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Sotalol Hydrochloride
Overview
What is Sorine?
Sorine (Sotalol Hydrochloride Tablets, USP) are an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl] methane-sulfonamide monohydrochloride. The molecular formula is CHNOS∙HCl and is represented by the following structural formula:
Sorine Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.
What does Sorine look like?
What are the available doses of Sorine?
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What should I talk to my health care provider before I take Sorine?
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How should I use Sorine?
Oral Sorine (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 (see ), 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 Sorine (Sotalol Hydrochloride Tablets, 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 determine the response to antiarrhythmic therapy, including sotalol.
In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of nonsustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure.
In a multicenter open-label long-term study of sotalol in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Sotalol is also 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 and is marketed under the brand name BETAPACE AF. Sorine is not approved for the AFIB/AFL indication and should not be substituted for BETAPACE AF because only BETAPACE AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.
As with other antiarrhythmic agents, Sorine (Sotalol Hydrochloride) Tablets should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment (see ). Sorine (Sotalol Hydrochloride) Tablets should be administered only after appropriate clinical assessment (see ), and the dosage of Sorine (Sotalol Hydrochloride) Tablets must be individualized for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.
What interacts with Sorine?
Sorine (Sotalol Hydrochloride Tablets) are contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to sotalol.
What are the warnings of Sorine?
Mortality: The National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial I (CAST I) was a long-term, multi-center, double-blind study in patients with asymptomatic, non-life-threatening ventricular arrhythmias, 1 to 103 weeks after acute myocardial infarction. Patients in CAST I were randomized to receive placebo or individually optimized doses of encainide, flecainide, or moricizine. The Cardiac Arrhythmia Suppression Trial II (CAST II) was similar, except that the recruited patients had had their index infarction 4 to 90 days before randomization, patients with left ventricular ejection fractions greater than 40% were not admitted, and the randomized regimens were limited to placebo and moricizine.
CAST I was discontinued after an average time-on-treatment of 10 months, and CAST II was discontinued after an average time-on-treatment of 18 months. As compared to placebo treatment, all three active therapies were associated with increases in short-term (14-day) mortality, and encainide and flecainide were associated with significant increases in longer-term mortality as well. The longer-term mortality rate associated with moricizine treatment could not be statistically distinguished from that associated with placebo.
The applicability of these results to other populations (e.g., those without recent myocardial infarction) and to other than Class I antiarrhythmic agents is uncertain. Sotalol hydrochloride is devoid of Class I effects, and in a large (n=1,456) controlled trial in patients with a recent myocardial infarction, who did not necessarily have ventricular arrhythmias, sotalol did not produce increased mortality at doses up to 320 mg/day (see ). On the other hand, in the large post infarction study using a non-titrated initial dose of 320 mg once daily and in a second small randomized trial in high-risk post-infarction patients treated with high doses (320 mg BID), there have been suggestions of an excess of early sudden deaths.
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Because of the variable temporal recurrence of arrhythmias, it is not always possible to distinguish between a new or aggravated arrhythmic event and the patient's underlying rhythm disorder. (Note, however, that Torsade de Pointes is usually a drug-induced arrhythmia in people with an initially normal QT.) Thus, the incidence of drug-related events cannot be precisely determined, so that the occurrence rates provided must be considered approximations. Note also that drug-induced arrhythmias may often not be identified, particularly if they occur long after starting the drug, due to less frequent monitoring. It is clear from the NIH-sponsored CAST (see ) that some antiarrhythmic drugs can cause increased sudden death mortality, presumably due to new arrhythmias or asystole, that do not appear early in treatment but that represent a sustained increased risk.
Overall in clinical trials with sotalol, 4.3% of 3257 patients experienced a new or worsened ventricular arrhythmia. Of this 4.3%, there was new or worsened sustained ventricular tachycardia in approximately 1% of patients and Torsade de Pointes in 2.4%. Additionally, in approximately 1% of patients, deaths were considered possibly drug-related; such cases, although difficult to evaluate, may have been associated with proarrhythmic events.
Torsade de Pointes arrhythmias were dose related, as is the prolongation of QT (QT) interval, as shown in the table below.
In addition to dose and presence of sustained VT, other risk factors for Torsade de Pointes were gender (females had a higher incidence), excessive prolongation of the QT interval (see table below) and history of cardiomegaly or congestive heart failure. Patients with sustained ventricular tachycardia and a history of congestive heart failure appear to have the highest risk for serious proarrhythmia (7%). Of the patients experiencing Torsade de Pointes, approximately two-thirds spontaneously reverted to their baseline rhythm. The others were either converted electrically (D/C cardioversion or overdrive pacing) or treated with other drugs (see ). It is not possible to determine whether some sudden deaths represented episodes of Torsade de Pointes, but in some instances sudden death did follow a documented episode of Torsade de Pointes. Although sotalol therapy was discontinued in most patients experiencing Torsade de Pointes, 17% were continued on a lower dose.
