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SOTALOL

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Overview

What is SOTALOL?

Sotalol hydrochloride, is 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 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 tablets (AF) is d,l-N-[4-[l-hydroxy-2-[(l-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is CHNOS•HCl and is represented by the following structural formula:

Each tablet contains 80 mg, 120 mg, or 160 mg of sotalol hydrochloride. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid.



What does SOTALOL look like?



What are the available doses of SOTALOL?

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What should I talk to my health care provider before I take SOTALOL?

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How should I use SOTALOL?

Sotalol hydrochloride tablets (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 hydrochloride tablets (AF) can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets (AF) (See ).

In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (See ).

Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name BETAPACE (sotalol hydrochloride). BETAPACE, 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).


What interacts with SOTALOL?

Sotalol hydrochloride tablets is contraindicated in patients with sinus bradycardia ( 450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (


What are the warnings of SOTALOL?

Ventricular Arrhythmia

Sotalol hydrochloride tablets (AF) can cause serious ventricular arrhythmias, primarily torsade de pointes (tdp) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to the dose of sotalol hydrochloride tablets (AF). Factors such as reduced creatinine clearance, gender (female) and larger doses increase the risk of tdp. The risk of tdp can be reduced by adjustment of the sotalol hydrochloride tablets (AF) dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval.

Treatment with sotalol hydrochloride tablets (AF) must therefore be started only in patients observed for a minimum of three days on their maintenance dose in a facility that can provide electrocardiographic monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Calculation of the creatinine clearance must precede administration of the first dose of sotalol hydrochloride tablets (AF). For detailed instructions regarding dose selection, see .

Proarrhythmia in Atrial Fibrillation/Atrial Flutter Patients

In eight controlled trials of patients with AFIB/AFL and other supraventricular arrhythmias (N=659) there were four cases of torsade de pointes reported (0.6%) during the controlled phase of treatment with sotalol hydrochloride tablets (AF). The incidence of torsade de pointes was significantly lower in those patients receiving total daily doses of 320 mg or less (0.3%), as summarized in Table 5 below. Both patients who had torsade de pointes in the group receiving > 320 mg/day were receiving 640 mg/day. In the group receiving ≤ 320 mg daily, one case of tdp occurred at a daily dose of 320 mg on day 4 of treatment and one case occurred on a daily dose of 160 mg on day 1 of treatment.

Prolongation of the QT interval is dose related, increasing from baseline an average of 25, 40, and 50 msec in the 80, 120, and 160 mg groups, respectively, in the clinical dose-response study. In this clinical trial sotalol hydrochloride tablets (AF) treatment was not initiated if the QT interval was greater than 450 msec and during therapy the dose was reduced or discontinued if the QT interval was ≥ 520 msec.

Experience in patients with ventricular arrhythmias is also pertinent to the risk of torsade de pointes in patients with AFIB/AFL (see below).

Table 5 Incidence of Torsade de Pointes in Controlled Trials of AFIB and Other Supraventricular Arrhythmias
SOTALOL HYDROCHLORIDE TABLETS (AF) (DAILY DOSE)
Any Dose(N=659)> 320 mg/day(N=62)≤ 320 mg/day(N=597)≤ 240 mg/day(N=340)Placebo(N=358)
n(%)n(%)n(%)n(%)n(%)
Torsade de pointes4 (0.6%)2 (3.2%)2 (0.3%)1 (0.3%)0


Proarrhythmia in Ventricular Arrhythmia Patients: [see Sotalol Hydrochloride Package Insert]

In patients with a history of sustained ventricular tachycardia, the incidence of torsade de pointes during sotalol treatment was 4% and worsened VT in about 1%; in patients with other less serious ventricular arrhythmias the incidence of torsade de pointes was 1% and new or worsened VT in about 0.7%. 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 in patients with VT/VF were dose related, as was the prolongation of QT (QT) interval, as shown in Table 6 below.

Table 7 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.

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 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 ventricular arrhythmia 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.

