Copyright: Merative US L.P. 1973, 2023. PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS. Taking certain other medicines with Sotalol AF can increase the chance that you will get the dangerous abnormal heartbeat discussed in "What is the most important information I should know about Sotalol AF?" Sotalol AFis not for everyone with irregular heartbeats (atrial fibrillation). Sotalol hydrochloride tablets, however, should not be substituted for sotalol hydrochloride tablets (AF) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information). Other drugs may affect sotalol, including prescription and over-the-counter medicines, vitamins, and herbal products. Does Sotalol AF interact with other drugs you are taking? At any time while you are taking Sotalol AF, watch for signs that you may be getting this different type of abnormal heartbeat and call your doctor if they occur. http://www.appco.com.au/appguide/default.asp" (2006): 6. Effectiveness. You may need to take sotalol for the rest of your life. Both the Class III and beta-blocking effects of sotalol were linearly related with the plasma concentrations. Patients should continue to be monitored in this way for a minimum of 3 days on the maintenance dose. 76385-127-50, To minimize the risk of induced arrhythmia, patients initiated or re-initiated on Sotalol Hydrochloride Tablets (AF) should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance. Find 14 user ratings and reviews for Sotalol AF Oral on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction . propranolol, diltiazem, Xarelto, digoxin, rivaroxaban, flecainide, sotalol, magnesium sulfate, propafenone, Multaq. There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Follow your doctor's instructions about tapering your dose. Check your blood sugar levels regularly as directed by your doctor. Stability studies indicate that the suspension is stable when stored at controlled room temperature (15 to 30C/59 to 86F) and ambient humidity for three (3) months. 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 a small study (n=25) of patients with implanted defibrillators treated concurrently with sotalol, the average defibrillatory threshold was 6 joules (range 2 to 15 joules) compared to a mean of 16 joules for a non-randomized comparative group primarily receiving amiodarone. Drug information provided by: Merative, Micromedex. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh, Boxed Warnings, Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . The average peak to trough concentration ratio was 2. In one study, a U.S. multicenter, randomized, placebo-controlled, double-blind, dose-response trial of patients with symptomatic primarily paroxysmal AFIB/AFL, three fixed dose levels of Sotalol AF (80 mg, 120 mg and 160 mg) twice daily and placebo were compared in 253 patients. Click here for an email preview. Each time you get a refill, you will receive patient information. Beximco Pharmaceuticals USA Inc.4110 Regal Oaks Drive, P.O. In a study of systemic hemodynamic function measured invasively in 12 patients with a mean LV ejection fraction of 37% and ventricular tachycardia (9 sustained and 3 non-sustained), a median dose of 160 mg twice daily of sotalol produced a 28% reduction in heart rate and a 24% decrease in cardiac index at 2 hours post dosing at steady-state. Properly discard this product when it is expired or no longer needed. SOTALOL HYDROCHLORIDE AF- sotalol hydrochloride tables af tablet. 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. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. If you have these conditions, read the provided information carefully. Make sure laboratory personnel and all your doctors know you use this drug. Hypokalemia should be corrected before initiation of Sotalol AF therapy (see. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction. Consult your doctor for more details. For detailed instructions regarding dose selection, see, Table 5 Incidence of Torsade de Pointes in Controlled Trials of AFIB and Other Supraventricular Arrhythmias, Table 6 Percent Incidence of Torsade de Pointes and Mean QT. Patients usually start with a low dose of sotalol. Once you begin taking Sotalol AF, do not start taking any new medicines until you check with your doctor. Consult your doctor before you accept any other sotalol product that does not provide this patient information. Patients were followed for 12 months. If your child cannot eat regularly, is vomiting, or has symptoms of low blood sugar (such as sweating, shaking), tell the doctor right away. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given Sotalol AF (see WARNINGS). You may report side effects to FDA at 1-800-FDA-1088. Sotalol AF is a medicine that is given to patients with atrial fibrillation (irregular heartbeats). The use of Sotalol AF in children with renal impairment has not been investigated. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen). Prior to initiation of Sotalol AFtherapy, the patient should be advised to read the patient package insert and reread it each time therapy is renewed. You will need frequent medical tests. The fine solid particles are the water-insoluble inactive ingredients of the tablets. Treatment has been initiated in some patients receiving I.V. Call your doctor at once if you have: fast or pounding heartbeats, fluttering in your chest; sudden dizziness (like you might pass out); slow heartbeats (especially if you feel light-headed); Common side effects of sotalol may include: This is not a complete list of side effects and others may occur. 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. Royal Pharmaceutical Society of Great Britain. If renal function deteriorates, reduce the daily dose in half by administering the drug once daily as described in Initiation of Sotalol AF Therapy, Step 3. 