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:

NCS HealthCare of KY, Inc dba Vangard Labs

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Amiodarone Hydrochloride Tablets, 200 mg are white to off-white, round-shaped, flat beveled-edge, uncoated tablets with bisect on one side and other side is plain; one side of bisect is debossed with 'ZE' and other side is debossed with '65' and are supplied as follows: NDC 0615-8213-39 in blistercards of 30 tablets NDC 0615-8213-05 in blistercards of 15 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container. Manufactured by: Cadila Healthcare Ltd. India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 06/17

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
Medication Guide
Amiodarone Hydrochloride
(A-mi-OH-da-rone HYE-droe-KLOR-ide)
Tablets
Rx only
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 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 amiodarone hydrochloride 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.
Amiodarone hydrochloride 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.
Amiodarone Hydrochloride Tablets can cause other serious side effects.
See "What are the possible side
effects of Amiodarone Hydrochloride Tablets?" If you get serious side
effects during treatment you may
need to stop amiodarone hydrochloride tablets, have your dose changed,
or get medical treatment. Talk
with your doctor before you stop taking amiodarone.
You may still have side effects after stopping amiodarone
hydrochloride tablets because the medicine
stays in your body months after treatment is stopped.
Tell all your healthcare providers that you take or took amiodarone
hydrochl

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
AMIODARONE HYDROCHLORIDE TABLETS
DESCRIPTION
Amiodarone hydrochloride is a member of a class of antiarrhythmic
drugs with predominantly Class III
(Vaughan Williams' classification) effects. Amiodarone 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, USP 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.
Each amiodarone hydrochloride tablet intended for oral administration
contains 200 mg of amiodarone
hydrochloride. In addition each tablet contains the following inactive
ingredients: colloidal silicon
dioxide, corn starch, lactose monohydrate, magnesium stearate,
povidone and sodium starch glycolate.
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:
a prolongation of the myocardial cell-action potential duration and
refractory period and
non-competitive antagonism of α- and β-adrenoceptors.
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
discontinuat