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
Rythmol Indications, Dosage, Storage, Stability - Propafenone
Rythmol Indications, Dosage, Storage, Stability - Propafenone
INDICATIONS
In patients without structural
heart disease,
RYTHMOL (propafenone HCl) is indicated to prolong the time
to recurrence of
- paroxysmal atrial
fibrillation/ flutter
(PAF) associated with disabling symptoms.
- paroxysmal supraventricular
tachycardia (PSVT)
associated with disabling symptoms.
As with other agents, some patients with atrial
flutter treated with
propafenone have developed 1:1 conduction, producing an increase
in ventricular rate. Concomitant treatment
with drugs that increase the functional
AV refractory period
is recommended.
The use of Rythmol in patients with chronic
atrial fibrillation
has not been evaluated. Rythmol should not be used to control
ventricular rate
during atrial fibrillation.
RYTHMOL is also 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
RYTHMOL, its use with lesser ventricular arrhythmias is not recommended,
even if patients are symptomatic,
and any use of the drug
should be reserved for patients in whom, in the opinion of the
physician, the potential
benefits outweigh the risks.
Initiation of RYTHMOL treatment,
as with other antiarrhythmics used to treat life-threatening ventricular
arrhythmias, should be carried out in the hospital.
RYTHMOL, like other antiarrhythmic
drugs, has not been shown to enhance survival in patients with ventricular
or atrial arrhythmias.
DOSAGE AND ADMINISTRATION
The dose of RYTHMOL (propafenone
HCl) must be individually titrated on the basis
of response and tolerance.
It is recommended that therapy be initiated with 150 mg
propafenone given every eight hours (450 mg/day). Dosage may be
increased at a minimum
of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and
if necessary, to 300 mg every
8 hours (900 mg/day). The usefulness and safety of dosages exceeding
900 mg per
day have not been established. In
those patients in whom significant
widening of the ORS complex
or second or third degree
AV block occurs, dose
reduction should be considered.
As with other antiarrhythmic
agents, in the elderly or in patients with marked previous myocardial
damage, the dose of RYTHMOL
should be increased more gradually during the initial
phase of treatment.
HOW SUPPLIED
RYTHMOL (propafenone HCl) tablets are supplied as scored, round,
film-coated tablets containing either 150 mg, 225 mg
or 300 mg of propafenone
hydrochloride and embossed with 150, 225 or 300 and an arched triangle
on the same side.
150 mg (white):
Bottle of 100 - NDC# 0044-5022-02
Hospital Unit Dose (100 tablets-strips of 10) - NDC# 0044-5022-10
225 mg (white):
Bottle of 100 - NDC #0044-5024-02
Hospital Unit Dose (100 tablets-strips of 10) - NDC# 0044-5024-10
300 mg (white):
Bottle of 100 - NDC# 0044-5023-02
Hospital Unit Dose (100 tablets-strips of 10) - NDC# 0044-5023-10
Storage
Store at controlled room
temperature 15°-30°
C( 59°-86° F). Dispense in a tight, light-resistant container
as defined in the U.S.P.
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