Pacerone 400 mg/1

Amiodarone Hydrochloride · TABLET · Upsher-Smith Laboratories, LLC

No Recall History

Plain English

Pacerone is a tablet containing amiodarone hydrochloride at 400 mg/1, taken oral. Manufactured by Upsher-Smith Laboratories, LLC.

Key Facts

Brand Name: Pacerone
Generic Name: Amiodarone Hydrochloride
NDC Code (Product): 0245-1645
Manufacturer: Upsher-Smith Laboratories, LLC
Strength: 400 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA075135
Marketing Start: 07/02/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,163 reports

asthenia988 reports

fatigue902 reports

off label use868 reports

drug ineffective709 reports

product use in unapproved indication672 reports

nausea616 reports

cough603 reports

atrial fibrillation600 reports

dizziness578 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Dosage must be individualized based on severity of arrhythmia and response. Use the lowest effective dose. Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment. 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 ) Recommended Dosage: 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 tablet dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Administration: Administer Pacerone tablets consistently with regard to meals [see Clinical Pharmacology (12.3) ] . Administration of Pacerone tablets in divided doses with meals is suggested f…

Contraindications

4 CONTRAINDICATIONS 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. 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.

Drug Interactions

7 DRUG INTERACTIONS Because of amiodarone's long half-life, expect drug interactions to persist for weeks to months after discontinuation of amiodarone. Drug interactions with amiodarone are described in Table 1 below. Table 1: Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment Pharmacodynamic Interactions QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents Increased risk of Torsade de Pointes. Avoid concomitant use. Negative Chronotropes digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. Pharmacokinetic Interactions CYP450 Inhibitors grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine, certain protease inhibitors Increased exposure of amiodarone. Avoid concomitant use. CYP450 Inducers St. John's Wort Reduced amiodarone serum levels. Cyclosporine Increased plasma levels of …

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions (5.2) ] Hepatic Injury [see Warnings and Precautions (5.3) ] Worsened Arrhythmia [see Warnings and Precautions (5.4) ] Visual Impairment and Loss of Vision [see Warnings and Precautions (5.5) ] Thyroid Abnormalities [see Warnings and Precautions (5.6) ] Bradycardia [see Warnings and Precautions (5.7) ] Peripheral Neuropathy [see Warnings and Precautions (5.10) ] Photosensitivity and Skin Discoloration [see Warnings and Precautions (5.11) ] The most common reactions (>1%) leading to discontinuation of amiodarone include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical t…

Frequently Asked Questions

What is Pacerone used for?

Pacerone contains Amiodarone Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Pacerone a controlled substance?

Pacerone is not classified as a controlled substance by the DEA.

What is the generic name for Pacerone?

The generic name for Pacerone is Amiodarone Hydrochloride. There are 12 other brand versions of Amiodarone Hydrochloride.

What is the NDC code for Pacerone 400 mg/1?

The NDC (National Drug Code) for Pacerone 400 mg/1 is 0245-1645, listed by Upsher-Smith Laboratories, LLC.

Product NDC

0245-1645

Package NDC

0245-1645-01

Other Amiodarone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)