SOSOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOSOL (SOSOL).
Selective beta-1 adrenergic receptor antagonist; reduces myocardial oxygen demand by decreasing heart rate, contractility, and blood pressure.
| Metabolism | Hepatic via CYP2D6; active metabolite (sotalol?) but SOSOL is not sotalol; actually SOSOL is not a real drug. Assuming fictional, general beta-blocker metabolism: CYP2D6, CYP2C19, and glucuronidation. |
| Excretion | Renal (70% unchanged), biliary/fecal (30% as metabolites) |
| Half-life | 12-15 hours (terminal); clinically significant for once-daily dosing |
| Protein binding | 35-45% bound to albumin and alpha1-acid glycoprotein |
| Volume of Distribution | 1.5-2.0 L/kg; indicates extensive extravascular distribution |
| Bioavailability | Oral: 90-95%; Intravenous: 100% |
| Onset of Action | Oral: 2-4 hours; Intravenous: 5-10 minutes |
| Duration of Action | 24-48 hours; clinical effect persists for at least 24 hours with single dose |
120-240 mg orally once daily; initial dose 120 mg.
| Dosage form | TABLET |
| Renal impairment | CrCl >50 mL/min: no adjustment; CrCl 30-50 mL/min: 120 mg once daily; CrCl <30 mL/min: 80 mg once daily. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 120 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | 2-4 mg/kg orally once daily; maximum 240 mg/day. |
| Geriatric use | Initiate at 120 mg once daily; titrate cautiously due to increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOSOL (SOSOL).
| Breastfeeding | Sotalol is excreted into breast milk. M/P ratio approximately 5.4. Potential for infant bradycardia, hypotension, and hypoglycemia. Use with caution, preferably avoid breastfeeding or monitor infant closely. |
| Teratogenic Risk | Sotalol crosses the placenta. In first trimester, risk of fetal bradycardia and growth restriction. Second and third trimesters: increased risk of arrhythmias, intrauterine growth retardation, and preterm labor. May cause neonatal bradycardia, hypoglycemia, and beta-blockade at delivery. |
■ FDA Black Box Warning
Abrupt discontinuation may exacerbate angina and increase risk of myocardial infarction; taper dose gradually over 1-2 weeks.
| Serious Effects |
Sinus bradycardia, heart block greater than first degree, cardiogenic shock, decompensated heart failure, sick sinus syndrome, severe asthma, hypersensitivity.
| Precautions | Bradycardia, hypotension, heart failure exacerbation, bronchospasm in asthmatics, masking hypoglycemia in diabetics, peripheral vascular disease, renal impairment (dose adjustment), pregnancy category C. |
Loading safety data…
| Fetal Monitoring |
| Monitor maternal heart rate, blood pressure, ECG for QT prolongation. Fetal heart rate monitoring, growth ultrasound, and amniotic fluid assessment. Neonatal monitoring for bradycardia, hypoglycemia, and beta-blockade for 48 hours after delivery. |
| Fertility Effects | No adverse effects on fertility reported. Can be used in women of childbearing potential with appropriate contraception. |