Tikosyn is available only to hospitals and prescribers who have received appropriate tikosyn dosing and treatment initiation education. Bioequivalence studies of tikosyn were only performed between the highest 500 mcg and lowest capsule dose strengths 125 mcg. Clinical pharmacy program guidelines for dofetilide arizona. Please see the accompanying tikosyn full prescribing information, including boxed warning, medication guide, and important safety information. Tikosyn dofetilide is an antiarrhythmic drug with class iii cardiac action. The primary safety endpoint was major bleeding that occurred during or within 2 days of stopping study treatment.
Refer to prescribing information for more complete information. Therapy with tikosyn must be initiated and, if necessary, reinitiated in a. Ranexa may be used with betablockers, nitrates, calcium channel blockers, antiplatelet therapy, lipidlowering therapy, ace inhibitors, and angiotensin receptor blockers. In order to provide you with relevant and meaningful content we need to know more about you.
Stop taking linzess and call your doctor right away if you get severe diarrhea during treatment with linzess. Tikosyn is a heart rhythm medicine, also called an antiarrhythmic. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Always remember to talk with your doctor or pharmacist if you have questions. Dofetilide is used to correct irregular heartbeat of patients with atrial fibrillation or atrial flutter to a normal heart rhythm. The sdss provided on this web site were developed in good faith and believed accurate.
Tikosyn, also called dofetilide generic name, is one of. Side effects of betapace and tikosyn that are similar include headache, dizziness, diarrhea, nausea, stomach upset or pain, and sleep problems. Learn how to inititate tikosyn dofetilide treatment for your patients. 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. Medication information for your tikosyn dofetilide admission. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Information from the accs raterhythm dosing table on the drug dofetilide, including recommended dosage and major. Phase 3 trial of defibrotide for the treatment of severe venoocclusive disease and multiorgan failure. Thyrogen thyrotropin alfa for injection, for intramuscular use initial u. Major bleeding was defined as clinically overt bleeding that met 1 of the following criteria. Qt interval should be used if the heart rate is prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Tikosyn has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Linzess can cause serious side effects, including diarrhea, the most common side effect, which can sometimes be severe. If you receive any new prescriptions, please make sure the prescribing doctor is aware you are on dofetilide tikosyn to check for drugdrug interactions. Must be initiated or re initiated in a facility that can provide crcl calculation, ecg monitoring, and cardiac resuscitation. Prescriber signature date please mail or fax this document to. The national hiv curriculum is an aids education and training center aetc program supported by the health resources and services administration hrsa of the u. Full prescribing information, medication guide, tikosyn treatment guidelines and certification form, and will be available on the tikosyn rems program website for 6 months from the date of. Prescribing information, clinical studies, and slide decks all materials are available for download in their original formats as pdf or powerpoint. Side effects of betapace and tikosyn that are similar include headache, dizziness, diarrhea, nausea, stomach upset. Tikosyn is used in people with atrial fibrillation or atrial flutter. Feb 01, 2020 dofetilide increases the monophasic action potential duration in a predictable, concentration.
Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Cimetidine at 400 mg bid the usual prescription dose coadministered with. Zithromax azithromycin 250 mg and 500 mg tablets, for oral use zithromax azithromycin for oral suspension initial u. Tikosyn dofetilide capsules prescribing information. In the united states it is only available by mail order or through specially trained local pharmacies. Please see full prescribing information, including boxed warning, and medication guide.
Dofetilide belongs to the group of medicines known as antiarrhythmics. Available only to hospitals and prescribers who have received appropriate dosing and treatment initiation education. Full prescribing information, medication guide, tikosyn. It is important that you do not miss or skip a dose of tikosyn dofetilide during treatment. This effect, and the related increase in effective refractory period, is observed in the atria and ventricles in both resting and paced electrophysiology studies. 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 facility that can provide. Tikosyn pharmacokinetics absorption bioavailability.
Find patient medical information for tikosyn oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Full prescribing information 1 indications and usage ranexa is indicated for the treatment of chronic angina. Highlights of prescribing information these highlights do not. Oral dosage forms that should not be crushed 2016 you may purchase a wall chart version of this list at. Comparison of ixekizumab with etanercept or placebo in moderatetosevere psoriasis uncover2 and uncover3. Dofetilide fda prescribing information, side effects and uses. There is no information about the effectiveness of hemodialysis in removing. Parent or guardian, if under 18 years of age 2 3 the pfizer patient assistance program is a joint program of. Thus, when searching for drug information, many times the problem facing a pharmacist is not a lack of resources, but rather too many resources from which to choose. Betapace and tikosyn belong to different drug classes. Considerations for use from the atrial fibrillation toolkit. These highlights do not include all the information needed to use zithromax safely and effectively.