Nonetheless, Sorine (Sotalol Hydrochloride Tablets) should be used with particular caution if the QT is greater than 500 msec on-therapy and serious consideration should be given to reducing the dose or discontinuing therapy when the QT exceeds 550 msec. Due to the multiple risk factors associated with Torsade de Pointes, however, caution should be exercised regardless of the QT interval. The table below relates the incidence of Torsade de Pointes to on-therapy QT and change in QT from baseline. It should be noted, however, that the highest on-therapy QT was in many cases the one obtained at the time of the Torsade de Pointes event, so that the table overstates the predictive value of a high QT.
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| ( ) Number of patients assessed | ||||||
| *highest on-therapy value | ||||||
| Daily Dose (mg) | Incidence ofTorsade de Pointes | Mean QT*(msec) | ||||
| 80 | 0 | (69) | 463 | (17) | ||
| 160 | 0.5 | (832) | 467 | (181) | ||
| 320 | 1.6 | (835) | 473 | (344) | ||
| 480 | 4.4 | (459) | 483 | (234) | ||
| 640 | 3.7 | (324) | 490 | (185) | ||
| >640 | 5.8 | (103) | 512 | (62) | ||
| ( ) Number of patients assessed | ||||||
| On-Therapy QTInterval (msec) | Incidence ofTorsade de Pointes | Change in QTInterval FromBaseline (msec) | Incidence ofTorsade de Pointes | |||
| <500 | 1.3% | (1787) | <65 | 1.6% | (1516) | |
| 500-525 | 3.4% | (236) | 65-80 | 3.2% | (158) | |
| 525-550 | 5.6% | (125) | 80-100 | 4.1% | (146) | |
| >550 | 10.8% | (157) | 100-130 | 5.2% | (115) | |
| >130 | 7.1% | (99) |
Congestive Heart Failure:
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Electrolyte Disturbances:
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Conduction Disturbances
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Recent Acute MI:
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The following warnings are related to the beta-blocking activity of Sorine.
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What are the precautions of Sorine?
Renal Impairment: Sotalol hydrochloride is mainly eliminated via the kidneys through glomerular filtration and to a small degree by tubular secretion. There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of sotalol. Guidance for dosing in conditions of renal impairment can be found under .
Drug Interactions
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Drug/Laboratory Test Interactions
The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with sotalol, a specific method, such as a high performance liquid chromatographic assay with solid phase extraction (e.g., J. Chromatogr. 385:241, 1987) should be employed in determining levels of catecholamines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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/m) or in mice, during a 24-month study at 4141-7122 mg/kg/day (approximately 450-750 times the MRHD as mg/kg or 36-63 times the MRHD as mg/m).
Sotalol 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 9 times the MRHD as mg/m) prior to mating, except for a small reduction in the number of offspring per litter.
Pregnancy Category B
Although there are no adequate and well-controlled studies in pregnant women, sotalol HCl has been shown to cross the placenta, and is found in amniotic fluid. There has been a report of subnormal birth weight with sotalol. Therefore, Sorine (Sotalol HCl) Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk.
Nursing Mothers:
Pediatric Use:
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What are the side effects of Sorine?
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What should I look out for while using Sorine?
Sorine (Sotalol Hydrochloride Tablets) are contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to sotalol.
What might happen if I take too much Sorine?
Intentional or accidental overdosage with sotalol hydrochloride has rarely resulted in death.
How should I store and handle Sorine?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515Sorine (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: Overbagged with 10 tablets per bag, NDC 55154-5616-0Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container (USP).Manufactured by .Maple Grove, MN 55369Repackaged By:Cardinal HealthZanesville, OH 43701L35230570516Revised 0515
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action
.In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m body surface area (BSA). A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥ 90 mg/m in children.
Non-Clinical Toxicology
Sorine (Sotalol Hydrochloride Tablets) are contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to sotalol.Renal Impairment: Sotalol hydrochloride is mainly eliminated via the kidneys through glomerular filtration and to a small degree by tubular secretion. There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of sotalol. Guidance for dosing in conditions of renal impairment can be found under .
During premarketing trials, 3186 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral sotalol, of whom 2451 received the drug for at least two weeks. The most important adverse effects are Torsade de Pointes and other serious new ventricular arrhythmias (see ), occurring at rates of almost 4% and 1%, respectively, in the VT/VF population. Overall, discontinuation because of unacceptable side-effects was necessary in 17% of all patients in clinical trials, and in 13% of patients treated for at least two weeks. The most common adverse reactions leading to discontinuation of sotalol are as follows: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.
Occasional reports of elevated serum liver enzymes have occurred with sotalol therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of sotalol and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients.
The following table lists as a function of dosage the most common (incidence of 2% or greater) adverse events, regardless of relationship to therapy and the percent of patients discontinued due to the event, as collected from clinical trials involving 1292 patients with sustained VT/VF.
In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QT ≥525 msec were seen in 2 patients at the 210 mg/m daily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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