Sotylize (orally)

Sotylize (orally)

Sotylize (oral) Oral route (solution)

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on oral sotalol or converted from intravenous sotalol to oral administration should be placed in a facility that provides cardiac resuscitation, continuous electrocardiographic monitoring, and creatinine clearance calculations. Sotalol can cause life-threatening ventricular tachycardia associated with QT prolongation. Do not initiate sotalol therapy if the baseline QTc is greater than 450 ms. If the QT interval prolongs to 500 ms or more, the dose must be reduced, the interval between doses increased, or the drug discontinued. Adjust dosing interval based on creatinine clearance.

Oral route (tablet)

To minimize the risk of drug-induced cardiac arrhythmia, sotalol should be initiated or restarted in a facility that allows cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT prolongation. If the QT interval prolongs to 500 ms or more, reduce the dose, extend the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosage.

Uses for Sotylize

Sotalol is a beta blocker. It works by affecting the response to nerve impulses in certain parts of the body, such as the heart. This causes the heart to beat slower and at a more consistent rhythm.

This medicine is only available with a doctor's prescription.

Before using Sotylize

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of sotalol in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the usefulness of sotalol oral solution or Betapace® and Betapace® AF tablets in the elderly. However, older patients are at higher risk of age-related kidney problems, which may require caution and dose adjustment in patients receiving this drug.

There is no information on the relationship between age and the effects of sotalol tablets in geriatric patients.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Bepridil
• Cisaprid
• Dronedaron
• Fingolimod
• Grepafloxacin
• Levoketoconazol
• Levomethadyl
• Mesoridazin
• Pimozid
• Piperaquin
• Saquinavir
• Sparfloxacin
• Terfenadin
• Thioridazin
• Vernakalant
• Ziprasidon

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acecainid
• Acetazolamid
• Adagrasib
• Albuterol
• Alfuzosin
• Amilorid
• Amiodaron
• Amisulprid
• Amitriptylin
• Amoxapin
• Anagrelid
• Apomorphin
• Arformoterol
• Aripiprazol
• Aripiprazol Lauroxil
• Arsentrioxid
• Artemether
• Asenapin
• Astemizol
• Atazanavir
• Azithromycin
• Azosemid
• Bambuterol
• Bedaquilin
• Bemetizid
• Bendroflumethiazid
• Benzthiazid
• Bitolterol
• Broxaterol
• Bumetanid
• Buprenorphin
• Buserelin
• Canrenoate
• Ceritinib
• Chloralhydrat
• Chloroquin
• Chlorpromazin
• Chlorthalidon
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clenbuterol
• Clofazimin
• Clomipramin
• Clonidin
• Clopamid
• Clotiapin
• Clozapin
• Colterol
• Crizotinib
• Cyclobenzaprin
• Cyclothiazid
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramin
• Deslorelin
• Deutetrabenazin
• Dexmedetomidin
• Dibenzepin
• Digoxin
• Diltiazem
• Disopyramid
• Dofetilid
• Dolasetron
• Domperidon
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Eliglustat
• Encainid
• Encorafenib
• Enfluran
• Entrectinib
• Adrenalin
• Eribulin
• Erythromycin
• Escitalopram
• Ethacrynsäure
• Etozolin
• Etrasimod
• Famotidin
• Felbamat
• Fenoldopam
• Fenoterol
• Fenquizon
• Fexinidazol
• Flecainid
• Fluconazol
• Fluoxetin
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemid
• Galantamin
• Gatifloxacin
• Gemifloxacin
• Gepiron
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrin
• Haloperidol
• Halothan
• Hexoprenalin
• Histrelin
• Hydrochlorothiazid
• Hydroflumethiazid
• Hydrochinidin
• Hydroxychloroquin
• Hydroxyzin
• Ibutilid
• Iloperidon
• Imipramin
• Indacaterol
• Indapamid
• Indecainid
• Inotuzumab Ozogamicin
• Iobenguane I 131
• Iohexol
• Isoetharin
• Isofluran
• Isradipin
• Itraconazol
• Ivabradin
• Ivosidenib
• Ketoconazol
• Lacosamid
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolid
• Levalbuterol
• Levofloxacin
• Lidocain
• Lidoflazin
• Lofexidin
• Lopinavir
• Lumefantrin
• Macimorelin
• Mannit
• Mefloquin
• Metaproterenol
• Methadon
• Methotrimeprazin
• Metolazon
• Metronidazol
• Mexiletin
• Mifepriston
• Mirtazapin
• Mizolastin
• Moricizin
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptylin
• Octreotid
• Ofloxacin
• Olanzapin
• Olodaterol
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxymetazolin
• Ozanimod
• Pacritinib
• Paliperidon
• Panobinostat
• Papaverin
• Paroxetin
• Pasireotid
• Pazopanib
• Pentamidin
• Perphenazin
• Phenobarbital
• Pimavanserin
• Pipamperon
• Pirbuterol
• Piretanid
• Pitolisant
• Polythiazid
• Ponesimod
• Posaconazol
• Prilocain
• Primidon
• Probukol
• Procainamid
• Procaterol
• Prochlorperazin
• Promethazin
• Propafenon
• Protriptylin
• Quetiapin
• Quinethazon
• Chinidin
• Chinin
• Quizartinib
• Ranolazin
• Relugolix
• Reproterol
• Ribociclib
• Rimiterol
• Risperidon
• Ritodrin
• Ritonavir
• Rivastigmin
• Salmeterol
• Selpercatinib
• Sertindol
• Sertralin
• Sevofluran
• Siponimod
• Natriumphosphat
• Natriumphosphat, zweibasisch
• Natriumphosphat, einbasisch
• Solifenacin
• Sorafenib
• Spiramycin
• Spironolacton
• Sulfamethoxazol
• Sulpirid
• Sultoprid
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Terbutalin
• Tetrabenazin
• Ticrynafen
• Tocainid
• Tolterodin
• Toremifen
• Torsemid
• Trazodon
• Tretoquinol
• Triamteren
• Trichlormethiazid
• Triclabendazol
• Trifluoperazin
• Trimethoprim
• Trimipramin
• Triptorelin
• Tulobuterol
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxin
• Verapamil
• Vilanterol
• Vinflunin
• Voclosporin
• Voriconazol
• Vorinostat
• Xipamid
• Zolmitriptan
• Zotepin
• Zuclopenthixol

