Amerikas Savienotās Valstis - angļu - 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

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) ].

Amerikas Savienotās Valstis - angļu - 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

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

nucare pharmaceuticals, inc. - 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 f

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

eon labs, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets (see warnings ), including a 1.5% to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, their use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride tablet usp treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to

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

aidarex pharmaceuticals llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets, usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets, usp (see warnings ), including a 1.5 to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to determi

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

proficient rx lp - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets, usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets, usp (see warnings ), including a 1.5 to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to determi

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

ncs healthcare of ky, inc dba vangard labs - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets, usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets, usp (see warnings ), including a 1.5 to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to determi

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

rebel distributors corp - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets (see warnings ), including a 1.5% to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride tablet usp treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to d

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

pd-rx pharmaceuticals, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets usp are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. because of the proarrhythmic effects of sotalol hydrochloride tablets (see warnings ), including a 1.5% to 2% rate of torsade de pointes or new vt/vf in patients with either nsvt or supraventricular arrhythmias, their use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of sotalol hydrochloride tablet usp treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. the response to treatment should then be evaluated by a suitable method (e.g., pes or holter monitoring) prior to continuing the patient on chronic therapy. various approaches have been used to