NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER (NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER).

How it works

Amino acid mixture for parenteral nutrition; provides essential and nonessential amino acids to support protein synthesis and maintain nitrogen balance in patients unable to tolerate oral or enteral nutrition.

What the body does with it

Metabolism	Amino acids are metabolized via hepatic transamination, deamination, and incorporation into proteins; ammonia is converted to urea in the liver.
Excretion	Amino acids are primarily excreted via renal mechanisms, with <5% excreted unchanged in urine; majority of nitrogen is reincorporated into protein synthesis or converted to urea and excreted renally.
Half-life	Variable; depends on individual metabolic and nutritional status; typical terminal half-life of infused amino acids is approximately 1-2 hours after infusion cessation, reflecting rapid clearance from plasma.
Protein binding	Negligible; amino acids are small molecules that do not significantly bind to plasma proteins (<5% bound).
Volume of Distribution	0.2-0.4 L/kg; distributes into extracellular fluid and total body water; reflects rapid equilibration with lean body mass.
Bioavailability	Not applicable; administered exclusively intravenously; bioavailability is 100% by IV route.
Onset of Action	Intravenous: Immediate upon infusion; pharmacodynamic effects (e.g., protein synthesis stimulation) occur within minutes to hours.
Duration of Action	Duration of action is transient and dependent on infusion rate; metabolic effects persist for several hours post-infusion as amino acids are incorporated into body protein pool.

Classification & Brands

Dosing & administration

Administered intravenously. Initial dose: 0.6-1.0 g amino acids/kg/day (4-6.7 mL/kg/day) infused over 12-24 hours. Maximum: 2 g amino acids/kg/day (13.3 mL/kg/day).

Dosage form	INJECTABLE
Renal impairment	GFR >50 mL/min: No adjustment. GFR 20-50 mL/min: Reduce dose by 50% (0.3-0.5 g/kg/day). GFR <20 mL/min: Avoid or use under strict monitoring with essential amino acid formulations.
Liver impairment	Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50% (0.3-0.5 g/kg/day). Child-Pugh C: Avoid use due to risk of hepatic encephalopathy.
Pediatric use	Neonates: 1.5-3.0 g amino acids/kg/day (10-20 mL/kg/day) infused over 24 hours. Children: 1.0-2.0 g/kg/day (6.7-13.3 mL/kg/day). Adjust based on metabolic requirements and monitoring.
Geriatric use	Consider lower initial doses (0.6-0.8 g/kg/day) with gradual titration to avoid fluid overload and metabolic complications. Monitor renal function and electrolyte balance closely. Maximum dose: 1.5 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 NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER (NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER).

Breastfeeding	Excreted into breast milk; M/P ratio unknown. Use with caution in nursing mothers. Consider benefits versus risks.
Teratogenic Risk	Amino acid solutions are generally considered safe in pregnancy when used for maternal indication. No specific teratogenic risk is identified. However, use only if clearly needed during all trimesters.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Severe hepatic failure with hyperammonemia","Severe uremia (not on dialysis)","Inborn errors of amino acid metabolism","Hypersensitivity to any component","Uncorrected metabolic acidosis"]

Clinical Precautions

Precautions

["Risk of hyperglycemia, hyperosmolarity, and osmotic diuresis","Monitor fluid and electrolyte balance","Possible hyperammonemia in hepatic impairment","Risk of infection from IV catheter","Not for peripheral vein administration due to high osmolarity"]

Clinical Tips & Counseling

Drug interactions

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NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER (NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER).

How it works

What the body does with it

Metabolism	Amino acids are metabolized via hepatic transamination, deamination, and incorporation into proteins; ammonia is converted to urea in the liver.
Excretion	Amino acids are primarily excreted via renal mechanisms, with <5% excreted unchanged in urine; majority of nitrogen is reincorporated into protein synthesis or converted to urea and excreted renally.
Half-life	Variable; depends on individual metabolic and nutritional status; typical terminal half-life of infused amino acids is approximately 1-2 hours after infusion cessation, reflecting rapid clearance from plasma.
Protein binding	Negligible; amino acids are small molecules that do not significantly bind to plasma proteins (<5% bound).
Volume of Distribution	0.2-0.4 L/kg; distributes into extracellular fluid and total body water; reflects rapid equilibration with lean body mass.
Bioavailability	Not applicable; administered exclusively intravenously; bioavailability is 100% by IV route.
Onset of Action	Intravenous: Immediate upon infusion; pharmacodynamic effects (e.g., protein synthesis stimulation) occur within minutes to hours.
Duration of Action	Duration of action is transient and dependent on infusion rate; metabolic effects persist for several hours post-infusion as amino acids are incorporated into body protein pool.

Classification & Brands

Dosing & administration

Administered intravenously. Initial dose: 0.6-1.0 g amino acids/kg/day (4-6.7 mL/kg/day) infused over 12-24 hours. Maximum: 2 g amino acids/kg/day (13.3 mL/kg/day).

Dosage form	INJECTABLE
Renal impairment	GFR >50 mL/min: No adjustment. GFR 20-50 mL/min: Reduce dose by 50% (0.3-0.5 g/kg/day). GFR <20 mL/min: Avoid or use under strict monitoring with essential amino acid formulations.
Liver impairment	Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50% (0.3-0.5 g/kg/day). Child-Pugh C: Avoid use due to risk of hepatic encephalopathy.
Pediatric use	Neonates: 1.5-3.0 g amino acids/kg/day (10-20 mL/kg/day) infused over 24 hours. Children: 1.0-2.0 g/kg/day (6.7-13.3 mL/kg/day). Adjust based on metabolic requirements and monitoring.
Geriatric use	Consider lower initial doses (0.6-0.8 g/kg/day) with gradual titration to avoid fluid overload and metabolic complications. Monitor renal function and electrolyte balance closely. Maximum dose: 1.5 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 NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER (NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER).

Breastfeeding	Excreted into breast milk; M/P ratio unknown. Use with caution in nursing mothers. Consider benefits versus risks.
Teratogenic Risk	Amino acid solutions are generally considered safe in pregnancy when used for maternal indication. No specific teratogenic risk is identified. However, use only if clearly needed during all trimesters.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Severe hepatic failure with hyperammonemia","Severe uremia (not on dialysis)","Inborn errors of amino acid metabolism","Hypersensitivity to any component","Uncorrected metabolic acidosis"]