DOFETILIDE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Aurobindo Pharma Limited

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 contraindicated in patients with congenital or acquired long QT syndromes. Dofetilide capsules should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities). Dofetilide capsules are also contraindicated in patients with severe renal impairment (calculated creatinine clearance <20 mL/min). The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with dofetilide capsules are  contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions ), as each of these drugs cause a substantial increase in dofetilide plasma concentrations. In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on dofetilide capsules. The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with dofetilide capsules are contraindicated (see PRECAUTIONS, Drug-Drug Interactions ) because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation. Dofetilide capsules are also contraindicated in patients with a known hypersensitivity to the drug.

Огляд продуктів:

Dofetilide Capsules 125 mcg (0.125 mg) are light orange colored cap and white colored body, size “4” hard gelatin capsule filled with white to off-white powder and printed with “DOF” on cap and “125” on body, and are available in:             Bottles of 60                           NDC 59651-118-60             Bottles of 500                         NDC 59651-118-05 Dofetilide Capsules 250 mcg (0.25 mg) are peach colored cap and peach colored body, size “4” hard gelatin capsule filled with white to off-white powder and printed with “DOF” on cap and “250” on body, and are available in:             Bottles of 60                           NDC 59651-119-60             Bottles of 500                         NDC 59651-119-05 Dofetilide Capsules 500 mcg (0.5 mg)  are peach colored cap and white colored body, size “2” hard gelatin capsule filled with white to off-white powder and printed with “DOF” on cap and “500” on body, and are available in:              Bottles of 60                           NDC 59651-120-60             Bottles of 500                         NDC 59651-120-05 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP). Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

DOFETILIDE - DOFETILIDE CAPSULE
Aurobindo Pharma Limited
----------
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 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 E

Характеристики продукта

DOFETILIDE - DOFETILIDE CAPSULE
AUROBINDO PHARMA LIMITED
----------
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 is 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 to
sparingly soluble in acetone
and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium
hydroxide, practically
insoluble in isopropyl alcohol and water.
Dofetilide capsules contain the following inactive ingredients: corn
starch, magnesium
stearate and silicified microcrystalline cellulose. The empty hard
gelatin capsule shell
contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules
are imprinted with
black edible ink containing 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 block of the other repolarizing
potas