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. |
| Molecular Weight | 344.4 |
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 | Insufficient human data; use only if benefit outweighs risk. |
| 2nd trimester | Insufficient human data; use only if benefit outweighs risk. |
| 3rd trimester | Insufficient human data; use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for NUTRESTORE (NUTRESTORE).
| Placental transfer | Unknown; based on molecular weight <500 Da and lipophilicity, likely crosses placenta. |
| Breastfeeding | No human data; excreted in rat milk. Use caution. |
| Lactation Rating | L3 |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any component
| 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. |
| Food/Dietary | Take with meals to enhance absorption and reduce GI side effects. Avoid high-fiber meals immediately after dosing as may reduce absorption. No specific food restrictions. |
| Clinical Pearls |
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| 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. |
| 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. |
| NUTRESTORE is a multinutrient supplement; not a drug. No FDA approval for specific disease treatment. Use as adjunct, not replacement for standard therapy. |
| Patient Advice | Take with food to reduce gastrointestinal upset. · Do not exceed recommended dose. · Inform healthcare provider of all medications and supplements. · Store at room temperature, away from moisture. |