Amiodarone

(a mee' oh da rone)

 

PContraindicated In Pregnancy - Contraindicated in pregnancy

LContraindicated in lactation - Contraindicated in lactation

Molecule Info

 

Indication & Dosage

Oral  Ventricular arrhythmias  Adult: 800-1,600 mg/day in 1-2 divided doses for 1-3 wk until initial therapeutic response is achieved, then reduce dose to 600-800 mg/day in 1-2 divided doses for 1 mth.  Maintenance: 400 mg/day; lower doses may be used for supraventricular arrhythmias.  Daily doses may be divided.  Close monitoring of the patient is recommended.  Use the minimum effective dose.  Hepatic impairment: Dosage reduction may be necessary.  Intravenous  Life-threatening ventricular arrhythmias  Adult: Recommended starting dose: About 1 g over 1st 24 hr.  Dose is given in a 3-phase sequence.  Initial rapid loading dose: Infuse 150 mg at a rate of 15 mg/minute; followed by the slow loading phase: Infuse 360 mg at a rate of 1 mg/minute; followed by the first maintenance phase: Infuse 540 mg at a rate of 0. 5 mg/minute.  After the 1st 24 hr, maintain infusion rate at 0. 5 mg/minute; rate may be increased to achieve effective suppression of arrhythmia.  For breakthrough episodes, supplemental doses of 150 mg may be given at 15 mg/minute; may repeat supplemental doses up to a max IV dose of 2. 2 g/24 hr.  Maintenance infusion at up to 0. 5 mg/minute may be continued for up to 2-3 wk with caution.  Concentrate for inj should be diluted prior to admin.  Conversion to Oral   therapy will depend on the administered dose of the IV therapy and the bioavailability of the Oral   drug.  Hepatic impairment: Dosage reduction may be necessary.  Intravenous  Pulseless ventricular fibrillation or ventricular tachycardia  Adult: Initial: 300 mg if VF or VT recurs, to be given as a single dose by rapid IV inj.  Supplemental dose: 150 mg followed by an infusion of 1 mg/minute for 6 hr, then 0. 5 mg/minute.  Max: 2. 1 g daily.  Hepatic impairment: Dosage reduction may be necessary. Reconstitution: To make solution for 1st rapid loading infusion or supplemental infusion: Add 3 ml of amiodarone HCl concentrate to 100 ml of dextrose 5% to give a final conc of 1. 5 g/ml; for slow infusion: Add 18 ml of amiodarone HCl concentrate to 500 ml of dextrose 5% to give a final conc of 1. 8 mg/ml; for subsequent maintenance infusions, diluted solutions with conc ranging from 1-6 mg/ml may be used.  Solutions with conc ≥2 mg/ml should be administered via a central venous catheter.  Incompatibility: Y-site incompatibility: Cefamandole, sodium bicarbonate, heparin, aminophylline.  Syringe incompatibility: Heparin.  Admixture incompatibility: Cefazolin sodium, cefamandole, mezlocillin sodium, sodium bicarbonate, heparin sodium, aminophylline.

Administration

May be taken with or without food.  Take consistently w/ or w/o meals.  Take w/ meals if high dose or to reduce GI discomfort.

Overdosage

Symptoms include hypotension, cardiogenic shock, bradycardia, AV block and hepatotoxicity.  Hypotension and cardiogenic shock should be treated by slowing the infusion rate or with vasopressor drugs, positive inotropic agents and volume expansion.  Bradycardia and AV block may require temporary pacing.  Monitor hepatic enzyme concentrations.  Amiodarone is not dialyzable.

Contraindications

Hypersensitivity to amiodarone or iodine.  Severe sinus node dysfunction, 2nd and 3rd degree heart block, cardiogenic shock, pregnancy.

