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:

McKesson Corporation dba SKY Packaging

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 mg

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. 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 embryofetal toxicity at doses less tha

Product summary:

Product: 63739-387 NDC: 63739-387-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

McKesson Corporation dba SKY Packaging
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MEDICATION GUIDE
AMIODARONE HYDROCHLORIDE TABLETS
(A MI OH DA RONE)
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 r

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
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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 is 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 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 is contraindicated in patients with (4):
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•
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WARNINGS AND PRECAUTIONS
•
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ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ, INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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)
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
pace make r.
Known hypersensitivity to the drug or any of its compo