CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER (CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER).
Provides essential amino acids and calories for protein synthesis and energy metabolism in parenteral nutrition.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle; hepatic and renal pathways. |
| Excretion | Renal (primarily as amino acids and metabolites); >90% of infused amino acids are eliminated via renal excretion as nitrogenous waste (urea, ammonia) and oxidized to CO2 and water; <10% excreted unchanged in bile/feces. |
| Half-life | Amino acids have variable individual half-lives; the terminal elimination half-life for the amino acid mixture is approximately 1.5–2 hours, reflecting rapid distribution and metabolism; clinically, cessation of infusion leads to rapid decline in plasma amino acid levels. |
| Protein binding | Amino acids: minimal protein binding (<10%); not significantly bound to albumin or other plasma proteins. |
| Volume of Distribution | Amino acids: Vd approximately 0.2–0.4 L/kg, reflecting distribution primarily to extracellular fluid and rapid cellular uptake; clinical meaning: rapid equilibration with body tissues. |
| Bioavailability | Intravenous: 100% (not available by oral route as a therapeutic formulation; oral amino acids would undergo first-pass metabolism, leading to bioavailability <100% but not clinically relevant for this product). |
| Onset of Action | Intravenous: within minutes; improvement in nitrogen balance and plasma amino acid levels detectable within 30–60 minutes of infusion start. |
| Duration of Action | Intravenous: duration depends on infusion rate; after discontinuation, metabolic effects (e.g., nitrogen sparing) persist for 4–6 hours as amino acids are cleared; continuous infusion is typically required to maintain effect. |
Intravenous infusion: 1.5 g/kg/day (amino acids) as part of parenteral nutrition; typical infusion rate 0.8-1.5 g/kg/hr.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <50 mL/min: Reduce dose to 0.5-0.8 g/kg/day; GFR <15 mL/min: Avoid or use with extreme caution, monitor BUN. |
| Liver impairment | Child-Pugh B or C: Use with caution; reduce dose by 50% in severe hepatic impairment due to risk of hyperammonemia. |
| Pediatric use | Infants and children: 1.5-3.0 g/kg/day (amino acids) IV; adjust based on age and clinical status. |
| Geriatric use | Start at lower end of dosing range (1.0-1.2 g/kg/day) due to reduced renal and hepatic function; monitor fluid and electrolyte balance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER (CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER).
| Breastfeeding | Excretion into breast milk is minimal and unlikely to cause adverse effects in the nursing infant. There is no specific M/P ratio available. The product is considered compatible with breastfeeding; however, use with caution and monitor infant for any signs of metabolic imbalance. |
| Teratogenic Risk | CLINISOL 15% SULFITE FREE (a balanced amino acid solution) is considered low risk for teratogenicity. No specific fetal risks have been identified in animal studies or human experience. However, as with all parenteral nutrition, ensure appropriate monitoring and use only when clearly needed during pregnancy. Third trimester use may require caution due to altered maternal metabolism. |
■ FDA Black Box Warning
Not for intravenous administration of undiluted solution; must be admixed with dextrose, electrolytes, vitamins, and trace elements to prevent hyperosmolar complications.
| Serious Effects |
Severe hepatic failure, inborn errors of amino acid metabolism, anuria, severe acidosis, hypersensitivity to any component.
| Precautions | Monitor fluid and electrolyte balance, acid-base status, and serum osmolality; risk of hyperglycemia, azotemia, and metabolic acidosis; use with caution in hepatic or renal impairment. |
Loading safety data…
| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, renal function (BUN, creatinine), hepatic function (ALT, AST), and acid-base balance. Fetal monitoring may include ultrasound for growth and well-being if maternal nutritional status is compromised. Check for signs of fluid overload and thrombosis. |
| Fertility Effects | No known adverse effects on fertility. Parenteral nutrition may restore ovulatory cycles in malnourished women. Use in pregnancy should be based on maternal nutritional requirements and clinical necessity. |