Amiodarone

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mayne Pharma Inc.

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 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 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 electrophysio

Product summary:

Amiodarone HCl Tablets, 100 mg, are yellow colored, round, flat faced beveled edge tablets with debossings of “AS” on one side and “100” on the other side.       Bottles of 30 tablets                   NDC 51862-154-30 Amiodarone HCl Tablets, 200 mg, are yellow colored, round, flat beveled edge tablets with “AS” and “200” debossed on either side of the break line on one side and plain on the other side.       Bottles of 60 tablets                   NDC 51862-155-60 Amiodarone HCl Tablets, 400 mg, are yellow colored, oval, biconvex tablets with “AS” and “400” debossed on either side of the break line on one side and plain on the other side.       Bottles of 30 tablets                   NDC 51862-156-30             Keep tightly closed. Store at Controlled Room Temperature, 20 ° to 25 °C (68 ° to 77 °F) (see USP Controlled Room Temperature). Protect from light and moisture. Dispense in a light-resistant, tight container with a child-resistant closure. This product’s label may have been revised after this copy was produced. For more information about the current full prescribing information, please visit www.maynepharma.com. Distributed by: MAYNE PHARMA   GREENVILLE, NC 27834 Manufactured by: MURTY PHARMACEUTICALS, INC. LEXINGTON, KY 40509 Issued:   October   2017                                     P069- 08

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMIODARONE HCL- AMIODARONE HYDROCHLORIDE TABLET
Mayne Pharma Inc.
----------
MEDICATION GUIDE
Amiodarone HCl Tablets
a MEE oh da rone hye droe KLOR ide Tablets
Rx only
Read the Medication Guide that comes with Amiodarone HCl 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
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 stoppi

Summary of Product characteristics

AMIODARONE HCL- AMIODARONE HYDROCHLORIDE TABLET
MAYNE PHARMA INC.
----------
AMIODARONE
AMIODARONE HCL TABLETS
RX ONLY
DESCRIPTION
Amiodarone is a member of a class of antiarrhythmic drugs with
predominantly Class III (Vaughan
Williams' classification) effects, available for oral administration,
as yellow, round, flat faced beveled
edge tablets containing 100 mg of amiodarone hydrochloride, and
yellow, round, flat beveled edge,
scored tablets containing 200 mg of amiodarone hydrochloride, and
yellow, oval, biconvex, scored
tablets containing 400 mg of amiodarone hydrochloride. The inactive
ingredients present in 100 mg,
200 mg, and 400 mg tablets are: lactose monohydrate, sodium starch
glycolate, povidone, colloidal
silicon dioxide, magnesium stearate, and Pigment D&C Yellow 10
Aluminum Lake. 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 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 reflected