Special Precautions

Close monitoring is recommended as amiodarone may worsen arrhythmia especially when used concurrently with other anti-arrhythmic drugs or drugs that prolong QT interval.  May cause hypotension and bradycardia.  May increase risk of liver toxicity.  May cause visual disturbance/impairment; corneal refractive laser surgery is not recommended in patients on amiodarone treatment.  May cause lung damage; monitor for pulmonary toxicity e. g.  acute respiratory distress syndrome.  Monitor liver functions regularly.  May affect defibrillation or pacing thresholds of cardiac devices.  Correct electrolyte imbalance before starting treatment.  Caution when used in patients undergoing surgery.  Avoid excessive sunlight exposure due to increased risk of photosensitivity.  Hepatic impairment, thyroid disease, elderly.  Lactation.

Adverse Drug Reactions

Blue-grey discolouration of skin, photosensitivity, peripheral neuropathy, paraesthesia, myopathy, ataxia, tremor, nausea, vomiting, metallic taste, hypothyroidism, hyperthyroidism, alopoecia, sleep disturbances, corneal microdeposits, hot flushes, sweating.  Heart block, bradycardia, sinus arrest, hepatotoxicity, heart failure. Potentially Fatal: Pulmonary toxicity including pulmonary fibrosis and interstitial pneumonitis, hepatotoxicity, thyrotoxicity.  Ventricular arrhythmias, pulmonary alveolitis, exacerbation of arrhythmias and rare serious liver injury.  Generally in patients with high doses and having preexisting abnormalities of diffusion capacity.

Drug Interactions

Potentiation of antiarrhythmic drugs.  Possible increased risk of adverse effects when used with anaesthetic agents.  Monitor plasma levels of amiodarone when used with HIV protease inhibitors.  Cimetidine may increase serum levels of amiodarone.  Concurrent use may increase serum levels of ciclosporin.  May increase risk of myopathy or rhabdomyolysis when used with HMG-CoA reductase inhibitors.  Rifampin may reduce the serum levels of amiodarone. Potentially Fatal: Potentiation of antiarrhythmic drugs.  Possible increased risk of adverse effects when used with anaesthetic agents.  Monitor plasma levels of amiodarone when used with HIV protease inhibitors.  Cimetidine may increase serum levels of amiodarone.  Concurrent use may increase serum levels of ciclosporin.  May increase risk of myopathy or rhabdomyolysis when used with HMG-CoA reductase inhibitors.  Rifampin may reduce the serum levels of amiodarone.

Food Interaction

St John's wort may reduce serum levels of amiodarone.  Grapefruit juice may increase serum levels of amiodarone.

 

Pregnancy Category (US FDA)

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.

 

Storage

Intravenous  : Store at 15-25°C.  Oral:  Store at 20-25°C.

Mechanism of Action

Amiodarone is a class III antiarrhythmic agent which inhibits stimulation, prolongs action potential and refractory period in myocardial tissues.  It also decreases AV conduction and sinus node function.  Sinus rate is reduced by 15-20%, PR and QT intervals are increased.  Amiodarone can cause marked sinus bradycardia or sinus arrest and heart block.  In acute IV doses, amiodarone may exert a mild negative inotropic effect. Onset: IV: 1-30 minutes. Duration: IV: 1-3 hr.  Absorption: Oral   admin: Variable and erratically absorbed from the GI tract; average bioavailability is about 50%.  Distribution: Extensively distributed to body tissues; accumulates in muscles and fats.  Crosses the placenta and enters breast milk.  Protein-binding: 96% Metabolism: Yields desethylamiodarone; may undergo enterohepatic recycling.  Excretion: Mainly in the faeces via bile; via urine.  Terminal elimination half-life: About 50 days; may range from 20-100 days due to extensive tissue distribution.

mph Class

Cardiac Drugs

ATC Classification

C01BD01 - amiodarone; Belongs to class III antiarrhythmics.

