Amiodarone Hydrochloride (Page 7 of 8)

Post-Marketing Reports

In post-marketing surveillance, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, urticaria, eosinophilic pneumonia, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, renal impairment, renal insufficiency, acute renal failure, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pulmonary alveolar hemorrhage, pleural effusion, pleuritis, pseudotumor cerebri, parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy), syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, demyelinating polyneuropathy, hallucination, confusional state, disorientation, delirium, epididymitis, and impotence, also have been reported with amiodarone therapy.

OVERDOSAGE

There have been cases, some fatal, of amiodarone hydrochloride overdose.

In addition to general supportive measures, the patient’s cardiac rhythm and blood pressure should be monitored, and if bradycardia ensues, a β-adrenergic agonist or a pacemaker may be used. Hypotension with inadequate tissue perfusion should be treated with positive inotropic and/or vasopressor agents. Neither amiodarone hydrochloride nor its metabolite is dialyzable.

The acute oral LD50 of amiodarone hydrochloride in mice and rats is greater than 3,000 mg/kg.

DOSAGE AND ADMINISTRATION

BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE HYDROCHLORIDE TABLET THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.

In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of amiodarone hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardia usually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats.

Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see PRECAUTIONS, Drug Interactions).

Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablets dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenance dose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings, and/or programmed electrical stimulation and by patient tolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity (see CLINICAL PHARMACOLOGY).

The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient’s arrhythmia and response to therapy.

When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone hydrochloride tablets and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

Loading Dose (Daily)

Adjustment and Maintenance Dose (Daily)

Ventricular Arrhythmias

1 to 3 weeks

~1 month

usual maintenance

800 mg to 1,600 mg

600 mg to 800 mg

400 mg

HOW SUPPLIED

Amiodarone Hydrochloride Tablets for oral administration are available as:

200 mg: Round, flat-faced, beveled edge, yellow tablets debossed “E” over bisect, “144” below bisect, plain on the reverse side and supplied as:

Boxes of 10 x10 UD 100 NDC 63739-387-10

Keep tightly closed.

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 as defined in the USP.

Medication Guide

Amiodarone Hydrochloride Tablets (a-meé-oh-da-rone)

Rx only

Read the Medication Guide that comes with Amiodarone Hydrochloride Tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

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 damage
liver damage
worse heartbeat problems
thyroid problems

Call your doctor or get medical help right away if you have any symptoms such as the following:

shortness of breath, wheezing, or any other trouble breathing; coughing, chest pain or spitting up of blood
nausea or vomiting; passing brown or dark-colored urine; feel more tired than usual; your skin and whites of your eyes get yellow; or have stomach pain
heart pounding, skipping a beat, beating very fast or very slowly; feel light-headed or faint
weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in your menses, swelling of your neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in the elderly, or tremor.

Because of these possible side effects, Amiodarone Hydrochloride Tablets should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated.

Amiodarone Hydrochloride Tablets can cause other serious side effects. See “What are the possible or reasonably likely side effects of Amiodarone Hydrochloride Tablets?” for more information.

If you get serious side effects during treatment with Amiodarone Hydrochloride Tablets you may need to stop Amiodarone Hydrochloride Tablets, have your dose changed, or get medical treatment. Talk with your doctor 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 months after treatment is stopped.

Tell all your healthcare providers that you take or took Amiodarone Hydrochloride Tablets. This information is very important for other medical treatments or surgeries you may have.

What are Amiodarone Hydrochloride Tablets?

Amiodarone Hydrochloride Tablets are a medicine used in adults to treat life-threatening heartbeat problems called ventricular arrhythmias, for which other treatment did not work or was not tolerated. Amiodarone Hydrochloride Tablets have not been shown to help people with life-threatening heartbeat problems live longer. Treatment with Amiodarone Hydrochloride Tablets should be started in a hospital to monitor your condition. You should have regular check-ups, blood tests, chest x-rays, and eye exams before and during treatment with Amiodarone Hydrochloride Tablets to check for serious side effects.

Amiodarone Hydrochloride Tablets have not been studied in children.

Who should not takeAmiodarone Hydrochloride Tablets?

Do not take Amiodarone Hydrochloride Tablets if you:

have certain heart conditions (heart block, very slow heart rate, or slow heart rate with dizziness or light-headedness)
have an allergy 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.

What should I tell my doctor before starting Amiodarone Hydrochloride Tablets?

Tell your doctor about all of your medical conditions including if you:

have lung or breathing problems
have liver problems
have or had thyroid problems
have blood pressure problems
are pregnant or planning to become pregnant. Amiodarone Hydrochloride Tablets can harm your unborn baby. Amiodarone Hydrochloride Tablets can stay in your body for months after treatment is stopped. Therefore, talk with your doctor before you plan to get pregnant.
are breastfeeding. Amiodarone Hydrochloride Tablets pass into your milk and can harm your baby. You should not breastfeed while taking Amiodarone Hydrochloride Tablets. Also, Amiodarone Hydrochloride Tablets can stay in your body for months after treatment is stopped.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Amiodarone Hydrochloride Tablets and certain other medicines can interact with each other causing serious side effects. Sometimes the dose of Amiodarone Hydrochloride Tablets or other medicines must be changed when they are used together. Especially, tell your doctor if you are taking:

antibiotic medicines used to treat infections
depression medicines
blood thinner medicines
HIV or AIDS medicines
cimetidine (Tagamet®), a medicine for stomach ulcers or indigestion
loratadine (for example: Claritin® , Alavert®), a medicine for allergy symptoms
seizure medicines
diabetes medicines
cyclosporine, an immunosuppressive medicine
dextromethorphan, a cough medicine
medicines for your heart, circulation or blood pressure
water pills (diuretics)
high cholesterol or bile medicines
narcotic pain medicines
St. John’s Wort

Know the medicines you take. Keep a list of them with you at all times and show it to your doctor and pharmacist each time you get a new medicine. Do not take any new medicines while you are taking Amiodarone Hydrochloride Tablets unless you have talked with your doctor.

