Sotalol hydrochloride 80 mg tablets summary of product. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, i kr. Sotalol hydrochloride information, side effects, warnings. Heart rhythm control for atrial fibrillation black box warning patients should be in a facility for at least 3 days with ecg monitoring, cardiac resuscitation available, and crcl calculated when initiating or reinitiating. Sotalol is available under the following different brand names. Substitution for oral sotalol in patients who are unable to take sotalol orally 1. Do not initiate sotalol therapy if the baseline qtc is longer than 450 ms. Betapace sotalol hydrochloride is an antiarrhythmic drug with class ii betaadrenoreceptor blocking and class iii cardiac action potential duration prolongation properties.
At concentrations covering several orders of magnitude, dofetilide blocks only i kr with no relevant block of the other repolarizing potassium currents. If the qt interval prolongs to 500 ms or greater, the dose must be reduced, the duration of. Sotalol af is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium the upper chambers of the heart that allow blood to flow. Maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillationflutter 1. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of. What sotalol tablets are and what are they used for sotalol belongs to a group of drugs called betaadrenergic blocking agents or betablockers. Dosing suggested for children with normal renal function aged. Evaluation of sotalol prescribing practices in adult. The prolongation reflects a change in the repolarisation time because there was no change in the qs interval.
Your healthcare provider will use your kidney function as a guide to determining your starting. Read all of this leaflet carefully before you start taking this medicine. Sotalol sandoz tablets should be taken with water, preferably one to two hours before meals. Effect of long term treatment with metoprolol and sotalol. This medicine may cause changes in your blood sugar levels. Sotalol hydrochloride tablets, usp af betapace af 80. Sotalol betapace, sorine considerations for use usfda approved indications. What you need to know before you take sotalol tablets 3. If the initial dose was not tolerated it was decreased to 80 mg once daily, but if it was tolerated it was increased to 160 mg twice daily. Sotalol is a prescription drug indicated for the treatment of lifethreatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia vt. Use graph in prescribing information where age in months is plotted on a logarithmic scale.
The primary route of elimination is renal excretion. Mylan manufactures sotalol hydrochloride tablets, usp af betapace af in strengths of 80 mg120 mg160 mg. Oral dosage of sotalol hydrochloride should be adjusted gradually allowing two to three days between dosing increments in order to attain steadystate and to. For the maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation or atrial flutter who are currently in sinus.
Precautions and warnings with sotalol there are several precautions and warnings with sotalol to be aware of before starting treatment. Use of dolasetron injection for the prevention of chemotherapyinduced nausea and vomiting is contraindicated because the risk of qt prolongation is higher with the doses required for this indication. It is supplied as a white, capsuleshaped tablet for oral administration. It is supplied as a lightblue, capsuleshaped tablet for oral administration. Sotalol does not bind to plasma proteins and is not metabolised. Sotalol hydrochloride for intravenous use is an antiarrhythmic agent indicated for. Precautions and warnings with sotalol heart home page. Sotalol hydrochloride tablets, usp are an antiarrhythmic drug with class ii betaadrenoreceptor blocking and class iii cardiac action potential duration prolongation properties. These highlights do not include all the information needed to use cuvitru safely and effectively. Squats are a great representation of when life gets rough. Administration of sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide may reduce blood concentrations of sotalol by 26%.
There is very little intersubject variability in plasma levels. Sotalol hydrochloride, is an antiarrhythmic drug with class ii betaadrenoreceptor blocking and class iii cardiac action potential duration prolongation properties. Sotalol and sotalol af cant be substituted for one another. Your kidney function must be measured using a simple blood test before you start taking the drug, as the kidneys remove sotalol from the body. Measurements of heart rate at rest and during bicycle exercise indicated that metoprolol and sotalol in the doses selected were equipotent as beta blockers. Sotalol is a competitive inhibitor of the rapid potassium channel. Sotalol betapace is usually taken twice a day and sotalol betapace af is usually taken once or twice a day. Sotalol hydrochloride injection sotalol hydrochloride. Sotalol af is a betablocker that affects the heart and circulation blood flow through arteries and veins sotalol af is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium the upper chambers of the heart that allow blood to flow into the heart. Sotalol is an antiarrhythmic drug used to treat ventricular arrhythmia. Refer to prescribing information for more complete information. Highlights of prescribing information ventricular arrhythmias.
Dofetilide shows vaughan williams class iii antiarrhythmic activity. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Continually monitor patients with each uptitration in dose, until they reach steady state. Sotalol considerations for use american college of cardiology. This package insert must be read carefully prior to product use. For example, it is important to know that the medication may actually increase the risk of lifethreatening arrhythmias and can worsen certain medical conditions, such as asthma or heart failure.
