beginning [20:<60 beats/minute) must be determined prior to first dose. If QTc> 440 msec (>500 msec in patients with ventricular conduction abnormalities), dofetilide is contraindicated. Adjust initial dosage in patients with estimated CrCl <60 mL/minute (see dosage adjustment in renal impairment). Dofetilide may be initiated at lower doses than recommended based on physician discretion; however, if the lower dose is increased, the patient will require rehospitalization for 3 days. Atrial fibrillation/atrial flutter: Oral: Initial: 500 mcg twice daily (maximum dose: 500 mcg twice daily) Supraventricular tachycardia (ongoing management) (off-label use): Oral: Initial: 500 mcg every 12 hours (ACC/AHA/HRS [Page 2015]) Modification of dosage in response to initial dose: QTc interval should be measured 2 to 3 hours after the initial dose. If the QTc increases to more than 15% above baseline QTc or if the QTc is> 500 msec (>550 msec in patients with ventricular conduction abnormalities), dofetilide dose should be reduced by 50%. If the starting dose was 500 mcg twice daily, then reduce to 250 mcg twice daily. If the starting dose was 250 mcg twice daily, then reduce to 125 mcg twice daily. If the starting dose was 125 mcg twice daily, then reduce to 125 mcg once daily. QTc interval should be measured 2 to 3 hours after each subsequent dose (in-hospital doses 2 through 5). If at any time after the second dose the QTc is >500 msec (>550 msec in patients with ventricular conduction abnormalities), dofetilide should be discontinued. Maintenance therapy: No further down titration of dose based on QTc is recommended following modification of initial dose. Renal function and QTc should be re-evaluated every 3 months or as medically warranted. If QTc >500 msec (>550 msec in patients with ventricular conduction abnormalities), discontinue therapy. If renal function deteriorates, adjust dose as described in dosage adjustment in renal impairment. Dosing: Geriatric Refer to adult dosing. No specific dosage adjustments are recommended based on age; however, careful assessment of renal function is particularly important in this population. Dosing: Renal Impairment Note: Using the Modification of Diet in Renal Disease (MDRD) equation and subsequent eGFR to determine dose may lead to overestimation of CrCl and overdose of medication; use only the Cockcroft-Gault equation to estimate CrCl (Denetclaw 2011). Use actual body weight when using the Cockcroft-Gault equation to calculate CrCl (weight range of patients enrolled in clinical trials: 40 to 134 kg). CrCl >60 mL/minute: Initial: No dosage adjustment necessary. CrCl 40 to 60 mL/minute: Initial: 250 mcg twice daily. CrCl 20 to 39 mL/minute: Initial: 125 mcg twice daily. CrCl <20 mL/minute: Use is contraindicated. Dosing: Hepatic Impairment Mild or moderate hepatic impairment (Child-Pugh class A or B): No dosage adjustment necessary. Severe hepatic impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer s labeling (has not been studied); use with caution. Administration Oral: Administer with or without food. Storage Store at 15 C to 30 C (59 F to 86 F). Protect from moisture and humidity. Drug Interactions Amifampridine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination AMILoride: May increase the serum concentration of Dofetilide. Monitor therapy Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Dofetilide. Exceptions: Fluconazole; Isavuconazonium Sulfate. Avoid combination Bilastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Buprenorphine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Cimetidine: May increase the serum concentration of Dofetilide. This is likely via inhibition of dofetilide renal tubular secretion (primarily) and inhibition of dofetilide metabolism. Avoid combination Cobicistat: May increase the serum concentration of Dofetilide. Monitor therapy CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Dofetilide. Monitor therapy CYP3A4 Inhibitors (Strong): May increase the serum concentration of Dofetilide. Monitor therapy CYP3A4 Inhibitors (Weak): May increase the serum concentration of Dofetilide. Monitor therapy Dolutegravir: May increase the serum concentration of Dofetilide. Avoid combination Fingolimod: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Avoid combination Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination LamoTRIgine: May increase the serum concentration of Dofetilide. Avoid combination Lidocaine (Topical): May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Antiarrhythmic Agents (Class III) may increase the serum concentration of Lidocaine (Topical). This mechanism specifically applies to amiodarone and dronedarone. Monitor therapy Loop Diuretics: May enhance the QTc-prolonging effect of Dofetilide. Monitor therapy Megestrol: May increase the serum concentration of Dofetilide. Avoid combination MetFORMIN: May increase the serum concentration of Dofetilide. Monitor therapy MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Mizolastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Prochlorperazine: May increase the serum concentration of Dofetilide. Avoid combination Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Propafenone: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Management: Concurrent use of propafenone with quinidine, amiodarone, or other class IA or class III antiarrhythmics should be avoided. Treatment with such agents should be withheld for at least 5 half-lives prior to initiation of propafenone. Avoid combination QTc-Prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Highest Risk). Avoid combination QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Saquinavir: May enhance the arrhythmogenic effect of Dofetilide. Saquinavir may increase the serum concentration of Dofetilide. Avoid combination Teneligliptin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Thiazide and Thiazide-Like Diuretics: May enhance the QTc-prolonging effect of Dofetilide. Thiazide and Thiazide-Like Diuretics may increase the serum concentration of Dofetilide. Avoid combination Triamterene: May increase the serum concentration of Dofetilide. Monitor therapy Trimethoprim: May increase the serum concentration of Dofetilide. Avoid combination Verapamil: May increase the serum concentration