Canada - English - Health Canada

pharmascience inc - sotalol hydrochloride - tablet - 80mg - sotalol hydrochloride 80mg - beta-adrenergic blocking agents

Canada - English - Health Canada

pharmascience inc - sotalol hydrochloride - tablet - 160mg - sotalol hydrochloride 160mg - beta-adrenergic blocking agents

Canada - English - Health Canada

pharmascience inc - sotalol hydrochloride - tablet - 240mg - sotalol hydrochloride 240mg - beta-adrenergic blocking agents

United States - English - NLM (National Library of Medicine)

american health packaging - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride/sotalol hydrochloride af tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride/sotalol hydrochloride af has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. sotalol hydrochloride/sotalol hydrochloride af tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of afib/afl) in patients with highly symptomatic afib/afl who are currently in sinus rhythm. limitation of use: because sotalol hydrochloride/sotalol hydrochloride af tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride af tablets. sotalol hydrochloride/sotalol hydrochloride (af)

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride/sotalol hydrochloride af tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride/sotalol hydrochloride af has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. sotalol hydrochloride/sotalol hydrochloride af tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of afib/afl) in patients with highly symptomatic afib/afl who are currently in sinus rhythm. limitation of use: because sotalol hydrochloride/sotalol hydrochloride af tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride af tablets. sotalol hydrochloride/sotalol hydrochloride (af) tablets

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride/sotalol hydrochloride af tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride/sotalol hydrochloride af has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. sotalol hydrochloride/sotalol hydrochloride af tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of afib/afl) in patients with highly symptomatic afib/afl who are currently in sinus rhythm. limitation of use: because sotalol hydrochloride/sotalol hydrochloride af tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride af tablets. sotalol hydrochloride/sotalol hydrochloride (af) is cont

United States - English - NLM (National Library of Medicine)

bayshore pharmaceuticals llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride tablets may not enhance survival in patients with ventricular arrhythmias. because of the proarrhythmic effects of sotalol hydrochloride tablets, 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 [ see warnings and precautions (5.2) .] sotalol hydrochloride tablets are contraindicated in patients with: - sinus bradycardia, sick sinus syndrome, second and third degree av block, unless a functioning pacemaker is present - congenital or acquired long qt syndromes - cardiogenic shock or decompensated heart failure - serum potassium <4 meq/l - bronchial asthma or related bronchospastic conditions - hypersensitivity to sotalol pregnancy category b there are no adequate and well-controlled studies in pregnant women. sotalol has been shown to cross the placenta, and is found in amniotic fluid. in animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (mrhd, based on surface area). animal reproductive studies are not always predictive of human response. reproduction studies in rats and rabbits during organogenesis at 9 and 7 times the mrhd (based on surface area), respectively, did not reveal any teratogenic potential associated with sotalol. in rabbits, a dose of sotalol 6 times the mrhd produced a slight increase in fetal death as well as maternal toxicity. this effect did not occur at sotalol dose 3 times the mrhd. 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. discontinue nursing on sotalol hydrochloride tablets. the safety and effectiveness of sotalol in children have not been established. however, the class iii electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (qtc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see dosage and administration (2.4) and clinical pharmacology (12.2) ]. sotalol is mainly eliminated via the kidneys. dosing intervals should be adjusted based on creatinine clearance [ see dosage and administration (2.5) ].