Table 6 Percent Incidence of Torsade de Pointes and Mean QT Interval by Dose For Patients With Sustained VT/VF
( ) Number of patients assessed
Daily Dose (mg)Incidence of torsade de pointesMean QT(msec)
800 (69)463 (17)
1600.5 (832)467 (181)
3201.6 (835)473 (344)
4804.4 (459)483 (234)
6403.7 (324)490 (185)
> 6405.8 (103)512 (62)
Table 7 Relationship Between QT Interval Prolongation and torsade de pointes
( ) Number of patients assessed
On-Therapy QT Interval (msec)Incidence of Torsade de PointesChange in QT Interval From Baseline (msec)Incidence of Torsade de Pointes
less than 5001.3% (1787)less than 651.6% (1516)
500-5253.4% (236)65-803.2% (158)
525-5505.6% (125)80-1004.1% (146)
> 55010.8% (157)100-1305.2% (115)
> 1307.1% (99)


Use with Drugs that Prolong QT Interval and Antiarrhythmic Agents

The use of sotalol hydrochloride tablets (AF) in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended. Such drugs include many antiarrhythmics, some phenothiazines, bepridil, tricyclic antidepressants, and certain oral macrolides. Class I or Class III antiarrhythmic agents should be withheld for at least three half-lives prior to dosing with sotalol hydrochloride tablets (AF). In clinical trials, sotalol hydrochloride tablets (AF) was not administered to patients previously treated with oral amiodarone for > 1 month in the previous three months. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (e.g., amiodarone) are not recommended as concomitant therapy with sotalol hydrochloride tablets (AF), because of their potential to prolong refractoriness (see ). There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics.

Congestive Heart Failure

Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta-blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients who have heart failure controlled by digitalis and/or diuretics, sotalol hydrochloride tablets (AF) should be administered cautiously. Both digitalis and sotalol slow AV conduction. As with all beta-blockers, caution is advised when initiating therapy in patients with any evidence of left ventricular dysfunction. In a pooled data base of four placebo-controlled AFIB/AFL and PSVT studies, new or worsening CHF occurred during therapy with sotalol hydrochloride tablets (AF) in 5 (1.2%) of 415 patients. In these studies patients with uncontrolled heart failure were excluded (i.e. NYHA Functional Classes III or IV). In other premarketing sotalol studies, new or worsened congestive heart failure (CHF) occurred in 3.3% (n=3257) of patients and led to discontinuation in approximately 1% of patients receiving sotalol. The incidence was higher in patients presenting with sustained ventricular tachycardia/fibrillation (4.6%, n=1363), or a prior history of heart failure (7.3%, n=696). Based on a life-table analysis, the one-year incidence of new or worsened CHF was 3% in patients without a prior history and 10% in patients with a prior history of CHF. NYHA Classification was also closely associated to the incidence of new or worsened heart failure while receiving sotalol (1.8% in 1395 Class I patients, 4.9% in 1254 Class II patients and 6.1% in 278 Class III or IV patients).

Electrolyte Disturbances

Sotalol hydrochloride tablets (AF) should not be used in patients with hypokalemia or hypomagnesemia prior to correction of imbalance, as these conditions can exaggerate the degree of QT prolongation, and increase the potential for torsade de pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.

Bradycardia/Heart Block

The incidence of bradycardia (as determined by the investigators) in the supraventricular arrhythmia population treated with sotalol hydrochloride tablets (AF) (N = 415) was 13%, and led to discontinuation in 2.4% of patients. Bradycardia itself increases the risk of torsade de pointes.

Recent Acute MI

Sotalol has been used in a controlled trial following an acute myocardial infarction without evidence of increased mortality (see ). Although specific studies of its use in treating atrial arrhythmias after infarction have not been conducted, the usual precautions regarding heart failure, avoidance of hypokalemia, bradycardia or prolonged QT interval apply.

The following warnings are related to the beta-blocking activity of sotalol hydrochloride tablets (AF).

Abrupt Withdrawal

Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias and, in some cases, myocardial infarction have been reported after abrupt discontinuation of beta-blocker therapy. Therefore, it is prudent when discontinuing chronically administered sotalol hydrochloride tablets (AF), particularly in patients with ischemic heart disease, to carefully monitor the patient and consider the temporary use of an alternate beta-blocker if appropriate. If possible, the dosage of sotalol hydrochloride tablets (AF) should be gradually reduced over a period of one to two weeks. If angina or acute coronary insufficiency develops, appropriate therapy should be instituted promptly. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized in patients receiving sotalol hydrochloride tablets (AF), abrupt discontinuation in patients with arrhythmias may unmask latent coronary insufficiency.

