What happens if I overdose Amiorone?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Amiorone:
Amiorone is usually handled and stored by a health care provider. If you are using Amiorone at home, store Amiorone as directed by your pharmacist or health care provider. Keep Amiorone out of the reach of children and away from pets.
Overdose of Amiorone in details
Tablet: Little is known to date about acute overdosage with Amiorone HCl. On account of specific pharmacokinetics, overdose is possible in general only in the course of long-term therapy.
The symptoms are usually confined to sinus bradycardia, sinoauricular and nodal disturbances in stimulus conduction as well as tachycardia interrupting spontaneously. Amiorone induced-bradycardia is atropine-resistant. Temporary pacemaker monitoring may therefore possibly be necessary.
In case of suspected overdose, the patient should be observed, because of the pharmacokinetics of Amiorone HCl, for a sufficiently long time in special view of the cardiac situation.
Neither Amiorone HCl nor its metabolites are dialyzable.
Injection: There have been reports of some fatal Amiorone overdose. Effects of unintentional IV Amiorone overdose include hypotension, cardiogenic shock, bradycardia, AV block, and hepatotoxicity. Hypotension and cardiogenic shock should be treated by slowing the infusion rate or with standard therapy of vasopressor drugs, inotropic agents, and volume expansion. Bradycardia and AV block may require temporary pacing. Closely monitor hepatic enzyme concentrations. Amiorone is not dialyzable.
What should I avoid while taking Amiorone?
Amiorone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Grapefruit and grapefruit juice may interact with Amiorone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Amiorone can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Amiorone warnings
Amiorone 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 Amiorone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
Because of the long half-life of Amiorone and its metabolite desethylamiodarone, the potential for adverse reactions or interactions, as well as observed adverse effects, can persist following Amiorone withdrawal.
Hypotension
Hypotension is the most common adverse reaction seen with intravenous Amiorone. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with intravenous Amiorone. Clinically significant hypotension during infusions was seen most often in the first several hours of treatment and was not dose related, but appeared to be related to the rate of infusion. Hypotension necessitating alterations in intravenous Amiorone therapy was reported in 3% of patients, with permanent discontinuation required in less than 2% of patients.
Treat hypotension initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. Monitor the initial rate of infusion closely and do not exceed the recommended rate.
In some cases, hypotension may be refractory and result in a fatal outcome.
Bradycardia and Atrio-ventricular Block
In 90 (4.9%) of 1836 patients in clinical trials, drug-related bradycardia that was not dose-related occurred while they were receiving intravenous Amiorone for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing Amiorone. In some patients, inserting a pacemaker is required. Despite such measures, bradycardia was progressive and terminal in 1 patient during the controlled trials. Treat patients with a known predisposition to bradycardia or AV block with Amiorone in a setting where a temporary pacemaker is available.
Hepatic Injury
Elevations of blood hepatic enzyme values [alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)] are commonly seen in patients with immediately life-threatening VT/VF. Interpreting elevated AST activity can be difficult because the values may be elevated in patients who have had recent myocardial infarction, congestive heart failure, or multiple electrical defibrillations. Approximately 54% of patients receiving intravenous Amiorone in clinical studies had baseline liver enzyme elevations, and 13% had clinically significant elevations. 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. Baseline abnormalities in hepatic enzymes are not a contraindication to treatment. Elevated bilirubin levels have been reported in patients administered intravenous Amiorone.
Acute, centrolobular confluent hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated with the administration of intravenous Amiorone.
In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of Amiorone therapy. Carefully monitor patients receiving Amiorone for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing Amiorone.
Proarrhythmia
Like all antiarrhythmic agents, Amiorone may cause a worsening of existing arrhythmias or precipitate a new arrhythmia, sometimes leading to fatal outcomes. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous Amiorone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous Amiorone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with Amiorone. Reserve the combination of Amiorone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent.
Correct hypokalemia, hypomagnesemia or hypocalcemia whenever possible before initiating treatment with Amiorone, 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.
Amiorone causes thyroid dysfunction in some patients, which may lead to potentially fatal breakthrough or exacerbated arrhythmias.
