Reliant Pharmaceuticals 03/27/04
News For Pharmacies---From Reliant Pharmaceuticals
Pharmaceuticals is now the sole owner and marketer of the RYTHMOL(propafenone
HCI) brand family of
products in the United States
Pharmaceuticals is also pleased to announce the availability of RYTHMOL
HCI) extended release capsules BID (every 12 hours)--a new, more
RYTHMOL (propafenone HCI) for patients with atrial
fibrillation(AFib). RYTHMOL SR is
indicated to prolong the time of recurrence of symptomatic AFib in
patients without structural heart disease.
In clinical trials, RYTHOMOL
delayed the time to first recurrence of symptomatic AFib, with
increased efficacy at each dose.
Three convenient BID (every 12 hours) dosing options are
available:225, 325, or 425 mg capsules. Physicians must titrate
for individual patient needs and tolerance. Treatment
initiation with new RYTHMOL SR
not require hospitalization and may result in cost savings to the
patient. No loading dose is required, and there is no need for
ongoing hepatic toxicity monitoring in patients with normal hepatic function.
should be initiated with RYTHMOL
MG bid (every 12 hours). If addition therapeutic effect is
needed, dosage may be increased at 5-day intervals9minimum).
The switch from RYTHMOL TID to BID dosing does not follow a 1 mg:1 mg
conversion rule. For example, patients taking 150 mg
propafenone TID (450 mg/day) would be switched to RYTHMOL
SR 325mg BID (650 mg/day). Pleade
see Pharmacokinetics and Metabolism section of full Prescribing Information.
ensure maximum knowledge of RYTHMOL SR, Reliant
Pharmaceuticals is currently rolling out multifaceted programs, including:
detailing by a dedicated cardiovascular specialty sales force
education programs designed to reinforce product information
comprehensive promotional campaign
expect this marketing effort to create a surge in demand for RYTHMOL
are encouraging pharmacists to contact their wholesalers in order to
ensure that ample supplies are available for prescription
fulfillment. To assist you in ordering RYTHMOL
have enclosed a fact sheet with product/packaging specifications and
Reliant Pharmaceuticals is committed to maintaining a position
partnership with our customers and we promise to prvide you with the
best possible service and support. If you would like additional
information about RYTHMOL SR and/or
our company, please feel free to contact our Customer Service
Department at 1-800-475-2140.
Andrew H. Isaacs
Brand Manager Reliant Pharmaceuticals
Boxed Warning on reverse side of this letter and enclosed Prescribing Information
(propafenone HCI) extented release capsules are indicated to prolong
the time to recurrence of symptomatic atrial fibrillation in patients
without structural heart disease.
The use of RYTHMOL
SR in patients with permanent atrial
fibrillation or in patients exclusively with atrial flutter or PSVT
has not been evaluated. RYTHMOL SR should not be used to
control ventricular rate during atrial fibrillation.
The effect of
RYTHMOL SR on mortality has not been determined ( see black box WARNINGS).
the National Heart, Lung and Blood Institue's Cardiac Arrhythmia
Suppression Trial (CAST), a long-term, umlti-center, randomized,
double-blind study in patients with asymptomatic non-life-threatening
ventricular arrhythmias who had a myocardial infarction more that six
days but less than two years previously, an increased rate of death
or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients
treated with encainide or flecainide (class 1C antiarrhythmics)
compared with that seen in patients assigned to placebo (3.0%;
22/725). The average duration of treatment with encainide or
flecainide in this study was ten months.
applicability of the CAST results to other populations (e.g. those
without recent myocardial infarction) or other antiarrhythmic drugs
is uncertain, but at present it is prudent to consider any 1C
antiarrhythmic to have a significant rist in patients with structural
heart disease. Given the lack of any evidence that these drugs
improve survival, antiarrghthmic agents should generally be avoided
in patients with non-life-threatening ventricular arrhythmias, even
if the patients are experienceing unpleasant, but not
life-threatening, symptoms or signs.
commonly reported adverse events in the trial included dizziness,
chest pain, palpitations, taste disturbance, dyspnea, nausea,
constipation, anxiety, fatigue, upper respiratior tract infection,
influenza, first degree heart block and vomiting.
1. RYTHMOL SR Prescribing Information, Reliant Pharmaceuticals.
2. Pritchet ED, Page RL, Carlson M, Undesser K. Fava G, for the
Tythmol Atrial Fibrillation Trial (RAFT) Investigators, Efficacy and
safety of sustained-rease propafenone SR) for patients with atrial
fibrillation. Am J. Carfiol, 2009-92-946.3. Meinerftz T. Lip GYH,
Lombardi Fet al. on behalf of the ERAFT Investigators Efficacy and
safety of propafenone sustained release in the prophylaxis of
sympthomatic paroxysmal atrial fibrillation (The European
Rythmol/Rytmonrm Atrial Fibrillation Trial [ERAFT] Study) Am J
Pharmaceuticals january 2004 RYTH-2001