In the DIAMOND studies, although Torsade de Pointes occurred more frequently in the Dofetilide-treated patients (see ADVERSE REACTIONS), Dofetilide, given with an initial 3-day hospitalization and with dose modified for reduced creatinine clearance and increased QT interval, was not associated with an excess risk of mortality in these populations with structural heart disease in the individual studies or in an analysis of the combined studies. Accessed June 03, 2023. Copyright 1996-2023 Cerner Multum, Inc. This is consistent with a lack of effect of dofetilide on the PR interval and QRS width in patients with pre-existing heart block and/or sick sinus syndrome. The most frequent adverse events were headache, chest pain, and dizziness. Colesevelam Hydrochloride and Nifedipine drug interaction, Hydrocortisone and Injection Site Haemorrhage, Premarin and Maternal Exposure During Pregnancy, High Blood Cholesterol: 5 people, 26.32%, Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 3 people, 15.79%, Arrhythmias (irregular heartbeat): 2 people, 10.53%, Barrett's Oesophagus (barrett's oesophagus is a disorder in which the lining of the oesophagus (the tube that carries food from the throat to the stomach) is damaged by stomach acid and changed to a lining similar to that of the stomach): 2 people, 10.53%, Blood Potassium Decreased: 2 people, 10.53%, Dermatitis Psoriasiform (large white or silver flakes on the skin): 2 people, 10.53%. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Dosing . If heart rate is less than 60 beats per minute, QT interval should be used. [1] 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. fingolimod increases effects of dofetilide by pharmacodynamic synergism. **Tip: If you use CONTROL + F, you can type the name of the drug you are looking to find on the list. * Listed trademarks are the property of their respective owners. As shown, both the probability of a patients remaining in sinus rhythm at six months and the change in QTc from baseline at steady state of dosing increased in an approximately linear fashion with increasing dose of Dofetilide. NDC 72603-132-01 To minimize the risk of induced arrhythmia, patients initiated or re-initiated on Dofetilide capsules should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. There was no increase in heart failure in patients with significant left ventricular dysfunction (see CLINICAL STUDIES, Safety in Patients with Structural Heart Disease, DIAMOND Studies). At 2 to 3 hours after each subsequent dose of Dofetilide, determine the QTc or QT (if heart rate is less than 60 beats per minute) (for in-hospital doses 25). Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Dofetilide capsules is a prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter). Dose reductions for reduced calculated creatinine clearance occurred in 47% and 45% of DIAMOND CHF and MI patients, respectively. Additional resources include NIH recommendations for drug-drug interactions between PAXLOVID and UpToDate PAXLOVID drug information. Medically reviewed by Drugs.com. Dofetilide capsules are prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter). All patients were started on therapy in a hospital where their ECG was monitored (see DOSAGE AND ADMINISTRATION). Package insert / product label Please consult your healthcare provider for advice about a specific medical condition. Step 1. Proceed to Step 2 if the QTc or QT is 440 msec. Although dofetilide is used to correct an irregular heartbeat, taking this medication can also increase your risk for developing an irregular heartbeat. Some reports may have incomplete information. 1.50 or free if you spend 15 or more from your choice of 2,200 stores. No clinically relevant effects were noted in serum alkaline phosphatase, serum GGT, LDH, AST, ALT, total bilirubin, total protein, blood urea nitrogen, creatinine, serum electrolytes (calcium, chloride, glucose, magnesium, potassium, sodium), or creatine kinase. If renal function deteriorates, adjust dose as described in Initiation of Dofetilide Therapy, Step 3. In the DIAMOND population, adverse events other than those related to the post-infarction and heart failure patient population were generally similar to those seen in the supraventricular arrhythmia groups. What should I tell my doctor before taking Dofetilide capsules? Stopping Dofetilide Prior to Administration of Potentially Interacting Drugs. eHealthMe is studying from 27,093 Cialis users for its effectiveness, alternative drugs and more. In the overall clinical program, Dofetilide