DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are 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 dofetilide 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 ). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. Dofetilide capsules are contraindicated in pat

Product summary:

Dofetilide capsules125 mcg (0.125 mg) are supplied as hard gelatin capsule, size "4", light orange colored cap and white colored body, imprinted with '598' on cap and body in black ink, and are available in: Dofetilide capsules250 mcg (0.25 mg) are supplied as hard gelatin capsule, size "4", peach colored cap and body, imprinted with '505' on cap and body in black ink, and are available in: Dofetilide capsules500 mcg (0.5 mg) are supplied as hard gelatin capsule, size "2", peach colored cap and white colored body, imprinted with '504' on cap and body in black ink, and are available in: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP). Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
----------
SPL MEDGUIDE
Dofetilide(doe-FET-i-lide) Capsules
Read the Medication Guide before you start taking dofetilide capsules
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 dofetilide
capsules?
Dofetilide capsules 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 dofetilide capsules, treatment with
dofetilide capsules 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 dofetilide
capsules that your doctor
prescribed for you.
While you take dofetilide capsules, 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 dofetilide capsule?
Dofetilide capsule is a prescription medicine that is used to treat an
irregular heartbeat (atrial fibrillation
or atrial flutter).
It is not known if dofetilide capsules are safe and effective in
children under 18 years of age.
Who should not take dofetilide capsules?
Do not take dofetilide capsules 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)*
•
verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN,
VERELAN PM, TARKA)*
•
ketoconazole (NIZORAL, XOLEGEL, EXTINA)*
•
trimethoprim alone (PROLOPRIM, TRIMPEX)* or the combination of
trimethoprim and
sulfamethoxazole (BACTRIM, SEPTRA SULFATRIM)*
•
prochlorperazine (COMPAZINE, COMPO)*
•
megestrol (MEGACE)*
•
dolutegravir (TIVICAY)*
•
hydrochlorothiazide alone or in combination with other medicines (such
as ESIDRIX,
EZIDE, HYDRODIURIL, HYD

Summary of Product characteristics

DOFETILIDE- DOFETILIDE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
DOFETILIDE CAPSULES
BOXED WARNING
To minimize the risk of induced arrhythmia, patients initiated or
re-initiated on
dofetilide capsules 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
Dofetilide is an antiarrhythmic drug with Class III (cardiac action
potential duration
prolonging) properties. Its molecular 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, USP 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.
Dofetilide capsules contain the following inactive ingredients:
silicified microcrystalline
cellulose, corn starch and magnesium stearate. The components of the
hard gelatin
capsule shell include gelatin, FD&C Yellow 6 and titanium dioxide.
Black imprinting ink
contains shellac, dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol,
strong ammonia solution, black iron oxide, potassium hydroxide and
purified water.
Dofetilide capsule is supplied for oral administration in three dosage
strengths: 125 mcg
(0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach
capsules, and
500 mcg (0.5 mg) peach and white capsules.
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CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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 bl