PACERONE- amiodarone hydrochloride tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Amiodarone Hydrochloride (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT)

थमां उपलब्ध:

Upsher-Smith Laboratories, LLC

INN (इंटरनेशनल नाम):

Amiodarone Hydrochloride

रचना:

Amiodarone Hydrochloride 400 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), Pacerone® (amiodarone hydrochloride) 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 hydrochloride tablets favorably affects survival. Pacerone® (amiodarone hydrochloride) 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, includin

उत्पाद समीक्षा:

Pacerone® (Amiodarone Hydrochloride) Tablets, 400 mg, are available 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 68° to 77°F (20° to 25°C) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. Protect from light. KEEP TIGHTLY CLOSED. Keep out of the reach of children.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

PACERONE- AMIODARONE HYDROCHLORIDE TABLET
Upsher-Smith Laboratories, LLC
----------
MEDICATION GUIDE
PACERONE® (PĀS-ƏR-ŌN) TABLETS
(AMIODARONE HCL)
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 problems
•
liver problems
•
worsening heartbeat problems
•
thyroid problems
Call your doctor or get medical help right away if you have any of the
following symptoms during
treatment with Pacerone® Tablets:
•
shortness of breath, wheezing, or any other trouble breathing;
coughing, chest pain, or spitting up
of blood
•
nausea or vomiting, brown or dark-colored urine, feel more tired than
usual, yellowing of your
skin or the whites of your eyes (jaundice), or right upper stomach
pain
•
heart pounding, skipping a beat, beating fast or 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.
Pacerone® Tablets should only be used in people 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 side effects of
Pacerone® Tablets?" If you get serious side effects during treatment
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 after stopping Pacerone® Tablets
because the medicine stays in your body
months after treatment is stopped.
Tell all your healthcare providers that you take or took Pacerone®
Tablets.
What are Pacerone® Tablets?
Amiodarone is a prescription medicine used to treat life-threatening
heartbeat problems called ventricular
arrhythmias, for whi

उत्पाद विशेषताएं

PACERONE- AMIODARONE HYDROCHLORIDE TABLET
UPSHER-SMITH LABORATORIES, LLC
----------
PACERONE
(AMIODARONE HYDROCHLORIDE) TABLETS, 400 MG
RX ONLY
DESCRIPTION
Pacerone
(amiodarone hydrochloride) tablets are a member of a class of
antiarrhythmic drugs with
predominantly Class III (Vaughan Williams' classification) effects,
available for oral administration as
light yellow, scored tablets. Each tablet for oral administration
contains 400 mg of amiodarone
hydrochloride. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, corn starch, lactose monohydrate, magnesium stearate,
povidone, and D&C yellow No. 10
aluminum lake. 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:
C
H I
NO · HCL MOLECULAR WEIG HT: 681.8
Amiodarone hydrochloride 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 hydrochloride is effective in the prevention or
suppression of experimentally
induced arrhythmias. The antiarrhythmic effect of amiodarone
hydrochloride may be due to at least two
major properties:
1. a prolongation of the myocardial cell-action potential duration and
refractory period and
2. non-competitive antagonism of α- and β-adrenoceptors.
Amiodarone hydrochloride 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 hydrochloride
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
electrophysio