procainamide (Rx)Brand and Other Names:Pronestyl (SR)

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection solution

  • 100 mg/mL
  • 500mg/mL
more...

Arrhythmia

Adjust dose to patient's response

IM Administration

  • 0.5-1 g IM q4-8hr

IV Administration

  • Loading dose: 100-200 mg/dose or 15-18 mg/kg; infuse slowly over 25-30 min not to exceed 50 mg/min; may repeat q5min PRN not to exceed 1 g 
  • Maintenance: 1-4 mg/min by continuous IV infusion
  • Renal impairment:

Renal Impairment

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

Hepatic Impairment

Reduce dose by 50%

Dosage Forms & Strengths

injection solution

  • 100 mg/mL
  • 500mg/mL
more...

Arrhythmia

Adjust dose to patient's response

IM Administration

  • 20-30 mg/kg/day IM divided q4-6hr; not to exceed 4 g/day

IV Administration

  • Loading dose: 3-6 mg/kg IV over 5 minutes, not to exceed 100 mg/dose; may repeat q5-10min PRN not to exceed 15 mg/kg/dose
  • Maintenance: 0.02-0.08 mg/kg/min IV infusion; not to exceed 2 g/24 hours 
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Interactions

Interaction Checker

procainamide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Increased antinuclear antibodies (50%)

            SLE-like syndrome (30%)

            1-10%

            Hypotension (5%)

            Frequency Not Defined

            Arrhythmias

            Asystole

            Heart block

            Wide PR or QRS

            Asthenia

            Ataxia

            Depression

            Chills

            Psychosis

            Abdominal pain

            Bitter taste

            N/V

            Myopathy

            Rash

            Leukopenia

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            Warnings

            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

            Mortality

            • 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

            Blood Dyscrasias

            • 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

            Contraindications

            Hypersensitivity to procainamide or other ingredients

            Complete heart block, 2°/3° AV block, SLE, torsade de pointes

            Cautions

            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

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: crosses into breast milk, discontinue drug or do not nurse

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Absorption

            Bioavailability: 75-95%

            Peak Plasma Time: 15-60 min (IV/IM)

            Distribution

            Protein Bound: 15-20%

            Vd: 2 L/kg (1.5 L if CHF)

            Metabolism

            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)

            Elimination

            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)

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            Administration

            IV Incompatibilities:

            Additive: bretylium, esmolol, milrinone

            Y-site: milrinone

            IV Compatibilities

            Additive: dobutamine, lidocaine, netilmicin

            Y-site: famotidine, heparin, KCl, ranitidine, Vit B/C and Amiodarone

            IV Preparation

            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
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            Images

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            Formulary

            FormularyPatient Discounts

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            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.

            Tier Description
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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