PREMASOL 6% IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PREMASOL 6% IN PLASTIC CONTAINER (PREMASOL 6% IN PLASTIC CONTAINER).

How it works

Intravenous amino acid solution providing essential and non-essential amino acids for protein synthesis, nitrogen balance, and maintenance of lean body mass. Amino acids are actively transported into cells and incorporated into proteins; also serves as a caloric source.

What the body does with it

Metabolism	Amino acids undergo deamination, transamination, and oxidation; metabolized primarily in the liver and to a lesser extent in other tissues. Nitrogen is converted to urea via the urea cycle.
Excretion	Renal elimination of amino acids and metabolites; complete metabolism with nitrogen excretion as urea in urine; minimal biliary/fecal excretion.
Half-life	Amino acids have rapid plasma clearance; elimination half-life varies from minutes to hours depending on individual amino acid; clinically, infused amino acids are cleared within 2-4 hours after infusion cessation.
Protein binding	Minimal protein binding; less than 10% bound to plasma proteins.
Volume of Distribution	Vd approximates total body water (0.5-0.7 L/kg) for most amino acids, indicating distribution throughout extracellular and intracellular spaces.
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: immediately upon infusion; effects on nitrogen balance and protein synthesis begin within hours to days.
Duration of Action	Duration depends on infusion rate and metabolic demand; effects persist for hours after infusion; continuous infusion required to maintain positive nitrogen balance.

Classification & Brands

Dosing & administration

Intravenous infusion: 1 to 1.5 g/kg/day (amino acids) as part of total parenteral nutrition; typically 500 mL to 1000 mL per day, infused over 12-24 hours.

Dosage form	INJECTABLE
Renal impairment	GFR < 50 mL/min: Reduce dose by 50%; monitor BUN and creatinine. GFR < 15 mL/min: Contraindicated or use with extreme caution (risk of azotemia).
Liver impairment	Child-Pugh Class A: Standard dose. Child-Pugh Class B: Reduce dose by 50%; avoid if encephalopathy present. Child-Pugh Class C: Contraindicated (risk of hepatic encephalopathy).
Pediatric use	Neonates and infants: 2-3 g/kg/day (amino acids); children older: 1-2 g/kg/day; titrate to metabolic tolerance. Administer via central line if >12.5% dextrose.
Geriatric use	No specific dose adjustment; monitor renal function and fluid status due to decreased GFR and potential for fluid overload. Use lower initial doses (0.8-1 g/kg/day).

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PREMASOL 6% IN PLASTIC CONTAINER (PREMASOL 6% IN PLASTIC CONTAINER).

Breastfeeding	Excreted in breast milk in low amounts; M/P ratio unknown. Considered compatible with breastfeeding when used for maternal nutrition.
Teratogenic Risk	PREMASOL 6% is a balanced amino acid solution. No teratogenic effects in animal studies; limited human data. No known fetal risk in any trimester when used as indicated.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

This product is not for use in patients with inborn errors of amino acid metabolism, such as maple syrup urine disease, phenylketonuria, or other defects in amino acid metabolism.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component","Inborn errors of amino acid metabolism","Severe hepatic failure with encephalopathy","Severe renal failure without dialysis","Uncorrected metabolic acidosis","Hyperammonemia"]

Clinical Precautions

Precautions

["Monitor for signs of hyperammonemia, especially in patients with hepatic insufficiency","Risk of metabolic acidosis, electrolyte imbalances, and hyperglycemia","Use with caution in patients with renal insufficiency, heart failure, or fluid overload","Ensure adequate caloric intake to prevent amino acids being used as energy source","Monitor liver function tests and serum ammonia levels"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

PREMASOL 6% IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PREMASOL 6% IN PLASTIC CONTAINER (PREMASOL 6% IN PLASTIC CONTAINER).

How it works

What the body does with it

Metabolism	Amino acids undergo deamination, transamination, and oxidation; metabolized primarily in the liver and to a lesser extent in other tissues. Nitrogen is converted to urea via the urea cycle.
Excretion	Renal elimination of amino acids and metabolites; complete metabolism with nitrogen excretion as urea in urine; minimal biliary/fecal excretion.
Half-life	Amino acids have rapid plasma clearance; elimination half-life varies from minutes to hours depending on individual amino acid; clinically, infused amino acids are cleared within 2-4 hours after infusion cessation.
Protein binding	Minimal protein binding; less than 10% bound to plasma proteins.
Volume of Distribution	Vd approximates total body water (0.5-0.7 L/kg) for most amino acids, indicating distribution throughout extracellular and intracellular spaces.
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: immediately upon infusion; effects on nitrogen balance and protein synthesis begin within hours to days.
Duration of Action	Duration depends on infusion rate and metabolic demand; effects persist for hours after infusion; continuous infusion required to maintain positive nitrogen balance.

Classification & Brands

Dosing & administration

Intravenous infusion: 1 to 1.5 g/kg/day (amino acids) as part of total parenteral nutrition; typically 500 mL to 1000 mL per day, infused over 12-24 hours.

Dosage form	INJECTABLE
Renal impairment	GFR < 50 mL/min: Reduce dose by 50%; monitor BUN and creatinine. GFR < 15 mL/min: Contraindicated or use with extreme caution (risk of azotemia).
Liver impairment	Child-Pugh Class A: Standard dose. Child-Pugh Class B: Reduce dose by 50%; avoid if encephalopathy present. Child-Pugh Class C: Contraindicated (risk of hepatic encephalopathy).
Pediatric use	Neonates and infants: 2-3 g/kg/day (amino acids); children older: 1-2 g/kg/day; titrate to metabolic tolerance. Administer via central line if >12.5% dextrose.
Geriatric use	No specific dose adjustment; monitor renal function and fluid status due to decreased GFR and potential for fluid overload. Use lower initial doses (0.8-1 g/kg/day).

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PREMASOL 6% IN PLASTIC CONTAINER (PREMASOL 6% IN PLASTIC CONTAINER).

Breastfeeding	Excreted in breast milk in low amounts; M/P ratio unknown. Considered compatible with breastfeeding when used for maternal nutrition.
Teratogenic Risk	PREMASOL 6% is a balanced amino acid solution. No teratogenic effects in animal studies; limited human data. No known fetal risk in any trimester when used as indicated.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

This product is not for use in patients with inborn errors of amino acid metabolism, such as maple syrup urine disease, phenylketonuria, or other defects in amino acid metabolism.