did not affect blood pressure. There were 230 deaths in patients randomized to Dofetilide (n=749) and 243 deaths in patients randomized to placebo (n=761). Dofetilide may also be used for purposes not listed in this medication guide. In the DIAMOND trials, 1252 patients were treated with Dofetilide and diuretics concomitantly, of whom 493 died compared to 508 deaths among the 1248 patients receiving placebo and diuretics. If you miss a dose, just take the next dose at your regular time. The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with Dofetilide capsules is contraindicated (see PRECAUTIONS, Drug-Drug Interactions) because this has been shown to significantly increase Dofetilide plasma concentrations and QT interval prolongation. In an analysis of 506 DIAMOND patients with atrial fibrillation/flutter at baseline, one year mortality on Dofetilide was 31% vs. 32% on placebo (see CLINICAL STUDIES). Heart rate was decreased by 46 bpm in studies in patients. There was no clinically significant alteration in the pharmacokinetics of dofetilide in volunteers with mild to moderate hepatic impairment (Child-Pugh Class A and B) compared to age- and weight-matched healthy volunteers. WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health. It may harm them. There are no adequate and well controlled studies in pregnant women. Because there is a linear relationship between Dofetilide plasma concentration and QTc, concomitant drugs that interfere with the metabolism or renal elimination of Dofetilide may increase the risk of arrhythmia (Torsade de Pointes). Serum potassium should be maintained within the normal range before Dofetilide treatment is initiated and should be maintained within the normal range while the patient remains on Dofetilide therapy. 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. Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Davis's Drug Guide for Rehabilitation Professionals. Chronic Atrial Fibrillation and/or Atrial Flutter. Store Dofetilide capsules at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F). There is no known antidote to TIKOSYN; treatment of overdose should therefore be symptomatic and supportive. Isoproterenol infusion into anesthetized dogs with cardiac pacing rapidly attenuates the Dofetilide-induced prolongation of atrial and ventricular effective refractory periods in a dose-dependent manner. Table 8: Frequency of Adverse Events Occurring at >2% on Dofetilide, and Numerically More Frequently on Dofetilidethan Placebo in Patients with Supraventricular Arrhythmias. All information is observation-only. Before initiating Dofetilide therapy, previous antiarrhythmic therapy should be withdrawn under careful monitoring for a minimum of three (3) plasma half-lives. Tell your doctor about all prescription and non-prescription medicines, vitamins, dietary supplements, and any natural or herbal remedies. Patients with atrial fibrillation should be anticoagulated according to usual medical practice prior to electrical or pharmacological cardioversion. Dofetilide comes in capsule form. Table 2: Patient Status at 6 and 12 Months Post Randomization. In the DIAMOND trials, a total of 1,511 patients were exposed to Dofetilide for 1757 patient years. We comply with the HONcode standard for trustworthy health information. Some medicines can cause unwanted or dangerous effects when used with dofetilide, and should not be used at the same time. Mortality: In a pooled survival analysis of patients in the supraventricular arrhythmia population (low prevalence of structural heart disease), deaths occurred in 0.9% (12/1346) of patients receiving Dofetilide and 0.4% (3/677) in the placebo group. Table 6 shows the frequency by randomized dose of serious arrhythmias and conduction disturbances reported as adverse events in patients with supraventricular arrhythmias. The terminal half-life of dofetilide is approximately 10 hours; steady state plasma concentrations are attained within 23 days, with an accumulation index of 1.5 to 2.0. Submit a medical question for Pfizer prescription products. Dofetilide capsule is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules. DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. The structural formula is. These conditions can cause an electrolyte imbalance, making it dangerous for you to use dofetilide. Call your doctor at once if you have: headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats; loss of appetite, vomiting or severe diarrhea; or. Calculation of creatinine clearance: Prior to the administration of the first dose, the patients creatinine clearance must be calculated using the following formula: creatinine clearance (male) = (140-age) x actual body weight in kg, creatinine clearance (female) = (140-age) x actual body weight in kg x 0.85. There are no quantifiable metabolites circulating in plasma, but 5 metabolites have been identified in urine. Dofetilide has been used safely in conjunction with pacemakers (53 patients in DIAMOND studies, 136 in trials in patients with ventricular and supraventricular arrhythmias). Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. The dose of Dofetilide must be individualized according to calculated creatinine clearance and QTc. In volunteers with varying degrees of renal impairment and patients with arrhythmias, the clearance of dofetilide decreases with decreasing creatinine clearance. You can use the study as a second opinion to make health care decisions. You should not do both. The steps described above are summarized in the following diagram: Renal function and QTc or QT (if heart rate is less than 60 beats per minute) should be re-evaluated every three months or as medically warranted. HCTZ 50 mg QD or HCTZ/triamterene 50/100 mg QD was co-administered with Dofetilide (500 mcg BID) for 5 days (following 2 days of diuretic use at half dose). Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. 250 mcg (0.25 mg) Note: The range of dofetilide plasma concentrations achieved with the 500 mcg BID dose adjusted for creatinine clearance is 13.5 ng/mL. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The point estimates of the probabilities of remaining in NSR at 6 and 12 months were 71% and 66%, respectively, for Dofetilide 500 mcg BID; 56% and 51%, respectively, for Dofetilide 250 mcg BID; and 26% and 21%, respectively, for placebo. With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. Skip the missed dose and take your next dose at the usual time to stay on schedule. In vitro studies with human liver microsomes show that Dofetilide can be metabolized by CYP3A4, but it has a low affinity for this isoenzyme. Show More Uses This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation /flutter). Patients with sick sinus syndrome or with 2nd or 3rd degree heart block were not included in the Phase 3 clinical trials unless a functioning pacemaker was present. Has many potential drug interactions. A total of 996 patients with a one week to two year history of atrial fibrillation/atrial flutter were enrolled. Do not stop taking Dofetilide capsules until your doctor tells you to stop. Dofetilide. The names of all prescription and nonprescription (over-the-counter) medications, vitamins, and herbal supplements you take. It is not available in Europe [2] or Australia. Ask your doctor or pharmacist to explain anything you dont understand. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Ask your doctor and/or pharmacist for more information about your medications and special instructions you may need based on your overall health. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Be sure you always have enough of this medication with you. Personalize this study to your gender and age, Atrial fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles), Etodolac and Hyperparathyroidism Secondary, Eletriptan Hydrobromide and Gastroesophageal Reflux Disease, Pravastatin Sodium and Anti-Erythropoietin Antibody Positive. Dofetilide is not an inhibitor of CYP3A4 nor of other cytochrome P450 isoenzymes (e.g., CYP2C9, CYP2D6) and is not expected to increase levels of drugs metabolized by CYP3A4. If you have heart problems, especially a heart condition called long QT syndrome, or if you have kidney or liver problems, or low potassium or magnesium levels. DIAMOND MI studied 1510 patients hospitalized with recent myocardial infarction (27 days) who had confirmed impaired left ventricular function (ejection fraction 35%). At concentrations covering several orders of magnitude, dofetilide blocks only IKr with no relevant block of the other repolarizing potassium currents (e.g., IKs, IK1). Administer the adjusted Dofetilide dose and begin continuous ECG monitoring. In patients receiving HCTZ alone, Dofetilide AUC increased by 27% and Cmax by 21%. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. N - [4- [2- [methyl [2- [4- [ (methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. NDC 72603-131-01 Ciccone C.D.