Pulmonary Injury
Early-onset Pulmonary ToxicityThere have been postmarketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with intravenous Amiorone. 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.
ARDS
Two percent (2%) of patients were reported to have adult respiratory distress syndrome (ARDS) during clinical studies involving 48 hours of therapy.
Pulmonary Fibrosis
There have been reports of early development of pulmonary fibrosis (within 1 to 3 months) following initiation of Amiorone treatment. Only 1 of more than 1000 patients treated with intravenous Amiorone in clinical studies developed pulmonary fibrosis. In that patient, the condition was diagnosed 3 months after treatment with intravenous Amiorone, during which time the patient received oral Amiorone. Pulmonary toxicity is a well-recognized complication of long-term Amiorone use.
Loss of Vision
Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment, have been reported in patients treated with oral Amiorone or intravenous Amiorone. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and neuritis may occur at any time following initiation of therapy. A causal relationship to the drug has not been clearly established. Perform an ophthalmic examination if symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision. Re-evaluate the necessity of Amiorone therapy if optic neuropathy or neuritis is suspected. Perform regular ophthalmic examination, including fundoscopy and slit-lamp examination, during administration of Amiorone.
Thyroid Abnormalities
Amiorone inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased T4 levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. Amiorone is also a potential source of large amounts of inorganic iodine and can cause either hypothyroidism or hyperthyroidism. Evaluate thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Because of the slow elimination of Amiorone and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid-function tests may persist for several weeks or even months following Amiorone withdrawal.
There have been postmarketing reports of thyroid nodules/thyroid cancer in patients treated with Amiorone. In some instances hyperthyroidism was also present.
Hyperthyroidism and Thyrotoxicosis
Amiorone causes hyperthyroidism in about 2% of patients. Thyrotoxicosis and arrhythmia with fatal outcome has been reported in the presence of pre-existing hyperthyroidism even following a single intravenous Amiorone dose. Consider the possibility of hyperthyroidism if any new signs of arrhythmia appear.
Hyperthyroidism may result from iodine load (type 1 Amiorone-induced thyrotoxicosis [type 1 AIT]; in particular in patients with underlying autonomous thyroid nodules or latent Grave’s disease). Hyperthyroidism may also result from direct Amiorone-induced destructive thyroiditis that occurs in individuals with no underlying thyroid disease (type 2 AIT), resulting in the release of preformed thyroid hormone into the bloodstream from damaged thyroid follicular epithelium. Mixed forms of hyperthyroidism as a result of both pathogenic mechanisms (excessive thyroid hormone production and thyroid destruction) can also occur. The risk of hyperthyroidism may be higher among patients with prior inadequate dietary iodine intake.
Identify hyperthyroidism by relevant clinical signs and symptoms, subnormal serum levels of thyroid stimulating hormone (TSH), abnormally elevated serum free T4, and elevated or normal serum T3. Since arrhythmia breakthroughs may accompany Amiorone-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of Amiorone. Amiorone hyperthyroidism may be followed by a transient period of hypothyroidism.
The institution of antithyroid drugs, β-adrenergic blockers or temporary corticosteroid therapy may be necessary. The action of antithyroid drugs may be especially delayed in Amiorone-induced thyrotoxicosis because of substantial quantities of preformed thyroid hormones stored in the gland. Radioactive iodine therapy is not recommended because of the low radioiodine uptake associated with Amiorone-induced hyperthyroidism.
When aggressive treatment of Amiorone-induced thyrotoxicosis has failed or Amiorone cannot be discontinued because it is the only drug effective against the resistant arrhythmia, surgical management may be an option. Experience with thyroidectomy as a treatment for Amiorone-induced thyrotoxicosis is limited, and this form of therapy could induce thyroid storm. Therefore, surgical and anesthetic management require careful planning.
Hypothyroidism
Hypothyroidism has been reported in 2 to 10% of patients receiving Amiorone and may be primary or subsequent to resolution of preceding Amiorone-induced hyperthyroidism. This condition may be identified by clinical symptoms and elevated serum TSH levels. Cases of severe hypothyroidism and myxedema coma, sometimes fatal, have been reported in association with Amiorone therapy. In some clinically hypothyroid Amiorone-treated patients, free thyroxine index values may be normal. Manage hypothyroidism by reducing the dose of or discontinuing Amiorone and considering the need for thyroid hormone supplement.
