Sotalol Hydrochloride Oral solution

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 heart rhythm problems and to slow rapid heartbeats. This medicine can help your heart to 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. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. 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 if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines to control heart rhythm

• methadone

• 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

• other beta-blockers like atenolol, metoprolol, propranolol and others

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?

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 these 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Sotalol Hydrochloride Oral tablet

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 heart rhythm problems and to slow rapid heartbeats. This medicine can help your heart to 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

• kidney disease

• liver disease

• history of low levels of potassium or magnesium

• 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 if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines to control heart rhythm

• methadone

• 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

• other beta-blockers like atenolol, metoprolol, propranolol and others

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?

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:

• chest pain

• cold, tingling, or numb hands or feet

• confusion

• diarrhea

• difficulty breathing, wheezing

• irregular heartbeat

• muscle aches and pains

• skin rash

• 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.

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 if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines to control heart rhythm

• methadone

• 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

• other beta-blockers like atenolol, metoprolol, propranolol and others

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.

Sotalol Hydrochloride Solution for injection

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 heart rhythm problems and to slow rapid heartbeats. This medicine can help your heart to 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 low blood pressure, slow heart rate, worsening heart failure, heart block, sick sinus syndrome, or Raynaud's disease

• kidney disease

• history of low levels of potassium or magnesium

• lung or breathing disease, like asthma or emphysema

• pheochromocytoma

• recent heart attack

• thyroid disease

• an unusual or allergic reaction to sotalol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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 if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amoxapine

• arsenic trioxide

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• cisapride

• droperidol

• haloperidol

• hawthorn

• medicines for malaria like chloroquine and halofantrine

• medicines to control heart rhythm like amiodarone, disopyramide, dofetilide, flecainide, ibutilide, propafenone

• methadone

• pentamidine

• pimozide

• phenothiazines like prochlorperazine, perphenazine, thioridazine, and others

• pimozide

• ranolazine

• tricyclic antidepressants like amitriptyline, imipramine, nortriptyline, and others

• troleandomycin

• ziprasidone

This medicine may also interact with the following medications:

• clonidine

• digoxin

• guanethidine

• medicines for angina or high blood pressure like diltiazem or verapamil

• medicines for colds and breathing difficulties

• medicines for diabetes

• other beta-blockers like atenolol, metoprolol, propranolol and others

• reserpine

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?

Your condition will be monitored carefully while you are receiving 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 these 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?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.