What happens if I overdose Amiodarone Borisovskiy?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Amiodarone Borisovskiy:
Amiodarone Borisovskiy is usually handled and stored by a health care provider. If you are using Amiodarone Borisovskiy at home, store Amiodarone Borisovskiy as directed by your pharmacist or health care provider. Keep Amiodarone Borisovskiy out of the reach of children and away from pets.
Overdose of Amiodarone Borisovskiy in details
Tablet: Little is known to date about acute overdosage with Amiodarone Borisovskiy 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. Amiodarone Borisovskiy 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 Amiodarone Borisovskiy HCl, for a sufficiently long time in special view of the cardiac situation.
Neither Amiodarone Borisovskiy HCl nor its metabolites are dialyzable.
Injection: There have been reports of some fatal Amiodarone Borisovskiy overdose. Effects of unintentional IV Amiodarone Borisovskiy 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. Amiodarone Borisovskiy is not dialyzable.
What should I avoid while taking Amiodarone Borisovskiy?
Amiodarone Borisovskiy 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 Amiodarone Borisovskiy 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). Amiodarone Borisovskiy 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.
Amiodarone Borisovskiy warnings
Amiodarone Borisovskiy 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 Borisovskiy therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
Because of the long half-life of Amiodarone Borisovskiy and its metabolite desethylamiodarone, the potential for adverse reactions or interactions, as well as observed adverse effects, can persist following Amiodarone Borisovskiy withdrawal.
Hypotension
Hypotension is the most common adverse reaction seen with intravenous Amiodarone Borisovskiy. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with intravenous Amiodarone Borisovskiy. 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 Amiodarone Borisovskiy 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 Amiodarone Borisovskiy for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing Amiodarone Borisovskiy. 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 Amiodarone Borisovskiy 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 Amiodarone Borisovskiy 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 Amiodarone Borisovskiy.
Acute, centrolobular confluent hepatocellular necrosis leading to hepatic coma, acute renal failure, and death has been associated with the administration of intravenous Amiodarone Borisovskiy.
In patients with life-threatening arrhythmias, the potential risk of hepatic injury should be weighed against the potential benefit of Amiodarone Borisovskiy therapy. Carefully monitor patients receiving Amiodarone Borisovskiy for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing Amiodarone Borisovskiy.
Proarrhythmia
Like all antiarrhythmic agents, Amiodarone Borisovskiy 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 Amiodarone Borisovskiy, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous Amiodarone Borisovskiy, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with Amiodarone Borisovskiy. Reserve the combination of Amiodarone Borisovskiy 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 Amiodarone Borisovskiy, 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.
Amiodarone Borisovskiy 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 Amiodarone Borisovskiy. 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 Amiodarone Borisovskiy treatment. Only 1 of more than 1000 patients treated with intravenous Amiodarone Borisovskiy in clinical studies developed pulmonary fibrosis. In that patient, the condition was diagnosed 3 months after treatment with intravenous Amiodarone Borisovskiy, during which time the patient received oral Amiodarone Borisovskiy. Pulmonary toxicity is a well-recognized complication of long-term Amiodarone Borisovskiy use.
Loss of Vision
Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment, have been reported in patients treated with oral Amiodarone Borisovskiy or intravenous Amiodarone Borisovskiy. 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 Amiodarone Borisovskiy therapy if optic neuropathy or neuritis is suspected. Perform regular ophthalmic examination, including fundoscopy and slit-lamp examination, during administration of Amiodarone Borisovskiy.
Thyroid Abnormalities
Amiodarone Borisovskiy 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. Amiodarone Borisovskiy 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 Amiodarone Borisovskiy and its metabolites, high plasma iodide levels, altered thyroid function, and abnormal thyroid-function tests may persist for several weeks or even months following Amiodarone Borisovskiy withdrawal.
There have been postmarketing reports of thyroid nodules/thyroid cancer in patients treated with Amiodarone Borisovskiy. In some instances hyperthyroidism was also present.
Hyperthyroidism and Thyrotoxicosis
Amiodarone Borisovskiy 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 Amiodarone Borisovskiy dose. Consider the possibility of hyperthyroidism if any new signs of arrhythmia appear.
Hyperthyroidism may result from iodine load (type 1 Amiodarone Borisovskiy-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 Amiodarone Borisovskiy-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 Amiodarone Borisovskiy-induced hyperthyroidism, aggressive medical treatment is indicated, including, if possible, dose reduction or withdrawal of Amiodarone Borisovskiy. Amiodarone Borisovskiy 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 Amiodarone Borisovskiy-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 Amiodarone Borisovskiy-induced hyperthyroidism.
When aggressive treatment of Amiodarone Borisovskiy-induced thyrotoxicosis has failed or Amiodarone Borisovskiy 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 Amiodarone Borisovskiy-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 Amiodarone Borisovskiy and may be primary or subsequent to resolution of preceding Amiodarone Borisovskiy-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 Amiodarone Borisovskiy therapy. In some clinically hypothyroid Amiodarone Borisovskiy-treated patients, free thyroxine index values may be normal. Manage hypothyroidism by reducing the dose of or discontinuing Amiodarone Borisovskiy and considering the need for thyroid hormone supplement.
Neonatal Injury
Amiodarone Borisovskiy 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 Amiodarone Borisovskiy is administered during pregnancy or if the patient becomes pregnant while taking Amiodarone Borisovskiy.
Exaggerated Effects of Perisurgical Therapy
Perform close perioperative monitoring in patients undergoing general anesthesia who are on Amiodarone Borisovskiy 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 Amiodarone Borisovskiy.
Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions have been reported with intravenous Amiodarone Borisovskiy including shock (sometimes fatal), cardiac arrest, and the following manifestations: hypotension, tachycardia, hypoxia, cyanosis, rash, flushing, hyperhidrosis and cold sweat. Since Amiodarone Borisovskiy 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 Amiodarone Borisovskiy?
Some medical conditions may interact with Amiodarone Borisovskiy 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 Amiodarone Borisovskiy 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 Amiodarone Borisovskiy Injection Solution. Check with your doctor to see if Amiodarone Borisovskiy 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 Amiodarone Borisovskiy 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.
Amiodarone Borisovskiy precautions
Corneal Microdeposits: Impairment of Vision: Corneal microdeposits appear in the majority of adults treated with Amiodarone Borisovskiy HCl.
Photosensitivity: Amiodarone Borisovskiy 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: Amiodarone Borisovskiy HCl may cause increased thyroxine levels. If any new signs of arrhythmia appear, the possibility of hyperthyroidism should be considered.
Amiodarone Borisovskiy HCl is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Amiodarone Borisovskiy 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 Amiodarone Borisovskiy HCl is an acceptable risk, Amiodarone Borisovskiy 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: Amiodarone Borisovskiy HCl should only be used during pregnancy if the potential benefit to the mother justifies the unknown risk to the fetus. When Amiodarone Borisovskiy HCl therapy is indicated, the mother should be advised to discontinue nursing.
Use in Children: The safety and effectiveness of Amiodarone Borisovskiy HCl in children have not been established.
What happens if I miss a dose of Amiodarone Borisovskiy?
Because you will receive Amiodarone Borisovskiy 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
