PREMASOL 10% IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PREMASOL 10% IN PLASTIC CONTAINER (PREMASOL 10% IN PLASTIC CONTAINER).

How it works

Provides essential amino acids for protein synthesis and maintenance of nitrogen balance.

What the body does with it

Metabolism	Amino acids are metabolized via transamination, deamination, and urea cycle in the liver.
Excretion	Amino acids in Premasol 10% are metabolized and the nitrogen is eliminated primarily as urea via renal excretion (80-90%). A small fraction is excreted in feces (5-10%) and as ammonia in urine. Biliary excretion is negligible.
Half-life	The terminal elimination half-life of infused amino acids is approximately 0.5-1 hour for most amino acids, reflecting rapid metabolism and distribution. Clinically, this supports continuous infusion to maintain plasma amino acid levels.
Protein binding	Amino acids are not significantly bound to plasma proteins; protein binding is less than 10% for most amino acid components.
Volume of Distribution	Volume of distribution for amino acids in Premasol 10% ranges from 0.2 to 0.4 L/kg, approximating total body water, indicating distribution into extracellular and intracellular compartments.
Bioavailability	Bioavailability is 100% for intravenous administration; oral or intramuscular routes are not applicable as Premasol 10% is intended for IV use only.
Onset of Action	Intravenous infusion: Rapid increase in plasma amino acid concentrations occurs within minutes, with clinical effects such as improved nitrogen balance observed within 1-2 hours of initiation.
Duration of Action	Intravenous infusion: After discontinuation, plasma amino acid levels decline rapidly, with metabolic effects lasting 2-4 hours depending on the amino acid composition and patient metabolic state.

Classification & Brands

Dosing & administration

1-2 g/kg/day intravenously as a continuous infusion or in divided doses; typical starting dose for adults with normal renal function: 1 g/kg/day.

Dosage form	INJECTABLE
Renal impairment	For GFR 30-59 mL/min: start at 0.8 g/kg/day and titrate based on protein tolerance; for GFR 15-29 mL/min: 0.6 g/kg/day; for GFR <15 mL/min or dialysis: 0.4-0.6 g/kg/day with careful monitoring.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: use with caution, maximum 0.5 g/kg/day or avoid.
Pediatric use	0.5-2 g/kg/day intravenously; for preterm infants: start at 0.5 g/kg/day; for term infants: 1 g/kg/day; for children: 1-2 g/kg/day based on clinical need.
Geriatric use	Start at lower end of adult dose (0.8-1 g/kg/day) and adjust based on renal function and fluid status; monitor for fluid overload and electrolyte imbalances.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for PREMASOL 10% IN PLASTIC CONTAINER (PREMASOL 10% IN PLASTIC CONTAINER).

Breastfeeding

Amino acids are normal constituents of breast milk; supplementation with intravenous amino acids increases maternal plasma levels and may increase milk amino acid content. The M/P ratio is not established. Limited data suggest no adverse effects in breastfed infants. Use with caution in lactating women only if clearly needed.

Teratogenic Risk

PREMASOL 10% (amino acid injection) is not teratogenic in animal studies at clinically relevant doses. In humans, no clear teratogenic risk has been identified with standard use; however, data are limited. First trimester rapid cell division and organogenesis may be affected by severe maternal metabolic disturbances. Second and third trimesters: risk is primarily related to maternal undernutrition or metabolic derangements rather than direct fetal toxicity. Use only when clearly indicated.

Warnings & precautions

■ FDA Black Box Warning

Not for use in patients with inborn errors of amino acid metabolism, hepatic failure, or severe metabolic acidosis.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to any component, inborn errors of amino acid metabolism, hepatic failure, severe metabolic acidosis, anuria, and galactosemia (if product contains galactose).

Clinical Precautions

Precautions

Monitor fluid and electrolyte status, acid-base balance, and blood glucose. Risk of hyperglycemia, hyperammonemia, and metabolic acidosis. Use with caution in renal insufficiency, hepatic impairment, and heart failure.

Clinical Tips & Counseling

Drug interactions

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PREMASOL 10% IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PREMASOL 10% IN PLASTIC CONTAINER (PREMASOL 10% IN PLASTIC CONTAINER).

How it works

Provides essential amino acids for protein synthesis and maintenance of nitrogen balance.

What the body does with it

Metabolism	Amino acids are metabolized via transamination, deamination, and urea cycle in the liver.
Excretion	Amino acids in Premasol 10% are metabolized and the nitrogen is eliminated primarily as urea via renal excretion (80-90%). A small fraction is excreted in feces (5-10%) and as ammonia in urine. Biliary excretion is negligible.
Half-life	The terminal elimination half-life of infused amino acids is approximately 0.5-1 hour for most amino acids, reflecting rapid metabolism and distribution. Clinically, this supports continuous infusion to maintain plasma amino acid levels.
Protein binding	Amino acids are not significantly bound to plasma proteins; protein binding is less than 10% for most amino acid components.
Volume of Distribution	Volume of distribution for amino acids in Premasol 10% ranges from 0.2 to 0.4 L/kg, approximating total body water, indicating distribution into extracellular and intracellular compartments.
Bioavailability	Bioavailability is 100% for intravenous administration; oral or intramuscular routes are not applicable as Premasol 10% is intended for IV use only.
Onset of Action	Intravenous infusion: Rapid increase in plasma amino acid concentrations occurs within minutes, with clinical effects such as improved nitrogen balance observed within 1-2 hours of initiation.
Duration of Action	Intravenous infusion: After discontinuation, plasma amino acid levels decline rapidly, with metabolic effects lasting 2-4 hours depending on the amino acid composition and patient metabolic state.

Classification & Brands

Dosing & administration

1-2 g/kg/day intravenously as a continuous infusion or in divided doses; typical starting dose for adults with normal renal function: 1 g/kg/day.

Dosage form	INJECTABLE
Renal impairment	For GFR 30-59 mL/min: start at 0.8 g/kg/day and titrate based on protein tolerance; for GFR 15-29 mL/min: 0.6 g/kg/day; for GFR <15 mL/min or dialysis: 0.4-0.6 g/kg/day with careful monitoring.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: use with caution, maximum 0.5 g/kg/day or avoid.
Pediatric use	0.5-2 g/kg/day intravenously; for preterm infants: start at 0.5 g/kg/day; for term infants: 1 g/kg/day; for children: 1-2 g/kg/day based on clinical need.
Geriatric use	Start at lower end of adult dose (0.8-1 g/kg/day) and adjust based on renal function and fluid status; monitor for fluid overload and electrolyte imbalances.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for PREMASOL 10% IN PLASTIC CONTAINER (PREMASOL 10% IN PLASTIC CONTAINER).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

Not for use in patients with inborn errors of amino acid metabolism, hepatic failure, or severe metabolic acidosis.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to any component, inborn errors of amino acid metabolism, hepatic failure, severe metabolic acidosis, anuria, and galactosemia (if product contains galactose).