Drug: Betapace AF

BETAPACE AF (sotalol hcl) , (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 is d,l-N-[4-[1- hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methanesulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S•HCl and is represented by the following structural formula: BETAPACE AF (sotalol hcl) tablets contain the following inactive ingredients: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.

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Adverse events that are clearly related to BETAPACE AF (sotalol hcl) 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 placebocontrolled studies with 275 patients with AFIB/AFL treated with 160-320 mg doses of BETAPACE AF, the following adverse events were reported at a rate of 2% or more in the 160-240 mg treated patients and greater than the rate in placebo patients (See Table 8). The data are presented by incidence of events in the BETAPACE AF and placebo groups by body system and daily dose. No significant irreversible non-cardiac end-organ toxicity was observed. Table 8: Incidence (%) of Common Adverse Events ( ≥ 2% in the 160-240 mg group and more frequent than on placebo) in Four Placebo-Controlled Studies of Patients with AFIB/AFL
Body System/Adverse Event
(Preferred Term) Placebo
N=282 BETAPACE AF Total Daily Dose 160-240
N=153 >240-320
N=122 CARDIO VASCULAR   Abnormality ECG 0.4 3.3 2.5   Angina Pectoris 1.1 2.0 1.6   Bradycardia 2.5 13.1 12.3   Chest Pain Cardiac/Non-Anginal 4.6 4.6 2.5   Disturbance Rhythm Atrial 2.1 2.0 1.6   Disturbance Rhythm Subjective 9.9 9.8 7.4 GASTROINTESTINAL   Appetite Decreased 0.4 2.0 1.6   Diarrhea 2.1 5.2 5.7   Distention Abdomen 0.4 0.7 2.5   Dyspepsia/Heartburn 1.8 2.0 2.5   Nausea/Vomiting 5.3 7.8 5.7   Pain Abdomen 2.5 3.9 2.5 GENERAL   Fatigue 8.5 19.6 18.9   Fever 0.7 0.7 3.3   Hyperhidrosis 3.2 5.2 4.9   Influenza 0.4 2.0 0.8   Sensation Cold 0.7 2.0 2.5   Weakness 3.2 5.2 4.9 MUSCULOSKELETAL/CONNECTIVE TISSUE   Pain Chest Musculoskeletal 1.4 2.0 2.5   Pain Musculoskeletal 2.8 2.6 4.1 NERVOUS SYSTEM   Dizziness 12.4 16.3 13.1   Headache 5.3 3.3 11.5   Insomnia 1.1 2.6 4.1 RESPIRATORY   Cough 2.5 3.3 2.5   Dyspnea 7.4 9.2 9.8   Infection Upper Respiratory 1.1 2.6 3.3   Tracheobronchitis 0.7 0.7 3.3 SPECIAL SENSES   Disturbance Vision 0.7 2.6 0.8 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 BETAPACE AF (sotalol hcl) 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 patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m2 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/m2 daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m2 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 QTc 525 msec were seen in 2 patients at the 210 mg/m2 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. 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 liability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with BETAPACE AF (sotalol hcl) during investigational use and foreign marketing experience. Read the Betapace AF (sotalol hcl) Side Effects Center for a complete guide to possible side effectsLearn More »

