AMIODARONE HYDROCHLORIDE - amiodarone hydrochloride tablet 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Amiodarone Hydrochloride Tablets, USP

(A-mee-OH-da-rone HYE-droe-KLOR-ide)


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:

Call your healthcare provider or get medical help right away if you have any of the following symptoms 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-ups, blood tests, chest x-rays before and during treatment with amiodarone hydrochloride tablets to check for serious side effects. You should also have lung function tests before starting treatment with amiodarone hydrochloride tablets.


What are amiodarone hydrochloride tablets?

Amiodarone hydrochloride tablets are a prescription medicine 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.

It is not known if amiodarone hydrochloride tablets are safe and effective in children.


Who should not take amiodarone hydrochloride tablets?

Do not take amiodarone hydrochloride tablets if you:

Before taking amiodarone hydrochloride tablets, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Amiodarone hydrochloride tablets and certain other medicines can affect with each other and cause serious side effects. You can ask your pharmacist for a list of medicines that interact with amiodarone hydrochloride tablets.


How should I take amiodarone hydrochloride tablets?

What should I avoid while taking amiodarone hydrochloride tablets?

What are the possible side effects of amiodarone hydrochloride tablets?

Amiodarone hydrochloride tablets can cause serious side effects, including:


The most common side effects of amiodarone hydrochloride tablets include:


Amiodarone hydrochloride tablets may affect fertility in males and females. It is not known if the effects are reversible. Talk to your healthcare provider if you have concerns about fertility.


These are not all the possible side effects of amiodarone hydrochloride tablets. For more information, ask your healthcare provider or pharmacist.


Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


How should I store amiodarone hydrochloride tablets?

Keep amiodarone hydrochloride tablets and all medicines out of the reach of children.


General information about the safe and effective use of amiodarone hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use amiodarone hydrochloride tablets for a condition for which it was not prescribed. Do not give amiodarone hydrochloride tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about amiodarone hydrochloride tablets that is written for health professionals.


What are the ingredients in amiodarone hydrochloride tablets?

Active Ingredient: amiodarone hydrochloride

Inactive Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides.


This Medication Guide has been approved by the U.S. Food and Drug Administration.


Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520


Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 038, India


Revised: 05/2020

Revised: 7/2020
Aurobindo Pharma Limited