Guest guest Posted July 22, 2004 Report Share Posted July 22, 2004 Hi to you all.... Is anyone out there familiar with the anti-arrhythmia drug, Tikosin. I have an ICD and my physicians feel there have been too many 'incidents' and they want to hospitalize me and start Tikosin. Any help would be appreciated. Thx, Lee Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 24, 2004 Report Share Posted July 24, 2004 Hi Lee, I uploaded this file to Zaplist just in case it doesn't copy and past correctly. Hope this helps. I will look for some journal articles and if I find any I will post them. Good Luck, Laurie the information below was copied and pasted from Medscape: With First DataBank and ASHP New Search TIKOSYN ORAL Drug Class Uses & Dosage • Uses • Dosage and Administration Adverse Effects Precautions Drug Interactions Overdose & Toxicity Pharmacology & Chemistry Preparations Patient Handout TIKOSYN ORAL Uses & Dosage Uses from First Databank Labeled Uses Atrial Fibrillation Atrial Flutter Cardioversion of Atrial Fibrillation Cardioversion of Atrial Flutter Unlabeled Uses Uses from AHFS DI™ Supraventricular Tachyarrhythmias Dofetilide is used for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of more than 1 week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. Dofetilide also is used for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation.In 2 randomized, double-blind, dose-response studies, about 30% of patients with atrial fibrillation/atrial flutter who received 500 mcg of dofetilide twice daily were successfully converted to normal sinus rhythm compared with about 10 or 6% of those receiving 250 or 125 mcg twice daily and 1% of those who received placebo. Approximately 70% of the patients who successfully achieved normal sinus rhythm did so within 24–36 hours of beginning dofetilide therapy. After 12 months of therapy, the probabilities of remaining in normal sinus rhythm were 58–66 or 25–21% in patients who had converted to normal sinus rhythm and were still receiving dofetilide (500 mcg twice daily) or placebo, respectively. In one of these studies, dofetilide also was more effective than sotalol (80 mg orally twice daily) in converting atrial fibrillation to normal sinus rhythm or maintaining normal sinus rhythm for up to 12 months. In a third study, dofetilide was effective in converting and preventing the recurrence of atrial fibrillation without affecting mortality in patients with congestive heart failure and reduced left ventricular function. Dosage and Administration from AHFS DI™ General null Initial Dosage (Based on Creatinine Clearance) Adjusted Dosage (for QTc Prolongation) 500 mcg twice daily 250 mcg twice daily 250 mcg twice daily 125 mcg twice daily 125 mcg twice daily 125 mcg once daily Dofetilide is administered orally twice daily without regard to meals.The recommended adult dosage of dofetilide is 500 mcg twice daily, which is modified according to creatinine clearance and QTc interval. The risk of torsades de pointes is related to the dosage of dofetilide, and clinicians may elect to initiate therapy with lower dosages. Dosages exceeding 500 mcg twice daily have been associated with an increased incidence of torsades de pointes. Commercially available dofetilide must be obtained through a restricted distribution program. Clinicians and pharmacies in institutions must confirm their participation in a designated Tikosyn® educational program before prescribing or ordering the drug; the drug is not available through community pharmacies. The status of clinicians who have participated in these programs may be verified on the internet (www.tikosynlist.com); for information regarding such educational programs, contact the manufacturer at 877- 845-6796.Because of the arrhythmogenic potential of dofetilide, the manufacturer recommends that both initiation of tharapy with the drug and any subsequent increases in dosage be performed in a hospital setting where creatinine clearance calculations, continuous ECG monitoring, and cardiac resuscitation can be performed and where the patient can be monitored by personnel trained in the management of serious ventricular arrhythmias. Prior to initiation of dofetilide, the creatinine clearance must be calculated and QTc interval (or QT interval if the heart rate is less than 60 beats/minute) must be determined using an average of 5–10 beats. If the QTc interval exceeds 440 msec (500 msec in patients with ventricular conduction abnormalities), dofetilide is contraindicated. If creatinine clearance is less than 60 mL/minute, the initial dosage of dofetilide must be reduced. (See Dosage and Administration: Special Populations.) Within 2–3 hours of administering the first dose of dofetilide, determine the QTc interval. If QTc interval has increased by more than 15% or exceeds 500 msec (550 msec in patients with ventricular conduction abnormalities), adjust subsequent dosages as follows: Within 2–3 hours after each subsequent dose of dofetilide (for in-hospital doses 2–5), determine the QTc interval. No further downward titration of dofetilide based on QTc is recommended. However, if at any time after the second dose of dofetilide is given the QTc exceeds 500 msec (550 msec in patients with ventricular conduction abnormalities), discontinue dofetilide. Continuous ECG monitoring should be performed for a minimum of 3 days or for a minimum of 12 hours after