Esamin

Approved (Labeled Uses):

• As part of total parenteral nutrition (TPN) in adults, children, and neonates, when oral or enteral feeding is contraindicated or insufficient. Designed to deliver balanced amino acids, energy (via D‑sorbitol), and electrolytes.
• Repletion of fluid and electrolyte deficits in surgical, trauma, or metabolic stress patients where nutrition and hydration must be delivered intravenously.

Clinically Accepted Off-Label Uses:

• Critically ill patients (burns, sepsis, major surgery, long‑term ICU stay) requiring combined protein, calories, and electrolyte support.
• Premature or low birth weight neonates needing early parenteral nutrition with amino acids, carbohydrate (sorbitol), and electrolytes.
• Malabsorption states or gastrointestinal dysfunction where mixed infusion avoids enteral route.

Amino Acid Component (protein):

• Adults: 0.8–2.0 g/kg/day depending on metabolic need (see stress categorization).
• Pediatrics/neonates:
• Preterm: start at ~1–1.5 g/kg/day, advancing to 3–4 g/kg/day.
• Term infants: ~2.5 g/kg/day, increasing to 3–3.5 g/kg/day.
• Children/adolescents: ~0.8–1.5 g/kg/day.

D‑Sorbitol (carbohydrate):

• Caloric equivalent ~2.5 kcal/g; typically ~3–5 mg/kg/min infusion rate, contributing to total energy intake (~25–35 kcal/kg/day depending on age/stress).

Electrolyte Content:

• Standard TPN electrolyte values per liter include:
• Sodium: ~60–90 mEq
• Potassium: ~20–40 mEq
• Magnesium: ~5–10 mEq
• Phosphate: ~20–40 mmol
• Calcium: ~5–15 mEq depending on age and needs.

Special Populations:

• Renal impairment: Adjust electrolytes (especially potassium, phosphate, calcium); protein dosing similar or slightly lower; regular lab monitoring.
• Hepatic impairment: Moderate protein dosing (1.0–1.2 g/kg/day); monitor for encephalopathy; adjust electrolytes based on liver function.

Administration Route & Frequency:

• Intravenous infusion only (via central or high‑flow peripheral line).
• Continuous infusion over 18–24 hours per day; maximum infusion rate adjusted to avoid metabolic overload.
• Mixed in TPN bag with lipids, vitamins, and trace elements per institutional protocol.

Duration & Dose Adjustments:

• Dose and duration guided by daily assessments of nutritional requirements, fluid/electrolyte labs, nitrogen balance, and metabolic demands.
• Gradual initiation (e.g., start at 50% goal rate, increase over 24–48 h) in refeeding risks.

D‑Sorbitol serves as a non‑insulin‑requiring carbohydrate source, delivering energy to reduce protein catabolism. Amino acids provide substrates for protein synthesis and nitrogen equilibrium, while electrolytes maintain physiological fluid balance, neuromuscular and cardiac function, and metabolic enzyme cofactor activity. Combined, the formulation supports lean mass preservation, energy needs, and homeostasis during periods of nutritional insufficiency.

• Absorption: Bypasses GI tract; all components delivered directly into systemic circulation.
• Distribution: Amino acids distribute into intra‑ and extracellular fluid compartments; sorbitol circulates and is metabolized in liver and kidney; electrolytes distribute in plasma and interstitial/bone compartments.
• Metabolism: Sorbitol converted primarily in liver to fructose and glucose via sorbitol dehydrogenase; amino acids metabolized via transamination and incorporation into protein.
• Elimination: Nitrogenous waste excreted as urea via kidneys; sorbitol metabolites eliminated as CO₂ or glucose, renal excretion; electrolytes excreted via urine and regulated hormonally (e.g., aldosterone, PTH).
• Onset & Half‑Life: Immediate effect upon infusion; amino acids and sorbitol half-lives are minutes to hours; no discrete half-life for electrolyte mix as a whole.

