Buy Rythmol Online

Propafenone (propafenone hydrochloride)

BOXED WARNING

Increased rate of death or reversed cardiac arrest rate reported in patients treated with encainide or flecainide (Class 1C antiarrhythmics) in a study of patients with asymptomatic non-life-threatening ventricular arrhythmias who had a MI >6 days but <2 yrs previously. Consider any 1C antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Avoid in patients with non-life-threatening ventricular arrhythmias, even if experiencing unpleasant, but not life-threatening signs/symptoms.

View FDA-Approved Full Prescribing Information for Rythmol

OTHER BRAND NAMES

Rythmol

THERAPEUTIC CLASS

Class IC antiarrhythmic

DEA CLASS

RX

INDICATIONS

To prolong the time to recurrence of paroxysmal atrial fibrillation/flutter and paroxysmal supraventricular tachycardia associated with disabling symptoms in patients without structural heart disease. Treatment of life-threatening documented ventricular arrhythmias (eg, sustained ventricular tachycardia).

ADULT DOSAGE

Paroxysmal Atrial Fibrillation/Flutter

Associated w/ Disabling Symptoms in Patients w/o Structural Heart Disease:

Initial: 150mg q8h (450mg/day)
Titrate: May increase at a minimum of 3 to 4 day intervals to 225mg q8h (675mg/day). May increase to 300mg q8h (900mg/day) if additional therapeutic effect is needed
Max: 900mg/day

Paroxysmal Supraventricular Tachycardia

Associated w/ Disabling Symptoms in Patients w/o Structural Heart Disease:

Initial: 150mg q8h (450mg/day)
Titrate: May increase at a minimum of 3 to 4 day intervals to 225mg q8h (675mg/day). May increase to 300mg q8h (900mg/day) if additional therapeutic effect is needed
Max: 900mg/day

Ventricular Arrhythmias

Initial: 150mg q8h (450mg/day)
Titrate: May increase at a minimum of 3 to 4 day intervals to 225mg q8h (675mg/day). May increase to 300mg q8h (900mg/day) if additional therapeutic effect is needed
Max: 900mg/day

Initiate therapy in the hospital for patients w/ sustained ventricular tachycardia

DOSING CONSIDERATIONS

Hepatic Impairment
Consider reducing dose

Elderly
Start at lower end of dosing range. Increase more gradually during initial phase

Other Important Considerations
Significant QRS Widening/2nd- or 3rd-Degree Atrioventricular Block: Consider reducing dose

Ventricular Arrhythmia w/ Marked Previous Myocardial Damage: Increase more gradually during initial phase

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 300mg*; (Rythmol) 150mg*, 225mg* *scored

CONTRAINDICATIONS

Heart failure (HF), cardiogenic shock, known Brugada syndrome, bradycardia, marked hypotension, bronchospastic disorders or severe obstructive pulmonary disease, marked electrolyte imbalance, and sinoatrial, AV, and intraventricular disorders of impulse generation or conduction (eg, sick sinus node syndrome, AV block) in the absence of an artificial pacemaker.

WARNINGS/PRECAUTIONS

Do not use to control ventricular rate during atrial fibrillation. Concomitant treatment with drugs that increase the functional AV nodal refractory period is recommended. May cause new or worsened arrhythmias; evaluate ECG prior to and during therapy to determine if response supports continued treatment. Brugada syndrome may be unmasked after exposure to therapy; perform ECG after initiation of treatment and d/c if changes are suggestive of Brugada syndrome. May provoke overt HF. Conduction disturbances (eg, 1st to 3rd-degree AV block, bundle branch block, intraventricular conduction delay, bradycardia), agranulocytosis, positive antinuclear antibody (ANA) titers, and exacerbation of myasthenia gravis reported. D/C if persistent or worsening elevation of ANA titers detected. May alter pacing and sensing thresholds of implanted pacemakers and defibrillators; monitor and reprogram devices accordingly during and after therapy. Reversible, short-term drop (within normal range) in sperm count may occur. Treatment of ventricular arrhythmias should be initiated in the hospital. Caution in patients with renal/hepatic dysfunction and in elderly.

ADVERSE REACTIONS

Unusual taste, N/V, dizziness, constipation, headache, fatigue, blurred vision, weakness.

DRUG INTERACTIONS

Avoid with Class IA and III antiarrhythmics (eg, quinidine, amiodarone) and withhold these agents for at least 5 half-lives prior to therapy. Inhibitors of CYP2D6 (eg, desipramine, paroxetine, ritonavir) and CYP3A4 (eg, ketoconazole, saquinavir, erythromycin) may increase levels; avoid simultaneous use with both a CYP2D6 and a CYP3A4 inhibitor. Amiodarone can affect conduction and repolarization; coadministration is not recommended. Fluoxetine may increase levels in extensive metabolizers. Rifampin may decrease levels and may increase norpropafenone (active metabolite) levels. May increase levels of digoxin, propranolol, metoprolol, and warfarin; monitor digoxin levels and INR. May result in severe adverse events (eg, convulsions, AV block, acute circulatory failure) with abrupt cessation of orlistat. May increase risk of CNS side effects of lidocaine. CYP1A2 inhibitors (eg, amiodarone, tobacco smoke) and cimetidine may increase levels.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Class 1C antiarrhythmic; has local anesthetic effects and direct stabilizing action on myocardial membranes. Reduces upstroke velocity (phase 0) of the monophasic action potential. Reduces the fast inward current carried by Na+ ions in Purkinje fibers and myocardial fibers. Diastolic excitability threshold is increased and effective refractory period prolonged. Reduces spontaneous automaticity and depresses triggered activity.

PHARMACOKINETICS

Absorption: Complete; absolute bioavailability (3.4%, 150mg dose), (10.6%, 300mg dose); Tmax=3.5 hrs. Distribution: (IV) Vd=252L; plasma protein binding (>95%); found in breast milk. Metabolism: Liver (rapid, extensive) via CYP3A4, 1A2, and 2D6; 5-hydroxypropafenone and N-depropylpropafenone (active metabolites). Elimination: T1/2=2-10 hrs (>90% of patients), 10-32 hrs (<10% of patients).

ASSESSMENT

Assess for HF, cardiogenic shock, sinoatrial/AV/intraventricular disorders, implanted pacemaker/defibrillator, bradycardia, marked hypotension, bronchospastic disorders or severe obstructive pulmonary disease, marked electrolyte imbalance, MI, renal/hepatic dysfunction, known Brugada syndrome, pregnancy/nursing status, and possible drug interactions. Evaluate ECG prior to therapy.

MONITORING

Monitor for proarrhythmic effects, signs/symptoms of conduction disturbances, agranulocytosis, HF, unmasking of Brugada syndrome, exacerbation of myasthenia gravis, and other adverse reactions. Monitor implanted pacemakers and defibrillators during and after therapy and reprogram accordingly. Evaluate ECG during therapy. Monitor ANA titers and renal/hepatic function. Monitor INR when given with warfarin.

PATIENT COUNSELING

Inform about risks/benefits of therapy. Advise to report symptoms that may be associated with electrolyte imbalance to physician. Inform to notify physician of all Rx, herbal/natural preparations, and OTC medications currently being taken or of any changes with these products. Instruct not to double the next dose if a dose is missed and to take next dose at the usual time.

STORAGE

20-25°C (68-77°F). (Rythmol) 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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