AMIODARONE HYDROCHLORIDE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Unichem Pharmaceuticals (USA), Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 v

Резиме производа:

Amiodarone Hydrochloride Tablets, USP are available in bottles of 60 tablets and 500 tablets as follows: 200 mg, NDC 29300-359-16 and NDC 29300-359-05, white to off white round-shaped flat faced beveled edged tablets debossed with "U" over score on one side and "359" on other side. Keep tightly closed. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Unichem Pharmaceuticals (USA), Inc.
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SPL MEDGUIDE
MEDICATION GUIDE
Amiodarone Hydrochloride (a" mee oh' da rone hye" droeklor' 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 because the
medicine stays in your body for months after trea

Карактеристике производа

AMIODARONE HYDROCHLORIDE - AMIODARONE HYDROCHLORIDE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
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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
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 tablets are 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 tablet 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 tablet is 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
neuropathy/neuritis (rare; may lead
to blind