Search Google: Amiodarone

 

 

Brand/Product Info


Total Products : 3   
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
CARDIRON Drug International Ltd Amiodarone hydrochloride BP 200mg Tablet 30's: 210.00 MRP
CORDARONE Sanofi Amiodarone hydrochloride BP 200mg Tablet 100mg x 30's, 200mg x 30's: 301.20 & 542.10 MRP
SOTALEX-80 Unimed & Unihealth Manufacturers Ltd. Amiodarone hydrochloride BP 200mg Tablet 30's: 240.00 MRP

Gen. MedInfo

 

IMPORTANT WARNING:

 

Amiodarone may cause lung damage that can be serious or life-threatening.  Tell your doctor if you have or have ever had any type of lung disease or if you have ever developed lung damage or breathing problems while taking amiodarone.  If you experience any of the following symptoms, consult your doctor immediately: fever, shortness of breath, wheezing, other breathing problems, cough, or coughing or spitting up blood.

 

Amiodarone may also cause liver damage.  Tell your doctor if you have or have ever had liver disease.  If you experience any of the following symptoms, consult your doctor immediately: nausea, vomiting, dark colored urine, excessive tiredness, yellowing of the skin or eyes, itching, or pain in the upper right part of the stomach.

 

Amiodarone may cause your arrhythmia to worsen or may cause you to develop new arrhythmias.  Tell your doctor if you have ever been dizzy or lightheaded or have fainted because your heartbeat was too slow and if you have or have ever had low levels of potassium or magnesium in your blood; heart or thyroid disease; or any problems with your heart rhythm other than the arrhythmia that is being treated.  Tell your Doctor if you are taking any of the following medications: antifungals such as fluconazole, ketoconazole, and itraconazole; azithromycin; beta blockers such as propranolol; calcium channel blockers such as diltiazem and verapamil; cisapride; clarithromycin; diuretics; dofetilide; erythromycin; fluoroquinolone antibiotics such as ciprofloxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, and sparfloxacin; other medications for irregular heartbeat such as digoxin, disopyramide, flecainide, phenytoin, procainamide, quinidine and sotalol; and thioridazine.  If you have any of the following symptoms, consult your doctor immediately: lightheadedness; fainting; fast, slow, or pounding heartbeat; or feeling that your heart has skipped a beat.

 

You will probably be hospitalized for one week or longer when you begin your treatment with amiodarone.  Your doctor will monitor you carefully during this time and for as long as you continue to take amiodarone.  Your doctor will probably start you on a high dose of amiodarone and gradually decrease your dose as the medication begins to work.  Your doctor may decrease your dose during your treatment if you develop side effects.  Follow your doctor's directions carefully.

 

Do not stop taking amiodarone without talking to your doctor.  You may be hospitalized when you stop taking amiodarone.  Amiodarone may remain in your body for some time after you stop taking it, so your doctor will watch you carefully during this time.

 

Keep all appointments with your doctor and the laboratory.  Your doctor will order certain tests, such as blood tests, X-rays, and electrocardiograms before and during your treatment to be sure that it is safe for you to take amiodarone and to check your body's response to the medication.

 

Your Doctor will give you the manufacturer's patient information sheet when you begin treatment with amiodarone and each time you refill your prescription.  Read the information carefully and ask your Doctor if you have any questions.  You can also obtain the Medication Guide from the FDA website: http://www. fda. gov/Drugs/DrugSafety/ucm085729. htm.

 

Talk to your doctor about the risks of taking amiodarone.

 

Why is this medication prescribed?

 

Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm when other medications did not help or could not be tolerated.  Amiodarone is in a class of medications called antiarrhythmic.  It works by relaxing overactive heart muscles.

 

How should this medicine be used?

 

Amiodarone comes as a tablet to take by mouth.  It is usually taken once or twice a day.  Your doctor will tell you to take amiodarone with or without food; be sure to take it the same way each time.  Follow the directions on your prescription label carefully, and ask your Doctor to explain any part you do not understand.  Take amiodarone exactly as directed.  Do not take more or less of it or take it more often than prescribed by your doctor.

 

Other uses for this medicine

 

Amiodarone is also sometimes used to treat other types of arrhythmias.  Talk to your doctor about the risks of using this drug for your condition.