Non-Allergic Bronchospasm (e.g., chronic bronchitis and emphysema)

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS.

Anaphylaxis

While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

Anesthesia

The management of patients undergoing major surgery who are being treated with beta-blockers is controversial. Protracted severe hypotension and difficulty in restoring and maintaining normal cardiac rhythm after anesthesia have been reported in patients receiving beta-blockers.

Diabetes

In patients with diabetes (especially labile diabetes) or with a history of episodes of spontaneous hypoglycemia, sotalol hydrochloride tablets (AF) should be given with caution since beta-blockade may mask some important premonitory signs of acute hypoglycemia; e.g., tachycardia.

Sick Sinus Syndrome

Sotalol hydrochloride tablets (AF) should be used only with extreme caution in patients with sick sinus syndrome associated with symptomatic arrhythmias, because it may cause sinus bradycardia, sinus pauses or sinus arrest. In patients with AFIB and sinus node dysfunction, the risk of torsade de pointes with sotalol hydrochloride tablets (AF) therapy is increased, especially after cardioversion. Bradycardia following cardioversion in these patients is associated with QT interval prolongation which is augmented due to the reverse use dependence of the Class III effects of sotalol hydrochloride tablets (AF). Patients with AFIB/AFL associated with the sick sinus syndrome may be treated with sotalol hydrochloride tablets (AF) if they have an implanted pacemaker for control of bradycardia symptoms.

Thyrotoxicosis

Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. The beta-blocking effects of sotalol hydrochloride tablets (AF) may be useful in controlling heart rate in AFIB associated with thyrotoxicosis but no study has been conducted to evaluate this.


What are the precautions of SOTALOL?

Renal Impairment

Sotalol hydrochloride tablets (AF) is eliminated principally 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 hydrochloride tablets (AF). Guidance for dosing in conditions of renal impairment can be found under "."

Information for Patients

Please refer to the patient package insert.

Prior to initiation of sotalol hydrochloride tablets (AF) therapy, the patient should be advised to read the patient package insert and reread it each time therapy is renewed. The patient should be fully instructed on the need for compliance with the recommended dosing of sotalol hydrochloride tablets (AF), the potential interactions with drugs that prolong the QT interval and other antiarrhythmics, and the need for periodic monitoring of QT and renal function to minimize the risk of serious abnormal rhythms.

Assessment of patients' medication history should include all over-counter, prescription and herbal/natural preparations with emphasis on preparations that may affect the pharmacodynamics of sotalol hydrochloride tablets (AF) such as other cardiac antiarrhythmic drugs, some phenothiazines, bepridil, tricyclic antidepressants and oral macrolides (see ). Patients should be instructed to notify their health care providers of any change in over-the-counter, prescription or supplement use. If a patient is hospitalized or is prescribed a new medication for any condition, the patient must inform the health care provider of ongoing sotalol hydrochloride tablets (AF) therapy. Patients should also check with their health care provider and/or pharmacist prior to taking a new over-the-counter medicine.

If patients experience symptoms that may be associated with altered electrolyte balance, such as excessive or prolonged diarrhea, sweating, or vomiting, or loss of appetite or thirst, these conditions should be immediately reported to their health care provider.

Patients should be instructed NOT to double the next dose if a dose is missed. The next dose should be taken at the usual time.

Drug Interactions

Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol.

Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin.

Sotalol hydrochloride tablets (AF) should be administered with caution in conjunction with calcium blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension.

Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Patients treated with sotalol hydrochloride tablets (AF) plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope.

Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemia may be masked.

Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with sotalol hydrochloride tablets (AF)

Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving sotalol hydrochloride tablets (AF).

No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin.

