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:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Amiodarone Hydrochloride

Composition:

Amiodarone Hydrochloride 100 mg

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 underlying arrhythmias, including ventric

Product summary:

Amiodarone Hydrochloride Tablets USP, 100 mg are round, flat, beveled edge, white tablets; one side plain, the second side engraved with "TARO" at the top and "55" below. They are available as follows: Amiodarone Hydrochloride Tablets USP, 200 mg are round, flat, beveled edge, light orange tablets; one side plain, the second side scored and engraved with "TARO" above the score and "56" below the score line and are available as follows: Amiodarone Hydrochloride Tablets USP, 300 mg are round, flat, beveled edge, peach tablets; one side plain, the second side scored and engraved with "TARO" above the score and "58" below the score line and are available as follows: Amiodarone Hydrochloride Tablets USP, 400 mg are round, flat, beveled edge, light yellow tablets; one side plain, the second side scored and engraved with "TARO" above the score and "59" below the score line and are available as follows: Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Taro Pharmaceuticals U.S.A., Inc.
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Dispense with Medication Guide available at:
https://www.taro.com/usa-medication-guides
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

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
TARO PHARMACEUTICALS U.S.A., 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 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 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 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, 300 mg and 400 mg. (3)
CONTRAINDICATIONS
Amiodarone hydrochloride tablets are 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), opti