Sotalol

Brand names: Betapace AF™Betapace®Sorine™

Chemical formula:

Drug Forms:
• Sotalol Hydrochloride Oral tablet [Atrial Arrhythmias] (below)
• Sotalol tablets (Betapace®)
• Sotalol Hydrochloride Oral tablet

Español:
• Clorhidrato de sotalol, Tableta oral [Arritmia auricular]
• Tabletas de sotalol (Betapace®)
• Sotalol Clorhidrato, Tableta oral

Sotalol Hydrochloride Oral tablet [Atrial Arrhythmias]

What is this medicine?

SOTALOL (SOE ta lole) is a beta-blocker. Beta-blockers reduce the workload on the heart and help it to beat more regularly. This medicine is used to treat patients with an atrial heart arrhythmia such as atrial fibrillation. This medicine can help your heart return to and maintain a normal rhythm.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•diabetes
•heart or vessel disease like slow heart rate, worsening heart failure, heart block, sick sinus syndrome or Raynaud's disease
•history of low levels of potassium or magnesium
•kidney disease
•liver disease
•lung or breathing disease, like asthma or emphysema
•pheochromocytoma
•recent heart attack
•thyroid disease
•an unusual or allergic reaction to sotalol, other beta-blockers, medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly. This could lead to serious heart-related effects.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this medicine may be used in children for selected conditions precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
•amoxapine
•arsenic trioxide
•certain antibiotics like gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, sparfloxacin, telithromycin
•cisapride
•droperidol
•haloperidol
•hawthorn
•levomethadyl
•maprotiline
•medicines for malaria like chloroquine and halofantrine
•medicines to control heart rhythm
•methadone
•other beta-blockers like atenolol, metoprolol, propranolol and others
•pentamidine
•phenothiazines like prochlorperazine, perphenazine, thioridazine, and others
•pimozide
•ranolazine
•tricyclic antidepressants like amitriptyline, imipramine, nortriptyline, and others
•vardenafil
•ziprasidone

This medicine may also interact with the following medications:
•antacids
•certain antibiotics such as clarithromycin and erythromycin
•clonidine
•digoxin
•medicines for angina or high blood pressure
•medicines for colds and breathing difficulties
•medicines for diabetes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You will be started on this medicine in a specialized facility for the first two or more days of treatment. Visit your doctor or health care professional for regular checks on your progress. Check your heart rate and blood pressure regularly while you are taking this medicine. Ask your doctor or health care professional what your heart rate and blood pressure should be, and when you should contact him or her. Your doctor or health care professional also may schedule regular blood tests and electrocardiograms to check your progress.

Because your condition and the use of this medicine carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications, and doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or pain while you are taking this medicine without asking your doctor or health care professional for advice. Some ingredients may increase your blood pressure.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•chest pain
•cold, tingling, or numb hands or feet
•confusion
•diarrhea
•difficulty breathing, wheezing
•irregular heartbeat
•muscle aches and pains
•slow heart rate
•sweating
•swollen legs or ankles
•tremor, shakes
•vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•change in sex drive or performance
•mental depression
•nausea
•weakness or tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

1 : 1 mixture (racemate) Sotalol
Systematic (IUPAC) name
(RS)-N-{4-[1-hydroxy-2-(propan-2-ylamino)ethyl]phenyl}methanesulfonamide
Identifiers
CAS number	3930-20-9
ATC code	C07AA07
PubChem	5253
DrugBank	DB00489
Chemical data
Formula	C12H20N2O3S
Mol. mass	272.3624 g/mol
Pharmacokinetic data
Bioavailability	>95%
Metabolism	Not metabolised
Half life	12 hours
Excretion	Renal Lactic (In lactating females)
Therapeutic considerations
Pregnancy cat.	B(US)
Legal status	℞ Prescription only
Routes	oral
Y(what is this?)  (verify)

Sotalol (trade names Betapace and Betapace AF, Berlex Laboratories, Sotalex and Sotacor, Bristol-Myers Squibb) is a drug used in individuals with rhythm disturbances (cardiac arrhythmias) of the heart, and to treat hypertension in some individuals.

