PACERONE- amiodarone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. - Recurrent ventricular fibrillation. - 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 tablets 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 amb

Product summary:

Pacerone® (Amiodarone HCl) Tablets, 200 mg, are available in Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PACERONE - AMIODARONE HYDROCHLORIDE TABLET
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
PACERONE® (PĀS-ƏR-ŌN) TABLETS
(AMIODARONE HCL)
Rx only
Read the Medication Guide that comes with Pacerone® Tablets before
you start taking them and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking with your doctor about your medical condition or your
treatment.
What is the most important information I should know about Pacerone®
Tablets?
Pacerone® Tablets can cause serious side effects that can lead to
death including:
•
lung damage
•
liver damage
•
worse heartbeat problems
•
thyroid problems
Call your doctor or get medical help right away if you have any
symptoms such as the following:
•
shortness of breath, wheezing, or any other trouble breathing;
coughing, chest pain, or spitting up
of blood
•
nausea or vomiting; passing brown or dark-colored urine; feel more
tired than usual; your skin and
whites of your eyes get yellow; or have stomach pain
•
heart pounding, skipping a beat, beating very fast or very slowly;
feel light-headed or faint
•
weakness, weight loss or weight gain, heat or cold intolerance, hair
thinning, sweating, changes in
your menses, swelling of your neck (goiter), nervousness,
irritability, restlessness, decreased
concentration, depression in the elderly, or tremor.
Because of these possible side effects, Pacerone® Tablets should only
be used in adults with life-
threatening heartbeat problems called ventricular arrhythmias, for
which other treatments did not work or
were not tolerated.
Pacerone® Tablets can cause other serious side effects. See "What are
the possible or reasonably likely
side effects of Pacerone® Tablets?" for more information.
If you get serious side effects during treatment with Pacerone®
Tablets you may need to stop Pacerone®
Tablets, have your dose changed, or get medical treatment. Talk with
your doctor before you stop taking
Pacerone® Tablets.
You may still have side effects aft

Summary of Product characteristics

PACERONE - AMIODARONE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
PACERONE
(AMIODARONE HCL) TABLETS, 100 MG AND 200 MG
RX ONLY
DESCRIPTION
Pacerone
(Amiodarone HCl) Tablets are a member of a class of antiarrhythmic
drugs with
predominantly Class III (Vaughan Williams' classification) effects,
available for oral administration in
100 mg and 200 mg strengths of amiodarone hydrochloride. Both
strengths of Pacerone
Tablets
contain the following inactive ingredients: lactose monohydrate,
magnesium stearate, povidone,
pregelatinized corn starch, sodium starch glycolate, stearic acid,
FD&C Red 40 (200 mg only) and
FD&C Yellow 6.
Amiodarone hydrochloride, the active ingredient in Pacerone
Tablets, is a benzofuran derivative: 2-
butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl
ketone hydrochloride.
The structural formula is as follows:
Amiodarone HCl is a white to cream-colored crystalline powder. It is
slightly soluble in water, soluble
in alcohol and freely soluble in chloroform. It contains 37.3% iodine
by weight.
CLINICAL PHARMACOLOGY
ELECTROPHYSIOLOGY/MECHANISMS OF ACTION
In animals, amiodarone HCl is effective in the prevention or
suppression of experimentally induced
arrhythmias. The antiarrhythmic effect of amiodarone may be due to at
least two major properties:
1. a prolongation of the myocardial cell-action potential duration and
refractory period and
2. noncompetitive α- and β -adrenergic inhibition.
Amiodarone prolongs the duration of the action potential of all
cardiac fibers while causing minimal
reduction of dV/dt (maximal upstroke velocity of the action
potential). The refractory period is
prolonged in all cardiac tissues. Amiodarone increases the cardiac
refractory period without
influencing resting membrane potential, except in automatic cells
where the slope of the prepotential is
reduced, generally reducing automaticity. These electrophysiologic
effects are reflected in a
decreased sinus rate of 15 to 20%, increased PR and QT intervals of
about 10%, the development of