Neonatal Injury
Amiorone can cause fetal harm when administered to a pregnant woman. Fetal exposure may increase the potential for adverse experiences including cardiac, thyroid, neurodevelopmental, neurological and growth effects in neonate. Inform the patient of the potential hazard to the fetus if Amiorone is administered during pregnancy or if the patient becomes pregnant while taking Amiorone.
Exaggerated Effects of Perisurgical Therapy
Perform close perioperative monitoring in patients undergoing general anesthesia who are on Amiorone therapy as they may be more sensitive to the myocardial depressant and conduction defects of halogenated inhalational anesthetics.
Interference with Corneal Refractive Laser Surgery
Advise patients that most manufacturers of corneal refractive laser surgery devices contraindicate corneal refractive laser surgery in patients taking Amiorone.
Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions have been reported with intravenous Amiorone including shock (sometimes fatal), cardiac arrest, and the following manifestations: hypotension, tachycardia, hypoxia, cyanosis, rash, flushing, hyperhidrosis and cold sweat. Since Amiorone contains dextrose, patients with allergy to corn or corn products are at risk for allergic reaction.
What should I discuss with my healthcare provider before taking Amiorone?
Some medical conditions may interact with Amiorone Injection Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have abnormal liver function tests or a history of liver problems; lung or breathing problems; other heart problems (eg, heart block, slow or irregular heartbeat); low blood pressure; thyroid problems; low blood potassium, magnesium, or calcium levels; or eye or vision problems
- if you have recently had severe or persistent diarrhea
- if you will be having surgery or receiving anesthesia, or if you have an implanted pacemaker or defibrillator
Some MEDICINES MAY INTERACT with Amiorone Injection Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for allergies, bacterial and fungal infections, blood thinning, cancer, constipation, cough, depression or other mental or mood problems, enlarged prostate, erectile dysfunction, heartburn or reflux problems, hepatitis C infection, high blood pressure, high cholesterol, HIV infection, immune system suppression, inflammation, irregular heartbeat or other heart problems, multiple sclerosis, nausea and vomiting, pain, seizures, stomach or bowel problems, Tourette syndrome), multivitamin products, and herbal or dietary supplements may interact with Amiorone Injection Solution. Check with your doctor to see if Amiorone Injection Solution may interact with any other medicine that you are taking.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Amiorone Injection Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Amiorone precautions
Corneal Microdeposits: Impairment of Vision: Corneal microdeposits appear in the majority of adults treated with Amiorone HCl.
Photosensitivity: Amiorone HCl has induced photosensitization in about 10% of patients. Some protection may be afforded by the use of sun-barrier creams or protective clothing.
Thyroid Abnormalities: Amiorone HCl may cause increased thyroxine levels. If any new signs of arrhythmia appear, the possibility of hyperthyroidism should be considered.
Amiorone HCl is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Amiorone HCl has several potentially fatal toxicities, the most important of which is pulmonary toxicity. Even in patients at high risk of arrhythmic death, in whom the toxicity of Amiorone HCl is an acceptable risk, Amiorone HCl poses major management problems that could be life-threatening in a population at risk of sudden death. Every effort should be made to utilize alternative agents first.
Use in Pregnancy & Lactation: Amiorone HCl should only be used during pregnancy if the potential benefit to the mother justifies the unknown risk to the fetus. When Amiorone HCl therapy is indicated, the mother should be advised to discontinue nursing.
Use in Children: The safety and effectiveness of Amiorone HCl in children have not been established.
What happens if I miss a dose of Amiorone?
Because you will receive Amiorone in a clinical setting, you are not likely to miss a dose.
References
- DrugBank. "amiodarone". http://www.drugbank.ca/drugs/DB01118 (accessed September 17, 2018).
- MeSH. "Potassium Channel Blockers". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- FDA Medication Guides. "Pacerone: FDA Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. ". https://www.fda.gov/downloads/Drugs/... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
