NEOPHAM 6.4%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEOPHAM 6.4% (NEOPHAM 6.4%).
NEOPHAM 6.4% is a sterile, nonpyrogenic, hypertonic solution of amino acids and glycerin used for parenteral nutrition. It provides essential and non-essential amino acids to support protein synthesis and energy metabolism, with glycerin serving as a non-glucose caloric source to reduce hyperglycemia. The amino acids are utilized for tissue repair and growth, while glycerin is metabolized via gluconeogenesis and glycolysis.
| Metabolism | Amino acids are primarily metabolized in the liver via transamination, deamination, and urea cycle. Glycerin is metabolized in the liver and kidneys via glycerol kinase to glycerol-3-phosphate, entering glycolysis or gluconeogenesis. Some amino acids undergo renal metabolism. |
| Excretion | Renal elimination of absorbed amino acids and metabolites; minimal biliary/fecal excretion. >90% of infused amino acids are reincorporated into body protein or metabolized; excess nitrogen excreted as urea in urine. |
| Half-life | Not applicable as a single entity; amino acids have varying half-lives (minutes to hours depending on individual amino acid and metabolic state). Clinical context: continuous infusion used for parenteral nutrition; no terminal elimination half-life defined for the mixture. |
| Protein binding | Variable; individual amino acids bind to albumin and other plasma proteins with low affinity. Overall binding ranges from <10% for most amino acids to up to 20-30% for tryptophan and tyrosine. |
| Volume of Distribution | Not applicable as a single drug; individual amino acids distribute into total body water. For most amino acids, Vd approximates 0.5-0.7 L/kg, reflecting distribution into extracellular and intracellular compartments. |
| Bioavailability | Intravenous: 100% (complete bioavailability). Not administered via other routes due to lack of absorption or local irritation; no oral or intramuscular formulation. |
| Onset of Action | Intravenous: nutritional effects begin within 1-2 hours as amino acids are taken up by tissues; metabolic effects (e.g., nitrogen retention) observed after 24-48 hours of continuous infusion. |
| Duration of Action | Intravenous: sustained as long as infusion continues; nutritional benefits persist for hours after discontinuation due to ongoing protein synthesis. Clinical note: duration depends on infusion rate and patient metabolic needs. |
Intravenous infusion of 6.4% amino acid solution at 0.8-1.5 g/kg/day (equivalent to 12.5-23.4 mL/kg/day) for protein replenishment; typical adult dose 500-1000 mL/day infused at 1-2 mL/min.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (GFR <25 mL/min) without dialysis; for GFR 25-50 mL/min, reduce dose by 50% and monitor BUN/creatinine; no adjustment needed for GFR >50 mL/min. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50% (max 0.5 g protein/kg/day); Child-Pugh C: contraindicated due to risk of hepatic encephalopathy. |
| Pediatric use | 0.5-1.0 g amino acids/kg/day (8-15 mL/kg/day of 6.4% solution) intravenously; for premature infants, start at 0.5 g/kg/day and increase by 0.5 g/kg/day to target 1.5-2.0 g/kg/day. |
| Geriatric use | No specific dose adjustment; use lower end of adult dosing (0.8 g/kg/day) due to decreased renal function and muscle mass; monitor fluid status and electrolytes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEOPHAM 6.4% (NEOPHAM 6.4%).
| Breastfeeding | Amino acids are naturally present in breast milk. No adverse effects expected. M/P ratio not determined; considered compatible with breastfeeding. |
| Teratogenic Risk | Amino acids are essential nutrients. No teratogenic effects reported. Use is generally considered safe during pregnancy when clinically indicated. |
| Fetal Monitoring | Monitor maternal electrolytes, acid-base balance, renal function, and liver function. Fetal surveillance as per standard obstetric care. |
■ FDA Black Box Warning
Not for use in patients with inborn errors of amino acid metabolism, such as maple syrup urine disease, or in patients with uncontrolled uremia or severe hepatic failure. Risk of metabolic acidosis, hyperammonemia, and fluid overload. Must be used with caution in patients with renal impairment or heart failure.
| Serious Effects |
Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria), severe hepatic failure with encephalopathy, uncontrolled uremia, hypersensitivity to any component, severe fluid overload, and hyperkalemia (if potassium containing).
| Precautions | Monitor plasma electrolytes, acid-base balance, liver function, and ammonia levels. Risk of hyperglycemia (especially with glucose-containing regimens), volume overload, and electrolyte disturbances. Use with caution in patients with hepatic or renal impairment. Not recommended for patients with severe hypertriglyceridemia or lipid metabolism disorders. |
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| Fertility Effects | No known adverse effects on fertility from amino acid supplementation. Used as part of parenteral nutrition in women of reproductive age without reported impact. |