AMIODARONE HYDROCHLORIDE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NCS HealthCare of KY, LLC dba Vangard Labs

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

Amiodarone Hydrochloride Tablets USP, 200 mg are white to off-white, round biconvex uncoated tablets debossed with “8” and “4” separated by a breakline on one side and “A” on the other side. Blistercards of 30          NDC 0615-8258-39 Blistercards of 15          NDC 0615-8258-05 Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

NCS HealthCare of KY, LLC dba Vangard Labs
----------
MEDICATION GUIDE
Amiodarone Hydrochloride Tablets, USP
(A-mee-OH-da-rone HYE-droe-KLOR-ide)
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 your body for months after treatment

Данни за продукта

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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.
AMIODARONE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: PULMONARY, HEPATIC AND CARDIAC TOXICITY
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Reserve amiodarone hydrochloride 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’s 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 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 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, 200 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; reversible), optic