TIKOSYN- dofetilide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND)

Available from:

Avera McKennan Hospital

INN (International Name):

DOFETILIDE

Composition:

DOFETILIDE 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TIKOSYN is 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. Because TIKOSYN can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES ). TIKOSYN is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. TIKOSYN has not been shown to be effective in patients with paroxysmal atrial fibrillation. TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes. TIKOSYN should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients wi

Product summary:

TIKOSYN 250 mcg (0.25 mg) capsules are supplied as No. 4 capsules, peach cap and body, printed with TKN 250 PFIZER, and are available in: NDC 69189-5810-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store at controlled room temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP).

Authorization status:

New Drug Application

Patient Information leaflet

Avera McKennan Hospital
----------
MEDICATION GUIDE
TIKOSYN® (Tee' ko sin)
(dofetilide) Capsules
Read the Medication Guide before you start taking TIKOSYN and each
time you get a refill. This
information does not take the place of talking with your doctor about
your condition or treatment.
What is the most important information I should know about TIKOSYN?
TIKOSYN can cause serious side effects, including a type of abnormal
heartbeat called Torsade de
Pointes, which can lead to death.
To establish the right dose of TIKOSYN, treatment with TIKOSYN must be
started in a hospital where
your heart rate and kidney function will be checked for the first 3
days of treatment. It is important that
when you go home, you take the exact dose of TIKOSYN that your doctor
prescribed for you.
While you take TIKOSYN, always watch for signs of abnormal heartbeat.
Call your doctor and go to the hospital right away if you:
•
feel faint
•
become dizzy, or
•
have a fast heartbeat
What is TIKOSYN?
TIKOSYN is a prescription medicine that is used to treat an irregular
heartbeat (atrial fibrillation or atrial
flutter).
It is not known if TIKOSYN is safe and effective in children under 18
years of age.
Who should not take TIKOSYN?
Do not take TIKOSYN if you:
•
have an irregular heartbeat called long QT syndrome
•
have kidney problems or are on kidney dialysis
•
take any of these medicines:
•
cimetidine (TAGAMET, TAGAMET HB)1
•
verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN,
VERELAN PM, TARKA)1
•
ketoconazole (NIZORAL, XOLEGEL, EXTINA)1
•
trimethoprim alone (PROLOPRIM, TRIMPEX)1 or the combination of
trimethoprim and
sulfamethoxazole (BACTRIM, SEPTRA SULFATRIM)1
•
prochlorperazine (COMPAZINE, COMPO)1
•
megestrol (MEGACE)1
•
dolutegravir (TIVICAY)1
•
hydrochlorothiazide alone or in combination with other medicines (such
as ESIDRIX,
EZIDE, HYDRODIURIL, HYDRO-PAR, MICROZIDE, or ORETIC)1
Ask your doctor if you are not sure if any of your medicines are the
kind listed above.
•
are allergic to do

Summary of Product characteristics

TIKOSYN- DOFETILIDE CAPSULE
AVERA MCKENNAN HOSPITAL
----------
TIKOSYN
(DOFETILIDE)
CAPS ULES
To minimize the risk of induced arrhythmia, patients initiated or
re-initiated on TIKOSYN 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. For detailed
instructions regarding dose selection, see DOSAGE AND ADMINISTRATION.
DESCRIPTION
TIKOSYN (dofetilide) is an antiarrhythmic drug with Class III (cardiac
action potential duration
prolonging) properties. Its empirical formula is C
H N O S and it has a molecular weight of 441.6.
The structural formula is
The chemical name for dofetilide is:
_N_-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide.
Dofetilide is a white to off-white powder. It is very slightly soluble
in water and propan-2-ol and is
soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M
hydrochloric acid.
TIKOSYN capsules contain the following inactive ingredients:
microcrystalline cellulose, corn starch,
colloidal silicon dioxide and magnesium stearate. TIKOSYN is supplied
for oral administration in three
dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250
mcg (0.25 mg) peach capsules,
and 500 mcg (0.5 mg) peach and white capsules.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
TIKOSYN (dofetilide) shows Vaughan Williams Class III antiarrhythmic
activity. The mechanism of
action is blockade of the cardiac ion channel carrying the rapid
component of the delayed rectifier
potassium current, I
. At concentrations covering several orders of magnitude, dofetilide
blocks only
I
with no relevant block of the other repolarizing potassium currents
(e.g., I
, I
). At clinically
relevant concentrations, dofetilide has no effect on sodium channels
(associated with Class I effect),
adrenergic alpha-receptors, or adrenergic beta-receptors.
ELECTROPHYS IOLOGY
TIKOSYN (dofetilide) increases the monophasic action potential
durati