Drugplain

Norpace 100 mg/1

disopyramide phosphate · CAPSULE, GELATIN COATED · Pfizer Laboratories Div Pfizer Inc

No Recall History
Plain English

Norpace is a capsule, gelatin coated containing disopyramide phosphate at 100 mg/1, taken oral. Manufactured by Pfizer Laboratories Div Pfizer Inc.

Key Facts

Brand Name
Norpace
Generic Name
disopyramide phosphate
NDC Code (Product)
0025-2752
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Strength
100 mg/1
Dosage Form
CAPSULE, GELATIN COATED
Route
ORAL
Marketing Status
Application #
NDA017447
Marketing Start
09/01/1977

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective148 reports
off label use78 reports
atrial fibrillation59 reports
dyspnoea53 reports
fatigue46 reports
malaise45 reports
dizziness39 reports
palpitations35 reports
asthenia33 reports
feeling abnormal29 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Norpace and Norpace CR are 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 Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Dosage & Administration

DOSAGE AND ADMINISTRATION The dosage of Norpace or Norpace CR must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of Norpace or Norpace CR 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 (either 150 mg every 6 hours for immediate-release Norpace or 300 mg every 12 hours for Norpace CR). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (either 100 mg every 6 hours for immediate-release Norpace or 200 mg every 12 hours for Norpace CR). 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 of immediate-release Norpace every 6 to 8 hours. Subsequent dosage adjustments should be …

Warnings

Warnings 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 Norpace or Norpace CR and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of Norpace or Norpace CR as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias. Negative Inotropic Properties: Heart Failure/Hypotension Norpace or Norpace CR may ca…

Contraindications

CONTRAINDICATIONS Norpace and Norpace CR are 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.

Drug Interactions

Drug Interactions Effects of other drugs on disopyramide pharmacokinetics: In vitro metabolic studies indicated that disopyramide is metabolized by cytochrome P450 3A4 and that inhibitors of this enzyme may result in elevation of plasma levels of disopyramide. Although specific drug interaction studies have not been done, cases of life-threatening interactions have been reported for disopyramide when given with clarithromycin and erythromycin.

Adverse Reactions

ADVERSE REACTIONS The adverse reactions which were reported in Norpace 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 distu…

Frequently Asked Questions

What is Norpace used for?

Norpace contains disopyramide phosphate. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.

Is Norpace a controlled substance?

Norpace is not classified as a controlled substance by the DEA.

What is the generic name for Norpace?

The generic name for Norpace is disopyramide phosphate. There are 9 other brand versions of disopyramide phosphate.

What is the NDC code for Norpace 100 mg/1?

The NDC (National Drug Code) for Norpace 100 mg/1 is 0025-2752, listed by Pfizer Laboratories Div Pfizer Inc.

Product NDC

0025-2752

Package NDC

0025-2752-31

Other Norpace Dosages

Other Disopyramide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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