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During premarketing trials, 3186 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral Betapace (sotalol) , of whom 2451 received the drug for at least two weeks. The most important adverse effects are Torsade de Pointes and other serious new ventricular arrhythmias (see WARNINGS), occurring at rates of almost 4% and 1%, respectively, in the VT/VF population. Overall, discontinuation because of unacceptable side-effects was necessary in 17% of all patients in clinical trials, and in 13% of patients treated for at least two weeks. The most common adverse reactions leading to discontinuation of Betapace (sotalol) are as follows: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.
Occasional reports of elevated serum liver enzymes have occurred with Betapace (sotalol) therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of Betapace (sotalol) and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients.
The following table lists as a function of dosage the most common (incidence of 2% or greater) adverse events, regardless of relationship to therapy and the percent of patients discontinued due to the event, as collected from clinical trials involving 1292 patients with sustained VT/VF.
Incidence (%) of Adverse Events and Discontinuations
|% Patients Discontinued
|Body as a whole|
|localized pain||1||1||2||2||2||3||< 1|
|chest pain||4||3||10||10||14||16||< 1|
|proarrhythmia||< 1||< 1||2||4||5||5||3|
|peripheral vascular disorder||1||2||1||1||2||3||< 1|
|cardiovascular disorder||1||< 1||2||2||2||3||< 1|
|vasodilation||1||< 1||1||2||1||3||< 1|
|AICD discharge||< 1||2||2||2||2||3||< 1|
|hypertension||< 1||1||1||1||2||2||< 1|
|sleep problem||1||1||5||5||6||8||< 1|
|altered consciousness||2||3||1||2||3||4||< 1|
|mood change||< 1||< 1||1||3||2||3||< 1|
|stroke||< 1||< 1||1||1||< 1||1||< 1|
|abdominal pain||< 1||< 1||2||2||2||3||< 1|
|colon problem||2||1||1||< 1||2||3||< 1|
|flatulence||1||< 1||1||1||2||2||< 1|
|pulmonary problem||3||3||5||3||4||8||< 1|
|upper respiratory tract problem||1||1||3||4||3||5||< 1|
|genitourinary disorder||1||0||1||1||2||3||< 1|
|sexual dysfunction||<1||1||1||1||3||2||< 1|
|abnormal lab value||1||2||3||2||1||4||< 1|
|weight change||1||1||1||< 1||2||2||< 1|
|extremity pain||2||2||4||5||3||7||< 1|
|back pain||1||< 1||2||2||2||3||< 1|
|Skin and Appendages|
|bleeding||1||< 1||1||< 1||2||2||< 1|
|visual problem||1||1||2||4||5||5||< 1|
|a) Because patients are counted at each dose level tested, the Any Dose column cannot be determined by adding across the doses.|
In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m² with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m² daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m² daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QTc ≥ 525 msec were seen in 2 patients at the 210 mg/m² daily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.
Potential Adverse Effects
Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with Betapace (sotalol) during investigational use and foreign marketing experience.
Read the Betapace (sotalol) Side Effects Center for a complete guide to possible side effects
Drugs undergoing CYP450 metabolism
Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Sotalol is not expected to inhibit or induce any CYP450 enzymes; therefore, it is not expected to alter the PK of drugs that are metabolized by these enzymes.
Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (e.g., amiodarone) are not recommended as concomitant therapy with Betapace (sotalol) , because of their potential to prolong refractoriness (see WARNINGS). There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with Betapace (sotalol) .
Single and multiple doses of Betapace (sotalol) do not substantially affect serum digoxin levels. Proarrhythmic events were more common in Betapace (sotalol) treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Betapace (sotalol) should be administered with caution in conjunction with calcium-blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension.
Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Patients treated with Betapace (sotalol) plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope.
Insulin and oral antidiabetics
Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with Betapace (sotalol) .
Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving Betapace (sotalol) .
No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin.
Administration of Betapace (sotalol) within 2 hours of antacids containing aluminum oxide and magnesium hydroxide should be avoided because it may result in a reduction in Cmax and AUC of 26% and 20%, respectively and consequently in a 25% reduction in the bradycardic effect at rest. Administration of the antacid two hours after Betapace (sotalol) has no effect on the pharmacokinetics or pharmacodynamics of sotalol.
Drugs prolonging the QT interval
Betapace (sotalol) should be administered with caution in conjunction with other drugs known to prolong the QT interval such as Class I and Class III antiarrhythmic agents, phenothiazines, tricyclic antidepressants, astemizole, bepridil, certain oral macrolides, and certain quinolone antibiotics (see WARNINGS).
Drug/Laboratory Test Interactions
The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with sotalol, a specific method, such as a high performance liquid chromatographic assay with solid phase extraction (e.g., J. Chromatogr. 385:241, 1987) should be employed in determining levels of catecholamines.
Read the Betapace Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/24/2011
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