Amino Acid, D-sorbitol, Vitamins & Electrolytes

Approved Indications:

• Parenteral Nutrition Support:
• Indicated in patients requiring total or supplemental parenteral nutrition due to inability to eat or absorb nutrients orally or enterally.
• Used in patients with malnutrition due to gastrointestinal disorders, cancer, burns, trauma, or surgery.
• Appropriate for pre- and post-operative nutrition in major surgical interventions.
• Severe Protein Deficiency States:
• Chronic wasting diseases (e.g., tuberculosis, AIDS).
• Cancer cachexia.
• Renal failure (as part of individualized nutritional regimens).
• Electrolyte and Fluid Imbalance:
• Used to correct or maintain electrolyte and fluid balance in acutely or chronically ill patients.
• Vitamin Deficiency States:
• Prevention and treatment of vitamin deficiencies in hospitalized patients receiving long-term IV therapy or those with restrictive diets.

Important Off-Label or Supportive Uses:

• As adjunctive nutrition in intensive care units (ICU).
• For critically ill neonates and pediatrics requiring parenteral nutritional support.

Route: Intravenous (IV) infusion only, preferably via central line for hypertonic solutions.

Adults:

• Typical Dose: 1–2 g/kg/day of amino acids, titrated according to protein needs.
• D-Sorbitol: Usually provided in 3–5% concentrations for energy support.
• Electrolytes: Dosage adjusted based on serum electrolyte levels.
• Vitamins: Standard multivitamin preparations are added per daily requirements.

Pediatrics:

• Neonates: 1–3 g/kg/day of amino acids; fluids and vitamins adjusted for age/weight.
• Children: 1–2 g/kg/day amino acids; careful monitoring of electrolytes.

Elderly:

• Dose similar to adults but monitor renal and hepatic function closely.

Renal/Hepatic Impairment:

• Dose modifications may be necessary.
• Lower amino acid intake may be recommended.
• Fluid volume and electrolytes require close monitoring to avoid overload.

Administration:

• Infuse slowly; rate depends on osmolality, clinical status, and volume tolerance.
• Usually given continuously over 12–24 hours per day.
• Requires aseptic preparation and administration via infusion pump.

This formulation works through the combined actions of its components:

• Amino Acids: Serve as building blocks for protein synthesis, tissue repair, and maintenance of nitrogen balance.
• D-Sorbitol: A carbohydrate providing caloric support and helping maintain energy requirements. It is metabolized to fructose and then glucose.
• Electrolytes: Maintain osmotic balance, acid-base equilibrium, and nerve/muscle function.
• Vitamins: Serve as coenzymes in metabolic reactions essential for energy production, antioxidant defense, and cellular repair. The combination enables the body to sustain normal physiologic and metabolic processes when oral/enteral nutrition is inadequate or impossible.

• Absorption: Administered IV; direct systemic bioavailability.
• Distribution: Amino acids and vitamins are widely distributed in intracellular and extracellular fluids. Electrolytes distribute according to fluid compartments.
• Metabolism:
• Amino acids are metabolized in the liver and muscles into proteins or used for energy.
• D-Sorbitol is metabolized primarily in the liver to fructose and glucose.
• Vitamins are processed according to type (e.g., fat-soluble stored in liver/adipose).
• Elimination:
• Nitrogenous waste (from amino acids) excreted via kidneys as urea.
• Electrolyte and fluid balance is managed by renal excretion.
• Excess water-soluble vitamins eliminated in urine.
• Half-life: Depends on component—ranging from minutes (electrolytes) to hours (some vitamins).

• Pregnancy: Not formally categorized by FDA; however, individual components (amino acids, vitamins, electrolytes) are generally considered safe in pregnancy when clinically necessary.
• Lactation:
• Excretion into breast milk: Likely for most water-soluble vitamins and some electrolytes.
• Risk to infant: Low when used under medical supervision.
• Caution: Use only if clinically indicated. Monitor fluid and electrolyte balance in pregnant/lactating patients.

• Primary Class: Parenteral Nutrition Solution
• Subclass: Multi-component intravenous nutrient formulation (Protein, Carbohydrate, Electrolyte, Vitamin combination)

• Known hypersensitivity to any component of the formulation
• Severe hepatic failure (risk of nitrogen retention)
• Severe renal impairment without dialysis
• Fluid overload states (e.g., pulmonary edema, decompensated heart failure)
• Hyperkalemia, hypercalcemia, or other uncorrected electrolyte imbalances
• Acidosis or uremia not properly managed

• High-Risk Groups: Renal, hepatic, and cardiac failure patients require careful monitoring.
• Metabolic Complications: Risk of hyperammonemia, metabolic acidosis, electrolyte disturbances.
• Infection Risk: Central line infusion carries risk of catheter-related bloodstream infections.
• Refeeding Syndrome: Monitor serum phosphate, potassium, and magnesium in malnourished patients starting parenteral nutrition.
• Monitoring:
• Daily labs: electrolytes, renal function, liver enzymes, glucose, acid-base status.
• Signs of intolerance: nausea, vomiting, hypotension, respiratory distress.

Common:

• Gastrointestinal: Nausea, vomiting, bloating
• Metabolic: Hyperglycemia, electrolyte imbalance
• Local: Infusion site pain, thrombophlebitis (especially with peripheral administration)

Serious/Rare:

• Anaphylaxis or hypersensitivity reactions
• Hyperammonemia
• Refeeding syndrome
• Hepatic dysfunction with prolonged use
• Infection/sepsis from intravenous access

Onset: Side effects may appear within hours to days after initiation; dose-dependent for metabolic disturbances.

• Drug–Drug:
• Diuretics: Risk of hypokalemia or volume depletion.
• Corticosteroids: Sodium and fluid retention.
• Anticoagulants: Risk of reduced efficacy due to vitamin K presence in some formulations.
• Insulin: Adjustments may be necessary due to carbohydrate (sorbitol) content.
• Drug–Food: Not applicable (parenteral route).
• Enzymes Involved: Not applicable (non-CYP450-mediated metabolism for most components).

• Clinical Nutrition Guidelines (ASPEN, ESPEN):
• Emphasize individualized parenteral nutrition based on energy and protein targets.
• Highlight importance of micronutrient supplementation in prolonged therapy.
• Recommend use of ready-to-use multi-chamber bags to reduce contamination risk.
• Safety Alerts:
• WHO and FDA emphasize strict aseptic handling and infusion pump use to prevent contamination and dosage errors.
• Updates on recommendations for infusion via central line for hyperosmolar solutions.

• Temperature: Store between 15°C to 25°C (59°F to 77°F)
• Humidity/Light: Protect from excessive humidity and direct sunlight
• Handling:
• Do not freeze; discard if frozen
• Inspect visually for particulate matter or discoloration before use
• Reconstitution:
• If supplied in separate chambers, mix thoroughly before use
• Use immediately after mixing; discard unused portion