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From: Reliant Pharmaceuticals 03/27/04 Important News For Pharmacies---From Reliant Pharmaceuticals Reliant Pharmaceuticals is now the sole owner and marketer of the RYTHMOL(propafenone HCI) brand family of products in the United States Reliant Pharmaceuticals is also pleased to announce the availability of RYTHMOL SR (propafenone HCI) extended release capsules BID (every 12 hours)--a new, more convenient formulation of 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 SR significantly 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 does 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. Therapy should be initiated with RYTHMOL SR 225 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. To ensure maximum knowledge of RYTHMOL SR, Reliant Pharmaceuticals is currently rolling out multifaceted programs, including:
Because we expect this marketing effort to create a surge in demand for RYTHMOL SR, we 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 SR, we have enclosed a fact sheet with product/packaging specifications and ordering/pricing information. 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. Sincerely, Andrew H. Isaacs RYTHMOL Family Brand Manager Reliant Pharmaceuticals Please see Boxed Warning on reverse side of this letter and enclosed Prescribing Information
Indication RYTHMOL SR (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). Important Safety Information WARNINGS Mortality: In 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. The 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. The most 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. References: 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 Cardiol 2002;90:1300-1306. Reliant Pharmaceuticals january 2004 RYTH-2001 |
From: ASPIRUS Clinics
ASPIRUS Clinics - Passion for excellence. Compassion for people
2720 Plaza Drive - Suite 1700 - Wausau, WI 54401
September 21, 2006
Dear Pharmacist:
This is to notify you that Dr. Jimmy B. Madagame, an Endocrinologist with Aspirus Westhill Medical Specialists in Wausau, Wisconsin has taken a leave from his employment with us and will not be practicing for an extended period of time. In the process of closing down his practice, we have been unable to locate a signature stamp.
Please be advised that if any prescriptions appear with his signature, they should be considered suspicious and reported immediately to Aspirus Westhill Medical Specialists (715-847-2004).
If you have any questions, please feel free to contact me at 715-847-2303. Thank you for your consideration.
Sincerely,
Jeffrey W. Todd, Regional Clinics Administrator