DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novadoz Pharmaceuticals LLC

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 capsules 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 is contraind

Product summary:

Dofetilide 125 mcg (0.125 mg) capsules are supplied as Size “4” hard gelatin capsules with white opaque body imprinted with “1” with black color band and light orange opaque cap imprinted with “MD” in black ink are available in: Dofetilide 250 mcg (0.25 mg) capsules are supplied as Size “4” hard gelatin capsules with peach opaque body imprinted with “2” with black color band and peach opaque cap imprinted with “MD” in black ink are available in: Dofetilide 500 mcg (0.5 mg) capsules are supplied as Size “2” hard gelatin capsules with white opaque body imprinted with “3” with black color band and peach opaque cap imprinted with “MD” in black ink are available in: Store at 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight (USP), child-resistant containers. Rx only Manufactured by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: Novadoz Pharmaceuticals LLC Piscataway, NJ 08854-3714 Issued on:                                February 2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOFETILIDE - DOFETILIDE CAPSULE
Novadoz Pharmaceuticals LLC
----------
MEDICATION GUIDE
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 are dofetilide capsules?
Dofetilide capsules are 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

Summary of Product characteristics

DOFETILIDE - DOFETILIDE CAPSULE
NOVADOZ PHARMACEUTICALS LLC
----------
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 capsules are 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 soluble in 1.0 N
sodium hydroxide,
acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl
alcohol and insoluble in
water.
Dofetilide capsules contain the following inactive ingredients:
magnesium stearate,
pregelatinized starch, silicified microcrystalline cellulose.The
capsule shell contains
titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg
capsule shell contains
D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron
oxide black,
propylene glycol and potassium hydroxide. Dofetilide capsules are
supplied for oral
19
27
3
5 2
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.
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 block of the other repolarizing
potassium currents (e.