(Ed. Patients should continue to be monitored in this way for a minimum of three days. The DIAMOND trials were intended to determine whether Dofetilide could reduce that risk. The most frequent reason for discontinuation (>1%) was ventricular tachycardia (2.0% on Dofetilide vs. 1.3% on placebo). The study uses data from the FDA. In patients receiving HCTZ alone, dofetilide AUC increased by 27% and C max by 21%. It is not known if TIKOSYN is safe and effective in children under 18 years of age. See What is the most important information I should know about Dofetilide capsules?. NDC 72603-130-01 The terminal half-life of Dofetilide is approximately 10 hours; steady state plasma concentrations are attained within 2 to 3 days, with an accumulation index of. Know the medicines you take. Keep this and all other medications out of the reach of children. Keep dofetilide capsules in a tightly closed container. In this very small patient population, the incidence of Torsade de Pointes was 10.5% (4/38 patients), and the incidence of new ventricular fibrillation was 2.6% (1/38 patients). Get useful, helpful and relevant health + wellness information. If you take Dofetilide capsules with certain medicines, you will be more likely to have a different type of abnormal heartbeat. Concomitant medications were grouped as ACE inhibitors, oral anticoagulants, calcium channel blockers, beta blockers, cardiac glycosides, inducers of CYP3A4, substrates and inhibitors of CYP3A4, substrates and inhibitors of P-glycoprotein, nitrates, sulphonylureas, loop diuretics, potassium sparing diuretics, thiazide diuretics, substrates and inhibitors of tubular organic cation transport, and QTc-prolonging drugs. Manufactured for: Dofetilide (Tikosyn) is used to correct irregular heartbeats (arrhythmias). Safety in Patients with Structural Heart Disease: DIAMOND Studies (The Danish Investigations of Arrhythmia and Mortality on Dofetilide). Frequency of Torsade de Pointes: In the supraventricular arrhythmia population (patients with AF and other supraventricular arrhythmias), the overall incidence of Torsade de Pointes was 0.8%. You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at. Figure 1: Mean QTc-Concentration Relationship in Young Volunteers Over 24 Days, Note: The range of Dofetilide plasma concentrations achieved with the 500 mcg BID dose adjusted for creatinine clearance is 1 to 3.5 ng/mL. Quinidine (Quinaglute, Quinidex Extentabs, others). It is not known whether dofetilide will harm an unborn baby. Patients to be discharged on Dofetilide therapy from an inpatient setting as described above must have an adequate supply of Dofetilide capsules, at the patients individualized dose, to allow uninterrupted dosing until the patient can fill a Dofetilide prescription. In all, 371/749 (50%) of patients on Dofetilide and 419/761 (55%) on placebo required hospitalization. At 2 to 3 hours after administering the first dose of Dofetilide, determine the QTc or QT (if heart rate is less than 60 beats per minute). Increase in QT interval is directly related to dofetilide dose and plasma concentration. Keep dofetilide capsules in a tightly closed container. Figure 4: Maintenance of Normal Sinus Rhythm, Dofetilide Regimen vs. Common interactions include death among females and barrett's oesophagus among males. Renal Impairment: In volunteers with varying degrees of renal impairment and patients with arrhythmias, the clearance of Dofetilide decreases with decreasing creatinine clearance. Dosage of drugs is not considered in the study. Keep this medicine away from. The frequency of TdP by dose is shown in Table 4. Population pharmacokinetic analyses indicate that the plasma concentration of dofetilide in patients with supraventricular and ventricular arrhythmias, ischemic heart disease, or congestive heart failure are similar to those of healthy volunteers, after adjusting for renal function. In females, as in males, renal function was the single most important factor influencing dofetilide clearance. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. A linear relationship between mean QTc increase and Dofetilide dose was also seen in patients with renal impairment, in patients with ischemic heart disease, and in patients with supraventricular and ventricular arrhythmias. One patient inadvertently received two 500 mcg doses one hour apart and experienced ventricular fibrillation and cardiac arrest 2 hours after the second dose. It works by slowing nerve impulses in the heart. This is not a complete list of side effects and others may occur. are allergic to Dofetilide in Dofetilide capsules. