(, Known hypersensitivity to any of the components of amiodarone, including iodine. In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received intravenous amiodarone for at least one week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. 3 DOSAGE FORMS AND STRENGTHS 8.5. Amiodarone is contraindicated in patients with: Amiodarone 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 therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. TheFood and Drug Administration (FDA) had been reluctant to approve the drug due to initial reports showing an increased incidence of adverse pulmonary effects. Dosage and Administration (2.3) 5/2023 Contraindications, Pregnancy (4) Removed 5/2023 . If such drugs are needed, reassess their dose and, where appropriate, measure plasma concentrations. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks. Advise female patients to discontinue nursing while being treated with amiodarone, as breast-feeding could expose the nursing infant to a significant dose of the drug. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. See full prescribing information for Amiodarone Hydrochloride Injection, USP. Peak serum concentrations after single 5 mg/kg 15-minute intravenous infusions in healthy subjects range between 5 and 41 mg/L. Chest radiographs will show irregular or uneven bilateral interstitial infiltrate changes (Figures 1 and 2). Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone. Administration of rifampin concomitantly with oral amiodarone has been shown to result in decreases in serum concentrations of amiodarone and desethylamiodarone. No carcinogenicity studies were conducted with intravenous administration of amiodarone. Maintenance dose: 400 mg orally per day Comments: May be administered once a day; twice a day dosing is recommended for total daily doses of 1000 mg or more or in patients who experience gastrointestinal tolerance. Carefully consider dose selection in an elderly patient. On the other hand, after intravenous amiodarone administration, there is evidence of activity well before significant concentrations of DEA are attained [see Clinical Trials(14)]. Data from all assigned treatment groups are pooled because none of the adverse reactions appeared to be dose-related. Amiodarone Hydrochloride has the following structural formula: Amiodarone Hydrochloride is a white to slightly yellow crystalline powder, and is very slightly soluble in water. Amiodarone-induced hyperthyroidism usually poses a greater hazard to the patient than hypothyroidism because of the possibility of thyrotoxicosis and arrhythmia breakthrough or aggravation, all of which may result in death. A placebo-controlled study of intravenous amiodarone (300 mg over 2 hours followed by 1200 mg/day) in post-coronary artery bypass graft patients with supraventricular and 2- to 3-consecutive-beat ventricular arrhythmias showed a reduction in arrhythmias from 12 hours on. Since arrhythmia breakthroughs may accompany amiodarone-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of amiodarone. Use amiodarone during pregnancy only if the potential benefit to the mother justifies the risk to the fetus. Seizure, associated with increased lidocaine concentrations, has been reported with concomitant administration of intravenous amiodarone. 8.3 Females and Males of Reproductive Potential 2.3 Transition From Intravenous Amiodarone to Oral Amiodarone . Preclinical studies in rodents have not shown any effect on the duration of gestation or on parturition. Write a review. The maintenance infusion was continued up to hour 48. Non loading dose regimen: Prescribe 1200 mg of amiodarone to be administered as a continuous infusion (ideally via a CVC). Hypothyroidism is easily managed with levothyroxine and is generally not a cause for discontinuing amiodarone. The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. Your doctor may adjust your dose as needed and tolerated. Triiodothyronine may also be added at times if TSH values have not decreased adequately. Circulation. European pharmaceutical companies began discussing with the institution in the mid-80s and threatened to suspend their (free) supply of the drugto American physicians, should the FDA notgrant official approval. Duration of Amiodarone Infusion* Initial Daily Dose of Oral Amiodarone * . Amiodarone hydrochloride tablets can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. This inhibition can result in unexpectedly high plasma levels of other drugs that are metabolized by those CYP450 enzymes or are substrates for p-glycoprotein. In a reproductive study in which amiodarone was given intravenously to rabbits at dosages of 5, 10, or 25 mg/kg per day (about 0.1, 0.3, and 0.7 times the maximum recommended human dose [MRHD] on a body surface area basis), maternal deaths occurred in all groups, including controls. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones, macrolide antibiotics, or azoles were administered concomitantly [see Drug Interactions (7)]. The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. 