Sorine

Name: Sorine

What is Sorine (sotalol)?

Sotalol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Sotalol is used to help keep the heart beating normally in people with certain heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation.

Another form of this medicine, called sotalol AF, is used to treat heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter.

Sotalol (Betapace, Sorine, Sotylize) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol may also be used for purposes not listed in this medication guide.

Before Using Sorine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sotalol in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sotalol oral solution in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

No information is available on the relationship of age to the effects of sotalol tablets in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Fingolimod
  • Grepafloxacin
  • Levomethadyl
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Vernakalant
  • Ziprasidone

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

  • Acecainide
  • Acetazolamide
  • Alfuzosin
  • Amiloride
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Azithromycin
  • Azosemide
  • Bedaquiline
  • Bemetizide
  • Bendroflumethiazide
  • Benzthiazide
  • Bumetanide
  • Buserelin
  • Canrenoate
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Chlorthalidone
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonidine
  • Clopamide
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Cyclothiazide
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dibenzepin
  • Digoxin
  • Diltiazem
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Encainide
  • Enflurane
  • Epinephrine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Ethacrynic Acid
  • Etozolin
  • Famotidine
  • Felbamate
  • Fenoldopam
  • Fenquizone
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Furosemide
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Histrelin
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indacaterol
  • Indapamide
  • Indecainide
  • Isoflurane
  • Isradipine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lacosamide
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lidocaine
  • Lidoflazine
  • Lopinavir
  • Lumefantrine
  • Mannitol
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metolazone
  • Metronidazole
  • Mexiletine
  • Mifepristone
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Oxymetazoline
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Piretanide
  • Pitolisant
  • Polythiazide
  • Posaconazole
  • Prilocaine
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinethazone
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Risperidone
  • Ritonavir
  • Rivastigmine
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Spiramycin
  • Spironolactone
  • Sulfamethoxazole
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Ticrynafen
  • Tizanidine
  • Tocainide
  • Tolterodine
  • Toremifene
  • Torsemide
  • Trazodone
  • Triamterene
  • Trichlormethiazide
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Xipamide
  • Zolmitriptan
  • Zotepine
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs 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 of the medicines.

  • Abarelix
  • Acarbose
  • Aceclofenac
  • Acemetacin
  • Albiglutide
  • Alogliptin
  • Amtolmetin Guacil
  • Arbutamine
  • Aspirin
  • Bromfenac
  • Bufexamac
  • Bunazosin
  • Canagliflozin
  • Celecoxib
  • Chlorpropamide
  • Choline Salicylate
  • Clonixin
  • Dapagliflozin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Doxazosin
  • Droxicam
  • Dulaglutide
  • Empagliflozin
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Exenatide
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Glimepiride
  • Glipizide
  • Glyburide
  • Ibuprofen
  • Indomethacin
  • Insulin Aspart, Recombinant
  • Insulin Degludec
  • Insulin Detemir
  • Insulin Glargine, Recombinant
  • Insulin Glulisine
  • Insulin Human Inhaled
  • Insulin Human Isophane (NPH)
  • Insulin Human Regular
  • Insulin Lispro, Recombinant
  • Ketoprofen
  • Ketorolac
  • Linagliptin
  • Liraglutide
  • Lixisenatide
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Metformin
  • Methyldopa
  • Mibefradil
  • Miglitol
  • Morniflumate
  • Moxisylyte
  • Nabumetone
  • Naproxen
  • Nateglinide
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenoxybenzamine
  • Phentolamine
  • Phenylbutazone
  • Piketoprofen
  • Pioglitazone
  • Piroxicam
  • Pramlintide
  • Pranoprofen
  • Prazosin
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Repaglinide
  • Rofecoxib
  • Rosiglitazone
  • Salicylic Acid
  • Salsalate
  • Saxagliptin
  • Sitagliptin
  • Sodium Salicylate
  • St John's Wort
  • Sulindac
  • Tamsulosin
  • Tenoxicam
  • Terazosin
  • Tiaprofenic Acid
  • Tolazamide
  • Tolbutamide
  • Tolfenamic Acid
  • Tolmetin
  • Trimazosin
  • Urapidil
  • Valdecoxib
  • Vildagliptin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Angina or
  • Bronchospasm or
  • Heart attack, recent or
  • Heart disease (eg, coronary insufficiency, heart failure, ischemic heart disease) or
  • Heart rhythm problem (eg, QT prolongation) or
  • Hypomagnesemia (low magnesium levels in the blood) or
  • Hypotension (low blood pressure)—Use with caution. May make these conditions worse.
  • Asthma or
  • Bradycardia (slow heartbeat), without a pacemaker or
  • Cardiogenic shock (shock caused by heart attack) or
  • Heart block, without a pacemaker or
  • Heart failure, uncontrolled or
  • Heart rhythm problem (eg, long QT syndrome) or
  • Hypokalemia (low potassium levels in the blood) or
  • Kidney disease, severe or
  • Sick sinus syndrome (type of abnormal heart rhythm), without a pacemaker or—Should not be used in patients with these conditions.
  • Diabetes or
  • Hyperthyroidism (overactive thyroid) or
  • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Lung disease (eg, bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition.