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Abarelix
• Acarbose
• Aceclofenac
• Acemetacin
• Albiglutid
• Alogliptin
• Aluminiumcarbonat, basisch
• Aluminiumhydroxid
• Aluminiumphosphat
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Canagliflozin
• Celecoxib
• Chlorpropamid
• Cholinsalicylat
• Clonixin
• Dapagliflozin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dihydroxyaluminiumaminoacetat
• Dihydroxyaluminium-Natriumcarbonat
• Dipyron
• Doxazosin
• Droxicam
• Dulaglutid
• Empagliflozin
• Ertugliflozin
• Etodolac
• Etofenamat
• Etoricoxib
• Exenatid
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazon
• Floctafenin
• Flufenaminsäure
• Flurbiprofen
• Glimepirid
• Glipizid
• Glyburid
• Ibuprofen
• Indomethacin
• Insulin Aspart, rekombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargin, rekombinant
• Insulin Glulisin
• Insulin menschlich inhaliert
• Insulin Human Isophan (NPH)
• Insulin Human Regular
• Insulin Lispro, rekombinant
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutid
• Lixisenatid
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magaldrat
• Magnesiumcarbonat
• Magnesiumhydroxid
• Magnesiumoxid
• Magnesiumperoxid
• Magnesiumtrisilikat
• Meclofenamat
• Mefenaminsäure
• Meloxicam
• Metformin
• Methyldopa
• Miglitol
• Morniflumate
• Moxisylyt
• Nabumeton
• Naproxen
• Nateglinid
• Nepafenac
• Nifluminsäure
• Nimesulid
• Nimesulid Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazon
• Parecoxib
• Phenoxybenzamin
• Phentolamin
• Phenylbutazon
• Piketoprofen
• Pioglitazon
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazon
• Proquazone
• Repaglinid
• Rofecoxib
• Rosiglitazon
• Salicylsäure
• Salsalat
• Saxagliptin
• Sitagliptin
• Natriumsalicylat
• Johanniskraut
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofensäure
• Tolazamid
• Tolbutamid
• Tolfenaminsäure
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Angina oder
• Bronchospasmus bzw
• Herzinfarkt, kürzlich oder
• Herzerkrankungen (z. B. Herzinsuffizienz, Herzinsuffizienz, ischämische Herzkrankheit) oder
• Herzrhythmusstörung (z. B. QT-Verlängerung) oder
• Hypomagnesiämie (niedriger Magnesiumspiegel im Blut) oder
• Hypotonie (niedriger Blutdruck) – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Asthma bzw
• Bradykardie (langsamer Herzschlag), ohne Herzschrittmacher oder
• Kardiogener Schock (Schock durch Herzinfarkt) oder
• Herzblock, ohne Herzschrittmacher oder
• Herzinsuffizienz, unkontrolliert oder
• Herzrhythmusstörung (z. B. langes QT-Syndrom) oder
• Hypokaliämie (niedriger Kaliumspiegel im Blut) oder
• Nierenerkrankung, schwere oder
• Sick-Sinus-Syndrom (Art der Herzrhythmusstörung), ohne Herzschrittmacher oder – sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

