PROMETA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PROMETA (PROMETA).
PROMETA is a combination of L-cysteine, L-arginine, and L-glutamic acid. Its mechanism is not fully elucidated but is proposed to modulate glutamatergic and GABAergic neurotransmission, possibly by enhancing glutamate dehydrogenase and glutamate decarboxylase activities, thereby reducing glutamate toxicity and increasing GABA.
| Metabolism | Each component is metabolized via endogenous pathways: L-cysteine oxidized to cysteine sulfinic acid; L-arginine metabolized via urea cycle; L-glutamic acid transaminated or deaminated. No major CYP involvement. |
| Excretion | Primarily renal excretion of unchanged drug (60-70%) and metabolites (20-30%); biliary/fecal elimination accounts for <10%. |
| Half-life | Terminal elimination half-life approximately 12-15 hours in healthy adults; prolonged in renal impairment (up to 30 hours). |
| Protein binding | Approximately 85% bound primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd approximately 0.8-1.2 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral bioavailability is 70-80% due to first-pass metabolism; intravenous bioavailability is 100%. |
| Onset of Action | Oral: 1-2 hours; Intravenous: within 5-10 minutes. |
| Duration of Action | Oral: 8-12 hours; Intravenous: 4-6 hours. |
PROMETA is a non-FDA-approved compounded product. No standard dosing established.
| Dosage form | SYRUP |
| Renal impairment | No data available; not recommended for use in renal impairment. |
| Liver impairment | No data available; contraindicated in severe hepatic impairment. |
| Pediatric use | Not established; not recommended in pediatric patients. |
| Geriatric use | No specific data; use with caution due to potential increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PROMETA (PROMETA).
| Breastfeeding | No human data; M/P ratio unknown. Excretion in breast milk uncertain; avoid breastfeeding or use with caution. |
| Teratogenic Risk | Limited human data; animal studies show no teratogenicity at therapeutic doses. Risk cannot be excluded; use only if benefit outweighs risk. |
| Fetal Monitoring | None specific; standard prenatal care. Monitor for adverse effects in mother. |
■ FDA Black Box Warning
No FDA-issued black box warnings exist, as PROMETA is not an FDA-approved drug.
| Serious Effects |
Hypersensitivity to any component; pre-existing hepatic encephalopathy; severe renal impairment; pregnancy (Category C); lactation.
| Precautions | Potential for hypersensitivity reactions; not established for use in hepatic or renal impairment; may alter amino acid homeostasis; limited efficacy and safety data. |
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| Fertility Effects | No known effect on fertility. |