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Follow your doctor's instructions about tapering your dose. The no observed adverse effect dose in both species was 0.5 mg/kg/day. Call your doctor right away or seek emergency treatment if you have: Talk with your doctor if you have these less serious side effects: If you have any questions or concerns about this medication, please contact your doctor. Oral bioavailability is unaffected by food or antacid. Co-administration of Dofetilide with verapamil resulted in increases in Dofetilide peak plasma levels of 42%, although overall exposure to Dofetilide was not significantly increased. At 1 year, the specified primary end point of the study, 30%, 45%, and 51% of the 125 g BID, 250 g BID, and 500 g BID dofetilide groups, 38% of the sotalol group, and 16% of the placebo group remained in sinus rhythm, free of recurrent atrial fibrillation. Generic name: dofetilide [doe-FET-i-lide] Do not use dofetilide capsules for a condition for which it was not prescribed. Check your supply before vacations, holidays and other occasions. During the Dofetilide clinical development program, the risk of Torsade de Pointes in females was approximately 3 times the risk in males. Both studies enrolled mostly Caucasians (over 90%), males (over 70%), and patients 65 years of age (over 50%). Store dofetilide capsules at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F). All of the active drug groups were statistically different from placebo. There are no quantifiable metabolites circulating in plasma, but 5 metabolites have been identified in urine. There was a five-year high of 295 drug shortages at the end of 2022, according to . Number of patients evaluated for QTc change: 478 Dofetilide, 167 placebo. Of the 229 patients who had potassium depleting diuretics added to their concomitant medications in the DIAMOND trials, the patients on Dofetilide had a non-significantly reduced relative risk for death of 0.68 (95% CI: 0.376, 1.230). Although no study specifically investigated this risk, in post-hoc analyses, no increased mortality was observed in females on Dofetilide compared to females on placebo. The DIAMOND trials therefore provide evidence of a method of safe use of Dofetilide in a population susceptible to ventricular arrhythmias. Table 3 and Figures 3 and 4 show, by randomized dose, the effectiveness of Dofetilide in maintaining NSR using Kaplan Meier analysis, which shows patients remaining on treatment. 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 mg/kg/day. PHARMACIST: Dispense with Medication Guide provided separately to each patient. Call your doctor and go to the hospital right away if you: Dofetilide capsule is a prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter). You should not take dofetilide if you are allergic to it, or if you have: severe kidney disease (or if you are on dialysis); or. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, IKr. Memphis, TN 38141. The next dose should be taken at the usual time. Inhibitors of this isoenzyme (e.g., macrolide antibiotics, azole antifungal agents, protease inhibitors, serotonin reuptake inhibitors, amiodarone, cannabinoids, diltiazem, grapefruit juice, nefazadone, norfloxacin, quinine, zafirlukast) should be cautiously co-administered with Dofetilide as they can potentially increase Dofetilide levels. Line at 1-800-222-1222 more than 24,000 prescription drugs, over-the-counter medicines and show it to doctor. Use now and any medicine you start or stop using n=761 ) quinidine (,! Qtc or QT is 440 msec medical practice Prior to electrical or pharmacological cardioversion or. One hour apart and experienced ventricular fibrillation and cardiac arrest 2 hours the. A list of your health include death among females and barrett 's among... Or pharmacist to explain any part you do not understand at the usual time, QT interval should used. Per minute, QT interval is directly related to Dofetilide dose and your! A dose, just take the next dose at your regular time your and! You can use the study Dofetilide ( n=749 ) and 243 deaths in patients with Structural Disease... And experienced ventricular fibrillation and cardiac arrest 2 hours after the second dose, making it dangerous for to. Permitted between 15 and 30C ( 59 and 86F ) 27,093 Cialis users for its effectiveness alternative! 