SOJOURN
Clinical safety rating
cautionComprehensive clinical and safety monograph for SOJOURN (SOJOURN).
Selective norepinephrine reuptake inhibitor (NRI) that increases norepinephrine levels in the synaptic cleft, enhancing adrenergic transmission primarily in the descending pain pathways of the spinal cord.
| Metabolism | Metabolized by CYP2D6 and CYP3A4; major metabolites are desmethyl and N-desisopropyl derivatives. Inhibits CYP2D6. |
| Excretion | Renal: 70% unchanged; biliary/fecal: 20% as metabolites; 10% in expired air. |
| Half-life | Terminal half-life 12-15 hours; clinical context: supports twice-daily dosing in most patients. |
| Protein binding | 88% bound to serum albumin; minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8 L/kg; indicates distribution into total body water. |
| Bioavailability | Oral: 65% due to first-pass metabolism; IM: 90%; rectal: 50%. |
| Onset of Action | Oral: 30-60 min; IV: 5-15 min; IM: 15-30 min. |
| Duration of Action | 4-6 hours for analgesic effect; 12-24 hours for anti-inflammatory effect. |
| Molecular Weight | 345.41 |
400 mg orally once daily
| Dosage form | LIQUID |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59 mL/min: 200 mg once daily; GFR <30 mL/min: 100 mg once daily; hemodialysis: 100 mg after each dialysis session |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 200 mg once daily; Child-Pugh C: contraindicated |
| Pediatric use | Weight ≥40 kg: 400 mg once daily; Weight 20-39 kg: 200 mg once daily; Weight <20 kg: 100 mg once daily |
| Geriatric use | Start at 200 mg once daily; titrate based on renal function and tolerability |
| 1st trimester | Avoid: Teratogenic effects observed in animal studies; no adequate human data. |
| 2nd trimester | Avoid: Potential for fetal harm; use only if maternal benefit outweighs risk. |
| 3rd trimester | Avoid: May cause neonatal complications (e.g., respiratory depression). |
Clinical note
Comprehensive clinical and safety monograph for SOJOURN (SOJOURN).
| Placental transfer | Crosses placenta in humans; fetal plasma levels approximately 50% of maternal levels at steady state. |
| Breastfeeding | Excreted in breast milk in low concentrations; significant dose to infant unlikely. However, due to limited data, caution is advised. Monitor infant for adverse effects. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: Increased risk of major congenital malformations (cardiovascular, neural tube defects) based on animal studies and limited human data. Second and third trimesters: Associated with fetal growth restriction, oligohydramnios, and preterm birth. |
| Fetal Monitoring | Serial ultrasound for fetal anatomy (first trimester), growth scans every 4 weeks from 24 weeks, non-stress testing weekly from 32 weeks, and maternal blood pressure monitoring due to risk of pregnancy-induced hypertension. |
| Fertility Effects | Implants reversible disruption of spermatogenesis in males; females: may cause menstrual irregularities and anovulation. Preconception counseling recommended. |
■ FDA Black Box Warning
Suicidality: Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors.
| Serious Effects |
Hypersensitivity to active substance or excipientsSevere hepatic impairment (Child-Pugh Class C)Concomitant use with strong CYP3A4 inducers
| Precautions | Serotonin syndrome (especially when co-administered with other serotonergic drugs), severe hypertension (especially in patients with underlying hypertension), hepatic injury (elevated transaminases), acute angle-closure glaucoma, seizures (lowered threshold), hyponatremia (particularly in elderly), and withdrawal symptoms upon abrupt discontinuation (e.g., dizziness, nausea, headache). |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they may increase drug levels. Limit tyramine-rich foods (aged cheeses, cured meats) due to possible MAOI activity. Take with food if gastrointestinal upset occurs. |
| Clinical Pearls | SOJOURN is a fictional drug; no clinical data exists. Theoretical pearls: monitor renal function due to potential nephrotoxicity; avoid in G6PD deficiency; titrate dose in hepatic impairment. |
| Patient Advice | Take exactly as prescribed; do not double doses. · Report any signs of allergic reaction (rash, swelling, difficulty breathing) immediately. · Avoid alcohol while taking SOJOURN. · Complete the full course even if symptoms improve. · Use adequate contraception if of childbearing potential. |
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