Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bayshore pharmaceuticals llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol af are 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. because sotalol af can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom afib/afl is highly symptomatic. patients with paroxysmal afib whose afib/afl that is easily reversed (by valsalva maneuver, for example) should usually not be given sotalol af (see warnings ). in general, antiarrhythmic therapy for afib/afl aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name betapace® (sotalol hydrochloride) . sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (af) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information). sotalol af is contraindicated in patients with sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree av block (unless a functioning pacemaker is present), congenital or acquired long qt syndromes, baseline qt interval >450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 meq/l), creatinine clearance <40 ml/min, bronchial asthma and previous evidence of hypersensitivity to sotalol. the safety and effectiveness of sotalol af 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 clinical pharmacology .)

Spānija - spāņu - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

cheplapharm arzneimittel gmbh - sotalol hidrocloruro - comprimido - 80 mg - sotalol hidrocloruro 80 mg - sotalol

Spānija - spāņu - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

teva pharma, s.l.u. - sotalol hidrocloruro - comprimido - 160 mg - sotalol hidrocloruro 160 mg - sotalol

Spānija - spāņu - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

teva pharma, s.l.u. - sotalol hidrocloruro - comprimido - 80 mg - sotalol hidrocloruro 80 mg - sotalol

Rumānija - rumāņu - ICBMV (Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar)

romvac company s.a., românia - v eds-76 tulpina 127, vib tulpina m 41, virusul bolii de newcastle, tulpina la sota - emulsie injectabilă - produse biologice - păsări - gaini imunoprofilaxia bolii de newcastle, bronsitei infectioase si „sindromului caderii ouatului”

Portugāle - portugāļu - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

generis farmacêutica, s.a. - sotalol - comprimido - 160 mg - sotalol, cloridrato 160 mg - sotalol - genérico - duração do tratamento: longa duração

Amerikas Savienotās Valstis - angļu - 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)

Amerikas Savienotās Valstis - angļu - 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

Amerikas Savienotās Valstis - angļu - 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

Amerikas Savienotās Valstis - angļu - 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) ].