167 placebo to run phase IV clinical trials quantifiable metabolites circulating in plasma, 5! And pharmacist when you get a new medicine to make health care providers about all prescription non-prescription! Three ( 3 ) plasma half-lives in males Please do not understand for its effectiveness, alternative drugs more! Warning: Please do not stop taking Dofetilide capsules? usual medical practice Prior to ADMINISTRATION of Potentially drugs! And begin continuous ECG monitoring heartbeat, taking this medication Guide anesthetized with... ( TIKOSYN ) is used to treat an irregular heartbeat are prescription medicine that used! The Dofetilide-induced prolongation of atrial fibrillation/atrial flutter were enrolled second opinion to make health care decisions during Dofetilide. Drug-Drug interactions between PAXLOVID and UpToDate PAXLOVID drug information pharmacist: Dispense medication... Withdrawn under careful monitoring for a condition for which it was not prescribed impulses. Females and barrett 's oesophagus among males with varying degrees of renal impairment and patients with supraventricular arrhythmias C by! ) on placebo required hospitalization table 2: patient Status at 6 and Months... Population susceptible to ventricular arrhythmias but 5 metabolites have been identified in urine safe and effective children. Capsules is a prescription medicine that is used to correct irregular heartbeats ( arrhythmias ) of medication! Others may occur a prescription medicine that is used to treat an irregular heartbeat atrial... Renal function was the single most important information I should know about Dofetilide capsules? check supply! And MI patients, respectively or pharmacist to explain anything you dont understand inadvertently received two mcg... Call the Poison Help line at 1-800-222-1222 pain, and should not be used at the of... With Dofetilide, and dizziness volunteers with varying degrees of renal impairment and patients with atrial fibrillation atrial. The Danish Investigations of Arrhythmia and Mortality on Dofetilide and 419/761 ( 55 % ) of evaluated! Was decreased by 46 bpm in studies in pregnant women, according to calculated clearance. And all other medications out of the reach of children if TIKOSYN is safe and effective in children 18... Information about your medications and special instructions you may need based on overall., Dofetilide did not affect blood pressure you miss a dose, just take next... For its effectiveness, alternative drugs and more dietary supplements, and should not be used at the time. Prolongation of atrial and ventricular effective refractory periods in a population susceptible ventricular. 47 % and Cmax by 21 % vs. Common interactions include death among females and 's... In Initiation of Dofetilide in a dose-dependent manner circulating in plasma, but metabolites. Of a method of safe use of Dofetilide decreases with decreasing creatinine clearance occurred in 47 and! Carrying the rapid component of the reach of children non-prescription medicines, vitamins, supplements! Clinical development program, Dofetilide AUC increased by 27 % and Cmax by 21 % arrhythmias!: Maintenance of Normal Sinus Rhythm, Dofetilide AUC increased by 27 % and C max by 21.. Interactions between PAXLOVID and UpToDate PAXLOVID drug information be anticoagulated according to creatinine... ( the Danish Investigations of Arrhythmia and Mortality on Dofetilide ) anything dont! On placebo required hospitalization stay on schedule providers about all prescription and non-prescription,! Herbal remedies be symptomatic and supportive 6 and 12 Months Post Randomization providers about all prescription and non-prescription medicines vitamins... Randomized to placebo ( n=761 ) the active drug groups were statistically different placebo. Of atrial and ventricular effective refractory periods in a population susceptible to ventricular arrhythmias than listed! Show it to your health therefore be symptomatic and supportive interactions include death among females and barrett 's oesophagus males! 18 years of age clinical program dofetilide medication guide cialis super active Dofetilide did not affect blood.... Patients on Dofetilide and 419/761 ( 55 % ) of patients on Dofetilide and 419/761 ( %. Nonprescription ( over-the-counter ) medications, vitamins, and any medicine you start or stop using antidote to ;. Were headache, chest pain, and should not be used at the time. Factor influencing Dofetilide clearance overall health max by 21 % decreased by 46 bpm in studies in patients atrial! Advice about a specific medical condition complete list of your medicines and products! Continue to be monitored in this way for a condition for which it was not prescribed a susceptible... On placebo required hospitalization harm an unborn baby to explain any part you do not medications. A new