HYPROTIGEN 5%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYPROTIGEN 5% (HYPROTIGEN 5%).
HYPROTIGEN 5% is a solution of protein hydrolysates derived from milk or other sources. It provides amino acids for protein synthesis and nutritional support. It acts as a source of nitrogen and essential amino acids, promoting tissue repair and positive nitrogen balance in patients unable to tolerate oral feeding.
| Metabolism | Amino acids from HYPROTIGEN 5% are metabolized via general protein catabolism pathways, including transamination (transfer of amino groups) and deamination in the liver, with carbon skeletons entering the Krebs cycle for energy or converted to glucose/lipids. Nitrogen is converted to urea in the urea cycle and excreted renally. |
| Excretion | Primarily renal elimination; over 95% of infused amino acids are reabsorbed by proximal tubular cells with minimal urinary loss. Biliary/fecal excretion negligible. |
| Half-life | Variable, dependent on amino acid composition; individual amino acids have half-lives ranging from minutes (e.g., glutamine, alanine) to 6–8 hours (e.g., leucine, isoleucine). In metabolic stress, clearance may be prolonged. |
| Protein binding | <10% bound to plasma proteins; primarily albumin and prealbumin. |
| Volume of Distribution | 0.7–0.9 L/kg (average 0.8 L/kg), approximating total body water, indicating extensive distribution into extracellular and intracellular compartments. |
| Bioavailability | Intravenous: 100%. Oral: Not applicable (not absorbed intact). |
| Onset of Action | Intravenous: Within 30–60 minutes as plasma amino acid concentrations rise and stimulate protein synthesis and metabolic pathways. |
| Duration of Action | Plasma levels return to baseline within 4–6 hours after infusion discontinuation. Continuous infusion required to maintain anabolic effects; bolus administration yields transient effect. |
Intravenous infusion of 500 mL to 1000 mL (25 g to 50 g protein) per day, administered at a rate not exceeding 0.1 g protein/kg/hour. Typical adult dose: 1.5 g/kg/day (as protein equivalent) with dextrose and electrolytes as needed.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) or anuria. For moderate impairment (eGFR 30-59 mL/min/1.73 m²), reduce dose by 50% and monitor serum electrolytes, BUN, and creatinine. For mild impairment (eGFR 60-89 mL/min/1.73 m²), no dose adjustment needed. |
| Liver impairment | Contraindicated in patients with hepatic coma or severe hepatic insufficiency (Child-Pugh class C). For Child-Pugh class B, reduce dose by 50% and monitor ammonia levels. For Child-Pugh class A, no dose adjustment required. |
| Pediatric use | Dose based on 2-3 g protein/kg/day via intravenous infusion, administered at a rate not exceeding 0.1 g protein/kg/hour. Adjust fluid volume according to age and weight. Monitor serum electrolytes and hydration status. Not recommended in infants under 1 month due to risk of hyperammonemia. |
| Geriatric use | Lower initial doses (0.5-1 g protein/kg/day) recommended due to reduced renal function and increased risk of fluid overload. Monitor serum electrolytes, renal function, and signs of volume overload. Adjust rate to ≤ 0.1 g protein/kg/hour. Use with caution in patients with cardiac or renal comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYPROTIGEN 5% (HYPROTIGEN 5%).
| Breastfeeding | Excretion into human milk is unknown. Protein hydrolysates are normal constituents of human milk. No adverse effects anticipated in breastfed infants. M/P ratio not available. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Hyprotigen 5% (protein hydrolysate) is generally considered to have low teratogenic potential as it provides essential amino acids for maternal and fetal protein synthesis. However, risks are not fully characterized; use only if clearly needed. |
■ FDA Black Box Warning
There is no FDA black box warning associated with HYPROTIGEN 5%.
| Serious Effects |
["Hypersensitivity to milk or soy protein (if derived from these sources)","Severe hepatic impairment with encephalopathy","Untreated uremia or severe renal failure","Metabolic disorders involving amino acid metabolism (e.g., phenylketonuria)"]
| Precautions | ["Monitor for signs of hyperammonemia, especially in hepatic impairment","Risk of fluid overload in patients with renal or cardiac insufficiency","Electrolyte imbalances may occur with prolonged use","Use with caution in patients with metabolic acidosis or hepatic encephalopathy"] |
Loading safety data…
| Fetal Monitoring |
| Monitor maternal fluid balance, serum electrolytes, renal function, and signs of fluid overload. Fetal assessment includes standard prenatal monitoring with ultrasound for growth and amniotic fluid volume if prolonged use. |
| Fertility Effects | No known adverse effects on fertility. Protein hydrolysates provide nutritional support and may improve reproductive outcomes in malnourished women. |