Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - sotalol hydrochloride - oral tablet - 160mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

tillomed laboratories ltd - sotalol hydrochloride - oral tablet - 40mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

tillomed laboratories ltd - sotalol hydrochloride - oral tablet - 80mg

États-Unis - anglais - NLM (National Library of Medicine)

upsher-smith laboratories, inc. - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sorine (sotalol hydrochloride) tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use : sorine (sotalol hydrochloride) tablets may not enhance survival in patients with ventricular arrhythmias. because of the proarrhythmic effects of sorine (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)]. sorine (sotalol hydrochloride) tablets are 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 sorine (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 sorine (sotalol hydrochloride) tablets. sorine (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, sorine (sotalol hydrochloride) tablets are also contraindicated in patients with: - baseline qt interval >450 ms - creatinine clearance <40 ml/min 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 sorine. 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)].

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - sotalol hydrochloride - oral tablet - 40mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

kent pharma (uk) ltd - sotalol hydrochloride - oral tablet - 40mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - sotalol hydrochloride - oral tablet - 40mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - sotalol hydrochloride - oral tablet - 160mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - sotalol hydrochloride - oral tablet - 160mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

kent pharma (uk) ltd - sotalol hydrochloride - oral tablet - 160mg