Sotalol is a non-selective beta blocker. It is also a potassium channel blocker and is therefore a class III anti-arrhythmic agent.

Indications

Sotalol is used to treat ventricular tachycardias^[1] as well as atrial fibrillation.^[2] Betapace AF is specifically labeled for atrial fibrillation.

Some evidence suggests that sotalol should be avoided in the setting of decreased ejection fraction due to an increased risk of death.^[3]

It has also been suggested that it be used in the prevention of atrial fibrillation.^[4]

While on sotalol patients may resume any physical activities.

References

1. ^ Boriani G, Lubinski A, Capucci A, et al. (December 2001). "A multicentre, double-blind randomized crossover comparative study on the efficacy and safety of dofetilide vs sotalol in patients with inducible sustained ventricular tachycardia and ischaemic heart disease". Eur. Heart J. 22 (23): 2180–91. doi:10.1053/euhj.2001.2679. PMID 11913480. http://eurheartj.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=11913480. 
2. ^ Singh BN, Singh SN, Reda DJ, et al. (May 2005). "Amiodarone versus sotalol for atrial fibrillation". N. Engl. J. Med. 352 (18): 1861–72. doi:10.1056/NEJMoa041705. PMID 15872201. http://content.nejm.org/cgi/pmidlookup?view=short&pmid=15872201&promo=ONFLNS19. 
3. ^ Waldo A, Camm A, deRuyter H, Friedman P, MacNeil D, Pauls J, Pitt B, Pratt C, Schwartz P, Veltri E (1996). "Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. The SWORD Investigators. Survival With Oral d-Sotalol". Lancet 348 (9019): 7–12. doi:10.1016/S0140-6736(96)02149-6. PMID 8691967. 
4. ^ Patel A, Dunning J (April 2005). "Is Sotalol more effective than standard beta-blockers for the prophylaxis of atrial fibrillation during cardiac surgery". Interact Cardiovasc Thorac Surg 4 (2): 147–50. doi:10.1510/icvts.2004.102152. PMID 17670378. http://icvts.ctsnetjournals.org/cgi/pmidlookup?view=long&pmid=17670378. 

