Dofetilide is a heart rhythm medicine, also called an antiarrhythmic. This emedtv page examines a number of important precautions for using dofetilide safely, including warnings of dangerous complications that may occur in some people who use this drug. Administration of tikosyn will initially be done in the hospital, where you can carefully be monitored. Convert pdf files to all major formats including excel, word, cad, powerpoint extract scanned pdf content using ocr with multilanguage support new. Department of health and human services food and drug administration silver spring md 20993 nda 020931s007. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Other than an increased incidence of nonossified 5 th metacarpal, and the occurrence of hydroureter and hydronephroses at doses as low as 1 mgkgday in the rat, structural. Keep taking dofetilide as you have been told by your doctor or other health care provider, even if you feel well. Aug 19, 2019 what other drugs will affect dofetilide tikosyn. Dofetilide capsules are also contraindicated in patients with severe renal impairment calculated creatinine clearance tikosyn for the treatment and prevention of ventricular tachyarrhythmias. Pdf versions of this article on the journals web site.
The following nuget package need to be installed additionally to preserve chart as image in word to pdf, and image conversions. Niosh list of antineoplastic and other hazardous drugs in. No further down titration of tikosyn based on qtc or qt is recommended. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Tikosyn dofetilide medication guide pfizer medical. With word 2007 in the xp operating system it was easy, i just clicked and draged pdf the document into the word document.
Discontinuation of dofetilide from qt prolongation and. Dofetilide fda prescribing information, side effects and. This page also lists situations in which this drug should not be taken. The most common 10% nonhematologic adverse drug reactions were rash, pruritis, headache, nausea, fatigue, alopecia, myalgia, and upper abdominal pain. Discontinuation of dofetilide from qt prolongation and ventricular. Edit pdf content, manipulate pages and pdf forms in real time. This section presents highlights of the contents of the tikosyn dofetilide product monograph and refers you to more detailed information in the text. You can ask your doctor or pharmacist for information about tikosyn that is written for health professionals. Material may be irritating to the mucous membranes and upper respiratory tract. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Continuation of therapy all members including new members requesting authorization for continuation of therapy must meet all initial authorization criteria. Furthermore, the combination of more than one drug is hypothesized to.
Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. In january 2016, the fda determined that while safety risks for tikosyn dofetilide still exist, the requirements of the rems program are no longer necessary to ensure that the benefits of the. Dofetilide has also been used in an offlabel manner to. Dofetilide is an oral class iii antiarrhythmic agent used for treatment and prevention of atrial fibrillation and flutter. This effect, and the related increase in effective refractory period, is observed in the atria and ventricles in both resting and paced electrophysiology studies. Tikosyn dofetilide capsules to minimize the risk of induced arrhythmia, patients initiated or reinitiated on tikosyn should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine. Word for the web doesnt let you insert objects, such as pdfs, into a document.
Because of this risk, dofetilide must be started in the hospital, where your healthcare provider will monitor your kidneys and heartbeat for three days to determine the best dofetilide dosage for you. Black box warning available only to hospitals and prescribers who have received appropriate dosing. The dose of tikosyn must be individualized according to calculated creatinine clearance and qtc. Onmel fda prescribing information, side effects and uses. Dofetilide dose reductions and discontinuations in women. Tikosyn definition of tikosyn by medical dictionary. This effect, and the related increase in effective refractory period, is observed in the atria and ventricles in.
Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Feb 11, 2020 sublocade contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphinecontaining product, followed by dose adjustment for a minimum of 7 days. Dofetilide considerations for use american college of cardiology. Pdf converter and editor able2extract professional. It is marketed under the trade name tikosyn by pfizer, and is available in the united states in capsules containing 125, 250, and 500 g of dofetilide.
Windows server 2003, windows vista, windows xp service pack 2. Initiate dosage at the lower end of the adult range. Dofetilide tikosyn manufacturers website the fda no longer requires the rems program for dofetilide as of march 9, 2016 dofetilide hcp website pfizer fda statement on rems program. Tikosyn dofetilide contraindications pfizer medical. Plasma protein binding of dofetilide is 6070%, is independent of plasma concentration, and is unaffected by renal impairment. This brochure contains the answers to some frequently asked questions about the medicine.