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride tablets have not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. sotalol hydrochloride tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of afib/afl) in patients with highly symptomatic afib/afl who are currently in sinus rhythm. limitation of use: because sotalol hydrochloride tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets. sotalol hydrochloride tablets are contraindicated in patients with: - sinus bradycardia, sick sinus syndrome, second and third degree av block, unless a functioning pacemaker is present - congenital or acquired long qt syndromes - cardiogenic shock or decompensated heart failure - serum potassium <4 meq/l - bronchial asthma or related bronchospastic conditions - hypersensitivity to sotalol for the treatment of afib/afl, sotalol hydrochloride tablets are also contraindicated in patients with: - baseline qt interval >450 msec risk summary both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see clinical considerations). in animal reproduction studies in rats, early resorptions were increased at 15 times the maximum recommended human dose (mrhd). in rabbits an increase in fetal death was observed at 2 times the mrhd administered as a single dose. sotalol did not reveal any teratogenic potential in rats or rabbits at 15 and 2 times the mrhd respectively (see data). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the united states (u.s.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations the incidence of vt is increased and may be more symptomatic during pregnancy. most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may, therefore, increase during pregnancy. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions sotalol has been shown to cross the placenta and is found in amniotic fluid. from published observational studies, the potential fetal adverse effects of sotalol use during pregnancy are growth restriction, transient fetal bradycardia, hyperbilirubinemia, hypoglycemia, uterine contractions, and possible intrauterine death. sotalol may have a greater effect on qt prolongation in the immature heart than in the adult heart, and therefore, conveys an increased risk of serious fetal arrhythmia and/or possible intrauterine death. monitor the newborn for symptoms of beta blockade. labor or delivery generally, risk of arrhythmias increases during the labor and delivery process; therefore, considering the proarrhythmia potential of the drug, patients treated with sotalol should be monitored continuously during labor and delivery. data animal data reproduction studies in rats and rabbits administered sotalol during organogenesis at 15 times and 2 times the mrhd as mg/m2 , respectively, did not reveal any teratogenic potential associated with sotalol. in pregnant rats, sotalol doses administered during organogenesis at approximately 15 times the mrhd as mg/m2 , increased the number of early resorptions, while no increase in early resorptions was noted at 2 times the mrhd as mg/m2 . in reproductive studies in rabbits, a sotalol dose (160 mg/kg/day) at 5 times the mrhd as mg/m2 produced a slight increase in fetal death, and maternal toxicity. however, one study from published data reported an increase in fetal deaths in rabbits receiving a single dose (50 mg/kg) at 2 times the mrhd as mg/m2 on gestation day 14. risk summary limited available data from published literature report that sotalol is present in human milk. the estimated daily infant dose of sotalol received from breastmilk is 0.8-3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of sotalol hydrochloride (see data ). the amount of the drug in breast milk is similar to the neonatal therapeutic dosage. therefore, there is potential for bradycardia and other symptoms of beta blockade such as dry mouth, skin or eyes, diarrhea or constipation in the breastfed infant. there is no information regarding the effects of sotalol on milk production. because of the potential serious adverse reactions to the breastfed child and the high level of sotalol in breast milk, advise women not to breastfeed while on treatment with sotalol hydrochloride. data sotalol is present in human milk in high levels. a prospective study evaluated 20 paired samples of breast milk and maternal blood from 5 mothers who elected to breastfeed. breast milk samples had a mean sotalol concentration of 10.5 mcg/ml (± 1.1 mcg/ml; range: 4.8 to 20.2 mcg/ml) compared to a simultaneous mean maternal plasma concentration of 2.3 mcg/ml (± 0.3 mcg/ml; range: 0.8 to 5.0 mcg/ml). the mean milk plasma ratio was 5.4:1 (range: 2.2 to 8.8). the estimated daily infant dose was 0.8-3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of sotalol. this is similar to recommended therapeutic dose in neonates. none of the mothers reported any adverse reactions in the breastfed infant. infertility based on the published literature, beta blockers (including sotalol) may cause erectile dysfunction. the safety and effectiveness of sotalol in children have not been established. however, the class iii electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (qtc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see dosage and administration (2.4) and clinical pharmacology (12.2)] . associated side effects of sotalol use in pediatric patients are those typical of a beta-blocking agent, and lead to discontinuation of the drug in 3 to 6% of patients. as in adults, the class iii antiarrhythmic action of sotalol in pediatric patients is associated with a significant proarrhythmic potential for adverse effects. in pediatric patients, the incidence of proarrhythmic side effects of sotalol varies from 0 to 22%; however, sotalol-induced torsade de pointes tachycardias are observed less frequently in the pediatric population. proarrhythmic effects of sotalol in pediatric patients included increased ventricular ectopy and exacerbation of bradycardia, the latter predominantly in patients with sinus node dysfunction following surgery for congenital cardiac defects. bradycardia may require emergency pacemaker implantation. close in-patient monitoring is recommended for several days. sotalol is mainly eliminated via the kidneys. adjust dosing intervals based on creatinine clearance [see dosage and administration (2.5)] .

United States - English - NLM (National Library of Medicine)

altathera pharmaceuticals, llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 15 mg in 1 ml - sotalol 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. sotalol is indicated for the treatment of life-threatening ventricular tachycardia. antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias. sotalol hydrochloride is contraindicated in patients with: - sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree av block without a pacemaker - congenital or acquired long qt syndromes, qt interval >450 ms - cardiogenic shock, decompensated heart failure - serum potassium <4 meq/l - bronchial asthma or related bronchospastic conditions - known hypersensitivity to sotalol risk summary both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see clinical considerations). in animal reproduction studies in r

United States - English - NLM (National Library of Medicine)

par pharmaceutical - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol may not enhance survival in patients with ventricular arrhythmias. because of the proarrhythmic effects of sotalol, 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 [see warnings and precautions (5.2).] sotalol is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of afib/afl) in patients with symptomatic afib/afl who are currently in sinus rhythm. limitation of use: because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for