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Dosing and Administration in Adults
  • Therapy with BETAPACE AF (sotalol hcl) must be initiated (and, if necessary, titrated) in a setting that provides continuous electrocardiographic (ECG) monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Patients should continue to be monitored in this way for a minimum of 3 days on the maintenance dose. In addition, patients should not be discharged within 12 hours of electrical or pharmacological conversion to normal sinus rhythm.
  • The QT interval is used to determine patient eligibility for BETAPACE AF (sotalol hcl) treatment and for monitoring safety during treatment. The baseline QT interval must be ≤ 450 msec in order for a patient to be started on BETAPACE AF (sotalol hcl) therapy. During initiation and titration, the QT interval should be monitored 2-4 hours after each dose. If the QT interval prolongs to 500 msec or greater, the dose must be reduced or the drug discontinued.
  • The dose of BETAPACE AF (sotalol hcl) must be individualized according o t calculated creati nine clearance. In patients with a creatinine clearance > 60 mL/min BETAPACE AF (sotalol hcl) is administered twice daily (BID) while in those with a creatinine clearance between 40 and 60 mL/m in, the dose is administered once daily Q(D). In patients with a creatinine clearance less than 40 mL/min BETAPACE AF is contraindicated. The recommended initial dose of BETAPACE AF (sotalol hcl) is 80 mg and is initiated as shown in the dosing algorithm described below. The 80 mg dose can be titrated upward to 120 mg during initial hospitailzation or after discharge on 80 mg in the event of recurrence, by rehospitalization and repeating the same steps used during the initiation of therapy (see Upward Titration of Dose).
  • Patients with atrial fibrillation should be anticoagulate d according to usual medical practice. Hypokalemia should be corrected before intiaition of BETAPACE AF therapy (see WARNINGS, Ventricular Arrhythmia).
  • Patients to be discharged on BETAPACE AF (sotalol hcl) therapy from an in-patient setting should have an adequate supply of BETAPACE AF (sotalol hcl) , to allow uninterrupted therapy until the patient can fill a BETAPACE AF (sotalol hcl) prescription.
Initiation of BETAPACE AF (sotalol hcl) Therapy Step 1. Electrocardiographic assessment: Prior to administration of the first dose, the QT interval must be determined using an average of 5 beats. If the baseline QT is greater than 450 msec (JT ≥ 330 msec if QRS over 100 msec), BETAPACE AF (sotalol hcl) is contraindicated. Step 2. Calculation of creatinine clearance: Prior to the administration of the first dose, the patient's creatinine clearance should be calculated using the following formula: creatinine clearance (male) = (140-age) x body weight in kg 72 x serum creatinine (mg/dL) creatinine clearance (female) = (140-age) x body weight in kg x 0.85 72 x serum creatinine (mg/dL) When serum creatinine is given in µmol/L, divide the value by 88.4 (1 mg/dL = 88.4 µmol/L). Step 3. Starting Dose: The starting dose of BETAPACE AF (sotalol hcl) is 80 mg twice daily (BID) if the creatinine clearance is > 60 mL/min, and 80 mg once daily (QD) if the creatinine clearance is 40-60 mL/min. If the creatinine clearance is < 40 mL/min BETAPACE AF (sotalol hcl) is contraindicated. Step 4. Administer the appropriate daily dose of BETAPACE AF (sotalol hcl) and begin continuous ECG monitoring with QT interval measurements 2-4 hours after each dose. Step 5. If the 80 mg dose level is tolerated and the QT interval remains < 500 msec after at least 3 days (after 5 or 6 doses if patient receiving QD dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg bid and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving QD doses). The steps described above are summarized in the following diagram: Upward Titration of Dose If the 80 mg dose level (given BID or QD depending upon the creatinine clearance) does not reduce the frequency of relapses of AFIB/AFL and is tolerated without excessive QT interval prolongation (i.e., ≥ 520 msec), the dose level may be increased to 120 mg (BID or QD depending upon the creatinine clearance). As proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment, Steps 2 through 5 used during initiation of BETAPACE AF (sotalol hcl) therapy should be followed when increasing the dose level. In the U.S. multicenter dose-response study, the 120 mg dose (BID or QD) was found to be the most effective in prolonging the time to ECG documented symptomatic recurrence of AFIB/AFL. If the 120 mg dose does not reduce the frequency of early relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation ( ≥ 520 msec), an increase to 160 mg (BID or QD depending upon the creatinine clearance), can be considered. Steps 2 through 5 used during the initiation of therapy should be used again to introduce such an increase. Maintenance of BETAPACE AF (sotalol hcl) Therapy Renal function and QT should be re-evaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is > 100 msec), the dose of BETAPACE AF (sotalol hcl) therapy should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is ≥ 520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued. If renal function deteriorates, reduce the daily dose in half by administering the drug once daily as described in Initiation of BETAPACE AF (sotalol hcl) Therapy, Step 3. Special Considerations The maximum