electrical or pharmacologic conversion to normal sinus rhythm, whichever is greater.Reevaluate renal function and QTc interval every 3 months or as medically warranted. If QTc exceeds 500 msec (550 msec in patients with ventricular conduction abnormalities), discontinue dofetilide and carefully monitor the patient until QTc returns to baseline levels. If renal function deteriorates, adjust dosage as described in Dosage and Administration: Special Populations. The manufacturer recommends that patients be hospitalized and closely monitored for 3 days (until steady-state plasma concentrations are obtained) whenever dofetilide dosage is increased. Previously successful use of such dosages of dofetilide does not eliminate the need for rehospitalization when the dosage is increased. Special Populations null Calculated Creatinine Clearance (mL/minute) Dosage 60 500 mcg twice daily 40–60 250 mcg twice daily 20 to 40 125 mcg twice daily 20 Dofetilide is contraindicated In patients with impaired renal function, dosage of dofetilide must be modified according to the degree of impairment. Because increase in QT interval and the risk of ventricular arrhythmias are directly related to plasma dofetilide concentrations, dosage adjustment based on calculated creatinine clearance is essential. The patient's creatinine clearance (Ccr) can be estimated by using the following formulas:No dosage adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh class A or . The pharmacokinetics of the drug have not been studied in patients with severe hepatic insufficiency (Child-Pugh class C) and such patients should be treated cautiously. New Search TIKOSYN ORAL Drug Class Use & Dosage Adverse Effects • Cautions Precautions Drug Interactions Overdose & Toxicity Pharmacology & Chemistry Preparations Patient Handout TIKOSYN ORAL Adverse Effects List & Discussion Adverse Effects List from First Databank More Frequent QT INTERVAL PROLONGATION severe TORSADES DE POINTES severe VENTRICULAR ARRHYTHMIAS severe VENTRICULAR TACHYCARDIA severe Less Frequent ABDOMINAL PAIN ANGIOEDEMA severe ATRIOVENTRICULAR BLOCK severe BACK PAIN BRADYCARDIA severe BUNDLE BRANCH BLOCK severe CARDIAC ARREST severe CEREBRAL ISCHEMIA severe CEREBROVASCULAR ACCIDENT severe CHEST PAIN severe COUGH, INCREASED DIARRHEA DIZZINESS DYSPNEA EDEMA severe FLU-LIKE SYMPTOMS HEADACHE HEART BLOCK severe HEPATIC FUNCTION IMPAIRMENT severe INSOMNIA MIGRAINE MYOCARDIAL INFARCTION severe NAUSEA PARESTHESIA severe RESPIRATORY TRACT INFECTION SKIN RASH SYNCOPE(FAINTING) severe VENTRICULAR FIBRILLATION severe New Search TIKOSYN ORAL Drug Class Use & Dosage Adverse Effects Precautions Drug Interactions Overdose & Toxicity Pharmacology & Chemistry Preparations Patient Handout TIKOSYN ORAL Precautions Drug Disease Contraindications from First DataBank Most Significant If you have any of these conditions and are taking this product, contact your doctor immediately. • Severe Renal Disease • Congenital Long QT Syndrome • Ventricular Arrhythmias • Torsades de Pointes Significant If you have any of these conditions and are taking this product, talk to your doctor. • Severe Diarrhea • Renal Disease • Disease of Liver • Sick Sinus Syndrome • 2nd Degree AV Heart Block • Complete Atrioventricular Block • Hypokalemia • Hypomagnesemia Possibly Significant If you have any of these conditions and are taking this product, you may want to talk to your doctor • Vomiting • Anorexia • Hyperhidrosis Pediatric Precautions RELATIVE CONTRAINDICATION • Precaution active between 1 days and 6570 Lactation Precautions PRECAUTION • NO DATA AVAILABLE • EFFECT ON THE INFANT IS UNKNOWN Pregnancy Precaurions ANIMAL STUDIES HAVE SHOWN ADVERSE EFFECT ON FETUS BUT NO WELL- CONTROLLED STUDIES IN HUMANS: POTENTIAL BENEFITS MAY WARRANT USE IN PREGNANT WOMEN DESPITE POTENTIAL RISKS; OR NO ANIMAL REPRODUCTION STUDIES AND NO ADEQUATE AND WELL-CONTROLLED STUDIES IN HUMANS. • Contraindications Congenital or acquired long QT syndromes; baseline QT or QTc interval exceeding 440 msec (500 msec in patients with ventricular conduction abnormalities). Severe renal impairment (calculated creatinine clearance below 20 mL/minute). Concomitant use of verapamil or cation transport system inhibitors (e.g., cimetidine, ketoconazole, megestrol, prochlorperazine, trimethoprim [alone or in combination with sulfamethoxazole]). (See Drug Interactions.) Known hypersensitivity to dofetilide. Warnings/Precautions Warnings Arrhythmogenic Effects. Dofetilide may cause serious ventricular arrhythmias, principally polymorphic ventricular tachycardia associated with QT interval prolongation (i.e., torsades de pointes). The risk of torsades de pointes can be reduced by controlling the plasma concentration (e.g., adjustment of initial dofetilide dosage according to creatinine clearance, avoiding certain drug interactions) and monitoring the ECG for excessive increases in the QT interval. In clinical trials, the overall incidence of torsades de pointes was 0.8% and was dose-related in patients with supraventricular arrhythmias. Most episodes of torsades de pointes occurred within the first 3 days of dofetilide therapy, and the risk was threefold greater in women than in men. TIKOSYN ORAL Preparations Dofetilide Routes Forms Strengths Brand Names Manufacturer Oral Capsules 0.125 mg Tikosyn®, Pfizer 0.25 mg Tikosyn®, Pfizer 0.5 mg Tikosyn®, Pfizer TIKOSYN ORAL Drug Class Use & Dosage Adverse Effects Precautions Drug Interactions Overdose & Toxicity Pharmacology & Chemistry Preparations Patient Handout TIKOSYN ORAL Patient Handout DOFETILIDE - ORAL The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. Common Brand Name(s): Tikosyn Warning This medication may sometimes produce new, irregular heartbeats (arrhythmias). It is recommended you stay in the hospital for 3 days where proper monitoring (e.g., renal function, EKG) and support (cardiac resuscitation) is available until your body adjusts to the effects of this medication. Consult your doctor or pharmacist for more information. Uses This medication is used to treat irregular heartbeats (symptomatic atrial fibrillation/flutter arrhythmias). It is used to restore normal heart rhythm, and also to maintain regular, steady heartbeats. How to Take this Medication This medication is taken by mouth as directed. When your dosage of dofetilide is started, restarted, or increased you will be monitored in a hospital (e.g., EKG and kidney function tests, and observation). This special monitoring will minimize the chances of developing serious side effects. Your dofetilide dosage is based on your medical condition (including heart and kidney function) and response to therapy. It is very important to continue taking this medication exactly as prescribed by your doctor. Taken improperly, or without proper monitoring, this medication can build up in your bloodstream and may actually cause new, very serious irregular heartbeats. Avoid grapefruit juice while using this medication unless your doctor instructs you otherwise. Side Effects Nausea or headache may occur. If these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dizziness, fainting, irregular heartbeat. Mineral imbalances can increase the risk of developing drug side effects. Tell your doctor immediately if you have symptoms indicating a possible mineral imbalance such as: muscle cramps or weakness, prolonged diarrhea, excessive thirst or sweating, vomiting, loss of appetite. If you notice other effects not listed above, contact your doctor or pharmacist. Precautions Tell your doctor your medical history, including: heart (e.g., prolonged QT interval) problems, kidney disease, liver disease, low blood potassium or magnesium, any allergies. Caution is advised when using this drug in the elderly, as they may have decreased kidney function. This may result in more side effects as dofetilide builds up in the bloodstream. Caution is advised when using this drug in females since they may be more sensitive to certain side effects (e.g., serious arrhythmias known as torsade de pointes). This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Interactions This drug is not recommended for use with: hydrochlorothiazide. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially of: drugs that interfere with kidney action (cation transport inhibitors, including prochlorperazine, megestrol, cimetidine, ketoconazole, and drugs containing trimethoprim), certain antipsychotics (e.g., chlorpromazine), " water pills " (diuretics such as furosemide), amiloride, triamterene, verapamil, diltiazem, metformin, azole antifungals (e.g., itraconazole), macrolide antibiotics (e.g., clarithromycin), protease inhibitors (e.g., ritonavir), quinine, zafirlukast, dronabinol, norfloxacin, antidepressants (nefazodone, and SSRI-types such as fluoxetine). Report other drugs which affect the heart rhythm (QTc prolongation), such as: pimozide, quinidine, sotalol, procainamide, sparfloxacin. Ask your doctor or pharmacist for more details. Certain other drugs for irregular heartbeats (Class I or III antiarrhythmic agents, including amiodarone) should be stopped for a period of time before starting dofetilide. Consult your doctor. If your doctor stops your dofetilide treatment in order to more safely prescribe an interacting drug, wait 2 days before starting the new drug, unless instructed otherwise. This allows the dofetilide to be removed from your bloodstream. Consult your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval. Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include fast or irregular heartbeat, fainting, and loss of consciousness. Notes Do not share this medication with others. Laboratory and/or medical tests (e.g., EKG, kidney function, potassium and magnesium blood tests) will be performed to monitor your progress. Missed Dose If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Storage Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from light and moisture. Advice to Patients from AHFS DI™ Importance of reading the manufacturer's patient information prior to beginning therapy and rereading it each time the prescription is refilled in case status has changed.Importance of informing clinician immediately if new rapid heartbeats, lightheadedness, or fainting occur; if clinician cannot be contacted, go to nearest hospital emergency room.Importance of adherence to dosage and medical appointment schedule. Take drug at same time each day and omit any missed doses. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Importance of women informing clinicians if they are or plan to become pregnant or breast-feed.Overview (see Users Guide). For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. Quote Link to comment Share on other sites More sharing options...
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