• Diabetes bzw
• Hyperthyreose (Schilddrüsenüberfunktion) oder
• Hypoglykämie (niedriger Blutzucker) – kann einige Anzeichen und Symptome dieser Krankheiten verdecken, wie z. B. einen schnellen Herzschlag.

• Nierenerkrankung – Mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

• Lungenerkrankung (z. B. Bronchitis, Emphysem) – Kann bei Patienten mit dieser Erkrankung zu Atembeschwerden führen.

Proper use of Sotylize

Only take this medicine as directed by your doctor. Do not take more of it, do not take it more often, or take it for longer than your doctor prescribed. If your supply of this medicine runs low, contact your doctor or pharmacist promptly. Do not let you run out of this medicine.

This medicine should be accompanied by a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

For the first three days, you will be given this medicine in a hospital where your heart rhythm can be monitored.

Your pharmacist may prepare the tablets into an oral liquid. Talk to your doctor or pharmacist if you have any concerns.

Measure the oral fluid using a marked measuring spoon, oral syringe, or medicine cup. The average teaspoon in the home may not hold the right amount of liquid.

If you are also taking an antacid made from aluminum or magnesium hydroxide, take it 2 hours before or 2 hours after taking sotalol.

Use only the brand of this medication that your doctor has prescribed for you. Different brands may not work the same way.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Bei Herzrhythmusstörungen:
  • Für orale Darreichungsformen (Lösung oder Tabletten):
    • Erwachsene – zunächst 80 Milligramm (mg) ein- oder zweimal täglich. Ihr Arzt kann Ihre Dosis bei Bedarf alle 3 Tage anpassen.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.
  • Für orale Darreichungsformen (Betapace® und Betapace® AF Tabletten):
    • Erwachsene – zunächst 80 Milligramm (mg) 2-mal täglich. Ihr Arzt kann Ihre Dosis bei Bedarf alle 3 Tage anpassen.
    • Kinder ab 2 Jahren: Die Dosis richtet sich nach dem Körpergewicht und muss von Ihrem Arzt festgelegt werden. Die Dosis beträgt zunächst üblicherweise 1,2 mg pro Kilogramm (kg) Körpergewicht dreimal täglich. Ihr Arzt kann Ihre Dosis je nach Bedarf anpassen. Allerdings beträgt die Dosis in der Regel nicht mehr als 2,4 mg pro kg Körpergewicht dreimal täglich.
    • Kinder unter 2 Jahren: Anwendung und Dosierung müssen von Ihrem Arzt festgelegt werden.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double the dose.

storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Protect from freezing.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using Sotylize

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood, urine and EKG tests are required to check for adverse effects.

Contact your doctor immediately if your heart rhythm changes. You may feel dizzy, faint, or have a fast, pounding, or irregular heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

This medicine may cause dizziness. Do not drive or do other dangerous activities until you know how this medicine affects you. Stand up slowly if you feel dizzy or lightheaded.

Do not stop or stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually reduce the amount you take before stopping it completely. Some medical conditions may worsen if the medicine is suddenly stopped, which can be dangerous.

Sotalol can cause heart failure in some patients. Contact your doctor immediately if you have chest pain or discomfort, enlarged neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet or lower legs, or weight gain.

This medicine may cause changes in your blood sugar levels. In addition, this medicine may cause signs of low blood sugar in patients who have diabetes or are fasting (e.g. surgery, irregular eating, vomiting), such as: B. a rapid pulse. Consult your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

Before you have surgery (including dental surgery) or emergency treatment, tell your doctor or dentist that you are using this medicine. You may need to stop using this medicine a few days before surgery or medical examination.