76385-126-50, 76385-127-01, Older adults may be more sensitive to the side effects of this drug, especially dizziness, tiredness, and QT prolongation (see above). During steady-state, the respective average increases above baseline of the QTc interval, in msec (%), were 2(+1%), 14(+4%) and 29(+7%) msec at the 3 dose levels. These products come with additional written information from the manufacturer for patients with atrial fibrillation/flutter. If the QT interval increased to 520 msec (or JT 430 msec if QRS >100 msec) the drug was discontinued. Your pharmacist may prepare an oral suspension (liquid) form of sotalol. From pediatric pharmacokinetic data the following is recommended. Therefore, Sotalol AFshould be used during pregnancy only if the potential benefit outweighs the potential risk. Sotalol shows very little intersubject variability in plasma levels. Step 1. Sotalol Hydrochloride Tablets, USP (AF) are presented as follows: For 80 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B107' on one side and scored on the other side. Important points about Sotalol AF. Ease of Use. 30 serious drug interactions. If you are taking an antacid containing aluminum or magnesium to treat heartburn or upset stomach wait at least 2 hours after your dose of Sotalol AF before you take the antacid. The intersubject variation for oral clearance was 22%. Sotalol AF can help you best if you take it as your doctor has prescribed it. 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. Your provider may adjust your dose as needed. Sotalol AF's most common side effects are tiredness, slow rate, shortness of breath, and dizziness. All patients had chronic AFIB for >2 weeks but <1 year at entry with a mean duration of 4.1 months. They need this information to make sure your medicines are safe to take at the same time. 16 . In a pooled data base of four placebo-controlled AFIB/AFL and PSVT studies, new or worsening CHF occurred during therapy with Sotalol AF in 5 (1.2%) of 415 patients. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension. 80mg 2X/day for over a year, lowered bp very well and stopped afib, side effect of fatigue, tiredness, will discuss with cardiologist to lower my dosage and hopefully with result of still controlling bp and afib as well as eliminating tiredness and fatigue. Get medical help right away if you develop: chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, fast/irregular heartbeat. In addition, patients should not be discharged within 12 hours of electrical or pharmacological conversion to normal sinus rhythm. Figure 2 Study 2 Time to First ECG-Documented Recurrence of Symptomatic AFIB/AFL/Death Since Randomization, Safety in Patients with Structural Heart Disease. Do not use a household spoon because you may not get the correct dose. Some side effects may not be reported. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Call your doctor for medical advice about side effects. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. To provide you with the most relevant and helpful information, and understand which Proarrhythmia in Atrial Fibrillation/Atrial Flutter Patients. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Twenty-five children in an unblinded, multicenter trial with supraventricular (SVT) and/or ventricular (VT) tachyarrhythmias, aged between 3 days and 12 years (mostly neonates and infants), received an ascending titration regimen with daily doses of 30, 90 and 210 mg/m2 with dosing every 8 hours for a total of 9 doses. Similar calculations should be made for increased doses as titration proceeds. The steady-state percent increases in the RR interval were 3, 9 and 12%. Guidance for dosing in conditions of renal impairment can be found under, 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Adverse events that are clearly related to Sotalol AF are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects. Tell your doctor right away if you have any serious side effects, including: new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Otherwise, call a poison control center right away. February 24, 2020. If you notice other effects not listed above, contact your doctor or pharmacist. This extemporaneously prepared oral solution of sotalol HCl (with suspended inactive particles) must be shaken well prior to administration. View NDC Code(s)NEW! What should I avoid while taking Sotalol AF? In patients with AFIB and sinus node dysfunction, the risk of Torsade de Pointes with Sotalol AF therapy is increased, especially after cardioversion. health information, we will treat all of that information as protected health In clinical trials, Sotalol AF was not administered to patients previously treated with oral amiodarone for >1 month in the previous three months. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Applies to sotalol: intravenous solution, oral solution, oral tablet. Your doctor will start you on Sotalol AF in the hospital and will check your heart rhythm for the first 2 or more days of treatment. Measure liquid medicine carefully. This is not a complete list of possible side effects. Values for QTc 525 msec were seen in 2 patients at the 210 mg/m2 daily dose level. The 120 mg dose was more effective than 80 mg, but 160 mg did not appear to have an added benefit. This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Calculation of creatinine clearance: Prior to the administration of the first dose, the patient's creatinine clearance should be calculated using the following formula: When serum creatinine is given in mol/L, divide the value by 88.4 (1 mg/dL = 88.4 mol/L). Thus, in neonates the time to steady-state may be as long as a week or longer. This content does not have an Arabic version. this version. The QT interval is used to determine patient eligibility for Sotalol AF treatment and for monitoring safety during treatment. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. British Medical Association. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. This survey is being conducted by the WebMD marketing sciences department. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh, Manufactured by . Along with its needed effects, sotalol may cause some unwanted effects. No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin. Call your doctor right away if you: If you cannot reach your doctor, go to the nearest hospital emergency room. They can help you if problems occur. In a study of patients with atrial fibrillation (AFIB)/flutter (AFIB/AFL) receiving three different oral doses of Sotalol AF given q12h (or q24h in patients with a reduced creatinine clearance), mean increases in QT intervals measured from 12-lead ECGs of 25 msec, 40 msec and 54 msec were found in the 80 mg, 120 mg, and 160 mg dose groups, respectively. Step 5. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The endpoint is achieved when a dispersion of fine particles in the syrup is obtained. Conclusions: Sotalol can be recommended as the drug of first choice for treatment of fetal AF and has been shown to be an effective and safe first-line treatment option for SVT, at least in the absence of hydrops. Do not start taking any other medicines without telling your doctor. However, never take an extra dose of Sotalol AF even if you do not feel well. In Canada - Call your doctor for medical advice about side effects. In these studies patients with uncontrolled heart failure were excluded (i.e., NYHA Functional Classes III or IV). The safety and effectiveness of Sotalol AF in childrenhave not been established. As with all beta-blockers, caution is advised when initiating therapy in patients with any evidence of left ventricular dysfunction. In patients who have heart failure controlled by digitalis and/or diuretics, Sotalol AF should be administered cautiously. If overdosage occurs, therapy with Sotalol AFshould be discontinued and the patient observed closely. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. RxNorm, Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Age per se does not significantly alter the pharmacokinetics of sotalol, but impaired renal function in geriatric patients can increase the terminal elimination half-life, resulting in increased drug accumulation. Sotalol AF can also cause other side effects. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. For 120 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B108' on one side and scored on the other side. Your doctor will do regular tests to check that the amount you're taking is still right for you. Placebo) at 12 Months, Table 3 Study 2Patient Status at 6 Months, Table 4 Study 2Median Time to Recurrence of Symptomatic AFIB/AFL/Death and Relative Risk (vs. Symptoms of hypoglycemia may be masked. Sign up for free and stay up to date on research advancements, health tips, current health topics, and expertise on managing health. Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name Betapace (sotalol hydrochloride). 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. A very serious allergic reaction to this drug is rare. Sotalol AF may help your heart stay beating regularly for a longer period of time. Copyright 1996-2023 Cerner Multum, Inc. 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. Discontinuation because of adverse events was dose related. As in adults Sotalol 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 550 msec. The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. Placebo) at 6 Months, Treatment with Sotalol 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. If any of these effects last or get worse, tell your doctor or pharmacist promptly. This drug may make you dizzy. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. During pregnancy, this medication should be used only when clearly needed. Administration of the antacid two hours after Sotalol AF has no effect on the pharmacokinetics or pharmacodynamics of sotalol. Sotalol has been used in a controlled trial following an acute myocardial infarction without evidence of increased mortality (see Safety in Patients with Structural Heart Disease). For ventricular arrhythmias, most adults will need 160 mg to 320 mg per day given in 2 or 3 divided doses, though higher doses may be needed for severe cases. Box 1060, Suwanee, GA 30024, USA, Manufactured by: Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If you miss taking a dose of Sotalol AF, just take your normal amount at the next scheduled time. This compounding procedure results in a solution containing 5 mg/mL of sotalol HCl. Keep using this medicine as directed, even if you feel well. Show More. For childrenaged about 2 years and greater, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Sotalol is a beta-blocker that affects the heart and circulation within the atrium and ventricles (the upper and lower chambers of the heart that allow blood to flow into and out of the heart). Step 2. discharge patient on current treatment. If the baseline QT is greater than 450 msec (JT 330 msec if QRS over 100 msec), Sotalol AFis contraindicated. If you cannot reach your doctor, go to the nearest hospital emergency room. If you are a consumer or patient please visit Take your Sotalol AF tablets with you and show them to the doctor or nurse. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. The combined analysis of two unblinded, multicenter trials (a single dose and a multiple dose study) with 59 children, aged between 3 days and 12 years, showed the pharmacokinetics of sotalol to be first order. Other dosage forms: intravenous solution Warning Oral route (Solution) fast, slow, irregular, pounding, or racing heartbeat or pulse, swelling of the face, fingers, feet, or lower legs, flushing or redness of the skin, especially on the face and neck, inability to move the arms, legs, or facial muscles, coughing that sometimes produces a pink frothy sputum, delusions of persecution, mistrust, suspiciousness, or combativeness, sores, ulcers, or white spots on the lips or in the mouth, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, Feeling of constant movement of self or surroundings, muscle aches, cramps, pains, or stiffness. information submitted for this request. 270 significant drug interactions. For detailed instructions regarding dose selection, and special cautions for people with renal impairment, seeDOSAGE AND ADMINISTRATION. Stopping suddenly may make your condition worse. Overall rating 4.7. If you are concerned about these or any other side effects, ask your doctor. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Symptoms of overdose may include: severe dizziness, fainting, unusually slower/faster/more irregular heartbeat, shortness of breath. In addition, tell your doctor about any problems you have with your heart or kidneys. The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods. This document does not contain all possible drug interactions. In all children, individualization of dosage is required. Patients should be instructed NOT to double the next dose if a dose is missed. 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