Sotalol
Dosing in kidney impairment
Dosage for Patients with Renal Impairment Adults Use of sotalol in any age group with decreased renal function should be at lower doses or increased intervals between doses. It will take much longer to reach steady-state with any dose and/or frequency of administration. Closely monitor heart rate and QT c . Dose escalations in renal impairment should be done after administration of at least 5 doses at appropriate intervals (Table 1).
Sotalol is partly removed by dialysis; specific advice is unavailable on dosing patients on dialysis. The initial dose of 80 mg and subsequent doses should be administered at the intervals listed in Table 1. [See table below.]
| Creatinine Clearance mL/min | Dosing Interval (hours) |
| > 60 | 12 |
| 30–59 | 24 |
| 10–29 | 36–48 |
| < 10 | Dose should be individualized |
Preparation and administration
Preparation of Extemporaneous Oral Solution Sotalol/Sotalol AF Syrup 5 mg/mL can be compounded using Simple Syrup containing 0.1% sodium benzoate (Syrup, NF) as follows: Measure 120 mL of Simple Syrup. Transfer the syrup to a 6-ounce amber plastic (polyethylene terephthalate [PET]) prescription bottle. An oversized bottle is used to allow for a headspace, so that there will be more effective mixing during shaking of the bottle.
Add five Sotalol Hydrochloride 120 mg tablets to the bottle. These tablets are added intact; it is not necessary to crush the tablets. The addition of the tablets can also be done first. The tablets can also be crushed if preferred. If the tablets are crushed, care should be taken to transfer the entire quantity of tablet powder into the bottle containing the syrup.
Shake the bottle to wet the entire surface of the tablets. If the tablets have been crushed, shake the bottle until the endpoint is achieved. Allow the tablets to hydrate for at least two hours. After at least two hours have elapsed, shake the bottle intermittently over the course of at least another two hours until the tablets are completely disintegrated.
The tablets can be allowed to hydrate overnight to simplify the disintegration process. The endpoint is achieved when a dispersion of fine particles in the syrup is obtained. This compounding procedure results in a solution containing 5 mg/mL of sotalol HCl. The fine solid particles are the water-insoluble inactive ingredients of the tablets.
Stability studies indicate that the suspension is stable for three months when stored at 15°C to 30°C (59°F to 86°F) [ see USP Controlled Room Temperature ] and ambient humidity.