Amiodarone Hydrochloride (Page 5 of 6)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Amiodarone HCl 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*).

Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with amiodarone hydrochloride tablets were negative.

In a study in which amiodarone HCl 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*).

*600 mg in a 60 kg patient (dose compared on a body surface area basis)

16 HOW SUPPLIED/STORAGE AND HANDLING

Amiodarone Hydrochloride Tablets, 200 mg are white to off-white, round-shaped, flat beveled-edge, uncoated tablets with bisect on one side and other side is plain; one side of bisect is debossed with ‘ZE’ and other side is debossed with ’65′ and are supplied as follows:

Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-6556-61

Storage:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Dispense in a tight, light-resistant container

17 PATIENT COUNSELING INFORMATION

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.

Manufactured by:

Cadila Healthcare Ltd.

India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number

Rev.: 11/18

MEDICATION GUIDE Amiodarone Hydrochloride

(A-mi-OH-da-rone HYE-droe-KLOR-ide) Tablets

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:

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 amiodarone hydrochloride 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 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 is amiodarone hydrochloride tablet?

Amiodarone hydrochloride tablet is 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 tablet is safe and effective in children.

Who should not take amiodarone hydrochloride tablets? Do not take amiodarone hydrochloride tablets if you:

have a serious heart problem called cardiogenic shock
have certain types of the heart condition called heart block, with or without a slow heart rate
have a slow heart rate with dizziness or lightheadedness, and you do not have an implanted pacemaker
are allergic to amiodarone, iodine, or any of the other ingredients in amiodarone hydrochloride tablets. See the end of this Medication
Guide for a complete list of ingredients in amiodarone hydrochloride tablets.

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

have lung or breathing problems
have liver problems
have or had thyroid problems
have a slow heart rate or blood pressure problems
have diarrhea or have had diarrhea for a long period of time
have been told that you have low levels of potassium, magnesium, or calcium in your blood
have an implanted pacemaker or defribrillator
if you plan to have surgery with general anesthesia
are pregnant or plan to become pregnant. Amiodarone hydrochloride tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with amiodarone hydrochloride tablets. Amiodarone hydrochloride tablets can stay in your body for months after treatment is stopped.
are breastfeeding or plan to breastfeed. Amiodarone hydrochloride tablets can pass into your breast milk and may harm your baby. You should not breast feed while taking amiodarone hydrochloride tablets. Amiodarone hydrochloride tablets can stay in your body for months after treatment is stopped. Talk to your healthcare provider about the best way to feed your baby during this time.

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?

When you are discharged from the hospital, take amiodarone hydrochloride tablets exactly as your doctor tells you to take it.
Your healthcare provider will tell you how much amiodarone hydrochloride tablets to take and when to take it.
Your healthcare provider may change your dose of amiodarone hydrochloride tablets as needed if your heart rhythm is controlled, or if you have certain side effects. Your healthcare provider should monitor you carefully when your dose of amiodarone hydrochloride tablet is being changed.
Take your dose of amiodarone hydrochloride tablets the same way each time, either with or without food.
If you take too much amiodarone hydrochloride tablets, call your healthcare provider or go to the nearest hospital emergency room right away. If you miss a dose, wait and take your next dose at your regular time. Do not take two doses at the same. Continue with your next regularly scheduled dose.

What should I avoid while taking amiodarone hydrochloride tablets?

Avoid drinking grapefruit juice during treatment with amiodarone hydrochloride tablets. Drinking grapefruit juice with amiodarone hydrochloride tablets may increase the amount of amiodarone hydrochloride tablets in your blood, and this may lead to side effects.
Amiodarone hydrochloride tablets can make your skin sensitive to sunlight. You could get severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin to help protect you if you must be in sunlight. Talk to your healthcare if you get a sunburn. See “Skin problems” in the Medication Guide section “What are the possible side effects of amiodarone hydrochloride tablets?” below.

What are the possible side effects of amiodarone hydrochloride tablets? Amiodarone hydrochloride tablets can cause serious side effects, including:

See “What is the most important information I should know about amiodarone hydrochloride tablets?”
Nerve problems. Amiodarone hydrochloride tablets can cause nerve problems. Call your healthcare provider if you develop symptoms of nerve problems, including: a feeling of “pins and needles” or numbness in your hands, legs, or feet, muscle weakness, uncontrolled movements, poor coordination, or trouble walking.
Skin problems. Amiodarone hydrochloride tablets can cause your skin to be more sensitive to the sun or turn a bluish-gray color.
People who have fair skin or people who have a lot of sun exposure may be more at risk for these skin problems. Some of the bluish-gray skin color may return to normal after stopping amiodarone hydrochloride tablets.
Thyroid problems. Amiodarone hydrochloride tablets can cause you to have either decreased thyroid function (hypothyroidism), which can sometimes be severe, or an overactive thyroid (hyperthyroidism), which can be severe.
If you develop decreased thyroid function during treatment with amiodarone hydrochloride tablets, your healthcare provider may need to reduce your dose or stop your treatment with amiodarone hydrochloride tablets, and possibly prescribe medicine to replace your thyroid hormone.
An overactive thyroid can cause you to produce too much thyroid hormone. You can have abnormal heartbeats even while you are receiving amiodarone hydrochloride tablets. Your healthcare provider may prescribe certain medicines to treat your overactive thyroid. Call your healthcare provider if you get any abnormal heart beats during treatment with amiodarone hydrochloride tablets. This may mean that you have an overactive thyroid.
Your healthcare provider should do tests to check your thyroid function before you start and during treatment with amiodarone hydrochloride tablets.
Call your healthcare provider if you develop any of the following symptoms of a thyroid problem during treatment with amiodarone hydrochloride tablets:
weakness
weight loss or weight gain
heat or cold intolerance
hair thinning
sweating
changes in your menstrual periods
swelling of your neck (goiter)
nervousness
irritability
restlessness
decreased concentration
feeling depressed (in the elderly)
tremor

The most common side effects of amiodarone hydrochloride tablets include:

lung problems
heartbeat problems
heart problems
liver problems

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?

Store amiodarone hydrochloride tablets at room temperature between 20° to 25°C (68° to 77°F).
Keep amiodarone hydrochloride tablets in a tightly closed container, and keep amiodarone hydrochloride tablets out of the light.

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 HCl

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

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

Manufactured by:

Cadila Healthcare Ltd.

India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number

Distributed by:Cardinal Health

Dublin, OH 43017

PR54669091118A

Rev.: 11/18

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