Pdf synergistic effect of dofetilide and mexiletine on prevention of. Dofetilide package insert pdf dofetilide tikosyn considerations for use. Tikosyn dofetilide is an antiarrhythmic drug with class iii. Dofetilide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium the upper chambers of the heart. For detailed instructions regarding dose selection, see dosage and administration. Do not change your tikosyn dose unless your doctor tells you to.
Two to three hours after receiving your first dose, your healthcare provider will monitor your heart rate and may reduce your amount if necessary. In the excel file, head over to the insert tab and then click the object button. Your doctor will do tests before you start and while you take tikosyn. Background dofetilide is a class iii antiarrhythmic agent approved for achieving and maintaining sinus rhythm in patients with symptomatic atrial fibrillation. Dofetilide tikosyn considerations for use usfda approved indications. For outlook, click inside of the body of an item, such as an email message or calendar event. Cover all aspects of your pdf work on your desktop. Full prescribing information, medication guide, tikosyn treatment guidelines. This medication guide summarizes the most important information about tikosyn. In the object window that appears, switch to the create from file tab and then click browse. More important, dofetilide is eliminated by cationic renal secretion, and three inhibitors of this process have been shown to increase systemic dofetilide exposure.
It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Dofetilide capsules should not be used in patients with a baseline qt interval or qtc 440 msec 500 msec in patients with ventricular conduction abnormalities. Aug 19, 2019 tikosyn dofetilide is an antiarrhythmic drug used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium the upper chambers of the heart. Tikosyn is a prescription medicine that is used to treat an irregular heartbeat atrial fibrillation or atrial flutter. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Pdf background although atrial fibrillation af is the most common. Clinicians and pharmacies in institutions must confirm their participation in a designated tikosyn educational program before. The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim alone or in combination with sulfamethoxazole, or ketoconazole with tikosyn is contraindicated see warnings and precautions, drugdrug interactions, as each of these drugs cause a substantial increase in dofetilide plasma concentrations. Appropriate studies have not been performed on the relationship of age to the effects of dofetilide in the pediatric. Pfizer reserves the right to change or cancel the pfizer patient assistance program, or terminate my enrollment, at any time.
The support provided through this program is not contingent on any future purchase. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. It is very slightly soluble in water and propan2ol and is soluble in 0. Microsoft word enables users to create and edit documents as they like. In the occasion that users find some pdf resources instrumental to supplement their paper work, they may want to insert the pdf into word document, especially insert multiple pages pdf files, for editing or other intentions. Dofetilide package insert pdf download easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tikosyn dofetilide. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Class iii antiarrhythmics such as dofetilide, ibutilide, and amiodarone are indicated for rhythm control. Dofetilide increases the monophasic action potential duration in a predictable, concentrationdependent manner, primarily due to delayed repolarization. Jan 01, 2019 onmel is indicated for the treatment of onychomycosis of the toenail due to trichophyton rubrum or t. Dofetilide has had limited clinical use, but has not been linked to an increased rate of serum enzyme elevations during therapy or to instances of clinically apparent liver injury. What is the most important information i should know about tikosyn. Knowledge to help support you with tikosyn dofetilide right now, you may have some questions about tikosyn.
This emedtv article contains more information on this medicine, including what it is prescribed for, dosing instructions, side effects, and more. Because of the arrhythmogenic potential, hospitalize and monitor closely provision of cl cr calculations, continuous ecg monitoring, and cardiac resuscitation patients for 3 days during treatment initiation. Insert an object in word or outlook office support. It is important that you do not miss or skip a dose of dofetilide during treatment. Tikosyn dofetilide dosage and administration pfizer medical. Dofetilide capsules are an antiarrhythmic drug with. It is not known if tikosyn is safe and effective in children under 18 years. Boxed warning to minimize the risk of induced arrhythmia, patients initiated or reinitiated on tikosyn should be placed for a minimum of 3 days in a. Dofetilide medicare coverage and copay details goodrx. Available by prescription, dofetilide is taken twice daily to help control certain irregular heart rates. Dofetilide guidelines for uconn john dempsey hospital. Dofetilide capsules are also contraindicated in patients with severe renal impairment calculated creatinine clearance systemic va classification primary. Pdf initiation of some rhythmcontrol therapies for atrial fibrillation af requires an inpatient hospital stay and telemetry monitoring, adding to. Tikosyn dofetilide side effects, images, uses, dosage.
