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Basic Drug Info
Drug Name:Betapace AF
Manufacturer:Berlex
Other Info:

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.



Clinical Trials:


Indications and Usage

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 -- Irregular heart beat resulting from a pathologic process in the cardiac ventricles.--2004

Atrial Fibrillation -- Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation.

Contraindications
BETAPACE AF (sotalol hydrochloride) is contraindicated in patients with sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree AV block (unless a functioning pacemaker is present), congenital or acquired long QT syndromes, baseline QT interval >450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 meq/L), creatinine clearance <40 mL/min, bronchial asthma and previous evidence of hypersensitivity to sotalol.
Sick Sinus Syndrome -- A condition caused by dysfunctions related to the SINOATRIAL NODE including impulse generation (CARDIAC SINUS ARREST) and impulse conduction (SINOATRIAL EXIT BLOCK). It is characterized by persistent BRADYCARDIA, chronic ATRIAL FIBRILLATION, and failure to resume sinus rhythm following CARDIOVERSION. This syndrome can be congenital or acquired, particularly after surgical correction for heart defects.

Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Long QT Syndrome -- A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Heart failure -- inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.