v • d • e Adrenergics Receptor Ligands α α1 Agonists: Amidephrine • Cirazoline • Dopamine • Epinephrine (Adrenaline) • Etilefrine • Isoprenaline • Levonordefrin • Metaraminol • Methoxamine • Methyldopa • Norepinephrine (Noradrenaline) • Oxymetazoline • Phenylephrine Antagonists: Alfuzosin • Arotinolol • Carvedilol • Doxazosin • Indoramin • L-765,314 • Labetalol • Moxisylyte • Nantenine • Phentolamine • Phenoxybenzamine • Prazosin • Silodosin • Tamsulosin • Terazosin • Tolazoline • Trimazosin • Urapidil α2 Agonists: (R)-3-Nitrobiphenyline • 4-NEMD • Amitraz • Apraclonidine • Brimonidine • Clonidine • Detomidine • Dexmedetomidine • Dopamine • Epinephrine (Adrenaline) • Etilefrine • Guanabenz • Guanfacine • Guanethidine • Guanoxabenz • Levonordefrin • Lofexidine • Medetomidine • Methyldopa • Norepinephrine (Noradrenaline) • Octopamine • Romifidine • Tizanidine • Tolonidine • Xylazine • Xylometazoline Antagonists: 1-PP • Atipamezole • BRL-44408 • Buspirone • Cirazoline • Efaroxan • Gepirone • Idazoxan • Ipsapirone • Mianserin • Mirtazapine • NAN-190 • Phentolamine • Phenoxybenzamine • Rauwolscine • SB-269,970 • Setiptiline • Spiroxatrine • Tandospirone • Tolazoline • Yohimbine α? Agonists: Anisodamine • Ephedrine • Ergotamine • Indanidine • Mephentermine • Midodrine • Mivazerol • Naphazoline • Phenylpropanolamine • Pseudoephedrine • Rilmenidine • Synephrine • Talipexole • Tetrahydrozoline β β1 Agonists: Denopamine • Dobutamine • Dopamine • Epinephrine (Adrenaline) • Etilefrine • Levonordefrin • Methyldopa • Norepinephrine (Noradrenaline) Antagonists: Acebutolol • Alprenolol • Amosulalol • Arotinolol • Atenolol • Bupranolol • Carvedilol • Celiprolol • Betaxolol • Bisoprolol • Dichloroisoprenaline • Esmolol • Labetalol • Metipranolol • Metoprolol • Nadolol • Nebivolol • Oxprenolol • Penbutolol • Pindolol • Practolol • Pronethalol • Propranolol • Sotalol • Tertatolol • Timolol • Tilisolol • Xamoterol β2 Agonists: Arformoterol • Bambuterol • Bitolterol • Carbuterol • Clenbuterol • Dopamine • Dopexamine • Epinephrine (Adrenaline) • Etilefrine • Fenoterol • Formoterol • Hexoprenaline • Indacaterol • Levonordefrin • Levosalbutamol • Methyldopa • Norepinephrine (Noradrenaline) • Orciprenaline • Pirbuterol • Procaterol • Reproterol • Rimiterol • Ritodrine • Salbutamol (Albuterol) • Salmeterol • Terbutaline • Tulobuterol Antagonists: Alprenolol • Amosulalol • Arotinolol • Bupranolol • Butaxamine • Carvedilol • Dichloroisoprenaline • ICI 118551 • Labetalol • Metipranolol • Nadolol • Oxprenolol • Penbutolol • Pindolol • Pronethalol • Propranolol • Sotalol • Tertatolol • Timolol • Tilisolol β3 Agonists: Amibegron • Arotinolol • Dopamine • Epinephrine (Adrenaline) • Etilefrine • Labetalol • Levonordefrin • Methyldopa • Norepinephrine (Noradrenaline) • Solabegron Antagonists: Carvedilol • SR 59230A β? Agonists: Arbutamine • BAAM • Befunolol • Broxaterol • Buphenine • Cimaterol • Ephedrine • Higenamine • Isoetarine • Isoxsuprine • Mabuterol • Methoxyphenamine • Oxyfedrine • Prenalterol • Pseudoephedrine • Ractopamine • Tretoquinol • Zilpaterol • Zinterol Reuptake Inhibitors Plasmalemmal NET Inhibitors Norepinephrine Reuptake Inhibitors: Atomoxetine (Tomoxetine) • Ciclazindol • Mazindol • Nisoxetine • Reboxetine • Tandamine • Tapentadol • Viloxazine; Norepinephrine-Dopamine Reuptake Inhibitors: Amineptine • Bupropion (Amfebutamone) • Fencamine • Fencamfamine • Lefetamine • LR-5182 • Manifaxine • Methylphenidate • Nomifensine • O-2172 • Radafaxine; Serotonin-Norepinephrine Reuptake Inhibitors: Bicifadine • Desvenlafaxine • Duloxetine • Milnacipran • Sibutramine • Tramadol • Venlafaxine; Serotonin-Norepinephrine-Dopamine Reuptake Inhibitors: Brasofensine • Diclofensine • DOV-102,677 • DOV-21,947 • DOV-216,303 • JNJ-7925476 • JZ-IV-10 • Methylnaphthidate • Naphyrone • NS-2359 • PRC200-SS • SEP-225,289 • SEP-227,162 • Tesofensine; Tricyclic Antidepressants: Amitriptyline • Butriptyline • Cianopramine • Clomipramine • Desipramine • Dosulepin • Doxepin • Imipramine • Lofepramine • Nortriptyline • Protriptyline • Trimipramine; Tetracyclic Antidepressants: Amoxapine • Maprotiline • Mianserin • Oxaprotiline; Others: Cocaine • Nefazodone • Nefopam • Ziprasidone TRPC6 Activators Adhyperforin • Hyperforin Vesicular VMAT Inhibitors Ibogaine • Reserpine • Tetrabenazine Releasing Agents Oxazolines: 4-Methylaminorex (4-MAR, 4-MAX) • Aminorex • Clominorex • Cyclazodone • Fenozolone • Fluminorex • Pemoline • Thozalinone; Phenethylamines (also Amphetamines, Cathinones, Phentermines, etc): 2-Hydroxyphenethylamine (2-OH-PEA) • 4-Methylamphetamine (4-MA) • 4-Methylmethamphetamine (4-MMA) • Alfetamine • Amphetamine (Dextroamphetamine, Levoamphetamine) • Amphetaminil • Amfepentorex • β-Methylphenethylamine (β-Me-PEA) • Benzodioxolylbutanamine (BDB) • Benzodioxolylhydroxybutanamine (BOH) • Benzphetamine • Buphedrone • Butylone • Cathine • Cathinone • Clobenzorex • Clortermine • Diethylcathinone (Diethylpropion, Amfepramone) • Dimethoxyamphetamine (DMA) • Dimethoxymethamphetamine (DMMA) • Dimethylamphetamine • Dimethylcathinone (Dimethylpropion, Metamfepramone) • Ephedrine (EPH) • Ethcathinone (Ethylpropion) • Ethylamphetamine • Ethylbenzodioxolylbutanamine (EBDB) • Ethylone • Fenethylline • Fenproporex • Flephedrone • Fludorex • Furfenorex • Hordenine • Indanorex • Indanylamphetamine (IAP) • Lisdexamfetamine • Lophophine (Homomyristicylamine) • Mefenorex • Mephedrone • Mephentermine • Methamphetamine (Desoxyephedrine, Methedrine; Dextromethamphetamine, Levomethamphetamine) • Methcathinone (Methylpropion) • Methedrone • Methoxymethylenedioxyamphetamine (MMDA) • Methoxymethylenedioxymethamphetamine (MMDMA) • Methylbenzodioxolylbutanamine (MBDB) • Methylenedioxyamphetamine (MDA; Tenamfetamine) • Methylenedioxyethylamphetamine (MDEA) • Methylenedioxyhydroxyamphetamine (MDOH) • Methylenedioxymethamphetamine (MDMA) • Methylenedioxymethylphenethylamine (MDMPEA; Homarylamine) • Methylenedioxyphenethylamine (MDPEA; Homopiperonylamine) • Methylone • Naphthylamphetamine (NAP) • Ortetamine • Oxaflozane • Parabromoamphetamine (PBA) • Parachloroamphetamine (PCA) • Parafluoroamphetamine (PFA) • Parafluoromethamphetamine (PFMA) • Parahydroxyamphetamine (PHA) • Paraiodoamphetamine (PIA) • Paramethoxyamphetamine (PMA) • Paramethoxyethylamphetamine (PMEA) • Paramethoxymethamphetamine (PMMA) • Paredrine (Norpholedrine, Oxamphetamine) • Phendimetrazine • Phenethylamine (PEA) • Phenmetrazine • Pholedrine • Phenpentermine • Phenpromethamine • Phentermine • Phenylpropanolamine (PPA) • Propylamphetamine • Pseudoephedrine (PSE) • Tiflorex (Flutiorex) • Tyramine (TRA) • Xylopropamine • Zylofuramine; Piperazines: 2,5-Dimethoxy-4-bromobenzylpiperazine (2C-B-BZP) • Benzylpiperazine (BZP) • Methoxyphenylpiperazine (MeOPP; Paraperazine) • Methylbenzylpiperazine (MBZP) • Methylenedioxybenzylpiperazine (MDBZP; Piperonylpiperazine) • Parafluorophenylpiperazine (pFPP; Fluoperazine); Others: 2-Aminoindane (2-AI) • 2-Aminotetralin (2-AT) • 2-Benzylpiperidine (2-BP) • 4-Benzylpiperidine (4-BP) • Clofenciclan • Cyclopentamine • Cypenamine • Cyprodenate • Feprosidnine • Gilutensin • Heptaminol • Hexacyclonate • Isometheptene • Methylhexanamine • Octodrine • Phthalimidopropiophenone • Propylhexedrine (PHX) • Tuaminoheptane (Tuamine) Enzyme Inhibitors Anabolism PAH Inhibitors 3,4-Dihydroxystyrene TH Inhibitors 3-Iodotyrosine • Aquayamycin • Bulbocapnine • Metirosine • Oudenone AAAD Inhibitors Benserazide • Carbidopa DBH Inhibitors Disulfiram • Nepicastat • Tropolone PNMT Inhibitors CGS-19281A • SKF-64139 • SKF-7698 Catabolism MAO Inhibitors Nonselective: Etryptamine • Furazolidone • Hydralazine • Iproclozide • Iproniazid • Isocarboxazid • Isoniazid • Linezolid • Mebanazine • Metryptamine • Nialamide • Phenelzine • Pheniprazine • Phenoxypropazine • Pivalylbenzhydrazine • Procarbazine • Safrazine • Tranylcypromine; MAO-A Selective: Befloxatone • Brofaromine • Cimoxatone • Clorgiline • Harmala Alkaloids (Harmine, Harmaline, Tetrahydroharmine, etc) • Minaprine • Moclobemide • Pirlindole • Toloxatone • Tyrima; MAO-B Selective: Lazabemide • Pargyline • Rasagiline • Selegiline * Note that MAO-B inhibitors also influence norepinephrine/epinephrine levels since they inhibit the breakdown of their precursor dopamine. COMT Inhibitors Entacapone • Tolcapone Others Precursors L-Phenylalanine → L-Tyrosine → L-DOPA (Levodopa) → Dopamine • L-DOPS (Droxidopa) Cofactors Ferrous Iron (Fe2+) • S-Adenosyl-L-Methionine • Vitamin B3 (Niacin, Nicotinamide → NADPH) • Vitamin B6 (Pyridoxine, Pyridoxamine, Pyridoxal → Pyridoxal Phosphate) • Vitamin B9 (Folic Acid → Tetrahydrofolic Acid) • Vitamin C (Ascorbic Acid) • Zinc (Zn2+) Others Activity Enhancers: Benzofuranylpropylaminopentane (BPAP) • Phenylpropylaminopentane (PPAP); Release Blockers: Bretylium • Guanethidine

