AMIODARONE HYDROCHLORIDE- amiodarone hydrochloride tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Cardinal Health

INN (Mezinárodní Name):

AMIODARONE HYDROCHLORIDE

Složení:

AMIODARONE HYDROCHLORIDE 200 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), 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. 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. Amiodarone 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

Přehled produktů:

Amiodarone hydrochloride tablets 200 mg are available as follows: Each round, pink tablet is scored and debossed with “93” and “9133” on one side, and plain and unscored on the other side available overbagged with 10 tablets per bag, NDC 55154-5492-0. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. This product’s label may have been updated. For current full prescribing information, please call 1-888-838-2872. Repackaged By: Cardinal Health Zanesville, OH 43701

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
Cardinal Health
----------
MEDICATION GUIDE
AMIODARONE HYDROCHLORIDE (A-mee-OH-da-rone HYE-droe-KLOR-ide) TABLETS
Rx only
Read the Medication Guide that comes with amiodarone hydrochloride
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 amiodarone
hydrochloride tablets?
Amiodarone hydrochloride 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, amiodarone hydrochloride
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.
Amiodarone hydrochloride tablets can cause other serious side effects.
See “What are the possible or
reasonably likely side effects of amiodarone hydrochloride tablets?”
for more information.
If you get serious side effects during treatment with amiodarone
hydrochloride tablets you may need to
stop amiodarone hydrochloride tablets, have your dos

Charakteristika produktu

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
CARDINAL HEALTH
----------
AMIODARONE HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Amiodarone hydrochloride is a member of a class of antiarrhythmic
drugs with predominantly Class III
(Vaughan Williams’ classification) effects, available for oral
administration as pink, scored tablets
containing 200 mg of amiodarone hydrochloride. The inactive
ingredients present are: colloidal silicon
dioxide, corn starch, FD&C Red 40, lactose monohydrate, magnesium
stearate, and povidone.
Amiodarone hydrochloride 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 M.W. 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 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:
•
•
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
amiodarone as they are evidence of its pharmacological action,
although amiodarone can cause marked
sinus bradycardia or sinus arrest and heart block. On rare occasi