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Pacerone (Amiodarone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Because of its life-threatening side effects and the substantial management difficulties associated with amiodarone use (see " WARNINGS " below), Pacerone® (Amiodarone HCl) Tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.

  1. Recurrent ventricular fibrillation.
  2. Recurrent hemodynamically unstable ventricular tachycardia.

As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone HCl favorably affects survival.

Pacerone® (Amiodarone HCl) Tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy and potential exacerbation of the arrhythmia, initiation of therapy with Pacerone® (Amiodarone HCl) Tablets should be carried out in the hospital.

DOSAGE AND ADMINISTRATION

BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, PACERONE® SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.

In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of Pacerone® has not been determined. Because of the food effect on absorption, Pacerone® should be administered consistently with regard to meals (see " CLINICAL PHARMACOLOGY "). Individual patient titration is suggested according to the following guidelines.

For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:    Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of Pacerone® in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardia usually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats.

Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see " PRECAUTIONS, Drug Interactions ").

Upon starting Pacerone® therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see " PRECAUTIONS, Drug Interactions "). When adequate arrhythmia control is achieved, or if side effects become prominent, Pacerone® dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see " CLINICAL PHARMACOLOGY, Monitoring Effectiveness "). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Pacerone® may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenance dose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings and/or programmed electrical stimulation and by patient tolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity (see " CLINICAL PHARMACOLOGY ").

The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient's arrhythmia and response to therapy.

When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

Loading Dose
(Daily)
Adjustment and Maintenance Dose
(Daily)
Ventricular
Arrhythmias
1 to 3 weeks ~1 month usual
maintenance
800 to
1,600 mg
600 to
800 mg
400 mg

HOW SUPPLIED

Pacerone® (Amiodarone HCl) Tablets are available in three strengths, containing 100 mg, 200 mg and 400 mg amiodarone hydrochloride, for oral administration.

Pacerone® Tablets, 100 mg, are available in bottles of 30 tablets (NDC 0245-0144-30), and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0245-0144-01). The 100 mg tablets are white, round-shaped, flat-faced, uncoated tablets, debossed with "P" on one side, and "U-S" above "144" on the reverse side.

Pacerone® Tablets, 200 mg, are available in bottles of 60 tablets (NDC 0245-0147-60), bottles of 90 tablets (NDC 0245-0147-90), bottles of 500 tablets (NDC 0245-0147-15) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0245-0147-01). The 200 mg tablets are pink, round-shaped, flat-faced, scored, uncoated tablets, debossed with "P200" on the unscored side, and "U-S" above and "0147" below the score on the reverse side.

Pacerone® Tablets, 400 mg, are available in bottles of 30 tablets (NDC 0245-0145-30), bottles of 100 tablets (NDC 0245-0145-11), bottles of 500 tablets (NDC 0245-0145-15) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0245-0145-01). The 400 mg tablets are light yellow, oval-shaped, scored, uncoated tablets, debossed with "P400" on the unscored side, and "01" to the left and "45" to the right of the score on the reverse side.

Store at room temperature, approximately 25°C (77°F). Protect from light.

Dispense in a tight, light-resistant container with a child-resistant closure.

UPSHER-SMITH LABORATORIES, INC.

Minneapolis, MN 55447

US Patent 5,785,995

PCPI.0803-00              Revised 0803

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