Essential Amino Acid, D-Sorbitol & Electrolytes

Allopathic
Indications

Approved Indications:

  • Nutritional support in:
    • Severe illness
    • Surgery
    • Malnutrition
    • Prolonged fasting
    • Cancer cachexia
    • Chronic renal failure (as adjunct to dialysis)
    • Liver disease (including hepatic encephalopathy)
  • Prevention and correction of electrolyte imbalance
  • Supportive therapy in gastrointestinal disorders (e.g., diarrhea, vomiting, ileostomy)
  • Parenteral nutrition support in post-operative or ICU patients unable to take oral nutrition

Clinically Accepted Off-label Uses:

  • Recovery from burns or trauma with high metabolic demand
  • Post-chemotherapy support to maintain nutritional balance
  • Geriatric nutrition supplementation
  • Debilitated patients with protein-calorie malnutrition
Dosage & Administration

Adults:

  • IV infusion (common):
    500–1000 mL/day depending on clinical condition
    Infuse slowly over 6–12 hours or as directed
  • Oral solution (if available):
    30–60 mL, 1–3 times daily before meals or as advised

Pediatrics:

  • Dosing must be adjusted by weight and clinical condition
  • Only used under medical supervision

Elderly:

  • Same as adult dose; adjust if renal or hepatic dysfunction is present

Renal Impairment:

  • Use with caution
  • Monitor urea, creatinine, and electrolytes
  • May require dose reduction or individualized amino acid formulation

Hepatic Impairment:

  • Certain amino acids (e.g., aromatic AAs) may be restricted in severe hepatic encephalopathy
  • Use branched-chain amino acid-rich formulations when indicated

Administration Route:

  • IV route (central or peripheral) for patients unable to take oral nutrition
  • Oral route preferred for mild to moderate supplementation

Duration:

  • Duration varies depending on indication; may range from a few days to several weeks
Mechanism of Action (MOA)

This combination provides comprehensive metabolic support by supplying essential amino acids (building blocks for protein synthesis), D-sorbitol (a caloric carbohydrate source with mild osmotic laxative effect), and electrolytes (for maintaining cellular function, neuromuscular excitability, fluid balance, and acid-base homeostasis). Essential amino acids are directly incorporated into metabolic pathways for tissue repair and protein regeneration, while sorbitol provides energy and may stimulate bile secretion. Electrolytes help restore or maintain homeostasis in critically ill or nutritionally compromised patients. The synergistic effect helps correct nutrient deficiencies, maintain nitrogen balance, and promote anabolic recovery.

Pharmacokinetics

Due to the multicomponent nature, pharmacokinetics vary by constituent:

Amino Acids:

  • Absorption (oral): Rapid via active transport in the small intestine
  • Distribution: Wide, enter tissue pools and muscle
  • Metabolism: Hepatic and extrahepatic transamination/deamination
  • Excretion: Minimal renal excretion (used for protein synthesis or metabolized to urea)

D-Sorbitol:

  • Absorption (oral): Slow; partially metabolized to fructose in liver
  • Bioavailability: ~60%
  • Metabolism: Hepatic; enters glycolytic/gluconeogenic pathways
  • Excretion: Excess amounts may be excreted via urine or cause osmotic diarrhea

Electrolytes:

  • Absorption: Nearly complete from GI tract (oral); 100% systemic availability (IV)
  • Distribution: Varies (e.g., Na+ mainly extracellular, K+ mainly intracellular)
  • Excretion: Primarily renal; adjusted based on serum levels and aldosterone
Pregnancy Category & Lactation

Pregnancy:

  • Classified as Generally Safe when used in clinically indicated doses
  • No evidence of teratogenicity from amino acids, sorbitol, or standard electrolytes
  • Use cautiously in hyperemesis gravidarum or severe malnutrition during pregnancy

Lactation:

  • Considered safe; components are natural dietary elements
  • No adverse effects on infants expected
  • Electrolyte monitoring may be needed in severely ill lactating mothers
Therapeutic Class
  • Primary Class: Nutritional Supplement
  • Subclasses:
    • Parenteral Nutrition Solutions
    • Amino Acid Infusions
    • Electrolyte Replacement Products
    • Caloric Support Agents (D-sorbitol-containing)
Contraindications
  • Known hypersensitivity to any component of the formulation
  • Hyperkalemia, hypernatremia, or other severe electrolyte disturbances
  • Renal failure without dialysis (risk of nitrogen/water overload)
  • Hepatic coma if formulation includes high levels of aromatic amino acids
  • Intestinal obstruction or perforation (for oral sorbitol-containing forms)
  • Severe dehydration without concurrent fluid replacement
Warnings & Precautions
  • Monitor electrolytes, renal function, and fluid status regularly, especially in critically ill or elderly
  • Risk of hyperosmolarity or fluid overload with IV administration
  • Use caution in diabetics (D-sorbitol may affect glycemic control)
  • Caution in hepatic encephalopathy – specific amino acid profiles preferred
  • Long-term use may require monitoring of nutritional markers (e.g., albumin, prealbumin, nitrogen balance)
  • May cause osmotic diarrhea with excessive oral sorbitol
  • Use aseptic precautions when administering IV
Side Effects

Common (usually mild):

  • GI (oral): Flatulence, bloating, nausea, osmotic diarrhea (from sorbitol)
  • IV-related: Mild thrombophlebitis at infusion site, flushing

Serious (rare or dose-related):

  • Electrolyte imbalances: Hyperkalemia, hypophosphatemia, hyponatremia
  • Renal overload: Particularly in renal impairment or CHF
  • Allergic reactions: Rash, itching, rarely anaphylaxis
  • Hyperammonemia: In severe hepatic dysfunction with certain amino acid profiles

Onset:

  • Side effects may occur within hours (osmotic effects) or over days (metabolic effects)
Drug Interactions
  • Potassium-sparing diuretics (e.g., spironolactone): Increased risk of hyperkalemia
  • ACE inhibitors/ARBs: Additive potassium effects
  • Corticosteroids: May cause sodium and fluid retention
  • Nephrotoxic drugs (e.g., aminoglycosides): Use with caution in renal impairment
  • Oral sorbitol may reduce absorption of some medications due to increased GI motility

Enzyme System Involvement:

  • No direct CYP450 involvement; interactions are physiological or fluid/electrolyte-based
Recent Updates or Guidelines
  • ESPEN and ASPEN guidelines endorse amino acid + electrolyte solutions as essential components of early nutritional intervention in ICU and surgical patients
  • Preference for branched-chain amino acids in hepatic disease highlighted
  • Restriction of sorbitol use in neonates and infants due to reports of gastrointestinal complications
  • Emerging interest in customized amino acid formulations based on specific metabolic needs (e.g., sepsis, burns, cancer)
Storage Conditions
  • IV solutions:
    • Store between 15°C to 25°C
    • Protect from light and freezing
    • Use within 24 hours after opening; discard unused portion
    • Shake well before use (if emulsified)
  • Oral solutions:
    • Store at 20°C to 30°C
    • Protect from moisture and direct sunlight
    • Keep tightly closed; refrigeration optional depending on manufacturer
  • Handling:
    • Use aseptic technique for IV administration
    • Do not mix with incompatible drugs in the same line or syringe