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RYTHMOL is indicated to:
- prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease.
- prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease.
- treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.
- The use of RYTHMOL in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use RYTHMOL to control ventricular rate during AF.
- 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 atrioventricular (AV) nodal refractory period is recommended.
- The use of RYTHMOL in patients with chronic atrial fibrillation has not been evaluated.
- 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.
- The effect of propafenone on mortality has not been determined [see BOXED WARNING].
DOSAGE AND ADMINISTRATION
The dose of RYTHMOL must be individually titrated on the basis of response and tolerance. Initiate therapy with RYTHMOL 150 mg 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). If additional therapeutic effect is needed, the dose of RYTHMOL may be increased to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established.
As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of RYTHMOL should be increased more gradually during the initial phase of treatment.
The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with the simultaneous administration of propafenone may significantly increase the concentration of propafenone and thereby increase the risk of proarrhythmia and other adverse events. Therefore, avoid simultaneous use of RYTHMOL with both a CYP2D6 inhibitor and a CYP3A4 inhibitor [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Dosage Forms And Strengths
150 mg and 225 mg scored, round, film-coated tablets.
Storage And Handling
RYTHMOL tablets are supplied as white, biconvex, scored, round, film-coated tablets containing either 150 mg or 225 mg of propafenone hydrochloride and embossed (on the same side) with GS and TF5 for the 150 mg tablet, and GS and F1X for the 225 mg tablet, in the following package sizes:
150 mg bottles of 100: NDC 0173-0792-20
225 mg bottles of 100: NDC 0173-0794-20
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Dispense in a tight, light-resistant container.
Manufactured for GlaxoSmithKline by: Halo Pharmaceutical, Inc., Whippany, NJ 07981. Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: March 2013
Last reviewed on RxList: 6/7/2013
This monograph has been modified to include the generic and brand name in many instances.
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