FREAMINE III 10%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FREAMINE III 10% (FREAMINE III 10%).

How it works

FREAMINE III 10% is a parenteral amino acid solution that provides essential and non-essential amino acids for protein synthesis and nitrogen balance in patients unable to tolerate oral or enteral nutrition.

What the body does with it

Metabolism	Amino acids are metabolized via hepatic and extrahepatic pathways, including transamination, deamination, and incorporation into proteins.
Excretion	Primarily renal; amino acids and nitrogenous waste products are excreted as urea and other metabolites. <5% fecal.
Half-life	Component-dependent: free amino acids t1/2 ~15–30 min; urea cycle intermediates ca. 2 h.
Protein binding	<10%, largely to albumin and unbound.
Volume of Distribution	~0.2–0.3 L/kg, distributing into total body water.
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: rapid (within minutes) as amino acids enter circulation.
Duration of Action	Effect persists as long as infusion maintains amino acid levels; clinical effect 8–12 h post infusion.

Classification & Brands

Dosing & administration

Intravenous administration as part of parenteral nutrition. Typical adult dose: 0.8-1.5 g amino acids/kg/day, infused continuously over 24 hours.

Dosage form	INJECTABLE
Renal impairment	GFR < 50 mL/min: reduce to 0.5-0.8 g amino acids/kg/day; GFR < 15 mL/min: 0.3-0.5 g/kg/day, monitor serum BUN and electrolytes.
Liver impairment	Child-Pugh class B or C: reduce dose by 50% to 0.4-0.7 g/kg/day; adjust based on ammonia levels and clinical tolerance.
Pediatric use	Neonates: 2-3 g amino acids/kg/day; Infants: 1.5-2.5 g/kg/day; Children: 1-2 g/kg/day. Administer via continuous IV infusion.
Geriatric use	Start at lower end of adult range (0.8 g/kg/day); monitor renal function and fluid status; adjust based on tolerance and metabolic parameters.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FREAMINE III 10% (FREAMINE III 10%).

Breastfeeding	Excretion in human milk unknown; compatible with breastfeeding if maternal benefit outweighs risk. M/P ratio not available.
Teratogenic Risk	Amino acid solutions are essential nutrients; no specific teratogenic risk identified in animal studies. Use in pregnancy only if clearly needed; no known fetal risks in any trimester, but safety not established.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Solutions containing aluminum may be toxic with prolonged administration, particularly in premature infants and patients with renal impairment. Aluminum accumulation may cause CNS or bone toxicity.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to any component, severe electrolyte or acid-base imbalance, anuria, inborn errors of amino acid metabolism (e.g., phenylketonuria), hyperammonemia, and severe hepatic or renal disease.

Clinical Precautions

Precautions

Use with caution in patients with hepatic failure, renal failure, metabolic acidosis, or fluid overload. Monitor serum electrolytes, acid-base balance, and renal function. Risk of hyperammonemia, particularly in neonates or hepatic impairment.

Clinical Tips & Counseling

Drug interactions

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FREAMINE III 10%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FREAMINE III 10% (FREAMINE III 10%).

How it works

What the body does with it

Metabolism	Amino acids are metabolized via hepatic and extrahepatic pathways, including transamination, deamination, and incorporation into proteins.
Excretion	Primarily renal; amino acids and nitrogenous waste products are excreted as urea and other metabolites. <5% fecal.
Half-life	Component-dependent: free amino acids t1/2 ~15–30 min; urea cycle intermediates ca. 2 h.
Protein binding	<10%, largely to albumin and unbound.
Volume of Distribution	~0.2–0.3 L/kg, distributing into total body water.
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: rapid (within minutes) as amino acids enter circulation.
Duration of Action	Effect persists as long as infusion maintains amino acid levels; clinical effect 8–12 h post infusion.

Classification & Brands

Dosing & administration

Intravenous administration as part of parenteral nutrition. Typical adult dose: 0.8-1.5 g amino acids/kg/day, infused continuously over 24 hours.

Dosage form	INJECTABLE
Renal impairment	GFR < 50 mL/min: reduce to 0.5-0.8 g amino acids/kg/day; GFR < 15 mL/min: 0.3-0.5 g/kg/day, monitor serum BUN and electrolytes.
Liver impairment	Child-Pugh class B or C: reduce dose by 50% to 0.4-0.7 g/kg/day; adjust based on ammonia levels and clinical tolerance.
Pediatric use	Neonates: 2-3 g amino acids/kg/day; Infants: 1.5-2.5 g/kg/day; Children: 1-2 g/kg/day. Administer via continuous IV infusion.
Geriatric use	Start at lower end of adult range (0.8 g/kg/day); monitor renal function and fluid status; adjust based on tolerance and metabolic parameters.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FREAMINE III 10% (FREAMINE III 10%).

Breastfeeding	Excretion in human milk unknown; compatible with breastfeeding if maternal benefit outweighs risk. M/P ratio not available.
Teratogenic Risk	Amino acid solutions are essential nutrients; no specific teratogenic risk identified in animal studies. Use in pregnancy only if clearly needed; no known fetal risks in any trimester, but safety not established.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Solutions containing aluminum may be toxic with prolonged administration, particularly in premature infants and patients with renal impairment. Aluminum accumulation may cause CNS or bone toxicity.