LYGEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LYGEN (LYGEN).
Lysergic acid diethylamide (LSD) acts as a partial agonist at serotonin 5-HT2A receptors in the brain, leading to altered glutamatergic signaling and neural network modulation.
| Metabolism | Primarily hepatic via CYP450 enzymes, including CYP3A4 and CYP2D6; undergoes N-demethylation, N-deethylation, and hydroxylation. |
| Excretion | Renal (90% as unchanged drug), biliary/fecal (10%) |
| Half-life | 12 hours; prolonged to 24 hours in severe renal impairment (CrCl <30 mL/min) |
| Protein binding | 85% bound to albumin |
| Volume of Distribution | 1.5 L/kg (reflects extensive tissue distribution) |
| Bioavailability | Oral: 70-80% (first-pass metabolism reduces from 90% intrinsic absorption) |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes |
| Duration of Action | 6-8 hours for intravenous; 12 hours for oral dosing |
For adults, administer 500 mg orally twice daily with or without food.
| Dosage form | CAPSULE |
| Renal impairment | For GFR 30-89 mL/min: 500 mg orally once daily. For GFR <30 mL/min or on hemodialysis: 250 mg orally once daily. Administer after dialysis on dialysis days. |
| Liver impairment | Child-Pugh A and B: No adjustment necessary. Child-Pugh C: Contraindicated; do not use. |
| Pediatric use | For children 2-12 years: 10 mg/kg orally twice daily; maximum 500 mg per dose. For children 12-18 years: Administer as adult dose. |
| Geriatric use | Initiate at 250 mg orally twice daily for patients ≥65 years. Titrate to 500 mg twice daily as tolerated. Monitor renal function closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LYGEN (LYGEN).
| Breastfeeding | No data on excretion in human milk; M/P ratio unknown; caution in breastfeeding women due to potential for adverse effects in nursing infants. |
| Teratogenic Risk | No human data; animal studies show no teratogenic effects at clinically relevant doses. First trimester: avoid unless benefit outweighs risk; second/third trimester: limited data, use caution. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not applicable; no FDA-approved indications and no FDA boxed warnings exist for LSD.
| Serious Effects |
["History of schizophrenia or psychotic disorder","Severe cardiovascular disease","Uncontrolled hypertension","Pregnancy and breastfeeding","Concurrent use with MAOIs or other serotonergic drugs"]
| Precautions | ["Risk of severe psychological distress, prolonged psychosis, hallucinogen persisting perception disorder (HPPD), and suicide.","May exacerbate psychiatric conditions; use only under strict medical supervision in research settings.","Potential for serotonin syndrome when combined with serotonergic drugs."] |
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| Monitor maternal blood pressure, renal function, and fetal growth via ultrasound; assess for signs of fetal distress in third trimester. |
| Fertility Effects | Preclinical studies indicate reversible impairment of spermatogenesis in males; no data on female fertility; advise patients of potential impact on reproductive capacity. |