DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Accord Healthcare, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ). Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules has not been shown to be effective in patients with paroxysmal atrial fibrillation. Dofetilide is contraindicated in patients with congenital or acquired long QT syndromes. Dofetilide should not be used in p

Product summary:

Dofetilide capsules, USP 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with a light orange cap and white body, printed with "HCl" in black ink on capsule body and are available in: Dofetilide capsules, USP 250 mcg (0.25 mg) capsules are supplied as No. 4 capsules, peach cap and body, printed with "HC2" in black ink on capsule body and are available in: Dofetilide capsules, USP 500 mcg (0.5 mg) capsules are supplied as No. 2 capsules, peach cap and white body, printed with "HC3" in black ink on capsule body and are available in: Store at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight (USP), child-resistant containers. Rx only Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: Intas Pharmaceuticals Limited, Plot No 5 to 14, Pharmez, Sarkhej-Bavla, National Highway No 8-A, Near Village Matoda, Tal Sanand, Ahmedabad - 382 213, Gujarat, India 51 3377 1 729475 Issued February 2022

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Accord Healthcare, Inc.
---------- 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 is dofetilide capsules?
Dofetilide capsules are 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) 1
•
verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN,
VERELAN PM, TARKA) 1
•
ketoconazole (NIZORAL, XOLEGEL, EXTINA) 1
•
trimethoprim alone (PROLOPRIM, TRIMP EX) 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, HYDRODIU

Summary of Product characteristics

DOFETILIDE- DOFETILIDE CAPSULE
ACCORD HEALTHCARE, INC.
----------
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 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:
CAPSULE FILL: colloidal anhydrous silica, magnesium stearate, maize
starch,
microcrystalline cellulose
CAPSULE SHELL: gelatin, titanium dioxide, and FD&C Yellow 6
IMPRINTING INK: iron oxide black, shellac, potassium hydroxide
Dofetilide capsules are 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.
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.g., I
, I
). At clinically relevant concentrations, dofetilide has no
effect on sodium channels (associated with Class I effect), adrenergic
a