PACERONE- amiodarone hydrochloride tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Cardinal Health

INN (International Adı):

Amiodarone Hydrochloride

Kompozisyon:

Amiodarone Hydrochloride 200 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Because of its life-threatening side effects and the substantial management difficulties associated with its 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. 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 ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-t

Ürün özeti:

Pacerone® (Amiodarone HCl) Tablets, 200 mg, are available : NDC 55154-5606-0 Overbagged with 10 tablets per bag Pacerone® Tablets, 200 mg, are pink, round, 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. Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure. This product's label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.upsher-smith.com or call 1-888-650-3789. Pacerone is a registered trademark of Upsher-Smith Laboratories, LLC Manufactured by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Distributed By: Cardinal Health Dublin, OH 43017 L32341270318A Revised 0617

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Cardinal Health
----------
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 which other treatment did not work or was not
tolerated. Pac

Ürün özellikleri

PACERONE- AMIODARONE HYDROCHLORIDE TABLET
CARDINAL HEALTH
----------
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 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 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.
2.
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 U-
waves and changes in T-wave contour. These changes should not require
discontinuation of Pacerone
Tablets as they are evidence of its pharm