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Disopyramide

Pronunciation

(dye soe PEER a mide)

Index Terms

  • Disopyramide Phosphate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Norpace: 100 mg, 150 mg

Generic: 100 mg, 150 mg

Capsule Extended Release 12 Hour, Oral:

Norpace CR: 100 mg, 150 mg

Brand Names: U.S.

  • Norpace
  • Norpace CR

Pharmacologic Category

  • Antiarrhythmic Agent, Class Ia

Pharmacology

Class Ia antiarrhythmic: Decreases myocardial excitability and conduction velocity; reduces disparity in refractory between normal and infarcted myocardium; possesses anticholinergic, peripheral vasoconstrictive, and negative inotropic effects

Absorption

60% to 83%

Distribution

Vd: Children: 1 L/kg; Adults: 0.8-2 L/kg

Metabolism

Hepatic; N-dealkylation to the active metabolite N-despropyldisopyramide (or mono-N-dealkylated [MND] metabolite) and other inactive metabolites

Excretion

Urine (~50% as unchanged drug; ~20% as MND; 10% other metabolites); feces (10% to 15%)

Clearance: Children: 3.76 mL/minute/kg (greater than adults)

Onset of Action

0.5-3.5 hours

Time to Peak

Serum: Immediate release: Within 2 hours; Controlled release: 4-7 hours

Duration of Action

Immediate release: 1.5-8.5 hours

Half-Life Elimination

Children: 3.15 hours; Adults: 4-10 hours (prolonged with heart failure and hepatic or renal impairment)

Protein Binding

Concentration dependent: 20% to 60%

Special Populations Note

Heart failure: Tmax and Cmax are increased.

Use: Labeled Indications

Life-threatening ventricular arrhythmias (eg, sustained ventricular tachycardia)

Use: Unlabeled

Alternative agent for the prevention of recurrent symptomatic focal atrial tachycardia (in combination with an AV nodal blocking agent), atrial fibrillation (especially vagally-induced), or atrial flutter (in combination with an AV nodal-blocking agent); obstructive hypertrophic cardiomyopathy (HCM) in combination with ventricular rate-controlling agents (eg, beta blockers or verapamil) to control symptoms of angina or dyspnea who are unresponsive to rate-controlling agents alone; atrial fibrillation in patients with HCM in combination with rate-controlling agents

Contraindications

Hypersensitivity to disopyramide or any component of the formulation; cardiogenic shock; preexisting second- or third-degree heart block (except in patients with a functioning artificial pacemaker); congenital long QT syndrome; sick sinus syndrome

Dosing: Adult

Ventricular arrhythmias: Oral: Note: Since newer agents with less toxicity are available, the use of disopyramide for this indication has fallen out of favor. Controlled release formulation not to be used when rapid achievement of disopyramide plasma concentrations is desired. A maximum dose up to 400 mg every 6 hours (immediate release) may be required for patients with severe refractory ventricular tachycardia.

<50 kg:

Immediate release: An initial loading dose of 200 mg may be administered if rapid onset is required. Maintenance dose: 100 mg every 6 hours

Controlled release: Maintenance dose: 200 mg every 12 hours

≥50 kg:

Immediate release: An initial loading dose of 300 mg may be administered if rapid onset is required. Maintenance dose: 150 mg every 6 hours. If rapid control is necessary and no response seen within 6 hours of loading dose, may increase maintenance dose to 200 mg every 6 hours.

Controlled release: Maintenance dose: 300 mg every 12 hours

Atrial fibrillation (maintenance of sinus rhythm) (off-label use; AHA/ACC/HRS [January, 2014]): Oral: Note: May be more desirable for patients with vagally-induced AF or hypertrophic cardiomyopathy associated with dynamic outflow tract obstruction; use in combination with a beta blocker or a non-dihydropyridine calcium channel blocker.

Immediate release: Usual dose: 100 to 200 mg every 6 hours

Controlled release: Usual dose: 200 to 400 mg every 12 hours

Hypertrophic cardiomyopathy (obstructive physiology) with or without atrial fibrillation (off-label use): Oral: Initial: Controlled release: 200 to 250 mg twice daily. If symptoms do not improve, increase by 100 mg/day at 2-week intervals to a maximum daily dose of 600 mg (Gersh, 2011; Sherrid, 2005).

Dosing: Geriatric

Refer to adult dosing. Dose with caution, starting at the lower end of dosing range.

Dosing: Pediatric

Arrhythmias: Oral: Immediate release:

<1 year: 10 to 30 mg/kg/24 hours in 4 divided doses

1 to 4 years: 10 to 20 mg/kg/24 hours in 4 divided doses

4 to 12 years: 10 to 15 mg/kg/24 hours in 4 divided doses

12 to 18 years: 6 to 15 mg/kg/24 hours in 4 divided doses

Dosing: Renal Impairment

Manufacturer's labeling:

Immediate release:

CrCl >40 mL/minute: 100 mg every 6 hours

CrCl 30 to 40 mL/minute: 100 mg every 8 hours

CrCl 15 to 30 mL/minute: 100 mg every 12 hours

CrCl <15 mL/minute: 100 mg every 24 hours

Controlled release:

CrCl >40 mL/minute: 200 mg every 12 hours

CrCl ≤40 mL/minute: Not recommended for use

Alternative recommendations (Aronoff, 2007): Immediate release:

CrCl >50 mL/minute: 100 to 200 mg every 8 hours

CrCl 10 to 50 mL/minute: 100 to 200 mg every 12 to 24 hours

CrCl <10 mL/minute: 100 to 200 mg every 24 to 48 hours

Dialysis: Not dialyzable (0% to 5%) by hemo- or peritoneal methods; supplemental dose is not necessary.

