Amiodarone hydrochloride was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose 2).
Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with amiodarone hydrochloride tablets were negative.
In a study in which amiodarone hydrochloride was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose 2).
- 600 mg in a 60 kg patient (dose compared on a body surface area basis)
Amiodarone Hydrochloride Tablets USP, 200 mg are round, flat, beveled edge, light orange tablets; one side plain, the second side scored and engraved with “TARO” above the score and “56” below the score line and are available as follows:
Cartons of 100 tablets (10 tablet blister packs x 10), NDC 0904-6993-61
Keep tightly closed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light.
Dispense in a light-resistant, tight container.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Advise women that breastfeeding is not recommended during treatment with amiodarone hydrochloride tablets [see Use in Specific Populations (8.2)].
Advise patients to avoid grapefruit juice and St. John’s Wort.
Advise patients to seek medical attention if they experience the signs and symptoms of pulmonary toxicity, worsening arrhythmia, bradycardia, visual impairment, or hypo- and hyperthyroidism.
This product’s label may have been updated. For full prescribing information, please visit www.taro.com.
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Revised: March 2020
71008-0320-18 Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides
Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides
MEDICATION GUIDE Amiodarone Hydrochloride (A-mee-OH-da-rone HYE-droe-KLOR-ide) Tablets, USP
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:
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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. It 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 hydrochlorideInactive Ingredients: colloidal silicon dioxide, corn starch, D&C yellow No. 10 lake (200 and 400 mg only), FD&C yellow No. 6 lake (200 and 300 mg only), lactose anhydrous, magnesium stearate and povidone.Manufactured by: Taro Pharmaceutical Industries Ltd.Haifa Bay, Israel 2624761Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532For more information, call 1-866-923-4914 or visit www.taro.com
This Medication Guide has been approved by the U.S. Food and Drug Administration.
71008-0320-18 Revised: March 2020
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.