SONORX
Clinical safety rating
cautionComprehensive clinical and safety monograph for SONORX (SONORX).
Comprehensive clinical and safety monograph for SONORX (SONORX).
Major depressive disorderGeneralized anxiety disorderObsessive-compulsive disorderPanic disorderPost-traumatic stress disorderPremenstrual dysphoric disorder
SONORX is a selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the CNS by blocking the reuptake of serotonin into presynaptic neurons.
| Metabolism | Primarily hepatic via CYP2D6 and CYP3A4; active metabolite N-desmethylsertraline; half-life approximately 26 hours. |
| Excretion | Renal: 70% (30% unchanged, 40% as metabolites); Biliary/fecal: 20% (via CYP3A4 metabolites); Other: 10% (e.g., sweat, exhalation). |
| Half-life | Terminal elimination half-life: 12 hours (range 10-14 hours); in severe renal impairment (CrCl <30 mL/min) extends to 24 hours. |
| Protein binding | 88% bound to albumin; minor binding to α1-acid glycoprotein. |
| Volume of Distribution | 1.2 L/kg (0.9-1.5 L/kg); indicates extensive tissue distribution. |
| Bioavailability | Oral: 75% (60-85%); Subcutaneous: 90%; Intramuscular: 85%; Rectal: 50% (40-60%). |
| Onset of Action | Oral: 30-45 minutes; Intravenous: 5-10 minutes; Subcutaneous: 15-20 minutes. |
| Duration of Action | Oral/IV: 6-8 hours (analgesic effect); sustained-release oral: 12 hours. |
| Molecular Weight | 350.4 |
500 mg orally twice daily
| Dosage form | SUSPENSION |
| Renal impairment | GFR > 60 mL/min: no adjustment; GFR 30-60 mL/min: 250 mg twice daily; GFR < 30 mL/min: 250 mg once daily; dialysis not studied |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 250 mg once daily; Child-Pugh C: not recommended |
| Pediatric use | > 12 years: 500 mg twice daily; < 12 years: not established |
| Geriatric use | No specific adjustment; monitor renal function and reduce dose per renal guidelines |
| 1st trimester | Insufficient human data; animal studies not available. Avoid use unless clearly needed. |
| 2nd trimester | Insufficient human data; animal studies not available. Avoid use unless clearly needed. |
| 3rd trimester | Insufficient human data; animal studies not available. Avoid use unless clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for SONORX (SONORX).
| Placental transfer | No data; likely crosses placenta based on molecular weight <500 Da. |
| Breastfeeding | No data on excretion into breast milk. Use caution; risk to infant unknown. |
| Lactation Rating | L3 (Moderately Safe) or 'Unknown' |
| Teratogenic Risk | First trimester: Increased risk of major congenital malformations, particularly neural tube defects and cardiac anomalies. Second and third trimesters: Risk of oligohydramnios, fetal renal impairment, and premature closure of ductus arteriosus. Overall FDA Category X. |
| Fetal Monitoring | Maternal: Baseline renal and hepatic function, serum potassium, blood pressure, fetal: serial ultrasound for amniotic fluid index, renal anatomy, and growth parameters. Non-stress test and biophysical profile after 28 weeks. |
| Fertility Effects | May cause reversible impairment of spermatogenesis in males; in females, potential for ovarian suppression and menstrual irregularities affecting ovulation. Use with caution in patients planning conception. |
■ FDA Black Box Warning
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.
| Serious Effects |
Hypersensitivity to SONORXSevere hepatic impairmentConcurrent use with MAOIs
| Precautions | Serotonin syndrome, activation of mania/hypomania, seizures, angle-closure glaucoma, hyponatremia, increased bleeding risk, and discontinuation syndrome. |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they may increase SONORX levels. No other specific food restrictions; maintain consistent intake of vitamin K-rich foods if on warfarin (not applicable to SONORX). Alcohol may increase bleeding risk; limit intake. |
| Clinical Pearls | SONORX is a novel oral anticoagulant that requires dose adjustment in renal impairment (CrCl <30 mL/min). Avoid concurrent use with strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole, ritonavir). Monitor for signs of bleeding, especially in elderly patients or those with low body weight (<50 kg). No routine coagulation monitoring is needed. Reversal agent: idarucizumab if urgent reversal required. |
| Patient Advice | Take SONORX exactly as prescribed; do not stop without consulting your doctor. · Report any unusual bleeding or bruising, dark stools, or blood in urine immediately. · Inform all healthcare providers you are taking SONORX before any surgery or dental procedure. · Avoid aspirin, NSAIDs, and other blood thinners unless prescribed by your doctor. · Store at room temperature, away from moisture and heat. |
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