DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus 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 contraindicated in pati

Product summary:

Dofetilide capsules 125 mcg (0.125 mg) are supplied as No. 4 capsules with a white opaque body and turquoise opaque cap, printed with ING 230 in black ink on the body and cap and are available in: Dofetilide capsules 250 mcg (0.25 mg) are supplied as No. 4 capsules, white opaque body and cap, printed with ING 231 in black ink on the body and cap and are available in: Dofetilide capsules 500 mcg (0.5 mg) are supplied as No. 2 capsules, white opaque body and cap, printed with ING 232 in black ink on the body and cap and are available in: Store at controlled room temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP). Rx only Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Made in Spain Revised: November 2019

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ingenus Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Dofetilide Capsules
(doe fet' i lide)
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)*
•
prochlorpe razine (COMPAZINE, COMPO)*
•
megestrol (MEGACE)*
•
dolutegravir (TIVICAY)*
•
hydrochlorothiazide alone or in combination with other medicines (such
as ESIDRIX, EZIDE,
HYDRODIURIL, H

Summary of Product characteristics

DOFETILIDE- DOFETILIDE CAPSULE
INGENUS PHARMACEUTICALS, LLC
----------
DOFETILIDE CAPSULES
To minimize the risk of induced arrhythmia, patients initiated or
re-initiated on
dofetilide 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 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, USP is a white to almost 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:
microcrystalline cellulose,
pregelatinized starch, colloidal silicon dioxide and magnesium
stearate, gelatin, titanium
dioxide and FD&C green 3 (0.125 mg), gelatin and titanium dioxide
(0.25 mg and 0.5
mg). The black imprint ink contains shellac, black iron oxide,
propylene glycol, strong
ammonia solution and potassium hydroxide. Dofetilide is supplied for
oral administration
in three dosage strengths: 125 mcg (0.125 mg) white opaque and
turquoise capsules,
250 mcg (0.25 mg) white opaque capsules, and 500 mcg (0.5 mg) white
opaque
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