AMIODARONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 underl

Product summary:

Amiodarone Hydrochloride Tablets, 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 NDC 68382-227-14 in bottle of 60 tablets 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 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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
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MEDICATION GUIDE Amiodarone Hydrochloride
( A-mi-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
your body for months after treatment is stopped.
You should have regula

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
REMEDYREPACK 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, 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
pace make r.
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; reversibl