pharmacopeia
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/api/v1/drug/disopyramide

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Sodium Channel Interactions; Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended.

Contraindications

Sourced from openFDA
  • Disopyramide phosphate is contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree AV block (if no pacemaker is present), congenital Q-T prolongation, or known hypersensitivity to the drug.contraindicated

Dosage & administration

Sourced from openFDA

The dosage of disopyramide phosphate capsules must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of disopyramide phosphate capsules is 400 to 800 mg per day given in divided doses. The recommended dosage for most adults is 600 mg/day given in divided doses (150 mg every 6 hours). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (100 mg every 6 hours). In the event of increased anticholinergic side effects, plasma levels of disopyramide should be monitored and the dose of the drug adjusted accordingly. A reduction of the dose by one third, from the recommended 600 mg/day to 400 mg/day, would be reasonable, without changing the dosing interval. For patients with cardiomyopathy or possible cardiac decompensation, a loading dose, as discussed below, should not be given, and initial dosage should be limited to 100 mg every 6 to 8 hours. Subsequent dosage adjustments should be made gradually, with close monitoring for the possible development of hypotension and/or congestive heart failure (see WARNINGS ). For patients with moderate renal insufficiency (creatinine clearance greater than 40 mL/min) or hepatic insufficiency, the recommended dosage is 400 mg/day given in divided doses (100 mg every 6 hours). For patients with severe renal insufficiency (C cr 40 mL/min or less), the recommended dosage regimen is 100 mg at intervals shown in the table below, with or without an initial loading dose of 150 mg.

Warnings & precautions

Sourced from openFDA

Mortality In the National Heart, Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had had a myocardial infarction more than 6 days but less than 2 years previously, an excessive mortality or non-fatal 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 (3.0%). The average duration of treatment with encainide or flecainide in this study was 10 months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain. Considering the known proarrhythmic properties of disopyramide phosphate and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of disopyramide phosphate as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias. Negative Inotropic Properties Heart Failure/Hypotension Disopyramide phosphate may cause or worsen congestive heart failure or produce severe hypotension as a consequence of its negative inotropic properties. Hypotension has been observed primarily in patients with primary cardiomyopathy or inadequately compensated congestive heart failure.

Adverse reactions

Sourced from openFDA

The adverse reactions which were reported in disopyramide phosphate clinical trials encompass observations in 1,500 patients, including 90 patients studied for at least 4 years. The most serious adverse reactions are hypotension and congestive heart failure. The most common adverse reactions, which are dose dependent, are associated with the anticholinergic properties of the drug. These may be transitory, but may be persistent or can be severe. Urinary retention is the most serious anticholinergic effect. The following reactions were reported in 10% to 40% of patients: Anticholinergic: dry mouth (32%), urinary hesitancy (14%), constipation (11%) The following reactions were reported in 3% to 9% of patients: Anticholinergic: blurred vision, dry nose/eyes/throat Genitourinary: urinary retention, urinary frequency and urgency Gastrointestinal: nausea, pain/bloating/gas General: dizziness, general fatigue/muscle weakness, headache, malaise, aches/pains The following reactions were reported in 1% to 3% of patients: Genitourinary: impotence Cardiovascular: hypotension with or without congestive heart failure, increased congestive heart failure (see WARNINGS ), cardiac conduction disturbances (see WARNINGS ), edema/weight gain, shortness of breath, syncope, chest pain Gastrointestinal: anorexia, diarrhea, vomiting Dermatologic: generalized rash/dermatoses, itching Central nervous system: nervousness Other: hypokalemia, elevated cholesterol/triglycerides The following reactions were reported in less than 1%: Depression, insomnia, dysuria, numbness/tingling, elevated liver enzymes, …

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Disopyramide phosphate was associated with decreased numbers of implantation sites and decreased growth and survival of pups when administered to pregnant rats at 250 mg/kg/day (20 or more times the usual daily human dose of 12 mg/kg, assuming a patient weight of at least 50 kg), a level at which weight gain and food consumption of dams were also reduced. Increased resorption rates were reported in rabbits at 60 mg/kg/day (5 or more times the usual daily human dose). Effects on implantation, pup growth, and survival were not evaluated in rabbits. There are no adequate and well-controlled studies in pregnant women. Disopyramide phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Disopyramide phosphate has been reported to stimulate contractions of the pregnant uterus. Disopyramide has been found in human fetal blood.

Overdosage

Sourced from openFDA

Symptoms Deliberate or accidental overdosage of oral disopyramide may be followed by apnea, loss of consciousness, cardiac arrhythmias, and loss of spontaneous respiration. Death has occurred following overdosage. Toxic plasma levels of disopyramide produce excessive widening of the QRS complex and Q-T interval, worsening of congestive heart failure, hypotension, varying kinds and degrees of conduction disturbance, bradycardia, and finally asystole. Obvious anticholinergic effects are also observed. The approximate oral LD 50 of disopyramide phosphate is 580 and 700 mg/kg for rats and mice, respectively. Treatment Experience indicates that prompt and vigorous treatment of overdosage is necessary, even in the absence of symptoms. Such treatment may be life-saving. No specific antidote for disopyramide phosphate has been identified. Treatment should be symptomatic and may include induction of emesis or gastric lavage, administration of a cathartic followed by activated charcoal by mouth or stomach tube, intravenous administration of isoproterenol and dopamine, insertion of an intra-aortic balloon for counterpulsation, and mechanically assisted ventilation.

Approval history

Sourced from openFDA
  • Sep 1, 1977NDANDA017447Pfizer
  • Jul 20, 1982NDANDA018655Pfizer
  • Feb 22, 1985ANDAANDA070101Teva
  • Feb 22, 1985ANDAANDA070102Teva
  • May 31, 1985ANDAANDA070173Dr Reddys Labs Sa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
955 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective14815%
  2. 2Off Label Use788.2%
  3. 3Atrial Fibrillation596.2%
  4. 4Dyspnoea535.5%
  5. 5Fatigue464.8%
  6. 6Malaise454.7%
  7. 7Dizziness394.1%
  8. 8Palpitations353.7%
  9. 9Asthenia333.5%
  10. 10Feeling Abnormal293.0%
  11. 11Headache252.6%
  12. 12Constipation242.5%
  13. 13Drug Ineffective For Unapproved Indication242.5%
  14. 14Drug Interaction242.5%
  15. 15Dry Mouth242.5%

Literature

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Recent PubMed references pinned to Disopyramide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Disopyramide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Disopyramide work?
Mechanism-of-action classes: Sodium Channel Interactions; Unknown Cellular or Molecular Interaction.
What is Disopyramide used for?
According to FDA labeling, Disopyramide carries indications including: Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Disopyramide?
Disopyramide is classified as Antiarrhythmics, class Ia, Antiarrhythmic, Sodium Channel Interactions, Unknown Cellular or Molecular Interaction, Cardiac Rhythm Alteration, Cell Membrane Alteration, Negative Inotropy.
What are the brand names for Disopyramide?
Disopyramide is marketed under brand names including Norpace.
What are the contraindications for Disopyramide?
Disopyramide labeling lists contraindications including: Disopyramide phosphate is contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree AV block (if no pacemaker is present), congenital Q-T prolongation, or known hypersensitivity to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for disopyramide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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