Patients with a history of symptomatic afibafl who are currently receiving sotalol hydrochloride for the maintenance of normal sinus should be transferred to sotalol hydrochloride tablets af because of the significant differences in labeling i. It also has a beta blocker effect, decreasing the hearts response to stress, lowering the heart rate, as well as the risk for. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308. Betapace however, should not be substituted for betapace af because of significant differences in labeling i.
Betapace af, sotalol hydrochloride af sotalol af uses. Sotalol is a medication used to treat and prevent abnormal heart rhythms. Sotalol dosing is complicated and confusing, with many different factors affecting the amount prescribed. Sotalol hydrochloride tablets usp af, 80 mg are white, capsuleshaped tablets, debossed to the left of bisect and 121 to the right of bisect on one side and plain on the other. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may. Sotalol prolonged the qt interval by 57% compared with metoprolol. Amiodarone and sotalol are commonly used for the maintenance of sinus rhythm, but the efficacy of these agents administered as highdose infusions for rapid conversion of atrial fibrillation is unknown. After successful cardioversion patients were randomized to receive placebo n114 or sotalol hydrochloride tablets af n118 at a starting dose of 80 mg twice daily. Sotalol af is a betablocker that affects the heart and circulation blood flow through arteries and veins. Raterhythm dosing table on the drug sotalol, including recommended dosage and major side effects. Take sotalol consistently, either with food or without food each time. Sotalol hydrochloride 160 mg tablets patient information leaflet. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
It also may mask symptoms of low blood glucose hypoglycemia. My understanding is that betapace or sotalol cannot be substituted for the af version but the af versioin can be subbed for the non af version because the package insert does have everything that the af package insert has plus the afib information. Sotalol is the generic form of the brandname drug betapace, used to treat a serious irregular heartbeat. Sotalol is an oral medication belonging to a group of medications known as antiarrhythmics. Betapace af sotalol hcl 6700802 to minimize the risk of induced arrhythmia, patients initiated or reinitiated on betapace 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. What is sotalol af betapace af, sotalol hydrochloride af. Sotalol crosses the blood brain barrier poorly, with cerebrospinal fluid concentrations only 10% of those in plasma. It is supplied as a white to offwhite, capsuleshaped, scored tablet for oral.
Sotalol, a methanesulfonanilide, is a class iii antiarrhythmic drug that is used for the treatment of both atrial and ventricular arrhythmias. Sotalol is also indicated for the treatment of documented lifethreatening. An estimation of glomerular filtration should be completed for patients who receive sotalol. Provides access to the latest drug monographs submitted to the food and drug administration fda. Its purpose is to slow the electrical impulses through the heart by blocking how potassium is able to leave the heart cell. Sotalol hydrochloride, is an antiarrhythmic drug with class ii. Check with your doctor right away if you are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, or weight gain. Sotalol betapace side effects, dosage, interactions. Package insert instructions must be followed accordingly. Rapid loading of sotalol or amiodarone for management of. Please see important safety information and full prescribing information on website. A local search option of this data can be found here. Use in this context would facilitate drug initiation in patients in whom ongoing prophylactic therapy is indicated.
Sotalol af is used to treat atrial fibrillation or heart flutter. The prescription medicine is in a class of drugs known as antiarrhythmics. Betapacebetapace af, sotalol oral solution, and sotalol injection are also contraindicated in sick sinus syndrome unless a functioning pacemaker is present, hypokalemia serum potassium less than 4 meql, andor a baseline qt interval more than 450 msec. Sotalol may cause high blood glucose, and the dosage of insulin or antidiabetic drugs may require adjustment. Click here to view a print quality pdf of this table. Sotalol af is used in people with atrial fibrillation or atrial flutter. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you. Sotalol is an antiarrhythmic drug with class ii betaadrenoreceptor blocking and class iii cardiac action potential duration prolongation properties. The study was discontinued early because of a significantly higher mortality rate in the sotalol group. If you need to break sotalol sandoz 80mg tablets into two halves, place on a flat surface and press down on the scored side with the forefinger. Sotalol fda prescribing information, side effects and uses. Sotalol hydrochloride injection is an aqueous formulation of sotalol hydrochloride for intravenous use. It is only recommended in those with significant abnormal heart rhythms due to potentially serious side effects.
Betapace af is distributed with a patient package insert that is appropriate for. Evidence does not support a decreased risk of death with long term. Sotalol hydrochloride, usp bayshore pharmaceuticals. Increase the dose as needed in increments of 80 mgday, every 3 days to a maximum 320. Generic sotalol cannot be substituted for betapace af due to different patient packaging, dosing information and labeling. A178522 this inhibition lengthens the duration of action potentials and the refractory period in the atria and ventricles. Accidental release measures contain spill and collect, as appropriate. Moderate use caution when administering sotalol together with betaagonists. Discharge patients on sotalol therapy from an inpatient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol. Capitals indicate lifethreatening, underlines indicate most frequent.
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