Uses of Sorine

  • It is used to treat certain types of life-threatening abnormal heartbeats.
  • It is used to keep a normal heartbeat in people who have a certain type of abnormal heartbeat (atrial fibrillation or atrial flutter).

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sorine?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • If a liquid (suspension) is made from the tablets, store at room temperature. Throw away any part not used after 3 months.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Dosage Forms and Strengths

Sorine (sotalol hydrochloride tablets, USP) are supplied as white capsule-shaped, scored tablets:

  • 80 mg tablets are imprinted "US" to the left and "12" to the right of the score and "80" on the unscored side.
  • 120 mg tablets are imprinted "US" to the left and "13" to the right of the score and "120" on the unscored side.
  • 160 mg tablets are imprinted "US" to the left and "14" to the right of the score and "160" on the unscored side.
  • 240 mg tablets are imprinted "US" to the left and "15" to the right of the score and "240" on the unscored side.

Drug Interactions

Antiarrhythmics and other QT Prolonging Drugs

Sotalol has not been studied with other drugs that prolong the QT interval such as antiarrhythmics, some phenothiazines, tricyclic antidepressants, certain oral macrolides and certain quinolone antibiotics. Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with sotalol hydrochloride, because of their potential to prolong refractoriness [see Warnings and Precautions (5.2)]. There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with sotalol hydrochloride.

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. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Calcium-Channel Blocking Drugs

Sotalol and calcium-blocking drugs can be expected to have additive effects on atrioventricular conduction or ventricular function. Monitor such patients for evidence of bradycardia and 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. Monitor such patients 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 [see Warnings and Precautions 5.7)].

Clonidine

Concomitant use with sotalol increases the risk of bradycardia. Because beta-blockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.

Antacids

Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.

PRINCIPAL DISPLAY PANEL - 80 mg Tablet Bottle Label

NDC 0245-0012-11

Sorine®
(Sotalol Hydrochloride
Tablets, USP)

80 mg

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 160 mg Tablet Bottle Label

NDC 0245-0014-11

Sorine®
(Sotalol Hydrochloride
Tablets, USP)

160 mg

100 Tablets
Rx only

UPSHER-SMITH

For the Consumer

Applies to sotalol: oral solution, oral tablet

Other dosage forms:

  • intravenous solution

Along with its needed effects, sotalol (the active ingredient contained in Sorine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sotalol:

More common
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • lightheadedness, dizziness, or fainting
  • nausea and vomiting
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain or swelling
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cough or hoarseness
  • decreased alertness
  • difficulty with speaking
  • dilated neck veins
  • double vision
  • extreme fatigue
  • feeling of warmth or heat
  • fever or chills
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irregular breathing
  • joint pain or swelling
  • loss of voice
  • lower back or side pain
  • nervousness
  • noisy breathing
  • painful, burning, or difficult urination
  • pounding in the ears
  • slow speech
  • weight gain
Rare
  • Fast breathing
  • pinpoint red spots on the skin

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

Symptoms of overdose
  • Anxiety
  • cold sweats
  • cool, pale skin
  • depression
  • increased hunger
  • nightmares
  • seizures
  • shakiness
  • slurred speech

Some side effects of sotalol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. 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:

More common
  • Acid or sour stomach
  • difficulty with sleeping
  • heartburn or indigestion
  • pain in the arms or legs
Less common
  • Changes in vision
  • decreased sexual performance or desire
  • loss of appetite
  • mood changes
  • night blindness
  • passing gas
  • skin rash
  • weight changes
Rare
  • Feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • itching skin
  • muscle aching or cramping
  • muscle pains or stiffness
  • quick to react or overreact emotionally
  • sensation of spinning
  • severe sunburn

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