The intravenous dose is approximately equal to the oral dose and administered at the same dosing frequency. Information in this brochure cannot take the place of a talk with. When conditions are met, we will authorize the coverage of tikosyn. One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drugs label, also known as the prescribing. Betapace is a betablocker and tikosyn is an antiarrhythmic drug. Transient kinetic and dynamic interactions between verapamil and dofetilide, a.
This medicine is used in people with atrial fibrillation or atrial flutter. Sdss are not intended to be used by greenstones patients as a replacement for, or as a complement to, prescribing information such as package inserts or the advice of a healthcare professional. Qt interval should be used if the heart rate is tikosyn when the heart rate is tikosyn is 500 mcg bid, as modified by the dosing algorithm. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tikosyn dofetilide. You may contact paramount by phone at 14198872520 with questions regarding the prior authorization process. Dofetilide is an antiarrhythmic drug is indicated for conversion of atrial fibrillationatrial flutter to normal sinus rhythm, or for maintenance of normal sinus rhythm in patients. Parent or guardian, if under 18 years of age 2 3 the pfizer patient assistance program is a joint program of pfizer inc. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. Tikosyn dofetilide dosage and administration pfizer medical. Only a patients physician can approve the use of two 125 mcg capsules in place of one 250 mcg capsule.
Clinical pharmacy program guidelines for dofetilide arizona program prior authorization medication dofetilide tikosyn markets in scope arizona 1. Direct all product information questions to pfizer medical information at 18004381985. Probabilities of tikosyn patients remaining at nsr at 6 and 12 months 250 mcg bid 500 mcg bid placebo 6 months 53. Dofetilide considerations for use american college of cardiology. It is not known if tikosyn is safe and effective in children under 18 years of age. Tikosyn dofetilide side effects, dosage, interactions drugs. Tikosyn is also contraindicated in patients with a known hypersensitivity to the drug see page 36. Tikosyn is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Highlights please see full prescribing information and patient information for tikosyn dofetilide capsules in back cover pocket. Diarrhea often begins within the first 2 weeks of linzess treatment. Spach, md principal investigator mountain west aetc professor of medicine division of infectious diseases. Tikosyn is the brand name of the drug dofetilide, which is used to treat atrial fibrillation and atrial flutter types of irregular heartbeats this prescription medicine belongs to a class of. Highlights of prescribing information ll the information needed to use multaq sa fely and effectively. These highlights do not include all the information needed.
Linzess linaclotide official site from allergan and. Dosing info and administration of tikosyn dofetilide. Dofetilide tikosyn treatment national hiv curriculum. Tikosyn po box 2147 morrisville, pa 190670647 fax 800. Keep taking tikosyn dofetilide as you have been told by your doctor or other health care provider, even if you feel well. Please choose the category that best describes you. One patient received very high multiples of the recommended dose 28 capsules, was treated with gastric aspiration 30 minutes later, and experienced no events. Interactions between tikosyn oral and dofetilideverapamil. Warning to minimize the risk of induced arrhythmia, patients initiated or reinitiated on tikosyn should be placed.
Highlights of prescribing information these highlights do not include all the information needed to use thyrogen safely and effectively. 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. Please fax signed forms to paramount at 18442562025. Raphael sung or cathy kenny, np, at 30339855, option 4 before starting the new medications. Dofetilide increases the monophasic action potential duration in a predictable, concentration. Tikosyn dofetilide overdosage pfizer medical information. Tikosyn 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 that allow blood to flow into the heart. The dose of tikosyn must be individualized according to calculated creatinine clearance and qtc. 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. Prescribing data from medicares prescription drug benefit, known as part d, was compiled and released by the centers for medicare and medicaid services, the federal agency that oversees the program. About tikosyn dofetilide please see full prescribing information, including boxed warning, and medication guide beginning on page 7.
If you receive any new prescriptions, please make sure the prescribing doctor is aware you. Tikosyn is a prescription medicine that is used to treat an irregular heartbeat atrial fibrillation or atrial flutter. These highlights do not include all the information needed to use tivicay safely and effectively. Tivicay dolutegravir tablets, for oral useinitial u. Zithromax is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria. Click here to view a print quality pdf of this table. Aug 26, 2019 the dose of tikosyn must be individualized according to calculated creatinine clearance and qtc. Dofetilide fda prescribing information, side effects and.
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