AMIODARONE HYDROCHLORIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Designación común internacional (DCI):

AMIODARONE HYDROCHLORIDE

Composición:

AMIODARONE HYDROCHLORIDE 200 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 u

Resumen del producto:

Amiodarone Hydrochloride Tablets USP, 100 mg are white to off-white, round-shaped, flat faced, bevel-edged, uncoated tablets debossed with '297' on one side and plain on other side and are supplied as follows: NDC 68382-297-06 in bottle of 30 tablets with child-resistant closure. Amiodarone Hydrochloride Tablets USP, 200 mg are white to off-white, round-shaped, flat beveled-edge, uncoated tablets with bisect on one side and other side is plain; one side of bisect is debossed with 'ZE' and other side is debossed with '65' and are supplied as follows: NDC 68382-227-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-227-14 in bottle of 60 tablets with child-resistant closure. NDC 68382-227-05 in bottle of 500 tablets NDC 68382-227-10 in bottle of 1000 tablets NDC 68382-227-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Amiodarone Hydrochloride Tablets USP, 400 mg are pale yellow to yellow, round-shaped, flat faced, bevel-edged, uncoated tablets debossed with '2' and '98' on either side of score line on one side and plain on other side and are supplied as follows: NDC 68382-298-06 in bottle of 30 tablets with child-resistant closure. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Zydus Pharmaceuticals USA Inc.
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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 because the medicine
stays in your body for months after treatment is stopped.

Ficha técnica

AMIODARONE HYDROCHLORIDE - AMIODARONE HYDROCHLORIDE TABLET
ZYDUS 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.
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 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 TABLET'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 tablet 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 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, 100 mg, 200 mg and 400 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