3. After conversion of the arrhythmia an amiodarone infusion can be given at a rate of 1mg/min over 6 hours and then a .5mg/min infusion over 18 hours. This should be administered as a dilute solution in 250ml 5% w/v dextrose. View NDC Code(s)NEW! In studies in healthy subjects following single intravenous administration (5 mg/kg of amiodarone over 15 min), the plasma concentration vs. time profile could be characterized by linear sum of four exponential terms with terminal elimination half-lives (t) of 9 - 36 days for amiodarone and 9 - 30 days for DEA. Intravenous amiodarone loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death [see Warnings and Precautions (5.3)]. This elevation, according to certain authors, is not indicative of having to stop the drug: nevertheless, close monitoring is recommended. Hypotension can be treated initially by decreasing the infusion rate. Posteroanterior radiographs of the chest taken at the time of clinical presentation and after three months of treatment. Amiodarone can be pro-arrhythmic and may worsen or precipitate new arrhythmias (e.g., torsades de pointes). Findings have included pulmonary infiltrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. When aggressive treatment of amiodarone-induced thyrotoxicosis has failed or amiodarone cannot be discontinued because it is the only drug effective against the resistant arrhythmia, surgical management may be an option. Prevention and early detection of this potential complication requires a chest radiograph obtained at baseline and annually thereafter. Table 4 provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. The incidence of thyroid tumors in rats was greater than the incidence in controls even at the lowest dose level tested, i.e., 5 mg/kg/day (much less, on a body surface area basis, than the maximum recommended human maintenance dose of 600 mg/day). Phenytoin decreases serum amiodarone levels. Effects of an inadvertent overdose of intravenous amiodarone include hypotension, cardiogenic shock, bradycardia, AV block, and hepatotoxicity. Therefore, an ECG should be performed at baseline and then annually. See 17 for PATIENT COUNSELING INFORMATION. See package insert for oral amiodarone. Although amiodarone use during pregnancy is uncommon, there have been a small number of published reports of congenital goiter/hypothyroidism and hyperthyroidism associated with oral administration. Plasma levels of flecainide have been reported to increase in the presence of oral amiodarone; adjust the dose of flecainide when these drugs are administered concomitantly. 1999; 22: 1.108-1.110. Objectives: Identify the mechanism of action of amiodarone. These highlights do not include all the information needed to use Amiodarone Hydrochloride Injection, USP safely and effectively. You will receive amiodarone in a hospital setting. Renal Impairment: Renal disease does not influence the pharmacokinetics of amiodarone or DEA. A potential interaction between clopidogrel and amiodarone resulting in ineffective inhibition of platelet aggregation has been reported. However, in a study in which amiodarone hydrochloride was orally 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 of 600 mg/day). The following adverse reactions have been identified during post-approval use of amiodarone. There has been limited experience in patients receiving intravenous amiodarone for longer than 3 weeks. First discovered in 1961 and leading up to the 70s, amiodarone was used for its antiarrhythmic properties, although not officially before the year 1985, when the United States finally approved its use. Hemodynamic and electrophysiologic interactions have also been observed after concomitant administration with propranolol, diltiazem, and verapamil. Perform close perioperative monitoring in patients undergoing general anesthesia who are on amiodarone therapy as they may be more sensitive to the myocardial depressant and conduction defects of halogenated inhalational anesthetics. The acute effectiveness of intravenous amiodarone in suppressing recurrent VF or hemodynamically unstable VT is supported by two randomized, parallel, dose-response studies of approximately 300 patients each. With this treatment, the patient experienced satisfactory clinical and radiological recovery. There have been reports of death associated with amiodarone-induced thyrotoxicosis. Change in vision such as blurry vision, seeing halos around lights, vision loss. Cardiovasculars: All rights reserved. Amiodarone adsorbs to polyvinyl chloride (PVC) tubing, but all of the clinical experience has been with PVC tubing and the concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect dosing in these studies. This may lead to low amiodarone serum levels and potential decrease in efficacy. Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. Amiodarone is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation / tachycardia ). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 0143-9875-25, To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001, or FDAat 1-800-FDA-1088 or, Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Introductory Offer: Save 10 percent on Cialis Together 4 pack - online only. Close monitoring is indicated during the loading phase and surrounding any dose adjustments. RxNorm, Breastfeeding . Advise female patients to discontinue nursing while being treated with amiodarone, as breast-feeding could expose the nursing infant to a . Amiodarone infiltrates alveolointerstitial bilateral basal lung fields; however, media have disappeared at follow-up (image further below). The increased risk occurs in patients with abnormal baseline thyroid function (autoimmune disease, goiter) and the elderly. For both studies, the median rate was 0.02 episodes per hour in patients receiving the high dose and 0.07 episodes per hour in patients receiving the low dose, or approximately 0.5 versus 1.7 episodes per day (p=0.07, 2-sided, in both studies). In 81% of patients with both baseline and on-therapy data available, the liver enzyme elevations either improved during therapy or remained at baseline levels. Other antiarrhythmic drugs, such as quinidine, procainamide, disopyramide, and phenytoin, have been used concurrently with amiodarone. The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology. Save 2.20. 14-16 The Canadian Trial of Atrial Fibrillation randomly. If only short term use is . Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available. Amiodarone shows considerable interindividual variation in response. Effect of Gender: Pharmacokinetics of amiodarone and DEA are similar in males and females. In these studies, patients with at least two episodes of VF or hemodynamically unstable VT in the preceding 24 hours were randomly assigned to receive doses of approximately 125 or 1000 mg over the first 24 hours, an 8-fold difference. This may be followed by a repeat infusion of 900mg in 500ml 5% dextrose over 24 hours infused at a rate of 21ml/hr. Low-dose amiodarone (100-300 mg per day) is effective for a wide variety of ventricular and supraventricular arrhythmias, including as part of a rhythm control strategy for patients with atrial fibrillation, especially when structural heart disease is present. However, therapy must be individualized, and it may be necessary to discontinue amiodarone in some patients. QT interval prolongation and TdP have been reported with the coadministration of loratadine and amiodarone. Amiodarone should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. Amiodarone has the potential to cause serious side effects that limit its use to life-threatening and hemodynamically unstable cardiac arrhythmias. Amiodarone hyperthyroidism may be followed by a transient period of hypothyroidism. Carefully monitor patients receiving amiodarone for evidence of progressive hepatic injury. On administration of oral amiodarone, review the need for digitalis therapy and reduce the dose of digitalis by approximately 50% or discontinue digitalis. Cimetidine inhibits CYP3A and can increase serum amiodarone levels. Lung damage is the best known: it is produced after long exposure to amiodarone (2.3), but there also have been reports of acute toxicity. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with intravenous amiodarone. Get Label RSS Feed, 4. DEA concentrations were not affected. Absorption is extremely slow, and bioavailability is also low and variable. (current), 3 ML amiodarone hydrochloride 50 MG/ML Injection, The recommended starting dose is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen (, In the event of breakthrough episodes of VF or hemodynamically unstable VT (, -Repeat the Initial Load described above as needed (infused over 10 minutes), Increase the rate of the maintenance infusion to achieve effective arrhythmia suppression. Finally, among other minor adverse effects, nearly 100% of patients receiving this drug for more than six months have cornea micro-deposits. In all patients, thyrotropin levels should be checked before initiating amiodarone therapy and every every months thereafter. Intravenous amiodarone concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Helps you get and maintain an erection when you need it. For continuous infusions that will exceed 2 hours, the solution must be prepared in polyolefin bag (Freeflex), rigid PVC . Figure 1B. (, The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. 10, Respiratory function tests show a restrictive pattern with decreased and diffuse total lung capacity. Apart from studies in patients with VT or VF, described below, there are two other studies of amiodarone showing an antiarrhythmic effect before significant levels of DEA could have accumulated. St. John's Wort (Hypericum perforatum) induces CYP3A. The development of maximal ventricular class III effects after oral amiodarone administration in humans correlates more closely with DEA accumulation over time than with amiodarone accumulation. Wheezing, fever, dyspnea, cough, hemoptysis, and phenytoin, have been identified post-approval! Decreased adequately serious side effects that limit its use to life-threatening and hemodynamically unstable arrhythmias! All the information needed to use amiodarone Hydrochloride Injection, USP safely and effectively satisfactory., Known hypersensitivity to any of the chest taken at the time clinical... Been used concurrently with amiodarone will exceed 2 hours, the patient satisfactory... And every every months thereafter clopidogrel and amiodarone resulting in ineffective inhibition of platelet aggregation has been with! Infusion was continued up to hour 48 advise female patients to discontinue nursing being... 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