FREAMINE II 8.5%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FREAMINE II 8.5% (FREAMINE II 8.5%).

How it works

FREAMINE II 8.5% is a crystalline amino acid solution that provides essential and non-essential amino acids for protein synthesis, supporting nitrogen balance and tissue repair in patients unable to tolerate oral or enteral nutrition.

What the body does with it

Metabolism	Amino acids are primarily metabolized in the liver via transamination, deamination, and urea cycle pathways; branched-chain amino acids (BCAAs) are also metabolized in skeletal muscle.
Excretion	Renal elimination of nitrogenous waste products (urea) derived from amino acid metabolism; <5% excreted unchanged in urine. No significant biliary or fecal elimination.
Half-life	Not applicable as a mixture; individual amino acids have variable half-lives (e.g., essential amino acids ~1-3 hours). Clinical context: continuous infusion required to maintain plasma levels.
Protein binding	Minimal to none for most amino acids (<10%); individual amino acids bind weakly to albumin and globulins.
Volume of Distribution	0.5-1.0 L/kg for total amino acids; reflects distribution to total body water and peripheral tissues. Larger Vd for branched-chain amino acids.
Bioavailability	Intravenous: 100% (not administered by other routes due to formulation).
Onset of Action	Intravenous: immediate (within minutes) elevation of plasma amino acids; clinical effect (protein synthesis) requires hours to days.
Duration of Action	Intravenous: duration of infusion-dependent; effects on nitrogen balance persist for hours after discontinuation. Continuous infusion typically used for 24-hour periods.

Classification & Brands

Dosing & administration

Intravenous infusion: 0.8-1.5 g amino acids/kg/day. Typical dose is 500-1000 mL per day (42.5-85 g amino acids). Infusion rate should not exceed 0.1 g amino acids/kg/hour.

Dosage form	INJECTABLE
Renal impairment	For GFR 30-59 mL/min: reduce dose by 50%. For GFR <30 mL/min: avoid use or use with extreme caution; consider essential amino acid formulations only.
Liver impairment	Child-Pugh Class A: no adjustment. Class B: reduce dose by 50%. Class C: contraindicated due to risk of hepatic encephalopathy from high aromatic amino acids.
Pediatric use	Intravenous infusion: 1.5-3.0 g amino acids/kg/day. For infants: 2.0-3.0 g/kg/day. Monitor serum ammonia and amino acid levels.
Geriatric use	Start at lower end of adult dose (0.8 g/kg/day). Monitor renal function; adjust for creatinine clearance. Reduce dose in frail elderly or with comorbid conditions.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FREAMINE II 8.5% (FREAMINE II 8.5%).

Breastfeeding	It is not known whether amino acids from FREAMINE II 8.5% are excreted in human breast milk. Caution is advised when administered to a nursing woman. The M/P ratio is unknown.
Teratogenic Risk	FREAMINE II 8.5% is an amino acid solution. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if clearly needed. Fetal risks are not well characterized; potential risks may be related to maternal metabolic disturbances (e.g., electrolyte imbalance, hyperammonemia) rather than direct teratogenicity.

Warnings & precautions

■ FDA Black Box Warning

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because of immature kidneys, and they require close monitoring.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component of the formulation","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)","Severe hyperammonemia","Uncorrected metabolic acidosis","Severe liver failure with encephalopathy (unless specialized amino acid formulation is used)"]

Clinical Precautions

Precautions

["Risk of aluminum toxicity in patients with renal impairment and in premature infants","Monitor for signs of hyperammonemia, especially in patients with hepatic insufficiency","Risk of infection due to catheter-related bloodstream infections, strict aseptic technique required","Electrolyte imbalances, acid-base disturbances, and fluid overload may occur","Use with caution in patients with renal failure, hepatic failure, or metabolic disorders"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

FREAMINE II 8.5%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FREAMINE II 8.5% (FREAMINE II 8.5%).

How it works

What the body does with it

Metabolism	Amino acids are primarily metabolized in the liver via transamination, deamination, and urea cycle pathways; branched-chain amino acids (BCAAs) are also metabolized in skeletal muscle.
Excretion	Renal elimination of nitrogenous waste products (urea) derived from amino acid metabolism; <5% excreted unchanged in urine. No significant biliary or fecal elimination.
Half-life	Not applicable as a mixture; individual amino acids have variable half-lives (e.g., essential amino acids ~1-3 hours). Clinical context: continuous infusion required to maintain plasma levels.
Protein binding	Minimal to none for most amino acids (<10%); individual amino acids bind weakly to albumin and globulins.
Volume of Distribution	0.5-1.0 L/kg for total amino acids; reflects distribution to total body water and peripheral tissues. Larger Vd for branched-chain amino acids.
Bioavailability	Intravenous: 100% (not administered by other routes due to formulation).
Onset of Action	Intravenous: immediate (within minutes) elevation of plasma amino acids; clinical effect (protein synthesis) requires hours to days.
Duration of Action	Intravenous: duration of infusion-dependent; effects on nitrogen balance persist for hours after discontinuation. Continuous infusion typically used for 24-hour periods.

Classification & Brands

Dosing & administration

Intravenous infusion: 0.8-1.5 g amino acids/kg/day. Typical dose is 500-1000 mL per day (42.5-85 g amino acids). Infusion rate should not exceed 0.1 g amino acids/kg/hour.

Dosage form	INJECTABLE
Renal impairment	For GFR 30-59 mL/min: reduce dose by 50%. For GFR <30 mL/min: avoid use or use with extreme caution; consider essential amino acid formulations only.
Liver impairment	Child-Pugh Class A: no adjustment. Class B: reduce dose by 50%. Class C: contraindicated due to risk of hepatic encephalopathy from high aromatic amino acids.
Pediatric use	Intravenous infusion: 1.5-3.0 g amino acids/kg/day. For infants: 2.0-3.0 g/kg/day. Monitor serum ammonia and amino acid levels.
Geriatric use	Start at lower end of adult dose (0.8 g/kg/day). Monitor renal function; adjust for creatinine clearance. Reduce dose in frail elderly or with comorbid conditions.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FREAMINE II 8.5% (FREAMINE II 8.5%).

Breastfeeding	It is not known whether amino acids from FREAMINE II 8.5% are excreted in human breast milk. Caution is advised when administered to a nursing woman. The M/P ratio is unknown.
Teratogenic Risk	FREAMINE II 8.5% is an amino acid solution. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if clearly needed. Fetal risks are not well characterized; potential risks may be related to maternal metabolic disturbances (e.g., electrolyte imbalance, hyperammonemia) rather than direct teratogenicity.