DOFETILIDE 0.125MG capsule DOFETILIDE 0.25MG capsule DOFETILIDE 0.5MG capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Granules Pharmaceuticals Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsule is 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 doefetilide capsule 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 capsule is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsule has not been shown to be effective in patients with paroxysmal atrial fibrillation. Dofetilide is contraindicated i

Product samenvatting:

Dofetilide capsules are supplied as:  125 mcg (0.125 mg): Hard gelatin capsule, orange opaque cap printed with "G125" and white opaque body printed with "024" contains white to off-white powder. Bottles of 60 Capsules   NDC 70010-024-06 250 mcg (0.25 mg):   Hard gelatin capsule, peach opaque cap printed with "G250" and peach opaque body printed with "025" contains white to off-white powder. Bottles of 60 Capsules     NDC 70010-025-06 500 mcg (0.5 mg): Hard gelatin capsule, peach opaque cap printed with "G500" and white opaque body printed with "026" contains white to off-white powder.   Bottles of 60 Capsules    NDC 70010-026-06 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in a tight child-resistant container as defined in the USP. Rx only Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Rev. 09/2019

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

DOFETILIDE 0.25MG- DOFETILIDE 0.25MG CAPSULE
DOFETILIDE 0.5MG- DOFETILIDE 0.5MG CAPSULE
Granules Pharmaceuticals Inc.
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SPL MEDGUIDE
MEDICATION GUIDE
Dofetilide (Do-fee-ti-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 is 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 is 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)*
•
hydro

Productkenmerken

DOFETILIDE 0.125MG- DOFETILIDE 0.125MG CAPSULE
DOFETILIDE 0.25MG- DOFETILIDE 0.25MG CAPSULE
DOFETILIDE 0.5MG- DOFETILIDE 0.5MG CAPSULE
GRANULES PHARMACEUTICALS INC.
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DOFETILIDE CAPSULES 0.125MG,0.25MG,0.5MG
RX ONLY
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:
colloidal silicon dioxide, corn
starch, gelatin, magnesium stearate, microcrystalline cellulose and
titanium dioxide. The
125 mcg capsules contain FD & C Yellow # 6 and D & C yellow # 10. The
250 mcg and
500 mcg capsules contain FD & C Yellow # 6 and FD& C Red # 40.
Dofetilide is supplied
for oral administration in three dosage strengths: 125 mcg (0.125 mg)
orange and white
capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach
and white
capsules. In addition, capsule printing ink contains ammonium
hydroxide, black iron
oxide, propylene glycol, and shellac glaze.
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