AMIODARONE HCL- 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:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amiodarone hydrochloride is 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 ventricular arrh

Product summary:

Amiodarone Hydrochloride Tablets, USP, 100 mg , are yellow colored, round, flat faced beveled edge tablets with “AS” debossed on one side and “100” debossed on the other side. Bottles of 30 tablets NDC 63629-9294-1 Keep tightly closed. Store at Controlled Room Temperature, 20° to 25° C (68° to 77° F) (see USP Controlled Room Temperature). Protect from light and moisture. Dispense in a light-resistant, tight container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMIODARONE HCL- AMIODARONE HYDROCHLORIDE TABLET
Bryant Ranch Prepack
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MEDICATIONGUIDE
AmiodaroneHydrochloride
(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 causeserioussideeffectsthat can
lead todeath, 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 af

Summary of Product characteristics

AMIODARONE HCL- AMIODARONE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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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 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)
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 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, and 400 mg. ( 3)
CONTRAINDICATIONS
Amiodarone hydrochloride 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