Amiodarone hcl 200 mg tablets
Amiodarone 200 mg
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Amiodarone is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat.
Read the Medication Guide provided by your pharmacist before you start using amiodarone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
OTHER NAME(S): Amiodarone Tablet.
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If you have any concerns about taking this medicine, ask your doctor or pharmacist.
If you become pregnant while taking this medicine, tell your doctor immediately.
thyroid problems heart problems that may cause you to faint. If you have a pacemaker, your doctor may allow the use of it. severe breathing problems low blood pressure heart disease or failure shock other heart conditions.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
Atrial fibrillation (AF or AFib) is an abnormality in the heart rhythm, which involves irregular and often rapid beating of the heart. Symptoms may include heart palpitations, dizziness, fainting, fatigue, shortness of breath, and chest pain. Atrial fibrillation treatment may include medication or procedures like cardioversion or ablation to normalize the heart rate.
Paroxysmal supraventricular tachycardia (PSVT) is an abnormal conduction of electricity in particular areas of the heart. PSVT was referred to at one time as paroxysmal atrial tachycardia or PAT, however, the term PAT is reserved for as specific heart condition. Symptoms of PSVT include weakness, shortness of breath, chest pressure, lightheadedness, and palpitations. PSVT is treated with medications or procedures that return the heart to its normal electrical pattern.
Amiodarone was discovered in 1961 and approved by the FDA in December 1985.
Common side effects include:
In some cases, the recurrence of atrial fibrillation in patients with amiodarone maintenance therapy, required prompt evaluation to rule out amiodarone-induced hyperthyroidism. The increased risk occurs in patients with abnormal baseline thyroid function (autoimmune disease, goiter) and the elderly. Women with positive antithyroid antibodies are seven times more at risk for this complication. We recommend an analysis of TSH, T4 and T3 at treatment start, one month into treatment and every six months thereafter.
Gastrointestinal disturbances such as nausea, vomiting, diarrhea, or anorexia are frequent (30%) at baseline. However, some of the most feared gastrointestinal side effects - hepatitis and liver cirrhosis - are rare (
Prof. Leopoldo Perez de Isla , FESC.
The two atoms of iodine contained in the amiodarone molecule, a benzofuran derivative, are essential to its antiarrhythmic properties. Using the Vaughan-Williams classification of antiarrhythmic drugs, amiodarone prolongs the Phase 3 action potential of cardiac cells and it also has all the Class 4 electrophysiological characteristics as well.
As a general rule, the doses used for life-threatening arrhythmias are higher than those for atrial fibrillation. Loading doses are sometimes associated with nausea, and this may limit their use.
Amiodarone increases concentrations of digoxin (sometimes to a clinically significant degree) and impairs the metabolism of warfarin, tending to potentiate its anticoagulant effect. Similarly the concentrations and effects of flecainide, quinidine, phenytoin and cyclosporin tend to rise with amiodarone. These interactions and others need to be taken into account when patients taking these drugs start amiodarone. Similar considerations apply to drugs such as atorvastatin and simvastatin which are metabolised in the liver by cytochrome P450 3A4. Amiodarone may impair their metabolism and hence potentially increase the risk of myopathy or rhabdomyolysis. The use of pravastatin as an alternative is probably to be preferred as it is not metabolised by cytochrome P450 3A4.
There is some correlation between efficacy and the plasma concentration of amiodarone. There may be a little more correlation between adverse effects and plasma concentration, but adverse effects can occur within the therapeutic range. Routine measurement of plasma concentrations is not commonly performed.
In the liver, amiodarone is metabolised to desethylamiodarone, which has similar activity and kinetics to the parent compound. This metabolism is almost completely inhibited by grapefruit juice, although it is not clear that this alters the clinical efficacy or toxicity in any significant way.
Peripheral neuropathy reported rarely with chronic administration; may resolve upon discontinuation of therapy See "What Are Side Effects Associated with Using Amiodarone?"
Side effects associated with use of Amiodarone, include the following:
Corneal microdeposits Demyelinating polyneuropathy.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Conversion to oral amiodarone after intravenous (IV) administration.
Age less than 1 year: 600-800 mg/1.73 m² every 24 hours or divided every 12 hours; continue therapy for 4-14 days and/or until adequate control achieved; if initial treatment effective, decrease dosage to 200-400 mg/1.73 m² every 24 hours or divided every 12 hours Age over 1 year: Until adequate control, 10-15 mg/kg/day orally once/day or divided every 12 hours; if effective, reduce to 5 mg/kg/day orally once/day or divided every 12 hours.
Dosage Forms and Strengths.
Recommended to start dosing at the lower end of the dosing range because elderly may be predisposed to toxicity.
Postmarketing side effects of amiodarone reported include:
Dosages of Amiodarone:
150 mg over first 10 min (15mg/min), followed by 360 mg over next 6 hours (1 mg/min), THEN 540 mg over remaining 18 hours (0.5 mg/min), for a total of 1000 mg over 24 hours before administering maintenance infusion Maintenance: 0.5 mg/min for a total 720 mg/24hr at a concentration of 1-6 mg/mL (360 mg/200mL), or 1.8 mg/mL Nexterone at rate of 278 mL/min Duration of therapy: May continue to administer 0.5 mg/min for 2-3 weeks regardless of patient's age, renal function or ventricular function.
