Sotalol 5 mg/mL oral solution

Concentration

5 mg/mL

Vehicles named

Simple syrup (Syrup NF), Sodium benzoate

The label's instructions

2.6 Preparation of Extemporaneous Oral Solution Betapace/Betapace 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 (5) Betapace/Betapace AF 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, take care 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.

Quoted verbatim from the Dosage and Administration section of the FDA label for BETAPACE, version 2, effective 2024-12-16. Open the label on DailyMed. 41 current labels for this drug carry these instructions.

Storage and beyond-use date

• “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.”

Only the storage conditions the source covers are listed. Use the BUD assistant for other cases. The BUD may not be later than any component's expiration date. Verify against the current official USP chapter.

Ingredient checks

No FDA compounding list or NIOSH flags for the active ingredient.

Source

FDA label (BETAPACE), Dosage and Administration.

For licensed clinicians. Use with clinical judgment.