Administration of sotalol hydrochloride tablets (AF) within 2 hours of antacids containing aluminum oxide and magnesium hydroxide should be avoided because it may result in a reduction in C and AUC of 26% and 20%, respectively and consequently in a 25% reduction in the bradycardic effect at rest. Administration of the antacid two hours after sotalol hydrochloride tablets (AF) has no effect on the pharmacokinetics or pharmacodynamics of sotalol.

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 to 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 to 7122 mg/kg/day (approximately 450 to 750 times the MRHD as mg/kg or 36 to 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

Reproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/m), respectively, did not reveal any teratogenic potential associated with sotalol HCl. In rabbits, a high dose of sotalol HCl (160 mg/kg/day) at 16 times the MRHD as mg/kg (6 times the MRHD as mg/m) produced a slight increase in fetal death likely due to maternal toxicity. Eight times the maximum dose (80 mg/kg/day or 3 times the MRHD as mg/m) did not result in an increased incidence of fetal deaths. In rats, 1000 mg/kg/day sotalol HCl, 100 times the MRHD (18 times the MRHD as mg/m), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m), no increase in early resorptions was noted. However, animal reproduction studies are not always predictive of human response.

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, sotalol hydrochloride tablets (AF) should be used during pregnancy only if the potential benefit outweighs the potential risk.

Nursing Mothers

Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Because of the potential for adverse reactions in nursing infants from sotalol hydrochloride tablets (AF), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


What are the side effects of SOTALOL?

Adverse events that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects. The common documented beta-blocking adverse events (bradycardia, dyspnea, and fatigue) and Class III effects (QT interval prolongation) are dose related.

In a pooled clinical trial population consisting of four placebo-controlled studies with 275 patients with AFIB/AFL treated with 160 to 320 mg doses of sotalol hydrochloride tablets (AF), the following adverse events were reported at a rate of 2% or more in the 160 to 240 mg treated patients and greater than the rate in placebo patients (see Table 8). The data are presented by incidence of events in the sotalol hydrochloride tablets (AF) and placebo groups by body system and daily dose. No significant irreversible non-cardiac end-organ toxicity was observed.

Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients, and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse events leading to discontinuation of sotalol hydrochloride tablets (AF) were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

In clinical trials involving 1292 patients with sustained VT/VF, the common adverse events (occurring in ≥ 2% of patients) were similar to those described for the AFIB/AFL population.

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.

In an unblinded multicenter trial of 25 pediatric 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, torsades de pointe, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.

Table 8 Incidence (%) of Common Adverse Events (≥ 2% in the 160 to 240 mg group and more frequent than on placebo) in Four Placebo-Controlled Studies of Patients with AFIB/AFL
Sotalol HCl Tablets (AF)(mg)
Body System/ Adverse Event (Preferred Term)N=282160 – 240N=153> 240 – 320N=122
CARDIOVASCULAR
  Abnormality ECG0.43.32.5
  Angina Pectoris1.12.01.6
  Bradycardia2.513.112.3
  Chest pain Cardiac/Non-Anginal4.64.62.5
  Disturbance Rhythm Atrial2.12.01.6
  Disturbance Rhythm Subjective9.99.87.4
GASTROINTESTINAL
  Appetite Decreased0.42.01.6
  Diarrhea2.15.25.7
  Distention Abdomen0.40.72.5
  Dyspepsia/Heartburn1.82.02.5
  Nausea/Vomiting5.37.85.7
  Pain Abdomen2.53.92.5
GENERAL
  Fatigue8.519.618.9
  Fever0.70.73.3
  Hyperhidrosis3.25.24.9
  Influenza0.42.00.8
  Sensation Cold0.72.02.5
  Weakness3.25.24.9
MUSCULOSKELETAL/CONNECTIVE TISSUE
  Pain Chest Musculoskeletal1.42.02.5
  Pain Musculoskeletal2.82.64.1
NERVOUS SYSTEM
  Dizziness12.416.313.1
  Headache5.33.311.5
  Insomnia1.12.64.1
RESPIRATORY
  Cough2.53.32.5
  Dyspnea7.49.29.8
  Infection Upper Respiratory1.12.63.3
  Tracheobronchitis0.70.73.3
SPECIAL SENSES
  Disturbance Vision0.72.60.8


Potential Adverse Effects

Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction also include rare reports of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritus, alopecia.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with sotalol hydrochloride tablets (AF) during investigational use and foreign marketing experience.


