Amiodarone Hydrochloride

Generic Name: amiodarone hydrochloride

Over-the-Counter (OTC)

Brand Names:

Amiodarone Hydrochloride

Amiodarone hydrochloride is an antiarrhythmic drug available for oral administration as scored tablets containing 200 mg of amiodarone hydrochloride.

Overview

Amiodarone hydrochloride is an antiarrhythmic drug available for oral administration as scored tablets containing 200 mg of amiodarone hydrochloride.

Uses

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.

Dosage

Initiate treatment with loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, reduce dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.

Side Effects

At the usual maintenance dose (400 mg/day) and above, causes adverse reactions in about three-fourths of all patients, resulting in discontinuation in 7 to 18%. Common effects include pulmonary toxicity, hepatic injury, thyroid abnormalities, and peripheral neuropathy.

Interactions

Interactions with QT-prolonging drugs, negative chronotropes, CYP450 inhibitors/inducers, cyclosporine, cholestyramine, antiarrhythmics, digoxin, HMG-CoA reductase inhibitors, warfarin, phenytoin, hepatitis C antivirals, and CYP3A substrates.

Warnings

BOXED WARNING: Pulmonary, hepatic and cardiac toxicity. Intended for use only in patients with indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Contraindicated in cardiogenic shock, sick sinus syndrome, second- or third-degree AV block, and bradycardia leading to syncope without a functioning pacemaker.

Pregnancy

May increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction.

Storage

Store at 20 to 25 degrees C (68 to 77 degrees F). Keep tightly closed. Protect from light. Dispense in a light-resistant, tight container.

Frequently Asked Questions

What is Amiodarone Hydrochloride used for?

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.

What are the side effects of Amiodarone Hydrochloride?

At the usual maintenance dose (400 mg/day) and above, causes adverse reactions in about three-fourths of all patients, resulting in discontinuation in 7 to 18%. Common effects include pulmonary toxicity, hepatic injury, thyroid abnormalities, and peripheral neuropathy.

Can I take Amiodarone Hydrochloride during pregnancy?

May increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction.

What are the important warnings for Amiodarone Hydrochloride?

BOXED WARNING: Pulmonary, hepatic and cardiac toxicity. Intended for use only in patients with indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Contraindicated in cardiogenic shock, sick sinus syndrome, second- or third-degree AV block, and bradycardia leading to syncope without a functioning pacemaker.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.