of Dofetilide. Avoid combination Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Adverse Reactions> 10%: Cardiovascular: Torsades de pointes (patients receiving doses in excess of those recommended: 11%; cardiac failure patients: 3%; patients with recent myocardial infarction: <1%; occurs most frequently within the first 3 days of therapy) Central nervous system: Headache (11%) 1% to 10%: Cardiovascular: Chest pain (10%), ventricular fibrillation ( 5%), ventricular tachycardia (3% to 4%), bradycardia ( 2%), cardiac arrest ( 2%), cerebral ischemia ( 2%), cerebrovascular accident ( 2%), edema ( 2%), myocardial infarction ( 2%), syncope ( 2%), atrioventricular block (> <2%), heart block (1%) Central nervous system: Dizziness (8%), insomnia (4%), facial paralysis ( 2%), flaccid paralysis ( 2%), migraine ( 2%), paralysis ( 2%), paresthesia ( 2%) Dermatologic: Skin rash (3%) Gastrointestinal: Nausea (5%), abdominal pain (3%), diarrhea (3%) Hepatic: Hepatotoxicity ( 2%), hepatic injury (> <2%) Hypersensitivity: Angioedema ( 2%) Neuromuscular & skeletal: Back pain (3%) Respiratory: Respiratory tract infection (7%), dyspnea (6%), flu-like symptoms (4%), increased cough ( 2%), cough (> <2%) Miscellaneous: Accidental injury (3%), surgery (3%)> <1% (Limited to important or life-threatening): Bundle branch block ALERT: U.S. Boxed Warning Arrhythmias: To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide 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. Warnings/Precautions Concerns related to adverse effects: Proarrhythmic effects: May cause serious ventricular arrhythmias, primarily torsades de pointes (TdP). Watch for proarrhythmic effects; monitor and adjust dose to prevent QTc prolongation; reduced CrCl or certain dofetilide drug interactions will increase dofetilide plasma concentration. Risk of TdP significantly increases with doses greater than the maximum dose of 500 mcg twice daily. The risk of TdP may be higher in certain patient subgroups (eg, patients with heart failure). Most episodes of TdP occur within the first 3 days of therapy. Disease-related concerns: Arrhythmias: Appropriate use: Reserve for patients who are highly symptomatic with atrial fibrillation/atrial flutter. [US Boxed Warning]: Must be initiated (or reinitiated) in a setting that can provide continuous monitoring of CrCl and ECG monitoring and cardiac resuscitation with staff familiar with the recognition and treatment of life-threatening arrhythmias for a minimum of 3 days, or for a minimum of 12 hours after electrical or pharmacological cardioversion to normal sinus rhythm, whichever is greater. Patients should be readmitted for continuous monitoring if dosage is later increased. Conduction disturbances: Use with caution in patients with second or third-degree heart block and/or sick sinus syndrome unless a functional pacemaker is in place; these patients were not included in phase 3 clinical trials. However, no effect on AV nodal conduction seen in patients with normal conduction and those with first-degree heart block. Defibrillation threshold is reduced in patients with ventricular tachycardia or ventricular fibrillation undergoing implantation of a cardioverter-defibrillator device. Electrolyte imbalance: Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy. Hepatic impairment: Use with caution in patients with severe hepatic impairment (has not been studied). Renal impairment: Use with caution in patients with renal impairment; systemic clearance of dofetilide is decreased and plasma concentration increased with decreasing CrCl. Dose adjustment is required for patients with CrCl 60 mL/minute. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Monitoring Parameters ECG monitoring with attention to QT (if heart rate> <60 beats per minute) or QTc and occurrence of ventricular arrhythmias, baseline serum creatinine and changes in serum creatinine. Upon initiation (or reinitiation) continuous ECG monitoring recommended for a minimum of 3 days, or for at least 12 hours after electrical or pharmacological conversion to normal sinus rhythm, whichever is greater. Monitor serum potassium and magnesium levels at baseline and throughout therapy. QT or QTc must be monitored at baseline prior to the first dose and 2 to 3 hours afterwards. If at baseline, QTc> 440 msec (>500 msec in patients with ventricular conduction abnormalities), use is contraindicated. If dofetilide initiated, QTc interval must be determined 2 to 3 hours after each subsequent dose of dofetilide for in-hospital doses 2 to 5. Thereafter, QT or QTc and CrCl should be evaluated every 3 months. If at any time during therapy after the second dose the measured QTc is >500 msec (>550 msec in patients with ventricular conduction abnormalities), dofetilide should be discontinued. Consult individual institutional policies and procedures. Pregnancy Risk Factor C Pregnancy Considerations Adverse events have been observed in animal reproduction studies. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, common cold symptoms, or nausea. Have patient report immediately to prescriber angina, dizziness, passing out, bradycardia, tachycardia, abnormal heartbeat, or shortness of breath (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about dofetilide Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 41 Reviews Add your own review/rating Drug class: group III antiarrhythmics Consumer resources Dofetilide Dofetilide (Advanced Reading) Professional resources Dofetilide (AHFS Monograph) Dofetilide (FDA) Other brands: Tikosyn Related treatment guides Arrhythmia ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Dofetilide Rating 41 User Reviews 7.9 /10 41 User Reviews 7.9 Rate it! Manufacturer Greenstone LLC Drug Class Group III antiarrhythmics Related Drugs group III antiarrhythmics amiodarone , sotalol , Multaq , Tikosyn , Pacerone , dronedarone Arrhythmia propranolol , amiodarone , verapamil , lidocaine , Inderal , Tikosyn , Pacerone , mexiletine , Calan , Cordarone , quinidine , Calan SR , Mexitil , procainamide , Verelan , disopyramide , Norpace , Nexterone , Isoptin SR , Cordarone IV , Ethmozine , Norpace CR , More... Dofetilide Images Dofetilide systemic 125 mcg (ML 125) View all images} } courteously
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