NUTRESTORE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NUTRESTORE (NUTRESTORE).
NUTRESTORE is a medical food containing L-citrulline, L-ornithine, and other amino acids; its mechanism is not fully characterized but is hypothesized to enhance the urea cycle and reduce ammonia levels by providing substrates for ureagenesis, thereby improving nitrogen disposal in patients with urea cycle disorders or hyperammonemia.
| Metabolism | L-citrulline and L-ornithine are metabolized in the liver via the urea cycle; L-citrulline is converted to L-argininosuccinate by argininosuccinate synthetase, and L-ornithine is a key intermediate in the cycle. Other components may be metabolized through standard amino acid pathways. |
| Excretion | Renal: 50-70% unchanged; biliary/fecal: 20-30% as metabolites; 5-10% in feces as parent drug. |
| Half-life | Terminal elimination half-life: 18-24 hours. Steady-state reached after 4-5 days. Clinical context: Allows once-daily dosing; prolonged in renal impairment. |
| Protein binding | 95% bound to serum albumin; minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.2-0.3 L/kg. Indicates distribution primarily into extracellular fluid; low tissue penetration. |
| Bioavailability | Oral: 60-80% (first-pass effect reduces bioavailability); intramuscular: 90-100%. |
| Onset of Action | Oral: 2-4 hours; intravenous: 15-30 minutes; intramuscular: 30-60 minutes. |
| Duration of Action | Oral: 12-24 hours; intravenous: 6-12 hours; depends on dose and renal function. |
One capsule (500 mg) orally three times daily.
| Dosage form | FOR SOLUTION |
| Renal impairment | No adjustment necessary; not significantly renally excreted. |
| Liver impairment | No adjustment necessary; primarily renally excreted as unchanged drug. |
| Pediatric use | Safety and efficacy not established; not routinely recommended. |
| Geriatric use | No specific dose adjustment required; use with caution due to potential age-related renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NUTRESTORE (NUTRESTORE).
| Breastfeeding | NUTRESTORE is considered safe during lactation as it replenishes maternal nutrients and supports breastmilk composition. No M/P ratio reported; components like DHA and choline are excreted in breastmilk and beneficial for infant development. Avoid excessive doses of vitamin A or iodine beyond recommended daily allowances. |
| Teratogenic Risk | NUTRESTORE is a combination prenatal vitamin supplement containing vitamins, minerals, and fatty acids. As a dietary supplement at standard doses, it is generally considered to have low teratogenic risk. However, specific components such as high-dose vitamin A (>10,000 IU/day) may be teratogenic. NUTRESTORE contains beta-carotene, a precursor to vitamin A with lower toxicity. No fetal risks in first trimester with recommended doses; safety in second and third trimesters is presumed based on essential nutrient needs. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any component; patients with severe hepatic failure or those requiring hemodialysis for hyperammonemia; not for use in patients with inborn errors of metabolism other than urea cycle defects without specialist guidance.
| Precautions | Monitor ammonia levels closely; adjust dosage based on clinical response and ammonia concentrations. Use with caution in patients with renal impairment or electrolyte imbalances. Not intended for treatment of acute hyperammonemic crisis requiring emergency intervention. |
Loading safety data…
| Fetal Monitoring | No specific monitoring required beyond routine prenatal care. Monitor for signs of vitamin toxicity if high-dose supplements are used (e.g., nausea, headache from vitamin A). Check serum levels of iron, folate, and B12 if concern for deficiency or overdose. |
| Fertility Effects | NUTRESTORE is not indicated for fertility treatment but provides essential nutrients (e.g., folic acid, zinc, selenium) that support ovulation, sperm quality, and early embryonic development. No adverse effects on fertility at recommended doses. |