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To minimize the risk of induced arrhythmia, patients initiated or reinitiated on Betapace (sotalol) should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Creatinine clearance should be calculated prior to dosing. For detailed instructions regarding dose selection and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION. Sotalol is also 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 and is marketed under the brand name Betapace (sotalol) AF. Betapace (sotalol) is not approved for the AFIB/AFL indication and should not be substituted for Betapace (sotalol) AF because only Betapace (sotalol) AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.
Betapace (sotalol hydrochloride) is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a light-blue, 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-N-[4-[1-hydroxy-2-[(1methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S·HCl and is represented by the following structural formula:
Betapace (sotalol) Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue color #2 (aluminum lake, conc.).
What are the possible side effects of sotalol (Betapace, Sorine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
- feeling like you might pass out;
- slow heartbeats;
- trouble breathing;
- unusual sweating, increased thirst; or
- swelling, rapid weight gain.
Less serious side effects may include:
What are the precautions when taking sotalol (Betapace)?
See also Warning section.
Before taking sotalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block unless you have a heart pacemaker), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney...
Last reviewed on RxList: 3/24/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Betapace Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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