Dosing: Hepatic Impairment

Manufacturer's labeling:

Immediate release: 100 mg every 6 hours

Controlled release: 200 mg every 12 hours

Extemporaneously Prepared

A 1 mg/mL oral suspension may be made with a tablet and Simple Syrup, NF. Crush one 100 mg tablet in a mortar and reduce to a fine powder. Add small portions of the vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 100 mL. Label “shake well” and “refrigerate”. Stable for 28 days.

A 10 mg/mL oral suspension may be made with tablets and Simple Syrup, NF. Crush ten 100 mg tablets in a mortar and reduce to a fine powder. Add small portions of the vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 100 mL. Label “shake well” and “refrigerate”. Stable for 28 days.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Administration

Do not break or chew controlled release capsules. Administer around-the-clock rather than 4 times/day (ie, 12-6-12-6, not 9-1-5-9) to promote less variation in peak and trough serum levels. Should be taken on an empty stomach.

Dietary Considerations

Should be taken on an empty stomach.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Amiodarone: May enhance the QTc-prolonging effect of Antiarrhythmic Agents (Class Ia). Amiodarone may increase the serum concentration of Antiarrhythmic Agents (Class Ia). Management: Avoid whenever possible. While considered contraindicated in some places, amiodarone U.S. prescribing information suggests that use could be considered under some circumstances, with careful monitoring. Reduce quinidine or procainamide dose by one third. Avoid combination

Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Beta-Blockers: Disopyramide may enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may enhance the negative inotropic effect of Disopyramide. Exceptions: Levobunolol; Metipranolol. Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Clarithromycin: May enhance the hypoglycemic effect of Disopyramide. Clarithromycin may enhance the QTc-prolonging effect of Disopyramide. Clarithromycin may increase the serum concentration of Disopyramide. Avoid combination

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Etravirine: May decrease the serum concentration of Disopyramide. Monitor therapy

Fingolimod: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class Ia). Avoid combination

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fosphenytoin: Disopyramide may enhance the QTc-prolonging effect of Fosphenytoin. Fosphenytoin may decrease the serum concentration of Disopyramide. Management: Seek alternatives when possible. Monitor patients receiving this combination closely for evidence of QT interval prolongation or changes in cardiac rhythm, as well as for decreased serum concentrations/therapeutic effects of disopyramide. Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Highest Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Highest Risk QTc-Prolonging Agents. Avoid combination

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Indapamide: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Consider therapy modification

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Itraconazole: May increase the serum concentration of Disopyramide. Avoid combination

Ivabradine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Ketoconazole (Systemic): May increase the serum concentration of Disopyramide. Avoid combination

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Lidocaine (Systemic): Disopyramide may enhance the arrhythmogenic effect of Lidocaine (Systemic). Disopyramide may increase the serum concentration of Lidocaine (Systemic). Specifically, the unbound/free fraction of lidocaine. Monitor therapy

Lidocaine (Topical): Disopyramide may enhance the arrhythmogenic effect of Lidocaine (Topical). Disopyramide may increase the serum concentration of Lidocaine (Topical). Specifically, the unbound/free fraction of lidocaine. Monitor therapy

Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Lurasidone: May enhance the QTc-prolonging effect of Disopyramide. Management: Consider alternatives to disopyramide in patients with acute lurasidone overdose. If disopyramide treatment cannot be avoided, monitor for excessive QTc interval prolongation. Consider therapy modification

Macrolide Antibiotics: May enhance the QTc-prolonging effect of Disopyramide. Macrolide Antibiotics may decrease the metabolism of Disopyramide. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. Avoid combination

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Avoid combination

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

PHENobarbital: May decrease the serum concentration of Disopyramide. Monitor therapy

Phenytoin: May decrease the serum concentration of Disopyramide. Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Propafenone: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class Ia). Management: Concurrent use of propafenone with quinidine, amiodarone, or other class IA or class III antiarrhythmics should be avoided. Treatment with such agents should be withheld for at least 5 half-lives prior to initiation of propafenone. Avoid combination

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

RifAMPin: May decrease the serum concentration of Disopyramide. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Verapamil: May enhance the adverse/toxic effect of Disopyramide. Of particular concern is the potential for profound depression of myocardial contractility. Avoid combination

Vinflunine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Adverse Reactions

Frequency not always defined. The most common adverse effects are related to cholinergic blockade. The most serious adverse effects of disopyramide are hypotension and cardiac failure.

