|Drug Name:||Betapace AF|
BETAPACE Syrup 5 mg/mL can be compounded using Simple Syrup containing 0.1% sodium benzoate (Syrup, NF) available from Humco Laboratories as follows: Measure 120 mL of Simple Syrup Transfer the syrup to a 6-ounce amber plastic (polyethylene terephthalate [PET]) prescription bottle.
NOTE: 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 120 mg tablets to the bottle.
These tablets are added intact; it is not necessary to crush the tablets.
NOTE: 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 approximately 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.
NOTE: 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.
This extemporaneously prepared oral solution of sotalol HCl (with suspended inactive particles) must be shaken well prior to administration.
This is to ensure that the amount of inactive solid particles per dose remains constant throughout the duration of use.Stability studies indicate that the suspension is stable when stored at controlled room temperature (15°-30°C/59°-86°F) and ambient humidity for three (3) months.
BETAPACE AF is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.
Because BETAPACE AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic.
Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given BETAPACE AF (see WARNINGS).
In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm.
Recurrence is expected in some patients (see Clinical Studies).
Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name BETAPACE (sotalol hydrochloride).BETAPACE, however, must not be substituted for BETAPACE AF because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).
Ventricular Arrhythmia: BETAPACE AF (sotalol) can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation.
QT interval prolongation is directly related to the dose of BETAPACE AF.
Factors such as reduced creatinine clearance, gender (female) and larger doses increase the risk of TdP.
The risk of TdP can be reduced by adjustment of the BETAPACE AF dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval.
Treatment with BETAPACE AF must therefore be started only in patients observed for a minimum of three days on their maintenance dose in a facility that can provide electrocardiographic monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias.
Calculation of the creatinine clearance must precede administration of the first dose of BETAPACE AF.For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION.