In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], Betapace was studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically.In a double-blind, randomized comparison of Betapace and procainamide given intravenously (total of 2 mg/kg Betapace vs. 19 mg/kg of procainamide over 90 minutes), Betapace suppressed PES induction in 30% of patients vs. 20% for procainamide (p=0.2).In a randomized clinical trial [Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial] comparing choice of antiarrhythmic therapy by PES suppression vs. Holter monitor selection (in each case followed by treadmill exercise testing) in patients with a history of sustained VT/VF who were also inducible by PES, the effectiveness acutely and chronically of Betapace was compared with that of 6 other drugs (procainamide, quinidine, mexiletine, propafenone, imipramine and pirmenol). excursions permitted to 15-30°C (59–86°F) [SeeManufactured for: Covis Pharma Zug, 6300 Switzerland. If you have thyroid disease, discuss with your doctor how this medication may affect your medical condition, how … dose should be multiplied by 0.68; the initial starting dose would be (30 X 0.68)=20 the other 120 mg imprinted with “BETAPACE” on one side and 120 mg doses were given once daily. Betapace is
Kidney health warning: Sotalol is primarily removed from your body through your kidneys. 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. the hypotension. indicated for the treatment of life-threatening, documented ventricular initial starting dose should be multiplied by 0.3; the starting dose would be Closely monitor heart rate and QTc.Dose escalations in renal
Visit the Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. ).Tablets contain the following Sotalol crosses the blood brain barrier poorly.Sotalol is not metabolized and is not expected to inhibit or induce any CYP450 enzymes.Excretion of sotalol is predominantly via the kidney in the unchanged form, and therefore lower doses are necessary in conditions of renal impairment No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin.No evidence of carcinogenic potential was observed in rats during a 24-month study at 137–275 mg/kg/day (approximately 30 times the maximum recommended human oral dose (MRHD) as mg/kg or 5 times the MRHD as mg/mSotalol has not been evaluated in any specific assay of mutagenicity or clastogenicity.No significant reduction in fertility occurred in rats at oral doses of 1000 mg/kg/day (approximately 100 times the MRHD as mg/kg or 18 times the MRHD as mg/mReproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/mBetapace (sotalol hydrochloride) has been studied in life-threatening and less severe arrhythmias.
half-lives if the patient's clinical condition permits [seeHospitalize patients initiated or re-initiated on sotalol
intervals should be adjusted based on creatinine clearance [seeIntentional or accidental overdosage with sotalol has In rats a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD, produced no increase in early resorptions.Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk.
The results are shown in Figure 2, Table 7 and Table 8.Discontinuation because of It helps to reduce the symptoms of congestive heart failure (e.g., swelling in the ankles, feet, and hands; shortness of breath; frequent fatigue) by helping to increase the strength of the heart so that it pumps more efficiently. In patients with reduced creatinine clearance (40-60 mL/min) the same 2.1 General Safety Measures for Initiation of Oral Sotalol Therapy . adrenergic blockers, exacerbations of Patients with bronchospastic diseases (for example For a child aged 1 month, the starting
Discontinue nursing on Betapace/Betapace AF.The safety and effectiveness of sotalol in children have not been established. the unchanged form, and therefore lower doses are necessary in conditions of
have additive effects on atrioventricular conduction or ventricular function.
effects of sotalol are manifested by increased In a small study (n=25) of patients with implanted daily doses of 30, 90 and 210 mg/m² with dosing every 8 hours for a total 9 particles are the water-insoluble inactive ingredients of the tablets.Stability studies indicate that
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