Procainamide Hydrochloride Oral capsule

What is this medicine?

PROCAINAMIDE (proe kane A mide) is an antiarrhythmic drug. It helps make your heart beat regularly. This medicine also helps to slow rapid heartbeats.

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:

• anemia or blood disease

• heart disease or previous heart attack

• immune system problems, like lupus

• kidney disease

• liver disease

• low blood pressure

• myasthenia gravis

• an unusual or allergic reaction to procainamide, procaine, other 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 may cause serious, heart-related side effects. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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

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:

• abarelix

• amoxapine

• apomorphine

• arsenic trioxide

• certain macrolide antibiotics

• certain quinolone antibiotics

• cisapride

• droperidol

• haloperidol

• hawthorn

• levomethadyl

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines for mental depression such as tricyclic antidepressants

• methadone

• other medicines to control heart rhythm

• pentamidine

• phenothiazines like chlorpromazine, mesoridazine, and thioridazine

• pimozide

• probucol

• ranolazine

• sertindole

• vardenafil

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• ranitidine

• succinylcholine

• trimethoprim

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 closely when you first begin therapy. Often, this drug is first started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your doctor or health care professional for regular checks on your progress. Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

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.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 may interfere with the effect of this medicine. Avoid alcoholic drinks.

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

• breathing problems

• changes in behavior, mood, or mental ability including mental depression

• chest pain, palpitations

• confusion

• dark yellow or brown urine

• feeling faint or lightheaded

• fever, chills, or sore throat

• hallucinations

• irregular or fast heartbeat

• joint or muscle pain

• swelling of feet or legs

• tingling or numbness in the hands or feet

• unusual bruising, bleeding, or pinpoint red spots on the skin

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• loss of appetite

• nausea

• stomach pain

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). Keep container tightly closed. Protect from moisture. Throw away any unused medicine after the expiration date.

Procainamide Hydrochloride Oral tablet

What is this medicine?

PROCAINAMIDE (proe kane A mide) is an antiarrhythmic drug. It helps make your heart beat regularly. This medicine also helps to slow rapid heartbeats.

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:

• anemia or blood disease

• heart disease or previous heart attack

• immune system problems, like lupus

• kidney disease

• liver disease

• low blood pressure

• myasthenia gravis

• an unusual or allergic reaction to procainamide, procaine, other 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 may cause serious, heart-related side effects. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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

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:

• abarelix

• amoxapine

• apomorphine

• arsenic trioxide

• certain macrolide antibiotics

• certain quinolone antibiotics

• cisapride

• droperidol

• haloperidol

• hawthorn

• levomethadyl

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines for mental depression such as tricyclic antidepressants

• methadone

• other medicines to control heart rhythm

• pentamidine

• phenothiazines like chlorpromazine, mesoridazine, and thioridazine

• pimozide

• probucol

• ranolazine

• sertindole

• vardenafil

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• ranitidine

• succinylcholine

• trimethoprim

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 closely when you first begin therapy. Often, this drug is first started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your doctor or health care professional for regular checks on your progress. Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

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.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 may interfere with the effect of this medicine. Avoid alcoholic drinks.

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

• breathing problems

• changes in behavior, mood, or mental ability including mental depression

• chest pain, palpitations

• confusion

• dark yellow or brown urine

• feeling faint or lightheaded

• fever, chills, or sore throat

• hallucinations

• irregular or fast heartbeat

• joint or muscle pain

• swelling of feet or legs

• tingling or numbness in the hands or feet

• unusual bruising, bleeding, or pinpoint red spots on the skin

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• loss of appetite

• nausea

• stomach pain

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). Keep container tightly closed. Protect from moisture. Throw away any unused medicine after the expiration date.

Procainamide Hydrochloride Oral tablet, extended-release

What is this medicine?

PROCAINAMIDE (proe kane A mide) is an antiarrhythmic drug. It helps make your heart beat regularly. This medicine also helps to slow rapid heartbeats.

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:

• anemia or blood disease

• heart disease or previous heart attack

• immune system problems, like lupus

• kidney disease

• liver disease

• low blood pressure

• myasthenia gravis

• an unusual or allergic reaction to procainamide, procaine, other 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. Do not cut, crush or chew this medicine. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly. This may cause serious, heart-related side effects. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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

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:

• abarelix

• amoxapine

• apomorphine

• arsenic trioxide

• certain macrolide antibiotics

• certain quinolone antibiotics

• cisapride

• droperidol

• haloperidol

• hawthorn

• levomethadyl

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines for mental depression such as tricyclic antidepressants

• methadone

• pentamidine

• other medicines to control heart rhythm

• phenothiazines like chlorpromazine, mesoridazine, and thioridazine

• pimozide

• probucol

• ranolazine

• sertindole

• vardenafil

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• ranitidine

• succinylcholine

• trimethoprim

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 closely when you first begin therapy. Often, this drug is first started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your doctor or health care professional for regular checks on your progress. Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

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.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 may interfere with the effect of this medicine. Avoid alcoholic drinks.

The tablet shell for some brands of this medicine does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

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

• breathing problems

• changes in behavior, mood, or mental ability including mental depression

• chest pain, palpitations

• confusion

• dark yellow or brown urine

• feeling faint or lightheaded

• fever, chills, or sore throat

• hallucinations

• irregular or fast heartbeat

• joint or muscle pain

• swelling of feet or legs

• tingling or numbness in the hands or feet

• unusual bruising, bleeding, or pinpoint red spots on the skin

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• loss of appetite

• nausea

• stomach pain

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). Keep container tightly closed. Protect from moisture. Throw away any unused medicine after the expiration date.

Procainamide Hydrochloride Solution for injection

What is this medicine?

PROCAINAMIDE (proe kane A mide) is an antiarrhythmic drug. It helps make your heart beat regularly. This medicine is used for heartbeat problems that may be life threatening.

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:

• anemia or blood disease

• heart disease or previous heart attack

• immune system problems, like lupus

• kidney disease

• liver disease

• low blood pressure

• myasthenia gravis

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or 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 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?

This does not apply.

What may interact with this medicine?

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

• abarelix

• amoxapine

• apomorphine

• arsenic trioxide

• certain macrolide antibiotics

• certain quinolone antibiotics

• cisapride

• droperidol

• haloperidol

• hawthorn

• levomethadyl

• maprotiline

• medicines for malaria like chloroquine and halofantrine

• medicines for mental depression such as tricyclic antidepressants

• methadone

• other medicines to control heart rhythm

• pentamidine

• phenothiazines like chlorpromazine, mesoridazine, and thioridazine

• pimozide

• probucol

• ranolazine

• sertindole

• vardenafil

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• ranitidine

• succinylcholine

• trimethoprim

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.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 dizzy, increase flushing and rapid heartbeats. Avoid alcoholic drinks.

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

• breathing problems

• changes in behavior, mood, or mental ability including mental depression

• chest pain, palpitations

• confusion

• dark yellow or brown urine

• feeling faint or lightheaded

• fever, chills, or sore throat

• hallucinations

• irregular or fast heartbeat

• joint or muscle pain

• swelling of feet or legs

• tingling or numbness in the hands or feet

• unusual bruising, bleeding, or pinpoint red spots on the skin

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• loss of appetite

• nausea

• stomach pain

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.