AMIODARONE HYDROCHLORIDE- 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:

AvKARE, Inc.

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 400 mg

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 HCl 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 e

Product summary:

Amiodarone HCl Tablets, 100 mg are round, flat, beveled edge, white tablets; one side plain, the second side engraved with "TARO" at the top and "55" below. Bottles of 90 Tablets                         NDC 42291-118-90 Amiodarone HCl Tablets, 200 mg are round, flat, beveled edge, light orange tablets; one side plain, the second side scored and engraved with "TARO" above the score and "56" below the score line. Amiodarone HCl Tablets, 300 mg are round, flat, beveled edge, peach tablets; one side plain, the second side scored and engraved with "TARO" above the score and "58" below the score line. Amiodarone HCl Tablets, 400 mg are round, flat, beveled edge, light yellow tablets; one side plain, the second side scored and engraved with "TARO" above the score and "59" below the score line and are available as follows: Bottles of 30 Tablets                 NDC 42291-139-30 Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
AvKARE, Inc.
----------
MEDICATION GUIDE
AMIODARONE HYDROCHLORIDE
(A-MEE-OH-DA-RONE HYE-DROE-KLOR-IDE)
TABLETS
What is the most important information I should know about amiodarone
HCl tablets?
Amiodarone HCl 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 HCl 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 HCl 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 HCl tablets can cause other serious side effects. See "
What are the possible side effects of
amiodarone HCl tablets?" If you get serious side effects during
treatment you may need to stop
amiodarone HCl tablets, have your dose changed, or get medical
treatment. Talk with your doctor before
you stop taking amiodarone HCl tablets.
You may still have side effects after stopping amiodarone HCl tablets
because the medicine stays in your
body months after treatment is stopped.
Tell all your healthcare providers that you take or took amiodarone
HCl tablets.
What are amiodarone HCl tablets?
Amiodarone HCl is a prescription medicine used to treat
life-thre

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
AVKARE, INC.
----------
AMIODARONE HCL TABLETS
RX ONLY
DESCRIPTION
Amiodarone HCl is a member of a class of antiarrhythmic drugs with
predominantly Class III (Vaughan
Williams' classification) effects, available for oral administration
as white, tablets containing 100 mg of
amiodarone hydrochloride, light orange, scored tablets containing 200
mg of amiodarone
hydrochloride, peach, scored tablets containing 300 mg of amiodarone
hydrochloride, and light yellow,
scored tablets containing 400 mg of amiodarone hydrochloride. The
inactive ingredients present are
colloidal silicon dioxide, corn starch, D&C yellow No. 10 lake (200
and 400 mg only), FD&C yellow
No. 6 lake (200 and 300 mg only), lactose anhydrous, magnesium
stearate and povidone. 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 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. 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 refle