AMIODARONE HYDROCHLORIDE- 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:

APOTEX Corp

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 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 are available for oral administration as pink, flat-faced, bevelled edge tablets, engraved “AMI” over Score “200” on one side, “APO” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2658-3) Bottles of 60 (NDC 60505-2658-6) Bottles of 500 (NDC 60505-2658-5) Bottles of 1,000 (NDC 60505-2658-8) Carton of 100 (10 x 10) Unit dose blisters (NDC-60505-2658-0). 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]. Dispense in a tight, light-resistant container [see USP]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
APOTEX Corp
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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 treatm

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
APOTEX CORP
----------
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 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 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, 200 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), optic
neuropathy/neuritis (