TONOCARD 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 TONOCARD, as well as its potential for other serious adverse effects, (see WARNINGS), its use to treat lesser arrhythmias is not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Initiation of treatment with TONOCARD, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. It is essential that each patient given TONOCARD be evaluated electrocardiographically and clinically prior to, and during, therapy with TONOCARD to determine whether the response to TONOCARD supports continued treatment.

Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

The dosage of TONOCARD must be individualized on the basis of antiarrhythmic response and tolerance, both of which are dose-related. Clinical and electrocardiographic evaluation (including Holter monitoring if necessary for evaluation) are needed to determine whether the desired antiarrhythmic response has been obtained and to guide titration and dose adjustment. Adverse effects appearing shortly after dosing, for example, suggest a need for dividing the dose further with a shorter dose-interval. Loss of arrhythmia control prior to the next dose suggests use of a shorter dose interval and/or a dose increase. Absence of a clear response suggests reconsideration of therapy.

The recommended initial dosage is 400 mg every 8 hours. The usual adult dosage is between 1200 and 1800 mg/day in a three dose daily divided regimen. Doses beyond 2400 mg per day have been administered infrequently. Patients who tolerate the t.i.d. regimen may be tried on a twice daily regimen with careful monitoring.

Some patients, particularly those with renal or hepatic impairment, may be adequately treated with less than 1200 mg/day.

No. 3409† Tablets TONOCARD, 400 mg, are oval, yellow, scored, film-coated tablets, coded 707 on one side and TONOCARD on the other side. They are supplied as follows:

NDC 61113-707-68 bottles of 100
(6505-01-203-6240, 400 mg 100†s)
NDC 61113-707-28 unit dose packages of 100

No. 3410 † Tablets TONOCARD, 600 mg, are oblong, yellow, scored, film-coated tablets, coded 709 on one side and TONOCARD on the other side. They are supplied as follows:

NDC 61113-709-68 bottles of 100
(6505-01-206-0273, 600 mg 100†s)
NDC 61113-709-28 unit dose packages of 100;

Storage

Store below 40°C (104°F); preferably between 15°C and 30°C (59°F and 86°F). Store in a well-closed container.

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