What should I look out for while using SOTALOL?

Sotalol hydrochloride tablets is contraindicated in patients with sinus bradycardia ( 450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (


What might happen if I take too much SOTALOL?

Intentional or accidental overdosage with sotalol has rarely resulted in death.


How should I store and handle SOTALOL?

Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Sotalol hydrochloride tablets (AF), 80 mg, oval white, scored, debossed MP 518 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-503-07Bottles of 60 unit of use          NDC 53489-503-06Bottles of 100                           NDC 53489-503-01Bottles of 250                           NDC 53489-503-03Bottles of 500                           NDC 53489-503-05Bottles of 1000                         NDC 53489-503-10Sotalol hydrochloride tablets (AF), 120 mg, oval white, scored, debossed MP 519 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-504-07Bottles of 60 unit of use          NDC 53489-504-06Bottles of 100                           NDC 53489-504-01Bottles of 250                           NDC 53489-504-03Bottles of 500                           NDC 53489-504-05Bottles of 1000                         NDC 53489-504-10Sotalol hydrochloride tablets (AF), 160 mg, oval white, scored, debossed MP 520 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-505-07Bottles of 60 unit of use          NDC 53489-505-06Bottles of 100                           NDC 53489-505-01Bottles of 250                           NDC 53489-505-03Bottles of 500                           NDC 53489-505-05Bottles of 1000                         NDC 53489-505-10Sotalol hydrochloride tablets (AF), 80 mg, oval white, scored, debossed MP 518 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-503-07Bottles of 60 unit of use          NDC 53489-503-06Bottles of 100                           NDC 53489-503-01Bottles of 250                           NDC 53489-503-03Bottles of 500                           NDC 53489-503-05Bottles of 1000                         NDC 53489-503-10Sotalol hydrochloride tablets (AF), 120 mg, oval white, scored, debossed MP 519 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-504-07Bottles of 60 unit of use          NDC 53489-504-06Bottles of 100                           NDC 53489-504-01Bottles of 250                           NDC 53489-504-03Bottles of 500                           NDC 53489-504-05Bottles of 1000                         NDC 53489-504-10Sotalol hydrochloride tablets (AF), 160 mg, oval white, scored, debossed MP 520 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-505-07Bottles of 60 unit of use          NDC 53489-505-06Bottles of 100                           NDC 53489-505-01Bottles of 250                           NDC 53489-505-03Bottles of 500                           NDC 53489-505-05Bottles of 1000                         NDC 53489-505-10Sotalol hydrochloride tablets (AF), 80 mg, oval white, scored, debossed MP 518 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-503-07Bottles of 60 unit of use          NDC 53489-503-06Bottles of 100                           NDC 53489-503-01Bottles of 250                           NDC 53489-503-03Bottles of 500                           NDC 53489-503-05Bottles of 1000                         NDC 53489-503-10Sotalol hydrochloride tablets (AF), 120 mg, oval white, scored, debossed MP 519 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-504-07Bottles of 60 unit of use          NDC 53489-504-06Bottles of 100                           NDC 53489-504-01Bottles of 250                           NDC 53489-504-03Bottles of 500                           NDC 53489-504-05Bottles of 1000                         NDC 53489-504-10Sotalol hydrochloride tablets (AF), 160 mg, oval white, scored, debossed MP 520 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-505-07Bottles of 60 unit of use          NDC 53489-505-06Bottles of 100                           NDC 53489-505-01Bottles of 250                           NDC 53489-505-03Bottles of 500                           NDC 53489-505-05Bottles of 1000                         NDC 53489-505-10Sotalol hydrochloride tablets (AF), 80 mg, oval white, scored, debossed MP 518 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-503-07Bottles of 60 unit of use          NDC 53489-503-06Bottles of 100                           NDC 53489-503-01Bottles of 250                           NDC 53489-503-03Bottles of 500                           NDC 53489-503-05Bottles of 1000                         NDC 53489-503-10Sotalol hydrochloride tablets (AF), 120 mg, oval white, scored, debossed MP 519 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-504-07Bottles of 60 unit of use          NDC 53489-504-06Bottles of 100                           NDC 53489-504-01Bottles of 250                           NDC 53489-504-03Bottles of 500                           NDC 53489-504-05Bottles of 1000                         NDC 53489-504-10Sotalol hydrochloride tablets (AF), 160 mg, oval white, scored, debossed MP 520 