recommended dose in patients with a calculated creatinine clearance greater than 60 mL/min is 160 mg BID, doses greater than 160 mg BID have been associated with an increased incidence of Torsade de Pointes and are not recommended. A patient who misses a dose should NOT double the next dose. The next dose should be taken at the usual time. Dosing and Administration in Children As in adults the following precautionary measures should be considered when initiating sotalol treatment in children: initiation of treatment in the hospital after appropriate clinical assessment; individualized regimen as appropriate; gradual increase of doses if required; careful assessment of therapeutic response and tolerability; and frequent monitoring of the QTc interval and heart rate. For children aged about 2 years and greater, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children (see CLINICAL PHARMACOLOGY) is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide. From pediatric pharmacokinetic data the following is recommended. For initiation of treatment, 30 mg/m2 three times a day (90 mg/m2 total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QTc, with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function. For children aged about 2 years or younger the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months. For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 X 0.97)=29.1 mg/m2, administered three times daily. For a child aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30 X 0.68)=20 mg/m2, administered three times daily. For a child aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30 X 0.3)=9 mg/m2. Similar calculations should be made for increased doses as titration proceeds. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer. In all children, individualization of dosage is required. As in adults BETAPACE AF (sotalol hydrochloride) should be used with particular caution in children if the QTc is greater than 500 msec on therapy and serious consideration should be given to reducing the dose or discontinuing therapy when QTc exceeds 550msec. The use of BETAPACE AF (sotalol hcl) (sotalol hydrochloride) in children with renal impairment has not been investigated. Sotalol elimination is predominantly via the kidney in the unchanged form. Use of sotalol in any age group with decreased renal function should be at lower doses or at increased intervals between doses. Monitoring of heart rate and QTc is more important and it will take much longer to reach steady-state with any dose and/or frequency of administration. Transfer to BETAPACE AF (sotalol hcl) from BETAPACE Patients with a history of symptomatic AFIB/AFL who are currently receiving BETAPACE for the maintenance of normal sinus should be transferred to BETAPACE AF because of the significant differences in labeling (i.e., patient package insert, dosing administration, and safety information). Transfer to BETAPACE AF (sotalol hcl) from Other Antiarrhythmic Agents Before starting BETAPACE AF (sotalol hcl) , previous antiarrhythmic therapy should generally be withdrawn under careful monitoring for a minimum of 2-3 plasma half-lives if the patient's clinical condition permits (see DRUG INTERACTIONS). Treatment has been initiated in some patients receiving I.V. lidocaine without ill effect. After discontinuation of amiodarone, BETAPACE AF should not be initiated until the QT interval is normalized (see WARNINGS). Preparation of Extemporaneous Oral Solution BETAPACE AF (sotalol hcl) Syrup 5 mg/mL can be compounded using Simple Syrup containing 0.1% sodium benzoate (Syrup, NF) available from Humco Laboratories as follows:
  1. Measure 120mL of Simple Syrup
  2. Transfer the syrup to a 6-ounce amber plastic (polyethylene terephthalate [PET]) prescription bottle. NOTE: An oversized bottle is used to allow for a headspace, so that there will be more effective mixing during shaking of the bottle.
  3. Add five (5) BETAPACE AF (sotalol hcl) 120 mg tablets to the bottle. These tablets are added intact; it is not necessary to crush the tablets. NOTE: The addition of the tablets can also be done first. The tablets can also be crushed if preferred. If the tablets are crushed, care should be taken to transfer the entire quantity of tablet powder into the bottle containing the syrup.
  4. Shake the bottle to wet the entire surface of the tablets. If the tablets have been crushed, shake the bottle until the endpoint is achieved.
  5. Allow the tablets to hydrate for approximately two hours.
  6. After at least two hours have elapsed, shake the bottle intermittently over the course of at least another two hours until the tablets are completely disintegrated. NOTE: The tablets can be allowed to hydrate overnight to simplify the disintegration process.
The endpoint is achieved when a dispersion of fine particles in the syrup is obtained. This compounding procedure results in a solution containing 5 mg/mL of sotalol HCl. The fine solid particles are the waterinsoluble inactive ingredients of the tablets. This extemporaneously prepared oral solution of sotalol HCl (with suspended inactive particles) must be shaken well prior to administration. This is to ensure that the amount of inactive solid particles per dose remains constant throughout the duration of use. Stability studies indicate that the suspension is stable when stored at controlled room temperature (15°-30°C/59°-86°F) and ambient humidity for three (3)months.

