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TIKOSYN
CHF and arrhythmias
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Drug Name:

TIKOSYN Rx

Generic Name and Formulations:
Dofetilide 125mcg, 250mcg, 500mcg; caps.

Company:
Pfizer Inc.

e-Prescribe this drug via Surescripts


Therapeutic Use:

Indications for TIKOSYN:

Maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter of >1 week duration who were converted to normal sinus rhythm (use only for highly symptomatic patients). Conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.

Adult Dose for TIKOSYN:

≥18yrs: see literature. Initiate only in appropriate clinical setting.

Children's Dose for TIKOSYN:

<18yrs: not recommended.

Pharmacological Class:

Class III antiarrhythmic.

Rems:

YES

Contraindications:

Long QT syndromes. Baseline QT interval or QTc >440msec (500msec in ventricular conduction abnormalities). Severe renal impairment (CrCl <20mL/min). Concomitant hydrochlorothiazide, cimetidine, verapamil, itraconazole, ketoconazole, inhibitors of renal cationic secretion (eg, trimethoprim), prochlorperazine, megestrol.

Warnings/Precautions:

Monitor QTc, renal function (do baseline CrCl) at least every 3 months, and all concomitant drugs (including OTC drugs, herbs, supplements). Paroxysmal atrial fibrillation. Heart rate <50beats/minute. Sick sinus syndrome. 2nd or 3rd degree heart block, unless paced. Renal or severe hepatic impairment. Maintain normal potassium, magnesium levels. Conditions affecting electrolyte levels. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. Stop dofetilide for at least 2 days before starting an interacting drug. Drugs that prolong QT interval (eg, phenothiazines, cisapride, bepridil, tricyclic antidepressants, some macrolides and fluoroquinolones): not recommended. Caution with drugs that undergo renal cationic secretion (eg, triamterene, metformin, amiloride) and with CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, SSRIs, amiodarone, cannabinoids, diltiazem, grapefruit juice, nefazodone, norfloxacin, quinine, zafirlukast); these may increase dofetilide levels. Allow at least 3 half-lives to elapse and monitor when withdrawing Class I or III antiarrhythmics before giving 1st dose of dofetilide (see literature); reduce serum amiodarone levels to <0.3mg/L or withdraw at least 3 months before starting dofetilide. Potassium-depleting diuretics, digoxin may increase risk of torsade de pointes.

Adverse Reactions:

Headache, chest pain, dizziness, respiratory tract infection, dyspnea, GI upset, flu syndrome, insomnia, back pain, rash, torsade de pointes (esp. in females), serious ventricular arrhythmias, sudden death, conduction disturbances.

Note:

This product is being made available only to those hospitals and prescribers who have received appropriate education from the manufacturer.

How Supplied:

Caps—14, 60

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