DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dofetilide (UNII: R4Z9X1N2ND) (Dofetilide - UNII:R4Z9X1N2ND)

Available from:

Major Pharmaceuticals

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 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 ). 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 patients with congenital or acquired long QT syndromes. Dofetilide capsules should not be used in pa

Product summary:

Dofetilide capsules, 125 mcg (0.125 mg) are supplied as No. 4 capsules with a dark caramel cap and white body, imprinted with ML 125 in black ink, and are available in: Cartons of 40 capsules (10 capsules each blister pack x 4), NDC 0904-6681-08 Dofetilide capsules, 250 mcg (0.25 mg) are supplied as No. 4 capsules with a light orange cap and light orange body, imprinted with ML 250 in black ink, and are available in: Cartons of 40 capsules (10 capsules each blister pack x 4), NDC 0904-6682-08 Dofetilide capsules, 500 mcg (0.5 mg) are supplied as No. 2 capsules with a light orange cap and white body, imprinted with ML 500 in black ink, and are available in: Cartons of 40 capsules (10 capsules each blister pack x 4), NDC 0904-6683-08 Body 125 250 500 Cap ML ML ML Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM MOISTURE AND HUMIDITY. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOFETILIDE- DOFETILIDE CAPSULE
Major Pharmaceuticals
----------
MEDICATION GUIDE
Dofetilide Capsules
(doe-FEH-till-ide)
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 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)1
•
verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN,
VERELAN PM, TARKA)1
•
ketoconazole (NIZORAL, XOLEGEL, EXTINA)1
•
trimethoprim alone (PROLOPRIM, TRIMPEX)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 ESIDR

Summary of Product characteristics

DOFETILIDE- DOFETILIDE CAPSULE
MAJOR PHARMACEUTICALS
----------
DOFETILIDE CAPSULES
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 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:
microcrystalline cellulose, corn starch,
colloidal silicon dioxide and magnesium stearate. The capsule shells
contain gelatin, titanium dioxide,
red iron oxide, yellow iron oxide, and black ink. The imprint ink
contains iron oxide black, shellac,
ethanol, n-butyl alcohol, isopropyl alcohol, propylene glycol, and
ammonium hydroxide. Dofetilide
capsules are supplied for oral administration in three dosage
strengths: 125 mcg (0.125 mg) dark
caramel and white capsules, 250 mcg (0.25 mg) light orange capsules,
and 500 mcg (0.5 mg) light
orange 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