Drug Notebook

FDA Alerts

    Positive ANA Titer
  • 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.

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procainamide
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(proe CANE a mide)

What is the most important information I should know about procainamide?

Oral forms of procainamide (tablets and capsules) are no longer marketed in the U.S.

Call your doctor immediately if you experience wheezing, chest pain, chest discomfort, worsening irregular heartbeats, a fever, a sore throat or an infection, a sore mouth, unusual bruising or bleeding, dark urine, hallucinations, severe dizziness, or fainting.

Take procainamide exactly as directed. Do not skip doses or change your dosing schedule without talking to your doctor.

Procainamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It may increase or decrease the effects of procainamide.

What is procainamide?

Oral forms of procainamide (tablets and capsules) are no longer marketed in the U.S.

Procainamide affects the way your heart beats.

Procainamide is used to treat seriously irregular heartbeat patterns.

Procainamide may be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking procainamide?

Before taking procainamide, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may not be able to take procainamide, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Procainamide 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 procainamide?

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

Take each dose with a full glass of water. Do not crush, chew, or open any formulation of this medication. Do not change your dosage or your dosing schedule without first talking to your doctor. Changes of this sort could make your condition much worse.

Store procainamide 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 it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Try not to miss any of your procainamide doses. Missing doses could be very dangerous.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include tiredness, dizziness, fainting, confusion, tremor, difficulty breathing, and an irregular heartbeat.

What should I avoid while taking procainamide?

Procainamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It may increase or decrease the effects of procainamide.
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