"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
(Generic versions may still be available.)
TONOCARD (tocainide hcl) 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, (tocainide hcl) 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, (tocainide hcl) 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 (tocainide hcl) be evaluated electrocardiographically and clinically prior to, and during, therapy with TONOCARD (tocainide hcl) to determine whether the response to TONOCARD (tocainide hcl) supports continued treatment.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
DOSAGE AND ADMINISTRATION
The dosage of TONOCARD (tocainide hcl) 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.
No. 3409† Tablets TONOCARD, (tocainide hcl) 400 mg, are oval, yellow, scored, film-coated tablets, coded 707 on one side and TONOCARD (tocainide hcl) 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, (tocainide hcl) 600 mg, are oblong, yellow, scored, film-coated tablets, coded 709 on one side and TONOCARD (tocainide hcl) 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;
Store below 40°C (104°F); preferably between 15°C and 30°C (59°F and 86°F). Store in a well-closed container.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Tonocard Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.