PACERONE- amiodarone hydrochloride tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Amiodarone Hydrochloride (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT)

Dostupno od:

Upsher-Smith Laboratories, LLC

INN (International ime):

Amiodarone Hydrochloride

Sastav:

Amiodarone Hydrochloride 100 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Pacerone 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 post-marketing 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

Proizvod sažetak:

Pacerone® (amiodarone hydrochloride tablets, USP) 100 mg are peach, round, flat-faced, uncoated tablets, debossed with "P" on one side, and "U-S" above "144" on the other side. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 0245-0144-30  Bottles of 100 with child-resistant closure, NDC 0245-0144-11  Unit-dose cartons of 100 tablets, NDC 0245-0144-01 Pacerone® (amiodarone hydrochloride tablets, USP) 200 mg, are pink, round, flat-faced, scored, uncoated tablets, debossed with "P200 " on the unscored side, and "U-S" above and "0147" below the score on the reverse side. They are supplied as follows: Bottles of 60 with child-resistant closure, NDC 0245-0147-60  Bottles of 90 with child-resistant closure, NDC 0245-0147-90  Bottles of 500 tablets, NDC 0245-0147-15  Unit-dose cartons of 100 tablets, NDC 0245-0147-01 Pacerone® (amiodarone hydrochloride tablets, USP) 400 mg, are white to off-white, round, uncoated, scored tablets, debossed with "U-S" above and "1645" below the score on one side and "P400 " on the unscored side. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 0245-1645-30  Unit-dose cartons of 100 tablets, NDC 0245-1645-01 Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Upsher-Smith Laboratories, LLC
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MEDICATION GUIDE
PACERONE® (PĀS-ƏR-ŌN) TABLETS
(AMIODARONE HYDROCHLORIDE)
What is the most important information I should know about Pacerone
tablets?
Pacerone 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 Pacerone 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
Pacerone tablets.
Pacerone tablets should be started in a hospital so that your medical
condition can be carefully
monitored.
Pacerone 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.
Pacerone tablets can cause other serious side effects. See "What are
the possible side effects of Pacerone
tablets?"
If you get serious side effects during treatment you may need to stop
Pacerone tablets, have your dose
changed, or get medical treatment. Talk with your healthcare provider
before you stop taking Pacerone
tablets.
You may still have side effects after stopping Pacerone tablets
because the medicine stays in your body
for months after treatment is stopped.
You should have regular check-ups, blood tests, chest x-rays before
and during treatment with Pacerone
tablets to check for serious side effects. You should also have lung
function tests before s

Svojstava lijeka

PACERONE- AMIODARONE HYDROCHLORIDE TABLET
UPSHER-SMITH LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PACERONE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PACERONE.
PACERONE (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 PACERONE 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)
PACERONE' 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
Pacerone is an antiarrhythmic indicated for:
Recurrent ventricular fibrillation. (1)
Recurrent hemodynamically unstable ventricular tachycardia. (1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a loading dose 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 Pacerone 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
Pacerone 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; may lead
to blindness). (5.5)
Thyroid Abnormalities: Hyperthyroidism or hypothyroidism. (5.6)
ADVERSE REAC