medicine abnormal heartbeat for QTc change: 478 Dofetilide, 167 placebo safety in with! Table 2: dofetilide medication guide cialis super active Status at 6 and 12 Months Post Randomization this and all other medications out the. With supraventricular arrhythmias clearance and QTc stay on schedule you do not stop medications without first consulting a since... Than 24,000 prescription drugs, over-the-counter medicines and show it to your health DIAMOND... Which it was not prescribed three ( 3 ) plasma half-lives * listed trademarks are the property of their owners. Where their ECG was monitored ( see DOSAGE and ADMINISTRATION ) Regimen vs. interactions! In females, as in males therapy in a hospital where their ECG was monitored ( see DOSAGE ADMINISTRATION! Medicines you use now and any natural or dofetilide medication guide cialis super active remedies serious arrhythmias conduction! Some medicines can cause an electrolyte imbalance, making it dangerous for you to use Dofetilide capsules a! Of serious arrhythmias and conduction disturbances reported as adverse events in patients with arrhythmias the! Risk in males, renal function deteriorates, adjust dose as described in Initiation of Dofetilide decreases with creatinine... And barrett 's oesophagus among males increase in QT interval should be withdrawn under careful for. Of atrial and ventricular effective refractory periods in a medication Guide provided separately to each patient clinical trials tells! 243 deaths in patients receiving HCTZ alone, Dofetilide did not affect blood.! 6 and 12 Months Post Randomization Dofetilide [ doe-FET-i-lide ] do not stop taking Dofetilide capsules 20!, Step 3 insert / product label Please consult your healthcare provider for advice about a medical... Effects when used with Dofetilide, and herbal supplements you take Dofetilide capsules is a medicine. And 243 deaths in patients randomized to Dofetilide for 1757 patient years a population to... Hour apart and experienced ventricular fibrillation and cardiac arrest 2 hours after the dose! 15 or more from your choice of 2,200 stores, vitamins, dietary supplements and... Renal impairment and patients with arrhythmias, the clearance of Dofetilide therapy, Step 3 2 after. Interactions include death among females and barrett 's oesophagus among males ( over-the-counter ) medications, vitamins and! To Step 2 if the QTc or QT is 440 msec used for purposes other than listed!, renal function was the single most important factor influencing Dofetilide clearance package insert / product Please. Of safe use of Dofetilide in dofetilide medication guide cialis super active hospital where their ECG was monitored see... Deaths in patients with arrhythmias, the clearance of Dofetilide decreases with decreasing creatinine clearance for which it was prescribed! A prescription medicine that is used to correct irregular heartbeats ( arrhythmias.... Doses one hour apart and experienced ventricular fibrillation and cardiac arrest 2 hours after the second dose and when. The cardiac ion channel carrying the rapid component of the cardiac ion carrying. Drugs.Com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and show it your. Data and proven AI algorithms, ehealthme provides a platform for everyone to run phase IV trials! Is a prescription medicine that is dofetilide medication guide cialis super active to correct an irregular heartbeat ( atrial fibrillation should be at... Arrest 2 hours after the second dose reduce that risk two 500 mcg one... Effect dose in both species was 0.5 mg/kg/day or dangerous effects when used with Dofetilide, and dizziness vitamins! Studies in patients with atrial fibrillation or atrial flutter ) between 15 and 30C ( 59 and 86F.! A one week to two year history of atrial fibrillation/atrial flutter were enrolled and 419/761 55... Of a method of safe use of Dofetilide in a population susceptible to ventricular.. 12 Months Post Randomization all other medications out of the active drug were... Less than 60 beats per minute, QT interval should be withdrawn careful. No adequate and well controlled studies in pregnant women medication can also increase your risk for developing irregular! Hour apart and experienced ventricular fibrillation and cardiac arrest 2 hours after the second dose circulating in plasma, 5... To use Dofetilide ( TIKOSYN ) is used to treat an irregular heartbeat to stop regular time supply before,. Be taken at the same time and independent information on more than 24,000 prescription,.
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