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Norpace-cr Generic Name & Formulations
Legal Class
Rx
General Description
Disopyramide (as phosphate) 100mg, 150mg; controlled-release caps.
Pharmacological Class
Class I antiarrhythmic.
See Also
How Supplied
Caps—100; CR—100, 500
Manufacturer
Norpace-cr Indications
Indications
Documented life-threatening ventricular arrhythmias.
Norpace-cr Dosage and Administration
Adult
200–400mg every 12hrs.
Children
Use immediate-release caps.
Norpace-cr Contraindications
Contraindications
Cardiogenic shock. 2nd- or 3rd- degree AV block, unless paced. Congenital QT prolongation. Severe renal insufficiency (CrCl ≤40mL/min): CR form not recommended.
Norpace-cr Boxed Warnings
Boxed Warning
Mortality.
Norpace-cr Warnings/Precautions
Warnings/Precautions
Excessive mortality or non-fatal cardiac arrest rate was seen in CAST trial. Correct potassium imbalance before starting. Discontinue if hypotension or CHF worsening occurs; if needed, restart at lower dose after cardiac compensation established. Reduce dose in 1st-degree AV block, consider discontinuing if persistent. Monitor closely or discontinue if QT prolongation or QRS widening occurs. Atrial tachyarrhythmias: digitalize first. Conduction defects. Cardiomyopathy. Renal or hepatic dysfunction. Urinary retention. BPH. Glaucoma. Myasthenia gravis. Chronic malnutrition. Elderly. Labor & delivery. Pregnancy (Cat.C): may stimulate uterine contractions. Nursing mothers: not recommended.
Norpace-cr Pharmacokinetics
See Literature
Norpace-cr Interactions
Interactions
Avoid other antiarrhythmics except in unresponsive, life-threatening arrhythmias. Avoid CYP3A4 inhibitors (eg, erythromycin, clarithromycin); may result in fatal interactions. Hypoglycemia with β-blockers, alcohol. Antagonized by hepatic enzyme inducers (eg, phenytoin). Do not give within 48hrs before or 24hrs after verapamil.
Norpace-cr Adverse Reactions
Adverse Reactions
Anticholinergic effects (eg, dry mouth, urinary retention, constipation, blurred vision), GI upset, dizziness, fatigue, impotence, hypotension, heart failure, AV block, edema, rash, hypoglycemia, hypokalemia, jaundice, blood dyscrasias, lupus-like syndrome, psychosis.
Norpace-cr Clinical Trials
See Literature
Norpace-cr Note
Not Applicable
Norpace-cr Patient Counseling
See Literature
