Dosing & Uses
Dosage Forms & Strengths
- 100 mg/mL
Adjust dose to patient's response
- 0.5-1 g IM q4-8hr
Reduce loading dose to 12 mg/kg
Reduce infusion to one third in moderate renal or cardiac impairment and two thirds in severe renal or cardiac impairment
Reduce dose by 50%
Dosage Forms & Strengths
- 100 mg/mL
Adjust dose to patient's response
- 20-30 mg/kg/day IM divided q4-6hr; not to exceed 4 g/day
Serious - Use Alternative
Significant - Monitor Closely
Increased antinuclear antibodies (50%)
SLE-like syndrome (30%)
Frequency Not Defined
Wide PR or QRS
Black Box Warnings
Positive ANA Titer
- Long-term administration often leads to positive antinuclear antibody (ANA) test result
- Positive result may occur with or without lupus erythematosus-like syndrome symptoms If a positive ANA titer develops, assess benefits vs risks of continuing procainamide
- National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST): Excessive mortality or nonfatal cardiac arrest (7.7%) shown with encainide or flecainide compared with placebo (3%)
- CAST was a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction >6 days but <2 yr previously
- Average duration of treatment w/ encainide or flecainide in CAST was 10 months
- Applicability of CAST results to other populations (eg, patients without recent MI) is uncertain
- Reserve use of Class IC antiarrhythmics for life-threatening ventricular arrhythmias: Considering the known proarrhythmic properties of procainamide & lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, procainamide use, as well as other antiarrhythmic agents, should be reserved for patients with life-threatening ventricular arrhythmias
- Agranulocytosis, bone marrow depression, leukopenia, neutropenia, aplastic/hypoplastic anemia, thrombocytopenia, & sequelae such as septicemia & septic shock have been reported at a rate of ~0.5%
- Most reported within recommended dosage range and within initial 3 months of treatment
- Fatalities have occurred (~20-25% mortality rate in reported agranulocytosis cases)
- Perform complete blood counts, including white cell, differential, & platelet counts at weekly intervals for the first 3 months & then frequently thereafter
- Check blood count if the patient develops any signs of infection (eg, fever, chills, sore throat, stomatitis), bruising, or bleeding.
- If any of these hematologic disorders is identified, discontinue drug & initiate appropriate treatment
- Blood counts usually return to normal within 1 month of discontinuation
- Caution in patients with preexisting marrow failure or cytopenia
Hypersensitivity to procainamide or other ingredients
Complete heart block, 2°/3° AV block, SLE, torsade de pointes
Acute ischemic heart disease, blood dyscrasias, cardiomyopathy, CHF, 1° heart block, liver disease, renal impairment, myasthenia gravis, post MI patients
May produce life-threatening hematologic disorders (leukopenia, agranulocytosis)
Concomitant use of digoxin, other class IA antiarrhythmics
Toxicity if serum level >12 mg/L [51 umol/L]
May exacerbate arhythmias or produce paradoxical ventricular tachycardia in AFib/AFlutter patients
Pregnancy & Lactation
Pregnancy Category: C
Lactation: crosses into breast milk, discontinue drug or do not nurse
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Class IA (membrane stabilizing) antiarrhythmic agent; inhibits recovery after repolarization resulting in decreasing myocardial excitability and conduction velocity
Direct membrane depressant that decreases conduction velocity, prolongs refractoriness, decreases automaticity and reduces repolarization abnormalities
Peak Plasma Time: 15-60 min (IV/IM)
Protein Bound: 15-20%
Vd: 2 L/kg (1.5 L if CHF)
Acetylated in liver to form N-acetylprocainamide (NAPA) (active); ratio of procainamide/NAPA depends upon acetylator phenotype and renal function
Metabolites (active): N-acetylprocainamide (NAPA)
Half-Life: 2.5-4.7 hr (parent drug), 6-8 hr (NAPA); increased in renal impairment and geriatrics
Renal Clearance: 150-600 mL/min
Excretion: Urine (30-60%), minimal in bile
Dialyzable: Yes (HD); no (PD)
Additive: bretylium, esmolol, milrinone
Additive: dobutamine, lidocaine, netilmicin
Y-site: famotidine, heparin, KCl, ranitidine, Vit B/C and Amiodarone
Solution: 2 g/250 mL D5W or NS (8 mg/mL)
Administration: infusion requires use of an infusion pump; run at 1-6 mg/min (7.5-45 mL/hr)
Slight yellow color of soln will not alter potency; however,
- Do not use when darker than light amber or if soln contains precipitate
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.