AMIODARONE HYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Amiodarone Hydrochloride (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT)

Доступна з:

Major Pharmaceuticals

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. 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 ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see Clinical Considerations) . In animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo-fetal toxicity at dose

Огляд продуктів:

Amiodarone Hydrochloride Tablets USP, 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 and are available as follows: Cartons of 100 tablets (10 tablet blister packs x 10), NDC 0904-6993-61 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 Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Major Pharmaceuticals
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Dispense with Medication Guide available at:
https://www.taro.com/usa-medication-guides
MEDICATION GUIDE
Amiodarone Hydrochloride
(A-mee-OH-da-rone HYE-droe-KLOR-ide) Tablets, USP
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 beca

Характеристики продукта

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
MAJOR PHARMACEUTICALS
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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._
•
•
•
INDICATIONS AND USAGE
Amiodarone hydrochloride tablets are an antiarrhythmic indicated for:
•
•
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, 300 mg and 400 mg. (3)
CONTRAINDICATIONS
Amiodarone hydrochloride tablets are contraindicated in patients with
(4):
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS
U.S.A., INC. AT 1-
866-923-4914 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
RESERVE AMIODARONE 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'S LIFE-THREATENING TOXICITIES INCLUDE PULMONARY (5.2),
HEPATIC (5.3), AND
PROARRHYTHMIC (5.4).
INITIATE UNDER HOSPITAL OR SPECIALIST SUPERVISION. (5)
Recurrent ventricular fibrillation. (1)
Recurrent hemodynamically unstable ventricular tachycardia. (1)
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 compone