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Betapace (Sotalol)
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J49 Betapace (Sotalol) Generic 10 tabs 40 mg $8.60
Price is per pack & not per tab.. eg: if pack size is 10 tabs & price is $2.75 then for 100 tabs the price would be $27.50
What is sotalol?
Sotalol is in a group of drugs called beta-blockers. Beta-blockers affect 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 and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sotalol?
You will receive your first few doses of sotalol in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, you may need to temporarily stop using sotalol. Be sure the surgeon knows ahead of time that you are using sotalol.

What should I discuss with my healthcare provider before taking sotalol?
Do not use this medication if you are allergic to sotalol, or if you have:
asthma;

certain heart conditions, especially "AV block" (unless you have a pacemaker);

a history of "Long QT syndrome"; or

severe or uncontrolled congestive heart failure.

Before using sotalol, tell your doctor if you are allergic to any drugs, or if you have:

breathing problems such as bronchitis or emphysema;

a history of heart disease or congestive heart failure;

diabetes;

kidney disease;

a thyroid disorder;

an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or

if you have recently had a heart attack.

If you have any of these conditions, you may not be able to use sotalol, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sotalol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sotalol?
You will receive your first few doses of sotalol in a hospital setting where your heart can be monitored in case the medication causes serious side effects.

Take sotalol exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Take this medication with a full glass of water.

Take sotalol at the same time every day.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

Tell your doctor if you have an illness that involves diarrhea or vomiting lasting more than a few hours. Prolonged diarrhea or vomiting can lower your potassium levels, making it dangerous for you to use sotalol.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested.

Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using sotalol.

If you need to have any type of surgery, tell the surgeon that you are using sotalol. You may need to briefly stop using sotalol before having surgery.

Store sotalol at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a sotalol overdose may include slow or fast heartbeats, shortness of breath, chest pain, swelling, hunger, weakness, confusion, sweating, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while taking sotalol?
Do not take an antacid within 2 hours before or after taking sotalol. Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol.

Sotalol side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

fast or pounding heartbeat, chest pain, shortness of breath;

feeling light-headed, fainting;

slow heartbeat;

unusual sweating, increased thirst; or

swelling, rapid weight gain.

Other less serious side effects are more likely to occur, such as:

mild diarrhea, nausea, vomiting;

headache;

sleep problems (insomnia); or

tired feeling.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Sotalol Dosing Information
Usual Adult Dose for Atrial Fibrillation:

Betapace:

Initial: 80 mg twice daily.

The initial dose may be increased 120 to 160 mg twice daily. The dosage should be adjusted gradually allowing 3 days between dosing increments in order to attain steady-state plasma concentrations and to allow monitoring of QT intervals. Graded dose adjustment will help prevent doses that are higher than necessary to control the arrhythmia. Most patients obtain a therapeutic response with a total daily dose of 160 to 320 mg given in two or three divided doses.

Usual Adult Dose for Atrial Flutter:

Betapace:

Initial: 80 mg twice daily.

The initial dose may be increased 120 to 160 mg twice daily. The dosage should be adjusted gradually allowing 3 days between dosing increments in order to attain steady-state plasma concentrations and to allow monitoring of QT intervals. Graded dose adjustment will help prevent doses that are higher than necessary to control the arrhythmia. Most patients obtain a therapeutic response with a total daily dose of 160 to 320 mg given in two or three divided doses.

Usual Adult Dose for Ventricular Arrhythmia:

Betapace AF:

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

If the 80 mg dose level is tolerated and the QT interval remains less than 500 msec after at least 3 days (after 5 or 6 doses if patient receiving once-daily dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg twice daily and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving once-daily doses).

If the 80 mg dose level (given twice a day or once-daily depending upon the creatinine clearance) does not reduce the frequency of relapses of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (i.e., greater than or equal to 520 msec), the dose level may be increased to 120 mg (twice a day or once-daily depending upon the creatinine clearance).

Maintenance dose: 120 to 160 mg orally 2 times a day. Renal function and QT should be reevaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is greater than 100 msec), the dose of sotalol should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is greater than or equal to 520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued.

Usual Pediatric Dose for Atrial Fibrillation:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day).
Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

1 year or younger:

The dosage recommended for children less than two years of age should be determined using the manufacturer's logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer's labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Usual Pediatric Dose for Atrial Flutter:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day).
Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

1 year or younger:

The dosage recommended for children less than two years of age should be determined using the manufacturer's logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer's labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Usual Pediatric Dose for Ventricular Arrhythmia:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day).
Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

1 year or younger:

The dosage recommended for children less than two years of age should be determined using the manufacturer's logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer's labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

What other drugs will affect sotalol?
Before taking sotalol, tell your doctor if you are using:

clonidine (Catapres);

digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);

guanethidine (Ismelin);

reserpine;

a diuretic (water pill);

drugs that can affect heart rhythm, such as bepridil (Vascor), cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);

any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), sotalol (Betapace);

antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);

medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);

a phenothiazine such as chlorpromazine (Thorazine), mesoridazine (Serentil), thioridazine (Mellaril), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine), trifluoperazine (Stelazine);

antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), trimipramine (Surmontil);

a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);

a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), verapamil (Calan, Covera, Isoptin, Verelan); or

medicine for asthma other breathing disorders, such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair).

If you are using any of these drugs, you may not be able to take sotalol, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect sotalol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?
Your pharmacist has additional information about sotalol written for health professionals that you may read.

 

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