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-505-07Bottles of 60 unit of use          NDC 53489-505-06Bottles of 100                           NDC 53489-505-01Bottles of 250                           NDC 53489-505-03Bottles of 500                           NDC 53489-505-05Bottles of 1000                         NDC 53489-505-10Sotalol hydrochloride tablets (AF), 80 mg, oval white, scored, debossed MP 518 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-503-07Bottles of 60 unit of use          NDC 53489-503-06Bottles of 100                           NDC 53489-503-01Bottles of 250                           NDC 53489-503-03Bottles of 500                           NDC 53489-503-05Bottles of 1000                         NDC 53489-503-10Sotalol hydrochloride tablets (AF), 120 mg, oval white, scored, debossed MP 519 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-504-07Bottles of 60 unit of use          NDC 53489-504-06Bottles of 100                           NDC 53489-504-01Bottles of 250                           NDC 53489-504-03Bottles of 500                           NDC 53489-504-05Bottles of 1000                         NDC 53489-504-10Sotalol hydrochloride tablets (AF), 160 mg, oval white, scored, debossed MP 520 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-505-07Bottles of 60 unit of use          NDC 53489-505-06Bottles of 100                           NDC 53489-505-01Bottles of 250                           NDC 53489-505-03Bottles of 500                           NDC 53489-505-05Bottles of 1000                         NDC 53489-505-10Sotalol hydrochloride tablets (AF), 80 mg, oval white, scored, debossed MP 518 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-503-07Bottles of 60 unit of use          NDC 53489-503-06Bottles of 100                           NDC 53489-503-01Bottles of 250                           NDC 53489-503-03Bottles of 500                           NDC 53489-503-05Bottles of 1000                         NDC 53489-503-10Sotalol hydrochloride tablets (AF), 120 mg, oval white, scored, debossed MP 519 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-504-07Bottles of 60 unit of use          NDC 53489-504-06Bottles of 100                           NDC 53489-504-01Bottles of 250                           NDC 53489-504-03Bottles of 500                           NDC 53489-504-05Bottles of 1000                         NDC 53489-504-10Sotalol hydrochloride tablets (AF), 160 mg, oval white, scored, debossed MP 520 on one side, the other side plain.Bottles of 30 unit of use          NDC 53489-505-07Bottles of 60 unit of use          NDC 53489-505-06Bottles of 100                           NDC 53489-505-01Bottles of 250                           NDC 53489-505-03Bottles of 500                           NDC 53489-505-05Bottles of 1000                         NDC 53489-505-10


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sotalol hydrochloride has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalol hydrochloride tablets (AF) is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above.

In children, a Class III electrophysiological 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
Sotalol hydrochloride tablets is contraindicated in patients with sinus bradycardia ( 450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (
Adverse events that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects. The common documented beta-blocking adverse events (bradycardia, dyspnea, and fatigue) and Class III effects (QT interval prolongation) are dose related.

In a pooled clinical trial population consisting of four placebo-controlled studies with 275 patients with AFIB/AFL treated with 160 to 320 mg doses of sotalol hydrochloride tablets (AF), the following adverse events were reported at a rate of 2% or more in the 160 to 240 mg treated patients and greater than the rate in placebo patients (see Table 8). The data are presented by incidence of events in the sotalol hydrochloride tablets (AF) and placebo groups by body system and daily dose. No significant irreversible non-cardiac end-organ toxicity was observed.

Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients, and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse events leading to discontinuation of sotalol hydrochloride tablets (AF) were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

In clinical trials involving 1292 patients with sustained VT/VF, the common adverse events (occurring in ≥ 2% of patients) were similar to those described for the AFIB/AFL population.

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.

In an unblinded multicenter trial of 25 pediatric 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, torsades de pointe, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.

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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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Professional

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. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).