Pregnancy:

• No designated FDA category (not a traditional drug). Nutritional support including amino acids, carbohydrate, and electrolytes is standard in cases where oral intake is insufficient. Known benefit in maternal‑fetal nutrition in prolonged fasting or surgical situations. Risks are minimal when monitored appropriately.

Lactation:

• Components reflect nutritional substrates typical in human milk metabolism; not expected to adversely affect breastfeeding infants. Caution advised if underlying maternal metabolic or renal disorders exist; ensure balanced maternal electrolytes.

• Primary Class: Parenteral nutritional support formulation.
• Subclass: Multi-component TPN solution—amino acid-based protein, D‑sorbitol carbohydrate, and electrolyte supplementation.

• Known hypersensitivity to any component (amino acids, sorbitol, or electrolyte salts).
• Severe hypernatremia, hyperkalemia, hyperphosphatemia, or hypercalcemia (unless adjusted appropriately).
• Inborn errors of amino acid metabolism.
• Uncontrolled fluid overload or severe congestive heart failure.
• Severe hepatic encephalopathy or end-stage liver failure not managed within metabolic protocol.

• High-Risk Groups: Preterm infants, renal or hepatic impairment, elderly, cardiac-compromised patients, fluid-restricted individuals.
• Major Risks: Fluid overload, electrolyte derangements (e.g. hypokalemia, hyperphosphatemia, hypermagnesemia), metabolic acidosis, hyperglycemia (from sorbitol), catheter-related infections or thromboses.
• Monitoring Needs: Frequent and serial monitoring of electrolytes, serum glucose, kidney and liver function, fluid balance, nitrogen status, acid–base status, and catheter-site integrity.
• Early Warning Signs: Tachycardia, arrhythmias, edema, nausea/vomiting, altered mental status, respiratory distress, blood glucose shifts.

Common:

• Mild nausea, bloating, infusion site irritation or phlebitis.
• Mild electrolyte shifts (e.g., transient hyperkalemia or hypokalemia, hypernatremia/hyponatremia depending on infusion).

Serious / Rare:

• Fluid overload or pulmonary edema.
• Metabolic acidosis or alkalosis depending on buffer content.
• Catheter-line sepsis or bloodstream infection.
• Hypersensitivity reactions (rare).

Onset is usually during or soon after infusion; dose- and rate-dependent side effects are minimized with careful control.

• Medication Interactions: Agents affecting potassium, magnesium, or calcium balance (e.g. diuretics, ACE inhibitors) may alter electrolyte needs.
• Nutrition Interactions: High phosphate without calcium buffer may precipitate in solution; magnesium deficiency impairs potassium and calcium utilization.
• Alcohol or Food: Not applicable for IV delivery.
• Enzymes: Sorbitol metabolism requires sorbitol dehydrogenase; amino acids not significantly metabolized via CYP450; low interaction risk.

• Clinical consensus emphasizes early initiation of mixed TPN including protein, carbohydrate, and electrolytes in ICU, burn, neonatal, and surgical patients to reduce catabolism and prevent electrolyte imbalance.
• Updated protocols recommend caution in refeeding syndrome, using graded infusion starts for carbohydrate (including sorbitol), electrolyte repletion (especially phosphate, magnesium), and close monitoring.
• Guidelines reinforce avoiding precipitation by careful calcium-phosphate ratio control and electrolyte compatibility in admixtures.

• Store packaged solution at 20 °C to 25 °C, away from heat and direct sunlight.
• Avoid freezing; discard if crystallization, cloudiness, or precipitation occurs.
• Mixed TPN admixtures containing amino acid, sorbitol, and electrolytes must be refrigerated at 2 °C to 8 °C, used within 24 hours of preparation, and warmed to room temperature before administration.
• Shake or gently invert bag to ensure homogeneity—do not shake vigorously.
• Prepare under aseptic conditions; inspect for clarity before infusion.