DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VGYAAN 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 Capsules are contraind

Product summary:

Dofetilide Capsules 125 mcg (0.125 mg) have a light orange opaque cap imprinted with "VP" in black ink and white opaque body imprinted with "125" in black ink. They are available as follows: NDC 72664- 229 -60 in bottles of 60 capsules. Dofetilide Capsules 250 mcg (0.25 mg) have a peach opaque cap imprinted with "VP" in black ink and peach opaque body imprinted with "250" in black ink. They are available as follows: NDC 72664- 230 -60 in bottles of 60 capsules. Dofetilide Capsules 500 mcg (0.5 mg) have a peach opaque cap imprinted with "VP" in black ink and white opaque body imprinted with "500" in black ink. They are available as follows: NDC 72664- 231 -60 in bottles of 60 capsules. Store at 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP). Distributed by: VGYAAN Pharmaceuticals LLC Skillman, NJ 08558 Rev.: 11/2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VGYAAN 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 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, HYDRO-

Summary of Product characteristics

DOFETILIDE- DOFETILIDE CAPSULE
VGYAAN PHARMACEUTICALS LLC
----------
DOFETILIDE CAPSULES
RX ONLY
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 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 soluble in 0.1
N sodium hydroxide,
acetone, and 0.1 N hydrochloric acid, very slightly soluble in water
and in isopropyl
alcohol.
Dofetilide Capsules contain the following inactive ingredients:
microcrystalline cellulose,
pregelatinized starch, colloidal silicon dioxide, magnesium stearate.
Additionally, the
empty hard gelatin capsule shell contains: FD&C Yellow No. 6, titanium
dioxide, gelatin
and water. Each capsule is imprinted with black pharmaceutical ink
which contains black
iron oxide, potassium hydroxide, propylene glycol, shellac and strong
ammonia solution.
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
19
27
3
5
2
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 bloc