This medicine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor immediately if you experience rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or swelling of your hands, face, or mouth while using this medication.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of Sotylize

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

More common

• Verschwommene Sicht
• Brustschmerzen, Engegefühl oder Unbehagen
• Verwirrung
• schwieriges oder erschwertes Atmen
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• schneller, langsamer, unregelmäßiger, hämmernder oder rasender Herzschlag oder Puls
• Benommenheit, Schwindel oder Ohnmacht
• Übelkeit und Erbrechen
• Schwitzen
• Schwellung von Gesicht, Fingern, Füßen oder Unterschenkeln
• ungewöhnliche Müdigkeit oder Schwäche

Less common

• Körperschmerzen oder Schmerzen
• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Kribbeln, Kribbeln oder Kribbeln
• Husten oder Heiserkeit
• verminderte Aufmerksamkeit
• Schwierigkeiten beim Sprechen
• erweiterte Halsvenen
• Doppeltsehen
• Gefühl von Wärme oder Hitze
• Fieber oder Schüttelfrost
• Rötung oder Rötung der Haut, insbesondere im Gesicht und am Hals
• Kopfschmerzen
• Unfähigkeit, Arme, Beine oder Gesichtsmuskeln zu bewegen
• Unfähigkeit zu sprechen
• unregelmäßige Atmung
• Gelenkschmerzen oder Schwellung
• Verlust der Stimme
• Schmerzen im unteren Rücken oder an der Seite
• Nervosität
• lautes Atmen
• Schmerzen, Brennen oder Schwierigkeiten beim Wasserlassen
• in den Ohren hämmern
• langsame Rede
• Magenschmerzen oder Schwellung
• Gewichtszunahme

Rarely

• Schnelles Atmen
• Punktgenaue rote Flecken auf der Haut

Incident not known

• Schwarzer, teeriger Stuhl
• Zahnfleischbluten
• Blut im Urin oder Stuhl
• blaue Lippen und Fingernägel
• Husten, der manchmal einen rosafarbenen, schaumigen Auswurf erzeugt
• Weinen
• Verfolgungswahn, Misstrauen, Misstrauen oder Kampfbereitschaft
• falsches oder ungewöhnliches Wohlbefinden
• Gefühl der Unwirklichkeit
• mentale Depression
• nicht in der Lage, sich zu bewegen
• blasse Haut
• Punktgenaue rote Flecken auf der Haut
• schnell reagieren oder emotional überreagieren
• schnell wechselnde Stimmungen
• Gefühl der Loslösung von sich selbst oder dem Körper
• Halsentzündung
• Wunden, Geschwüre oder weiße Flecken auf den Lippen oder im Mund
• Schwellungen in den Beinen und Knöcheln
• geschwollene Drüsen
• ungewöhnliche Blutungen oder Blutergüsse

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Angst
• verschwommene Sicht
• Brustschmerzen oder Unwohlsein
• kalter Schweiß
• Verwirrung
• kühle, blasse Haut
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• Depression
• schneller, hämmernder oder unregelmäßiger Herzschlag oder Puls
• erhöhter Hunger
• Albträume
• Anfälle
• Zittern
• langsamer oder unregelmäßiger Herzschlag
• undeutliches Sprechen
• Schwitzen
• ungewöhnliche Müdigkeit oder Schwäche

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Saurer oder saurer Magen
• Schwierigkeiten beim Schlafen
• Sodbrennen oder Verdauungsstörungen
• Schmerzen in den Armen oder Beinen

Less common

• Veränderungen im Sehvermögen
• verminderte sexuelle Leistungsfähigkeit oder vermindertes sexuelles Verlangen
• Appetitverlust
• Stimmungsschwankungen
• nacht Blindheit
• Gas geben
• Hautausschlag
• Gewichtsveränderungen

Rarely

• Gefühl ständiger Bewegung von sich selbst oder der Umgebung
• Haarausfall oder Haarausfall
• juckende Haut
• Muskelschmerzen, Krämpfe, Schmerzen oder Steifheit
• schnell reagieren oder emotional überreagieren
• Gefühl des Drehens
• schwerer Sonnenbrand

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Betapace
• Betapace AF
• Sorine
• Sotylisieren

Available dosage forms:

• Tablette
• Lösung

Therapeutic class: cardiovascular agents

Pharmacological class: Beta-blockers, non-selective

• Was ist der Unterschied zwischen Sotalol und Sotalol AF?

More information