How should I take Amiodarone Hydrochloride Tablets?

Take Amiodarone Hydrochloride Tablets exactly as prescribed by your doctor.
The dose of Amiodarone Hydrochloride Tablets you take has been specially chosen for you by your doctor and may change during treatment. Keep taking your medicine until your doctor tells you to stop. Do not stop taking it because you feel better. Your condition may get worse. Talk with your doctor if you have side effects.
Your doctor will tell you to take your dose of Amiodarone Hydrochloride Tablets with or without meals. Make sure you take Amiodarone Hydrochloride Tablets the same way each time.
Do not drink grapefruit juice during treatment with Amiodarone Hydrochloride Tablets. Grapefruit juice affects how Amiodarone Hydrochloride Tablets are absorbed in the stomach.
Taking too many Amiodarone Hydrochloride Tablets can be dangerous. If you take too many Amiodarone Hydrochloride Tablets, call your doctor or go to the nearest hospital right away. You may need medical care right away.
If you miss a dose, do not take a double dose to make up for the dose you missed. Continue with your next regularly scheduled dose.

What should I avoid while taking Amiodarone Hydrochloride Tablets?

Do not drink grapefruit juice during treatment with Amiodarone Hydrochloride Tablets. Grapefruit juice affects how Amiodarone Hydrochloride Tablets are absorbed in the stomach.
Avoid exposing your skin to the sun or sun lamps. Amiodarone Hydrochloride Tablets can cause a photosensitive reaction. Wear sun-block cream or protective clothing when out in the sun.
Avoid pregnancy during treatment with Amiodarone Hydrochloride Tablets. Amiodarone Hydrochloride Tablets can harm your unborn baby.
Do not breastfeed while taking Amiodarone Hydrochloride Tablets. Amiodarone Hydrochloride Tablets pass into your milk and can harm your baby.

What are the possible or reasonably likely side effects of Amiodarone Hydrochloride Tablets?

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

Amiodarone Hydrochloride Tablets can cause serious side effects that lead to death including lung damage, liver damage, worse heartbeat problems, and thyroid problems. See “What is the most important information I should know about Amiodarone Hydrochloride Tablets?”

Some other serious side effects of Amiodarone Hydrochloride Tablets include:

vision problems that may lead to permanent blindness. You should have regular eye exams before and during treatment with Amiodarone Hydrochloride Tablets. Call your doctor if you have blurred vision, see halos, or your eyes become sensitive to light.
nerve problems. Amiodarone Hydrochloride Tablets can cause a feeling of “pins and needles” or numbness in the hands, legs, or feet, muscle weakness, uncontrolled movements, poor coordination, and trouble walking.
thyroid problems. Amiodarone Hydrochloride Tablets can cause thyroid problems, including low thyroid function or overactive thyroid function. Your doctor may arrange regular blood tests to check your thyroid function during treatment with Amiodarone Hydrochloride Tablets. Call your doctor if you have weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in your menses, swelling of your neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in the elderly, or tremor.
skin problems. Amiodarone Hydrochloride Tablets can cause your skin to be more sensitive to the sun or to turn a bluish-gray color. In most patients, skin color slowly returns to normal after stopping Amiodarone Hydrochloride Tablets. In some patients, skin color does not return to normal.

Other side effects of Amiodarone Hydrochloride Tablets include nausea, vomiting, constipation, and loss of appetite.

Call your doctor about any side effect that bothers you.

These are not all the side effects with Amiodarone Hydrochloride Tablets. For more information, ask your doctor or pharmacist.

How should I store Amiodarone Hydrochloride Tablets?

Store Amiodarone Hydrochloride Tablets at room temperature. Protect from light. Keep Amiodarone Hydrochloride Tablets in a tightly closed container.
Safely dispose of Amiodarone Hydrochloride Tablets that are out-of-date or no longer needed.
Keep Amiodarone Hydrochloride Tablets and all medicines out of the reach of children.

General information about 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 share Amiodarone Hydrochloride Tablets with other people, even if they have the same symptoms that you have. It may harm them.

If you have any questions or concerns about Amiodarone Hydrochloride Tablets, ask your doctor or healthcare provider. This Medication Guide summarizes the most important information about Amiodarone Hydrochloride Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Amiodarone Hydrochloride Tablets that was written for healthcare professionals.

This product’s Medication Guide may have been updated. For current Medication Guide, please visit www.us.sandoz.com.

What are the ingredients in Amiodarone Hydrochloride Tablets?

Active Ingredient: amiodarone hydrochloride

Inactive Ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and D&C yellow No. 10 aluminum lake.

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

Tagamet is a registered trademark of SmithKline Beecham Pharmaceuticals Co.

Claritin is a registered trademark of Schering Corporation.

Alavertis a registered trademark of Wyeth.

Manufactured By:
Sandoz Inc.
506 Carnegie Center Suite 400
Princeton, NJ 08805

Distributed By:
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddington Rd., Concord, NC 28027
IS-4005690-R4
January 2011

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