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BETAPACE

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Overview

What is BETAPACE?

Betapace/Betapace AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Betapace is supplied as a light-blue, capsule-shaped tablet for oral administration. Betapace AF is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l--[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is CHNO S·HCl and is represented by the following structural formula:

Betapace

Betapace AF



What does BETAPACE look like?



What are the available doses of BETAPACE?

80 mg,120 mg and 160 mg tablets ()

What should I talk to my health care provider before I take BETAPACE?

How should I use BETAPACE?

Betapace/Betapace AF is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT).

Limitation of Use:

Betapace/Betapace AF may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of Betapace/Betapace AF, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions .

Withdraw other antiarrhythmic therapy before starting Betapace/Betapace AF and monitor carefully for a minimum of 2 to 3 plasma half-lives if the patient's clinical condition permits .

Hospitalize patients initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels are achieved, in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Initiate oral sotalol therapy in the presence of personnel trained in the management of serious arrhythmias. Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy. Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval (insert cross ref to renal dosing). Continually monitor patients with each uptitration in dose, until they reach steady state. Determine QTc 2 to 4 hours after every dose.

Discharge patients on sotalol therapy from an in-patient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription.

Advise patients who miss a dose to take the next dose at the usual time. Do not double the dose or shorten the dosing interval.


What interacts with BETAPACE?

Sorry No Records found


What are the warnings of BETAPACE?

Sorry No Records found


What are the precautions of BETAPACE?

Sorry No Records found


What are the side effects of BETAPACE?

Sorry No records found


What should I look out for while using BETAPACE?

Betapace/Betapace AF is contraindicated in patients with:

For the treatment of AFIB/AFL, Betapace/Betapace AF is also contraindicated in patients with:


What might happen if I take too much BETAPACE?

Intentional or accidental overdosage with sotalol has resulted in death.

Symptoms and Treatment of Overdosage

The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2–16 grams) of sotalol the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm.

The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half-life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested:

Bradycardia or Cardiac Asystole:

Heart Block:

Hypotension:

Bronchospasm:

Torsade de Pointes:


How should I store and handle BETAPACE?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and “BETAPACE,” are available as follows: NDC 70515-105-10 80 mg strength, bottle of 100NDC 70515-109-10 120 mg strength, bottle of 100NDC 70515-106-10 160 mg strength, bottle of 100Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and “BHCP” are available as follows:NDC 70515-115-06 80 mg strength, bottle of 60NDC 70515-119-06 120 mg strength, bottle of 60NDC 70515-116-06 160 mg strength, bottle of 60Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above.

In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m body surface area (BSA). A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥ 90 mg/m in children.

Non-Clinical Toxicology
Betapace/Betapace AF is contraindicated in patients with:

For the treatment of AFIB/AFL, Betapace/Betapace AF is also contraindicated in patients with:

Drugs which may enhance the neuromuscular blocking action of atracurium include: enflurane; isoflurane; halothane; certain antibiotics, especially the aminoglycosides and polymyxins; lithium; magnesium salts; procainamide; and quinidine.

If other muscle relaxants are used during the same procedure, the possibility of a synergistic or antagonist effect should be considered.

The prior administration of succinylcholine does not enhance the duration, but quickens the onset and may increase the depth, of neuromuscular block induced by atracurium besylate. Atracurium should not be administered until a patient has recovered from succinylcholine-induced neuromuscular block.

Betapace/Betapace AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. Factors such as reduced creatinine clearance, female sex, higher doses, reduced heart rate and history of sustained VT/VF or heart failure increase the risk of TdP. The risk of TdP can be reduced by adjustment of the sotalol dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval .

Correct hypokalemia or hypomagnesemia prior to initiating Betapace/Betapace AF, as these conditions can exaggerate the degree of QT prolongation, and increase the potential for Torsade de Pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.

Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment .

In general, do not use sotalol with other drugs known to cause QT prolongation .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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