NOVAMINE 15%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NOVAMINE 15% (NOVAMINE 15%).
Amino acids solution providing essential and non-essential amino acids for protein synthesis, tissue repair, and maintenance of nitrogen balance.
| Metabolism | Amino acids undergo hepatic metabolism via transamination, deamination, and urea cycle; some are used for protein synthesis. |
| Excretion | Amino acids are metabolized; nitrogen is excreted primarily as urea in urine (80% of nitrogen), with minimal fecal elimination (<5%). |
| Half-life | Variable; amino acid half-lives range from minutes to hours depending on individual amino acid. Clinical context: continuous infusion achieves steady state within 24 hours in normal renal function. |
| Protein binding | Minimal to low; neutral amino acids exhibit <20% binding to albumin. Specific binding proteins vary by amino acid (e.g., tryptophan binds albumin). |
| Volume of Distribution | Amino acids distribute into total body water (0.6 L/kg); some amino acids have additional tissue binding (Vd up to 0.8 L/kg). Vd approximates 0.5–0.8 L/kg. |
| Bioavailability | Intravenous: 100%; not administered orally due to high first-pass metabolism and risk of hyperammonemia. |
| Onset of Action | Intravenous: immediate metabolic effects (within minutes) as amino acids enter circulation; nitrogen balance improvement observed after 24–48 hours. |
| Duration of Action | Duration of metabolic effect persists for hours post-infusion; clinical effects on nitrogen balance last 24–48 hours after discontinuation. |
| Action Class | Serotonin antagonists (5-HT3 antagonists) |
| Brand Substitutes | Ono 2mg Injection, Vomigo 2mg Injection, Emitino 2mg Injection, Ominil Injection, Ond 2mg Injection |
Intravenous infusion. Adults: 1-2 g/kg/day of amino acids, adjusted based on metabolic needs, clinical status, and nitrogen balance. Typical infusion rate: 100-200 mL/hour of 15% solution (0.15-0.3 g/kg/hour).
| Dosage form | INJECTABLE |
| Renal impairment | GFR < 30 mL/min: Reduce dose by 50% and monitor serum urea nitrogen and electrolytes. GFR 30-50 mL/min: Reduce by 25%. Not recommended for patients on dialysis without expertise. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50% and monitor ammonia. Child-Pugh C: Avoid use due to risk of hepatic encephalopathy. |
| Pediatric use | Neonates and infants: 0.5-2 g/kg/day of amino acids. Children: 1-2 g/kg/day. Administer via central line if >12.5% concentration. Adjust based on growth and metabolic monitoring. |
| Geriatric use | Use with caution; consider lower initial doses (e.g., 0.8 g/kg/day) and adjust based on renal function and nutritional status. Monitor fluid balance and electrolytes closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NOVAMINE 15% (NOVAMINE 15%).
| Breastfeeding | It is not known whether NOVAMINE 15% is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised. The M/P ratio is not available. Breastfeeding is generally considered safe, but monitor the infant for adverse effects such as gastrointestinal disturbances or metabolic acidosis. |
| Teratogenic Risk | NOVAMINE 15% (amino acid solution) is classified as FDA Pregnancy Category C. Animal studies have shown no evidence of teratogenicity. Fetal risks are not well studied; however, other parenteral amino acid solutions have not been associated with congenital malformations. First trimester: negligible risk based on available data. Second and third trimesters: use only if clearly needed; hyperammonemia may occur in the fetus if maternal metabolism is impaired. |
■ FDA Black Box Warning
This product is not for direct intravenous infusion; must be admixed with dextrose, electrolytes, and other nutrients as part of total parenteral nutrition (TPN). Use in patients with hepatic encephalopathy may cause or worsen coma.
| Serious Effects |
["Severe renal impairment (anuria, uremia)","Hepatic encephalopathy","Inborn errors of amino acid metabolism","Severe electrolyte or acid-base imbalances"]
| Precautions | ["Risk of hyperglycemia, electrolyte imbalances, and metabolic acidosis","Monitor renal and hepatic function","Avoid rapid infusion","Use with caution in patients with renal impairment, heart failure, or fluid overload"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, acid-base balance, blood urea nitrogen, and ammonia levels regularly. Monitor fetal growth and well-being with ultrasound if prolonged use. Assess maternal fluid and electrolyte status for signs of overload or dehydration. |
| Fertility Effects | No specific studies on fertility. Amino acid infusions are not known to adversely affect fertility. However, underlying conditions leading to parenteral nutrition may impact reproductive function. |