If you would like more information, talk with your doctor. However, you can edit the pdf itself in word for the web, which lets you update the pdf s content, or copy and paste content from the pdf into a word document. Tikosyn is used in people with atrial fibrillation or atrial flutter. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Each vial also contains anhydrous citric acid and mannitol. Dofetilide is a class iii antiarrhythmic agent available for use in the united states and other countries for the acute termination of atrial fibrillation or flutter as well as prevention of atrial fibrillation or flutter recurrence. This microsoft save as pdf or xps addin for 2007 microsoft office programs supplements and is subject to the license terms for the 2007 microsoft office system software. Find patient medical information for dofetilide oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Dofetilide, a class iii antiarrhythmic drug, is frequently used for rhythm control in patients with af. Multi ingredient medications may also be listed when applicable. If at any time after the second dose of tikosyn is given the qtc or qt is greater than 500 msec 550 msec in patients with ventricular conduction abnormalities, tikosyn should be discontinued. Do not stop taking tikosyn until your doctor tells you to stop. Prior to initiating treatment, appropriate nail specimens for laboratory testing koh preparation, fungal culture, or nail biopsy should be obtained to confirm the diagnosis of onychomycosis. Dofetilide has also been used in an offlabel manner to treat paroxysmal supraventricular tachycardias. Tikosyn capsules contain the following inactive ingredients. Tikosyn, dofetilide dosing, indications, interactions. Depending on the version of word or outlook youre using, you can insert a variety of objects such as pdf files, excel charts or worksheets, or powerpoint presentations into a word document or an email message by linking or embedding them. Tikosyn the following information is not intended to endorse any particular medication.
Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. C indications maintenance of normal sinus rhythm delay in time to recurrence of atrial fibrillationatrial flutter afafl in patients with afafl lasting more than one week, and who have been converted to normal. Dovato is indicated as a complete regimen for the treatment of human immunodeficiency. Medicare coverage and pricing details for dofetilide. Dofetilide pill images what does dofetilide look like. If you miss a dose, just take the next dose at your regular time. Pdf cost of hospital admission for antiarrhythmic drug initiation in. Dofetilide is contraindicated in patients with congenital or acquired long qt syndromes. This information does not take the place of talking with your doctor about your condition or treatment. Any medicines supplied by the pfizer patient assistance program shall not be sold, traded, bartered, or transferred. Dofetilide has been shown to adversely affect in utero growth and survival of rats and mice when orally administered during organogenesis at doses of 2 or more mgkgday.
The drug comes in the form of a capsule that is taken twice daily. For nonprescription products, read the label or package ingredients carefully. Heart rhythm control for atrial fibrillation black box warning available only to hospitals and prescribers who have received appropriate dosing and treatment initiation education. Read the medication guide before you start taking tikosyn and each time you get a refill. Dailymed dacarbazine injection, powder, for solution. Antiarrhythmic effects of combining dofetilide and ranolazine in a. Pronunciation of dofetilide with 1 audio pronunciation, 6 translations and more for dofetilide. The patient must be registered to receive this drug. Sep 16, 2019 dofetilide capsules should not be used in patients with a baseline qt interval or qtc 440 msec 500 msec in patients with ventricular conduction abnormalities.
The terminal halflife of dofetilide is approximately 10 hours. Objectives the purpose of this study was to determine the incidence and correlates of qt prolongation or ventricular tachycardia vt resulting in discontinuation of dofetilide in a realworld setting. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tikosyn dofetilide. Dofetilide definition of dofetilide by medical dictionary. Learn more about medicare prescription drug plans and savings with goodrx. Browse to the location of your file, select the file, and then click open. Tikosyn dofetilide warnings and precautions pfizer. Dofetilide is metabolized to a small degree by the cyp3a4 isoenzyme of the cytochrome p450 system and an inhibitor of this system could increase systemic dofetilide exposure. Aug 15, 2019 use dofetilide as ordered by your doctor. Pfizer will maintain the pfizer national tikosyn database, which includes the record of all enrolled and certified health care settings and pharmacies that dispense and prescribers who prescribe tikosyn. The package contains docio library that allows you to create, read and edit word documents. May cause eye, skin, or respiratory system irritation. For a listing of dosage forms and brand names by country availability, see dosage forms sections.
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