>10%:

Gastrointestinal: Xerostomia (32%), constipation (11%)

Genitourinary: Urinary hesitancy (14% to 23%)

1% to 10%:

Cardiovascular: Cardiac conduction disturbance, cardiac failure, chest pain, edema, hypotension, syncope

Central nervous system: Dizziness, fatigue, headache, malaise, myasthenia, nervousness

Dermatologic: Generalized dermatosis, pruritus, skin rash

Endocrine & metabolic: Hypokalemia, increased serum cholesterol, increased serum triglycerides, weight gain

Gastrointestinal: Abdominal distention, anorexia, bloating, diarrhea, flatulence, nausea, vomiting

Genitourinary: Impotence (1% to 3%), urinary frequency, urinary retention, urinary urgency

Neuromuscular & skeletal: Myalgia

Ophthalmic: Blurred vision, xerophthalmia

Respiratory: Dry throat, dyspnea

<1% (Limited to important or life-threatening): Agranulocytosis, atrioventricular block, cardiac arrhythmia (new or worsened; proarrhythmic effect), cholestatic jaundice, dysuria, gynecomastia, hepatotoxicity, hypoglycemia, increased blood urea nitrogen, increased serum creatinine, increased serum transaminases, insomnia, paresthesia, peripheral neuropathy, psychosis, psychotic reaction, respiratory distress, skin bluster (toxic), systemic lupus erythematosus (rare; generally in patients previously receiving procainamide), thrombocytopenia

ALERT: U.S. Boxed Warning

Mortality:

In the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had an MI more than 6 days but less than 2 years previously, an excessive mortality or nonfatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3%). The average duration of treatment with encainide or flecainide in this study was 10 months.

The applicability of the CAST results to other populations (eg, those without recent MI) is uncertain. Considering the known proarrhythmic properties of disopyramide and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of disopyramide as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.

Warnings/Precautions

Concerns related to adverse effects:

• Hypotension: May occur during the initiation of therapy; monitor closely.

• Proarrhythmic effects: Watch for proarrhythmic effects; may cause QTc prolongation and subsequent torsade de pointes; avoid use in patients with diagnosed or suspected congenital long QT syndrome. Monitor and adjust dose to prevent QTc prolongation. Increases in QTc >25% over baseline should result in cessation or reduction in disopyramide dosing. Because of the risk of QTc prolongation and arrhythmias, disopyramide should be initiated within the hospital with cardiac monitoring. In patients with pre-existing cardiovascular disease, the incidence of proarrhythmic effects and mortality may be increased with Class Ia antiarrhythmic agents.

Disease-related concerns:

• Atrial fibrillation/flutter: Appropriate use: In patients with atrial fibrillation or flutter, block the AV node before initiating.

• BPH/urinary retention: Do not use in patients with BPH and/or urinary retention due to significant anticholinergic effects.

• Conduction disturbances: Use with caution in patients with bundle branch block or heart block.

• Electrolyte imbalance: Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy.

• Glaucoma: Do not use in patients with glaucoma due to significant anticholinergic effects.

• Heart failure (HF): Use with caution or avoid in patients with any degree of left ventricular dysfunction or history of HF; may precipitate or exacerbate condition.

• Hepatic impairment: Use with caution in patients with hepatic impairment; reduced dosage recommended.

• Myasthenia gravis: Do not use in patients with myasthenia gravis due to significant anticholinergic effects.

• Renal impairment: Use with caution in renal impairment; reduced dosage recommended. The controlled release form is not recommended for CrCl ≤40 mL/minute.

• Wolff-Parkinson-White syndrome: Use with caution in patients with Wolff-Parkinson-White syndrome.

Concurrent drug therapy issues:

• Drugs with QT prolongation potential: Avoid concurrent use with other drugs known to prolong QTc interval or decrease myocardial contractibility.

Other warnings/precautions:

• CAST trial: [U.S. Boxed Warning]: In the Cardiac Arrhythmia Suppression Trial (CAST), recent (>6 days but <2 years ago) myocardial infarction patients with asymptomatic, non-life-threatening ventricular arrhythmias did not benefit and may have been harmed by attempts to suppress the arrhythmia with flecainide or encainide. An increased mortality or nonfatal cardiac arrest rate (7.7%) was seen in the active treatment group compared with patients in the placebo group (3%). The applicability of the CAST results to other populations is unknown. Antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.

Monitoring Parameters

ECG, blood pressure, urinary retention, CNS anticholinergic effects (confusion, agitation, hallucinations, etc); disopyramide drug level (if available)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Disopyramide levels have been reported in human fetal blood. Disopyramide may stimulate contractions in pregnant women. In a case report, disopyramide use in the third trimester resulted in painful uterine contractions after the first dose and hemorrhage after the second dose (Abbi, 1999).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, constipation, dry mouth, nasal dryness, dry eyes, loss of strength and energy, bloating, flatulence, nausea, or muscle weakness. Have patient report immediately to prescriber angina, bradycardia, tachycardia, abnormal heartbeat, severe dizziness, passing out, shortness of breath, excessive weight gain, swelling of arms or legs, blurred vision, or difficult urination (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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