Aminosyn-PF 10% is a crystalline amino acid solution that provides essential and non-essential amino acids for protein synthesis and nitrogen balance in neonates and pediatric patients.
| Metabolism | Amino acids are deaminated in the liver; carbon skeletons enter various metabolic pathways (e.g., TCA cycle, gluconeogenesis). |
| Excretion | Renal: >90% as amino acids and metabolites; <10% fecal/biliary |
| Half-life | Variable; amino acids have half-lives of minutes to hours; clinical context: continuous infusion maintains steady state |
| Protein binding | Minimal; amino acids <5% bound to plasma proteins (albumin, globulins) |
| Volume of Distribution | 0.2-0.4 L/kg; reflects distribution into total body water and extracellular fluid |
| Bioavailability | IV: 100% |
| Onset of Action | IV: immediate upon infusion; positive nitrogen balance within 24-48 hours |
| Duration of Action | Duration equals infusion time; metabolic effects persist hours after discontinuation |
| Molecular Weight | Aminosyn-PF 10% is a mixture of amino acids with molecular weights ranging from 75.07 (glycine) to 204.23 (tryptophan). Average molecular weight approximately 140 Da. |
Intravenous infusion: 1-1.5 g amino acids/kg/day (protein equivalent) as part of total parenteral nutrition. Typical rate: 0.5-2.0 mL/kg/hour initially, titrated to metabolic needs.
| Dosage form | INJECTABLE |
| Renal impairment | GFR < 50 mL/min: Reduce dose to 0.5-0.8 g/kg/day. GFR < 15 mL/min: 0.2-0.5 g/kg/day, monitor for azotemia. Hemodialysis: 1.0-1.2 g/kg/day, adjust based on protein catabolic rate. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: 0.5-0.8 g/kg/day, avoid in severe encephalopathy. Child-Pugh C: Contraindicated or use specialized amino acid formulations (e.g., Hepatamine). |
| Pediatric use | Neonates: 1.0-2.0 g/kg/day IV, increase by 0.5 g/kg/day to target 2.5-3.5 g/kg/day. Infants (1-12 months): 1.5-2.5 g/kg/day IV. Children (1-12 years): 1.0-2.0 g/kg/day IV. Adolescents: 0.8-1.5 g/kg/day IV. Max infusion rate: 0.1 g/kg/hour. |
| Geriatric use | No specific dose adjustment; initiate at lower end (0.8-1.0 g/kg/day IV) due to potential renal impairment and decreased lean body mass. Monitor for fluid and electrolyte imbalance. |
| 1st trimester | Aminosyn-PF 10% is indicated for parenteral nutrition in preterm infants. In pregnancy, it should only be used if clearly needed. There are no adequate and well-controlled studies in pregnant women. Use during first trimester only if potential benefit justifies potential risk to the fetus. |
| 2nd trimester | Continue use if clearly needed. Monitor maternal and fetal status. No known teratogenicity from the amino acid components. |
| 3rd trimester | Use if clearly needed. Monitor for maternal and fetal metabolic disturbances. |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN-PF 10% (AMINOSYN-PF 10%).
| Placental transfer | Amino acids are actively transported across the placenta and are normally present in fetal blood. Exogenous amino acids administered intravenously may cross the placenta similarly. No specific data for this formulation; assumed to cross. |
| Breastfeeding | Aminosyn-PF 10% is administered intravenously; components are normal constituents of human milk. Excretion into breast milk is minimal. Use with caution in nursing mothers, but generally considered compatible with breastfeeding. |
| Lactation Rating | L1 - Safe |
| Teratogenic Risk | Aminosyn-PF 10% is a parenteral amino acid solution used for nutritional support. No teratogenic effects have been reported in humans; however, animal reproduction studies are not available. Use during pregnancy only if clearly needed, with careful monitoring of maternal and fetal status. There is no known risk of fetal malformations from standard use, but maternal metabolic disturbances (e.g., acidosis, electrolyte imbalances) from improper use could adversely affect the fetus. |
| Fetal Monitoring | Monitor maternal serum electrolytes, acid-base balance, blood urea nitrogen, serum ammonia, liver function tests, and glucose levels. Assess for signs of fluid overload or metabolic complications. Fetal monitoring (e.g., heart rate, growth) is recommended if maternal conditions such as preeclampsia or gestational diabetes develop. |
| Fertility Effects | No specific studies on fertility effects are available. It is unlikely that standard clinical use affects fertility, as it is a nutrient source. However, underlying maternal malnutrition or disease requiring parenteral nutrition may impact fertility. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any componentInborn errors of amino acid metabolismSevere hepatic impairmentSevere uremia without dialysisHyperammonemiaSevere electrolyte or acid-base imbalancesHemodynamically unstable patients
| Precautions | Risk of aluminum toxicity with prolonged use, especially in renal impairment, Hyperammonemia, particularly in neonates with hepatic dysfunction, Metabolic acidosis may occur, Monitor fluid and electrolyte balance, serum osmolarity, and liver function, Do not administer unless solution is clear and seal is intact |
| Food/Dietary | No oral food interactions as this is an intravenous formulation. However, total caloric intake must be balanced; ensure adequate non-protein calories are provided to prevent catabolism. |
| Clinical Pearls | Aminosyn-PF 10% is a parenteral amino acid solution designed for pediatric patients, including preterm infants. It contains taurine and lower concentrations of methionine and phenylalanine to reduce the risk of metabolic acidosis and hyperammonemia. Monitor serum electrolytes, BUN, and ammonia levels closely during infusion. Do not exceed recommended infusion rates to avoid hyperglycemia and osmotic diuresis. |
| Patient Advice | This medication is given through a vein and should only be administered by a healthcare professional. · Report any signs of infection at the IV site, such as redness, swelling, or pain. · Inform your doctor if you have liver or kidney disease, as dosage adjustments may be needed. · Regular blood tests will be required to monitor your response to treatment. |
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