A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tonocard Indications, Dosage, Storage, Stability - Tocainide HCl
Tonocard Indications, Dosage, Storage, Stability - Tocainide HCl
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
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.
HOW SUPPLIED
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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