SORINE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SORINE (SORINE).
Selective beta-1 adrenergic receptor antagonist; decreases cardiac output, heart rate, and blood pressure.
| Metabolism | Hepatic via CYP2D6; first-pass metabolism. |
| Excretion | Renal (80% unchanged) and biliary (15% as metabolites); 5% fecal. |
| Half-life | 4-6 hours in healthy adults; prolonged to 12-18 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 85% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 1.5 L/kg (0.8-2.0 L/kg), indicating extensive tissue penetration. |
| Bioavailability | Oral: 75-85% (high first-pass metabolism reduces to 60-70% in hepatic impairment). |
| Onset of Action | Oral: 30-45 minutes; IV: 5-10 minutes; IM: 15-30 minutes. |
| Duration of Action | Oral: 6-8 hours; IV: 4-6 hours; dose-dependent for severe infections. |
5 mg orally once daily, increased after 4 weeks to 10 mg orally once daily if tolerated and needed.
| Dosage form | TABLET |
| Renal impairment | eGFR 30-59 mL/min: 2.5 mg orally once daily; eGFR <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: 2.5 mg orally once daily; Child-Pugh B: not recommended; Child-Pugh C: contraindicated. |
| Pediatric use | Not approved for pediatric use. |
| Geriatric use | Initiate at 2.5 mg orally 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 SORINE (SORINE).
| Breastfeeding | Sotalol is excreted into breast milk with an M/P ratio of approximately 5.3. It accumulates in milk, with infant doses up to 0.5-1.0 mg/kg/day. Monitor infant for bradycardia and hypoglycemia. Avoid use if possible; if used, consider pumping and discarding milk during peak milk concentrations (2-4 hours post-dose). |
| Teratogenic Risk | SORINE (sotalol) is a class III antiarrhythmic that crosses the placenta. First trimester: Risk of congenital anomalies is low but not ruled out; avoid unless essential. Second and third trimesters: Risk of fetal bradycardia, intrauterine growth restriction, and hypoglycemia; may cause neonatal bradycardia and arrhythmia after delivery. Consider alternative therapy with lower fetal risk. |
■ FDA Black Box Warning
Abrupt discontinuation may exacerbate angina and risk myocardial infarction.
| Serious Effects |
Sinus bradycardia; heart block; cardiogenic shock; overt heart failure; hypersensitivity.
| Precautions | Beta-blocker withdrawal; bronchospasm in asthmatics; bradycardia; heart failure exacerbation; masking hypoglycemia; peripheral vascular disease. |
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| Fetal Monitoring | Monitor maternal heart rate, blood pressure, QTc interval, and serum potassium/magnesium. Fetal: serial ultrasound for growth, fetal heart rate monitoring, and prenatal fetal echocardiogram if prolonged therapy. Neonatal: observe for bradycardia, hypoglycemia, and arrhythmias for 48 hours post-delivery. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies show no impairment at clinically relevant doses. However, safety data in patients trying to conceive are lacking. |