TIKOSYN- dofetilide capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Pfizer Laboratories Div Pfizer Inc

INN (International Adı):

DOFETILIDE

Kompozisyon:

DOFETILIDE 0.125 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

TIKOSYN® 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with a light orange cap and white body, printed with TKN 125 PFIZER, and are available in: 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: TIKOSYN® 500 mcg (0.5 mg) capsules are supplied as No. 2 capsules, peach cap and white body, printed with TKN 500 PFIZER, and are available in: Obverse TKN 125 TKN 250 TKN 500 Reverse PFIZER PFIZER PFIZER Bottle of 14 0069-5800-61 0069-5810-61 0069-5820-61 Bottle of 60 0069-5800-60 0069-5810-60 0069-5820-60 Unit dose / 40 0069-5800-43 0069-5810-43 0069-5820-43 Store at controlled room temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP).

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

TIKOSYN- DOFETILIDE CAPSULE
Pfizer Laboratories Div Pfizer Inc
----------
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
ki

Ürün özellikleri

TIKOSYN- DOFETILIDE CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
----------
TIKOSYN
(DOFETILIDE)
CAPSULES
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
Dofetilide shows Vaughan Williams Class III antiarrhythmic activity.
The mechanism of
®
®
19
27
3
5 2
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.
ELECTROPHYSIOLOGY
Dofetilide increases the monophasic action potenti