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|Procainamide Controlled-Release

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Procainamide Controlled-Release

Generic Name: Procainamide Controlled-Release and Sustained-Release Tablets (proe-KANE-a-mide)
Brand Name: Examples include Procanbid and Pronestyl-SR

Taking Procainamide Controlled-Release for a prolonged period of time may lead to the development of antibodies in your blood that are sometimes associated with autoimmune diseases such as lupus. If you experience butterfly-shaped rash on the face, swollen or tender joints, unexplained fever, or severe or persistent tiredness, seizures, or mental or mood changes, contact your doctor.

Procainamide Controlled-Release should only be used to treat life-threatening irregular heartbeat. It has been associated with an increased risk of death when used to treat non-life-threatening irregular heartbeat. Talk with your doctor for more information.

Procainamide Controlled-Release may cause severe and sometimes fatal blood problems (eg, bone marrow suppression, low blood platelet or white blood cell levels, anemia). These side effects have occurred most often during the first 12 weeks of therapy. Lab tests, such as complete blood cell counts, may be performed weekly for the first 3 months of therapy and then periodically to monitor for these side effects. If you experience fever, chills, sore throat, mouth sores or irritation, or unusual bruising or bleeding, contact your doctor immediately. Your risk may be greater if you already have bone marrow or blood problems.

Procainamide Controlled-Release is used for:

Treating certain abnormal heart rhythms.

Procainamide Controlled-Release is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).

Do NOT use Procainamide Controlled-Release if:

you are allergic to any ingredient in Procainamide Controlled-Release
you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a local anesthetic (eg, procaine)
you have complete heart block, lupus, or certain severe abnormal heart rhythms (eg, torsades de pointes)
you are taking astemizole, cisapride, dofetilide, a phenothiazine (eg, chlorpromazine), a phosphodiesterase type 5 inhibitor (eg, sildenafil), terfenadine, or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Procainamide Controlled-Release:

Some medical conditions may interact with Procainamide Controlled-Release. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of liver or kidney disease; heart block, congestive heart failure, QT prolongation, or other heart problems; bone marrow problems; blood problems (eg, low blood platelet or white blood cell levels); myasthenia gravis; or digitalis (digoxin) toxicity

Some MEDICINES MAY INTERACT with Procainamide Controlled-Release. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antiarrhythmics (eg, amiodarone, quinidine), anticholinergics (eg, hyoscyamine), arsenic, astemizole, cisapride, dofetilide, droperidol, H₂ antagonists (eg, cimetidine), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, chlorpromazine), phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide, quinolone antibiotics (eg, ciprofloxacin), serotonin receptor antagonists (eg, dolasetron), terfenadine), trimethoprim, or ziprasidone because the risk of side effects, including irregular heartbeat, may be increased
Neuromuscular blockers (eg, succinylcholine) because actions or side effects may be increased by Procainamide Controlled-Release

This may not be a complete list of all interactions that may occur. Ask your health care provider if Procainamide Controlled-Release may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Procainamide Controlled-Release:

Use Procainamide Controlled-Release as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Procainamide Controlled-Release may be taken on an empty stomach or with food.
Swallow Procainamide Controlled-Release whole. Do not break, crush, or chew before swallowing.
Take Procainamide Controlled-Release regularly to receive the most benefit from it.
Continue to use Procainamide Controlled-Release even if you feel well. Do not miss any doses.
If you miss a dose of Procainamide Controlled-Release, take it as soon as possible. If it is almost time for our next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Procainamide Controlled-Release.

Important safety information:

Procainamide Controlled-Release may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Procainamide Controlled-Release.
Drinking alcohol may decrease the effectiveness of Procainamide Controlled-Release. Check with your doctor before drinking alcohol.
Do not exceed the recommended dose or use Procainamide Controlled-Release for longer than prescribed without checking with your doctor.
Do not suddenly stop taking Procainamide Controlled-Release without checking with your doctor.
Procainamide Controlled-Release may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
Procainamide Controlled-Release may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Procainamide Controlled-Release.
Procainamide Controlled-Release may interfere with certain lab tests. Make sure your doctor and laboratory personnel know you are using Procainamide Controlled-Release.
With some brands of Procainamide Controlled-Release, you may see what looks like the original tablet in your stool. This is normal.
LAB TESTS, including heart function tests, complete blood cell counts, and serum ANA titers, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Procainamide Controlled-Release with caution in the ELDERLY because they may be more sensitive to its effects.
Use Procainamide Controlled-Release with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Procainamide Controlled-Release during pregnancy. Procainamide Controlled-Release is excreted in breast milk. Do not breast-feed while you are taking Procainamide Controlled-Release.

Possible side effects of Procainamide Controlled-Release:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bitter taste.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly-shaped rash on the face; chest pain; dark urine; depression; diarrhea; dizziness or lightheadedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; loss of appetite; mood or mental changes; mouth sores or irritation; muscle pain or weakness; nausea; pale stools; seizures; stomach pain; severe or persistent tiredness; shortness of breath; swollen or tender joints; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dizziness; fast or irregular heartbeat; irregular or difficult breathing; severe drowsiness; tremor.

Proper storage of Procainamide Controlled-Release:

Store Procainamide Controlled-Release between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Procainamide Controlled-Release out of the reach of children and away from pets.

General information:

If you have any questions about Procainamide Controlled-Release, please talk with your doctor, pharmacist, or other health care provider.
Procainamide Controlled-Release is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Procainamide Controlled-Release. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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