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Drugs undergoing CYP450 metabolism: Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Digoxin: 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. Calcium blocking drugs: BETAPACE AF (sotalol hcl) 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. Catecholamine-depleting agents: 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 BETAPACE AF (sotalol hcl) plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope. Insulin and oral antidiabetics: Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemiamay bemasked. Beta-2-receptor stimulants: Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with BETAPACE AF (sotalol hcl) . Clonidine: Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving BETAPACE AF (sotalol hcl) . Other: No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin. Antacids: Administration of BETAPACE AF (sotalol hcl) within 2 hours of antacids containing aluminum oxide and magnesium hydroxide should be avoided because it may result in a reduction in Cmax 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 BETAPACE AF (sotalol hcl) 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. Read the Betapace AF Drug Interactions Center for a complete guide to possible interactions Learn More »

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BETAPACE AF (sotalol hcl) 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. Because BETAPACE AF can cause lifethreatening 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 BETAPACE 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). BETAPACE, however, must not be substituted for BETAPACE AF because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).

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BETAPACE AF (sotalol hcl) (sotalol hydrochloride) 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. Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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Intentional or accidental overdosage with sotalol has rarely resulted in death. Symptoms and Treatment of Overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2-16 grams) of sotalol the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with BETAPACE AF (sotalol hcl) should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels > 50 bpm. The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested: Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing. Heart Block: (second and third degree) transvenous cardiac pacemaker. Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful. Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant. Torsade de Pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate. Torsade DC cardioversion, transvenous cardiac pacing, de Pointes: epinephrine, magnesium sulfate.

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BETAPACE AF (sotalol hcl) (sotalol hydrochloride); capsule-shaped white scored tablets imprinted with the strength are available as follows: NDC 50419-115-06 80 mg strength, bottle of 60 in unit use package NDC 50419-119-06 120 mg strength, bottle of 60 in unit use package NDC 50419-116-06 160 mg strength, bottle of 60 in unit use package Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Manufactured in Finland. Rev. April 2007. FDA Rev date: 4/2/2003 Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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Renal Impairment: BETAPACE AF (sotalol hcl) (sotalol hydrochloride) 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 BETAPACE AF. Guidance for dosing in conditions of renal impairment can be found under "DOSAGE AND ADMINISTRATION." Information for Patients Please refer to the patient package insert. Prior to initiation of BETAPACE AF (sotalol hcl) 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 BETAPACE AF (sotalol hcl) , 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. Medications and Supplements: 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 BETAPACE AF such as other cardiac antiarrhythmic drugs, some phenothiazines, bepridil, tricyclic antidepressants and oral macrolides (see WARNINGS and Use With Drugs That Prolong QT Interval and Antiarrhythmic Agents). 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 BETAPACE AF (sotalol hcl) therapy. Patients should also check with their health care provider and/or pharmacist prior to taking a new over-the-counter medicine. Electrolyte Imbalance: 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. Dosing Schedule: 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. 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/m2) 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 theMRHD as mg/m2). 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/m2) 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/m2), 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/m2) 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/m2) 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/m2), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m2), 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 sub- normal birth weight with sotalol. Therefore, BETAPACE AF (sotalol hcl) 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 BETAPACE AF (sotalol hcl) , 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. Pediatric Use The safety and effectiveness of BETAPACE AF (sotalol hcl) 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.) Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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