Sotalol
سوتالول
❤️ Cardiovascular SystemClass III antiarrhythmic (beta-blocker)
Market / country: 🇺🇸 USA
Betapace (US)
🧮 Dose calculator
Life-threatening ventricular arrhythmia · Regimen source: FDA Sotalol · 2.2
- • Start in a facility with ECG monitoring for at least 3 days. Increase by 80 mg/day every 3 days only if QTc <500 ms. FDA Sotalol · 2.1FDA Sotalol · 2.2
- • Up to 480–640 mg/day has been used for refractory arrhythmias. FDA Sotalol · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Sinus bradycardia, sick sinus syndrome or 2nd/3rd-degree AV block without a pacemaker; long QT; cardiogenic shock or decompensated heart failure; serum potassium <4 mEq/L; bronchial asthma; hypersensitivity. FDA Sotalol · 4
Warnings
- • Boxed warning: life-threatening proarrhythmia (torsade). Initiate and up-titrate in a facility with ECG monitoring and creatinine clearance calculation. FDA Sotalol · Boxed Warning
Renal adjustment
- • eGFR < 60: Interval: CrCl 30–59 every 24 h; 10–29 every 36–48 h; <10 individualised. Escalate after at least 5 doses. FDA Sotalol · 2.5
Formulations
- 80 mg tablet (scored) — tablet 🇺🇸 USA FDA Sotalol · 3
- 120 mg tablet (scored) — tablet 🇺🇸 USA FDA Sotalol · 3
- 160 mg tablet (scored) — tablet 🇺🇸 USA FDA Sotalol · 3
- 240 mg tablet (scored) — tablet 🇺🇸 USA FDA Sotalol · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Sotalol · 8.1
“Risk Summary Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see Clinical Considerations) .”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Sotalol · 8.2
“Because of the potential serious adverse reactions to the breastfed child and the high level of sotalol in breast milk, advise women not to breastfeed while on treatment with sotalol hydrochloride .”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Sotalol · 8.4
“The safety and effectiveness of sotalol in children have not been established.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Sotalol · 8.3
“Infertility Based on the published literature, beta blockers (including sotalol) may cause erectile dysfunction.”
🔗 Reference links
- FDA (approval record)ANDA076140
- DailyMed (FDA label)FDA Sotalol
- MedlinePlus (NIH)Sotalol
- WHO ATC/DDDC07AA07
- Darooyab (Iran)Sotalol
🇮🇷 Registered in Iran Darooyab · G-1885/Sotalol
Dosage forms with Iranian generic codes, per Darooyab.
- 01163 · SOTALOL HCL 40MG TAB · قرص سوتالول هیدروکلراید ۴۰ میلیگرم
- 01164 · SOTALOL HCL 80MG TAB · قرص سوتالول هیدروکلراید ۸۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Sotalol · 3FDA Sotalol · 2.2FDA Sotalol · 2.1FDA Sotalol · 2.3FDA Sotalol · 4FDA Sotalol · Boxed WarningFDA Sotalol · 2.5FDA Sotalol · 8.1FDA Sotalol · 8.2FDA Sotalol · 8.4FDA Sotalol · 8.3FDA Sotalol · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1885/Sotalol
- Clinical review⚠ Unverified