Prolonged use often results in development of positive antinuclear antibody (ANA) titers.
Symptoms of systemic lupus erythematosus (SLE)-like syndrome may or may not accompany ANA titers.
Assess benefits versus risks of continued therapy if positive ANA titer develops.
Mortality
Excessive mortality or nonfatal cardiac arrest rate (7.7%) in encainide- or flecainide-treated patients with asymptomatic non-life-threatening ventricular arrhythmias (with MI history >6 days but <2 years) in NHLBI's long-term CAST study relative to placebo.
Applicability of CAST findings to other populations (e.g., those without recent MI) uncertain.
Because of procainamide's proarrhythmic properties and lack of evidence of improved survival for any antiarrhythmic drug, reserve procainamide for life-threatening ventricular arrhythmias.
Blood Dyscrasias
Agranulocytosis, bone marrow depression, neutropenia, hemoplastic anemia, and thrombocytopenia occur in approximately 0.5% of procainamide-treated patients, usually at recommended dosages.
Potentially fatal (e.g., in 20–25% of agranulocytosis cases).
Usually noted during the initial 12 weeks of therapy.
Perform CBCs, including leukocyte, differential, and platelet counts, at weekly intervals for the first 3 months of therapy and periodically thereafter.
Perform CBC promptly if any sign of infection (e.g., fever, chills, sore throat, stomatitis), bruising, or bleeding develops.
Discontinue procainamide if any of these hematologic disorders develops.
Blood cell counts usually return to normal 1 month after procainamide discontinuance.
Exercise caution in preexisting marrow failure or cytopenia of any type.
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:
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:
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.
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.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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