INDICATIONS AND USAGE
Ethmozine® is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician are life-threatening. Because of the proarrhythmic effects of Ethmozine®, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of Ethmozine® treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
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DOSAGE AND ADMINISTRATION
The dosage of Ethmozine® must be individualized on the basis of antiarrhythmic response and tolerance. Clinical, cardiac rhythm monitoring, electrocardiogram intervals, exercise testing, and/or programmed electrical stimulation testing may be used to guide antiarrhythmic response and dosage adjustment. In general, the patients will be at high risk and should be hospitalized for the initiation of therapy (see INDICATIONS AND USAGE).
The usual adult dosage is between 600 and 900 mg per day, given every 8 hours in three equally divided doses. Within this range, the dosage can be adjusted as tolerated, in increments of 150 mg/day at 3-day intervals, until the desired effect is obtained. Patients with life-threatening arrhythmias who exhibit a beneficial response as judged by objective criteria (Holter monitoring, programmed electrical stimulation, exercise testing, etc.) can be maintained on chronic Ethmozine® therapy. As the antiarrhythmic effect of Ethmozine® persists for more than 12 hours, some patients whose arrhythmias are well-controlled on a Q8H regimen may be given the same total daily dose in a Q12H regimen to increase convenience and help assure compliance. When higher doses are used, patients may experience more dizziness and nausea on the Q12 hour regimen.
Patients with Hepatic Impairment
Patients with hepatic disease should be started at 600 mg/day or lower and monitored closely, including measurement of ECG intervals, before dosage adjustment.
Patients with Renal Impairment
Patients with significant renal dysfunction should be started at 600 mg/day or lower and monitored closely, including measurement of ECG intervals, before dosage adjustment.
Transfer to Ethmozine®
Recommendations for transferring patients from another antiarrhythmic to Ethmozine® can be given based on theoretical considerations. Previous antiarrhythmic therapy should be withdrawn for 1-2 plasma half-lives before starting Ethmozine® at the recommended dosages. In patients in whom withdrawal of a previous antiarrhythmic is likely to produce life-threatening arrhythmias, hospitalization is recommended.
Transferred From | Start Ethmozine® |
Quinidine, Disopyramide | 6-12 hours after last dose |
Procainamide | 3-6 hours after last dose |
Encainide, Propafenone, Tocainide, or Mexiletine | 8-12 hours after last dose |
Flecainide | 12-24 hours after last dose |
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HOW SUPPLIED
Ethmozine® (moricizine hydrochloride) is available as oval, convex, film-coated tablets as follows:
200 mg (light green): | Bottles of 100 | (NDC 54092-046-01) |
Hospital Unit Dose Carton of 100 | (NDC 54092-046-52) |
250 mg (light orange): | Bottles of 100 | (NDC 54092-047-01) |
Hospital Unit Dose Carton of 100 | (NDC 54092-047-52) |
300 mg (light blue): | Bottles of 100 | (NDC 54092-048-01) |
Hospital Unit Dose Carton of 100 | (NDC 54092-048-52) |
Store at 25°C (77°F) excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]
Shire
Manufactured for
Shire US Inc., 7900 Tanners Gate Drive, Suite 200, Florence, KY 41042 USA
1-800-828-2088, Made in USA
©2001 Shire US Inc.
U.S. Patent 3,864,487
046 0117 006 / Rev. 2/02
6322-04 / February 2002
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