DOFETILIDE PACKAGE INSERT PDF

Dofetilide (Tikosyn) Considerations for Use*. US/FDA Special Notes. The patient must be registered to receive this drug; the hospital and pharmacy must. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Tikosyn (Dofetilide). (dofetilide) product monograph and refers you to more detailed information in read the patient package insert and reread it each time therapy is renewed in.

Author: Milkree Baramar
Country: Uzbekistan
Language: English (Spanish)
Genre: Career
Published (Last): 6 November 2012
Pages: 35
PDF File Size: 19.34 Mb
ePub File Size: 10.71 Mb
ISBN: 516-6-22131-190-5
Downloads: 1449
Price: Free* [*Free Regsitration Required]
Uploader: Nikonos

Major Pckage may induce hypokalemia, increasing the dofetiliide for proarrhythmic effects e. According to the manufacturer, Class I disopyramide, encainide, flecainide, lidocaine, mexiletine, moricizine, procainamide, propafenone, quinidine, and tocainide and Class III e.

In addition to potential pharmacokinetic interactions, erythromycin may cause QT prolongation and exhibit additive electrophysiologic effects with Class III antiarrhythmics. Because of the potential for TdP, use of dofetilide with methadone is contraindicated.

Because of the potential for TdP, use of hydroxychloroquine with dofetilide is contraindicated. This results in a possible increase in plasma concentrations of either drug. Your email has been sent. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.

Dofetilide Capsules

Major Use caution if dofetilide and aprepitant, fosaprepitant are used concurrently and monitor for an increase in dofetilide-related adverse effects, including QT prolongation and torsade de pointes TdPfor several days after administration of a multi-day aprepitant regimen. Dofetilide is metabolized to a small degree by CYP3A4. Careful patient monitoring and dose adjustment of dofetilide is recommended.

However, as a single mg intravenous dose, fosaprepitant only weakly inhibits CYP3A4 for a duration of 2 days; there is no evidence of CYP3A4 induction. Minor Coadministration of dofetilide with inducers of CYP3A4, such as nevirapine, may increase the metabolism of dofetilide. There was no increase in heart failure in patients with significant left dofetilife dysfunction.

Cases of QT prolongation and TdP have been reported during postmarketing use of fluvoxamine. The concomitant use of dronedarone with other drugs that prolong the QTc may induce TdP and is contraindicated.

Severe Use of dofetilide during and for 2 weeks after discontinuation of itraconazole treatment is contraindicated due to the potential elevated dofetilide concentrations and QT prolongation. Serious cardiovascular events including EKG changes i. Posaconazole is a potent inhibitor of CYP3A4, an pckage responsible for a portion of the metabolism of dofetilide.

  IEEE 16326 PDF

Additionally, posaconazole has been associated with prolongation of the QT interval as well as rare cases of torsade de pointes; packagw use with other drugs that may prolong the QT interval and are metabolized through CYP3A4, such as dofetilide.

insegt Severe Because of the potential ;ackage TdP, use of packzge with dofetilide is contraindicated. Erythromycin administration is associated with QT prolongation and TdP. Severe Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval in rare instances.

The risk of TdP can be reduced by avoiding excessive plasma dofetilide concentrations through adjustment of the initial dofetilide dose according to creatinine clearance, avoidance of potential drug interactions, and by ECG monitoring of the QT interval. Prolongation of the QT interval has also been reported with lenvatinib therapy. In the absence of electrolyte imbalances, these agents can be used together safely.

Since bradycardia is a risk factor for development of TdP, the potential occurrence inseft bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval.

Severe Because of the potential for torsade de pointes TdP sofetilide, use of gemifloxacin with dofetilide is contraindicated. Co-administration with nicardipine dofetilidee lead to an increase in serum levels of drugs that are CYP3A4 substrates including doeftilide. Dofetilide dofefilide classified by the FDA as a pregnancy risk category C drug. Because of the potential for TdP, use of the following drugs with dofetilide is contraindicated Zafirlukast: Dofetilide plasma concentrations are linearly related to drug dosage.

Coadministration of conivaptan with dofetilide should be undertaken with extreme caution. This interaction is proposed to occur primarily by inhibition of cationic renal tubular secretion of dofetilide by ketoconazole, however, inhibition of CYP 3A4 metabolism may also contribute. Dofetilide is associated with a well-established risk of QT prolongation and TdP.

Although there are no studies examining the effects of ranolazine in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation.

  CONCORDIA DISCORDANTIUM CANONUM PDF

Therefore, dofetilide should only be administered to pregnant women when the benefits to the mother justifies the potential fetal risks. Amlodipine is a weak CYP3A4 inhibitor. Grapefruit juice inhibits the cytochrome P 3A4 isozyme in the gut wall.

Administration of dofetilide requires a specialized care setting; treatment with dofetilide may be started only in patients placed for a minimum of 3 insegt in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic ECG monitoring, and cardiac resuscitation.

Renal elimination involves both glomerular filtration as well as active tubular secretion via the cation transport system, a process that can be inhibited by cimetidine and ketoconazole. Moderate Theoretically, bosentan can induce the hepatic metabolism of dofetilide via CYP3A4 isoenzymes. Severe Eribulin has been associated with QT prolongation.

Dofetilide is eliminated by cationic renal secretion, and tafenoquine may interfere with the renal elimination of dofetilide. Palbociclib is a weak time-dependent CYP3A4 inhibitor. Severe Hypokalemia or hypomagnesemia may occur with administration of potassium-depleting drugs such as loop diuretics and thiazide diuretics, increasing the potential for dofetilide-induced torsade de pointes.

Increases in QTc interval have been observed in healthy volunteers treated with sparfloxacin, and torsade de pointes has been reported in patients receiving sparfloxacin with disopyramide and amiodarone. Competition for renal elimination may increase plasma concentrations of dofetilide and increase the risk of pro-arrhythmias. To minimize the risk of proarrhythmias, patients initiated or re-initiated on dofetilide should be placed for pxckage or more days in a monitored facility with the capacity to monitor continuous ECG and CrCl and perform cardiac resuscitation.

Tikosyn (dofetilide) dose, indications, adverse effects, interactions from

insfrt Elderly patients have the greatest possibility of ingesting grapefruit and interacting medications and are the most vulnerable to the adverse clinical consequences. If renal function deteriorates, adjust the dose as described in the dosage guidelines for patients with renal impairment. Dronedarone administration is associated with a dose-related increase in the QTc interval.