AMIODARONE HYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

AvPAK

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - Cardiogenic shock. - Sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - Known hypersensitivity to the drug or to any of its components, including iodine. Risk Summary Available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. Untreated underlying arrhythmias, including ventric

Огляд продуктів:

Amiodarone hydrochloride tablets are available as follows: 100 mg, white, round, flat-faced, beveled-edge tablet. Debossed with "m" on the upper portion and "154" on the lower half on one side of the tablet, and plain on the other. 200 mg, white, round, flat-faced, beveled-edge, scored tablet. Debossed with "m" on the upper portion and "155" on the lower half on one side of the tablet with a score mark between and plain on the other. 400 mg, Oval-shaped, convex, yellow, scored tablet. Debossed with "m" on the left and "156" on the right with a score mark between on one side, and plain on the other. Dispensed in Blister Punch Material. For Institutional Use Only. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F).

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

AvPAK
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
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
hydrochloride tablets?
Amiodarone hydrochloride tablets can cause serious side effects that
can lead to death, including:
•
lung problems
•
liver problems
•
worsening of heartbeat problems
Call your healthcare provider or get medical help right away if you
have any of the following symptoms
during treatment with amiodarone hydrochloride tablets:
•
trouble breathing, wheezing, shortness of breath, coughing chest pain,
spitting up of blood, or fever
•
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-area
pain
•
heart pounding, skipping a beat, beating fast or slowly, feel
light-headed, or if you faint
•
vision problems, including blurred vision, see halos, or your eyes
become sensitive to light. You
should have regular eye exams before and during treatment with
amiodarone hydrochloride tablets.
Amiodarone hydrochloride tablets should be started in a hospital so
that your medical condition can be
carefully monitored.
Amiodarone hydrochloride tablets should only be used to treat people
who have been diagnosed with life-
threatening heartbeat problems called ventricular arrhythmias, when
other treatments did not work or you
cannot tolerate them.
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
healthcare provider before you stop taking amiodarone hydrochloride
tablets.
You may still have side effects after stopping amiodarone
hydrochloride tablets because the medicine stays
in

Характеристики продукта

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
AMIODARONE HYDROCHLORIDE TABLETS
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMIODARONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
AMIODARONE HYDROCHLORIDE TABLETS.
INITIAL U.S. APPROVAL: 1985
WARNING: PULMONARY, HEPATIC, AND CARDIAC TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
RESERVE AMIODARONE HYDROCHLORIDE TABLETS FOR PATIENTS WITH THE
INDICATED LIFE-
THREATENING ARRHYTHMIAS BECAUSE ITS USE IS ACCOMPANIED BY SUBSTANTIAL
TOXICITY,
SOME ALSO LIFE-THREATENING. UTILIZE ALTERNATIVE AGENTS FIRST. ( 1)
AMIODARONE HYDROCHLORIDE TABLETS LIFE-THREATENING TOXICITIES INCLUDE
PULMONARY (
5.2), HEPATIC ( 5.3), AND PROARRHYTHMIC ( 5.4).
INITIATE UNDER HOSPITAL OR SPECIALIST SUPERVISION. ( 5)
INDICATIONS AND USAGE
Amiodarone hydrochloride tablets is an antiarrhythmic indicated for:
Recurrent ventricular fibrillation. ( 1)
Recurrent hemodynamically unstable ventricular tachycardia. ( 1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a loading doses of 800 to 1600 mg/day until
initial therapeutic response occurs
(usually 1 to 3 weeks). Once adequate arrhythmia control is achieved,
or if side effects become prominent,
reduce amiodarone hydrochloride tablets dose to 600 to 800 mg/day for
one month and then to the
maintenance dose, usually 400 mg/day. ( 2)
DOSAGE FORMS AND STRENGTHS
Tablets, 100 mg, 200 mg, and 400 mg. ( 3)
CONTRAINDICATIONS
Amiodarone hydrochloride tablets are contraindicated in patients with
( 4):
Cardiogenic shock.
Sick sinus syndrome, second- or third-degree AV block, bradycardia
leading to syncope without a
functioning pacemaker.
Known hypersensitivity to the drug or any of its components.
WARNINGS AND PRECAUTIONS
Persistence of Adverse Effects: Adverse reactions and drug interaction
can persist for several weeks
following discontinuation. ( 5.1)
Impaired Vision: Corneal microdeposits (common; rever