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:

Advagen Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amiodarone Hydrochloride Tablets 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

Product summary:

Amiodarone Hydrochloride Tablets are available in three strengths as follows: 100 mg, Mottled pink, round, flat-faced, bevelled-edge tablets, engraved “^                                                                                                                       53” on one side and plain on other side. Bottles of 30 (NDC 72888-060-30) 200 mg, Mottled pink, round, flat-faced, bevelled-edge tablets, engraved ‘^’ over score and ‘54’ below score on one side and plain on other side Bottles of 60 (NDC 72888-039-60) Bottles of 500 (NDC 72888-039-05) Carton of 100 (10 x 10) Unit dose blisters (NDC 72888-039-09) 400 mg, Mottled pink, round, flat-faced bevelled-edge tablets, engraved “^” over score and “055” below score on one side and plain on the other side. Bottles of 30 (NDC 72888-061-30) Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container [See USP].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Advagen Pharma Limited
----------
MEDICATION GUIDE
AMIODARONE HYDROCHLORIDE TABLETS
(A-MEE-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 regular check-up

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
ADVAGEN PHARMA LIMITED
----------
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 Tablets 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, 400 mg. ( 3)
CONTRAINDICATIONS
Amiodarone Hydrochloride Tablets 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 microde