v • d • e Channel blocker: potassium channel blockers Antiarrhythmic III/delayed rectifier benzofuran (Amiodarone) • quaternary ammonium (Bretylium) • naphthalene (Bunaftine) • phenethylamine (Dofetilide) • sulfonamide (Ibutilide) • pyrimidinone (Nifekalant) • ethanolamine (Sotalol) • cyclopropane (Tedisamil) • E-4031 Other/ungrouped/unknown aminopyridine (3,4-Diaminopyridine, 4-Aminopyridine) • indole (Linopirdine, Paxilline)  • quaternary ammonium (Tetraethylammonium) • peptide (Maurotoxin, Charybdotoxin)

v • d • e Antiarrhythmic agents (C01B) Channel blockers class I (Na+ channel blockers) class Ia (Phase 0→ and Phase 3→) Procainamide # • Quinidine # • Ajmaline • Disopyramide • Prajmaline • Sparteine class Ib (Phase 3←) IV (Lidocaine #) • enteral (Mexiletine, Tocainide, Aprindine) class Ic (Phase 0→) Encainide • Flecainide • Lorcainide • Moricizine • Propafenone class III (Phase 3→, K+ channel blockers) Amiodarone • Bretylium • Bunaftine • Dofetilide • Ibutilide • Nifekalant • Sotalol • Tedisamil • E-4031 class IV (Phase 4→, Ca2+ channel blockers) Verapamil # • Diltiazem Receptor agonists and antagonists class II (Phase 4→, β blockers) Propranolol • Nadolol • Pindolol • cardioselective (Atenolol, Metoprolol, Acebutolol, Esmolol) A1 agonist Adenosine M2 muscarinic antagonist: Atropine • Quinidine • Disopyramide muscarinic agonist: Digoxin α receptors Quinidine • Verapamil • Amiodarone • Bretylium Ion transporters Na+ / K+-ATPase Digoxin # = WHO-EM

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