To be administered only by physicians experienced in treatment of life-threatening arrhythmias, who are thoroughly familiar with risks and benefits of amiodarone therapy, and have access to facilities adequate for monitoring effectiveness and side effects of treatment; because of long half-life of amiodarone and its metabolite desethylamiodarone, the potential for adverse reactions or interactions, as well as observed adverse effects, can persist following amiodarone withdrawal Adjust dosage based on adverse reaction and therapeutic response Avoid excessive exposure to sunlight; may cause photosensitivity Attempts to substitute other antiarrhythmic agents when amiodarone must be stopped is difficult due to the complex pharmacokinetics of the drug, including prolonged duration of action and half-life and difficulties predicting them, which in turn increases risk for drug interactions Hypothyroidism has been reported in 2 to 10% of patients receiving amiodarone and may be primary or subsequent to resolution of preceding amiodarone-induced hyperthyroidism; manage hypothyroidism by reducing the dose of or discontinuing amiodarone and considering the need for thyroid hormone supplement Risks of acute myocardial infarction (MI), AV block, cardiomegaly; especially with intravenous (IV) administration Bradycardia and atrio-ventricular block reported; treat bradycardia by slowing infusion rate or discontinuing therapy; in some patients, inserting a pacemaker is required; treat patients with a known predisposition to bradycardia or AV block in a setting where a temporary pacemaker is available Hypotension is the most common adverse reaction; in some cases, hypotension may be refractory and result in a fatal outcome; treat hypotension initially by slowing the infusion; additional standard therapy may include vasopressor drugs, positive inotropic agents, and volume expansion; monitor initial rate of infusion closely, not to exceed recommended rate Chronic administration of antiarrhythmic drugs may affect defibrillation or pacing thresholds in patients with implanted defibrillators, pacemakers; assess when therapy is initiated and throughout Correct hypokalemia, hypomagnesemia or hypocalcemia before initiating treatment as these disorders can exaggerate the degree of QTc prolongation and increase the potential for TdP; give special attention to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or in patients receiving concomitant diuretics and laxatives, systemic corticosteroids, amphotericin B (IV) or other drugs affecting electrolyte levels May increase risks of pulmonary fibrosis; liver disease; hypotension, bradycardia, hyperthyroidism; optic neuropathy; pleuraleffusion; pneumonitis (including eosinophilic pneumonia) Acute-onset (days to weeks) pulmonary injury reported in patients treated with IV amiodarone; findings have included pulmonary infiltrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia; some cases have progressed to respiratory failure or death Postoperatively, occurrences of adult respiratory distress syndrome reported in patients receiving amiodarone therapy who have undergone either cardiac or non-cardiac surgery; although patients usually respond well to vigorous respiratory therapy, in rare instances the outcome has been fatal; until further studies performed, monitor FiO2 and determinants of oxygen delivery to tissues (e.g., SaO2, PaO2) while taking amiodarone Use caution when administering concomitantly with drugs that prolong QTc interval Corneal microdeposits appear in majority of adults treated; usually discernible only by slit-lamp examination, but give rise to symptoms such as visual halos or blurred vision up to 10% of patients; corneal microdeposits are reversible upon reduction of dose or termination of treatment; asymptomatic microdeposits alone are not reason to reduce dose or discontinue treatment Causes increased INR; use caution when initiating therapy in patients treated with warfarin Close perioperative monitoring is recommended in patients undergoing general anesthesia who are on amiodarone therapy as they may be more sensitive to myocardial depressant and conduction effects of halogenated inhalational anesthetics Fatal cutaneous reactions reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis; discontinue therapy if symptoms of progressive skin rash occur Monitor hepatic enzymes regularly in patients receiving relatively high maintenance doses Peripheral neuropathy reported rarely with chronic administration; may resolve upon discontinuation of therapy Bradycardia, some requiring pacemaker insertion reported when ledipasvir/sofosbuvir or sofosbuvir with simeprevir initiated in patients on amiodarone; bradycardia generally occurred within hours to days, but in some cases up to 2 weeks after initiating antiviral treatment; monitor heart rate in patients taking or recently discontinuing amiodarone when starting antiviral treatment Drug interaction overview: Serious symptomatic bradycardia when co-administered with ledipasvir/sofosbuvir or with sofosbuvir with simeprevir; postmarketing cases of symptomatic bradycardia, some requiring pacemaker insertion and at least one fatal, have been reported when ledipasvir/sofosbuvir or sofosbuvir with simeprevir were initiated in patients on amiodarone; bradycardia generally occurred within hours to days, but in some cases up to 2 weeks after initiating antiviral treatment and resolved after discontinuation of antiviral treatment; monitor heart rate in patients taking or recently discontinuing amiodarone when starting antiviral treatment Concomitant use of drugs with depressant effects on sinus and AV node (e.g., digoxin, beta blockers, verapamil, diltiazem, ivabradine, clonidine) can potentiate electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block; monitor heart rate in patients on amiodarone and concomitant drugs that slow heart rate.
This drug may rarely cause vision changes. Very rarely, cases of permanent blindness have been reported. Tell your doctor right away if you develop any vision changes (such as seeing halos or blurred vision).
See also Side Effects section.
Amiodarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Common culprits and what you can do.
These medications may interact and cause very harmful effects. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.
These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.
These medications may cause some risk when taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.
A Condition With Low Thyroid Hormone Levels Abnormal Heart Rhythm Blurred Vision Chronic Heart Failure Deposits On The Eye Optic Neuropathy, A Disease Of The Optic Nerve Overactive Thyroid Gland Prolonged QT Interval On EKG Sinus Bradycardia Skin Discoloration Sudden Blindness And Pain Upon Moving The Eye Torsades De Pointes, A Type Of Abnormal Heart Rhythm Visual Halos Around Lights.
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