 

This medication may be prescribed for other uses; ask your Doctor for more information.

 

What Special Precautions should I follow?

 

Before taking amiodarone,

 

  • tell your Doctor if you are allergic to amiodarone, iodine, or any other medications.
  • tell your Doctor what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.  Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants such as trazodone; anticoagulants such as warfarin; certain cholesterol lowering medications such as atorvastatin, cholestyramine, lovastatin, and simvastatin; cimetidine; clopidogrel; cyclosporine; dextromethorphan; fentanyl; HIV protease inhibitors such as indinavir, and ritonavir; loratadine; medications for diabetes or seizures; methotrexate; narcotic medications for pain; and rifampin.  Many other medications may interact with amiodarone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.  Your doctor may have to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St.  John's wort.
  • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or problems with your blood pressure.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.  Talk to your doctor if you plan to become pregnant or breast-feed during the first several months after your treatment because amiodarone may remain in your body for some time after you stop taking it. If you become pregnant while taking amiodarone, consult your doctor.

 

talk to your doctor about the risks of taking this medication if you are 65 years of age or older.  Older adults should not usually take amiodarone because it is not as safe or effective as other medication that can be used to treat the same condition.

 

  • if you are having surgery, including dental surgery or laser eye surgery, tell your doctor or dentist that you are taking amiodarone.
  • plan to avoid unnecessary or prolonged exposure to sunlight or sunlamps and to wear protective clothing, sunglasses, and sunscreen.  Amiodarone may make your skin sensitive to sunlight.  Exposed skin may turn blue-gray and may not return to normal even after you stop taking this medication.
  • you should know that amiodarone may cause vision problems including permanent blindness.  Be sure to have regular eye exams during your treatment and Consult your doctor if your eyes become sensitive to light or if you see halos, or have blurred vision or any other problems with your vision.
  • you should know that amiodarone may remain in your body for several months after you stop taking it.  You may continue to experience side effects of amiodarone during this time.  Be sure to tell every health care provider who treats you or prescribes any medication for you during this time that you have recently stopped taking amiodarone.

 

What special dietary instructions should I follow?

 

Do not drink grapefruit juice while you are taking this medication.

 

What should I do if I forget a dose?

 

Skip the missed dose and continue your regular dosing schedule.  Do not take a double dose to make up for a missed one.

 

What side effects can this medication cause?

 

Amiodarone may cause side effects.  Tell your doctor if any of these symptoms are severe or do not go away:

 

  • constipation
  • loss of appetite
  • headache
  • decreased sex drive
  • difficulty falling asleep or staying asleep
  • flushing
  • dry eyes
  • changes in ability to taste and smell
  • changes in amount of saliva
  • rash
  • weight loss or gain
  • restlessness
  • intolerance to heat or cold
  • thinning hair
  • excessive sweating
  • changes in menstrual cycle
  • swelling in the front of the neck
  • eye pain
  • swelling of the hands, feet, ankles, or lower legs
  • uncontrollable shaking of a part of the body
  • movements that you cannot control
  • poor coordination or trouble walking
  • numbness or tingling in the hands, legs, and feet
  • muscle weakness

 

Some side effects can be serious.  If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, consult your doctor immediately:

 

Amiodarone may cause other side effects.  Consult your doctor if you have any unusual problems while taking this medication.

 

What Storage conditions are needed for this medicine?

 

Keep this medication in the container it came in, tightly closed, and out of reach of children.  Store it at room temperature and away from excess heat and moisture.  Protect this medication from light.  Throw away any medication that is outdated or no longer needed.  Talk to your Doctor about the proper disposal of your medication.

 

In case of emergency/overdose

 

In case of overdose, consult your doctor.  If the victim has collapsed or is not breathing, immidiately consult local medical emergency services.

 

Symptoms of overdose may include:

 

  • slow heartbeat
  • nausea
  • blurred vision
  • lightheadedness
  • fainting