DOFETILIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

MSN LABORATORIES PRIVATE LIMITED

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 is contraind

Produkto santrauka:

Dofetilide 125 mcg (0.125 mg) capsules are supplied as Size “4” hard gelatin capsules with white opaque body imprinted with “1” with black color band and light orange opaque cap imprinted with “MD” in black ink are available in: Dofetilide 250 mcg (0.25 mg) capsules are supplied as Size “4” hard gelatin capsules with peach opaque body imprinted with “2” with black color band and peach opaque cap imprinted with “MD” in black ink are available in: Dofetilide 500 mcg (0.5 mg) capsules are supplied as Size “2” hard gelatin capsules with white opaque body imprinted with “3” with black color band and peach opaque cap imprinted with “MD” in black ink are available in: Store at 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight (USP), child-resistant containers. Rx only Manufactured by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: MSN Pharmaceuticals Inc. Piscataway, NJ 08854-3714 Issued on:                                February 2020

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

DOFETILIDE - DOFETILIDE CAPSULE
MSN LABORATORIES PRIVATE LIMITED
----------
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 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 (

Prekės savybės

DOFETILIDE - DOFETILIDE CAPSULE
MSN LABORATORIES PRIVATE LIMITED
----------
DOFETILIDE CAPSULES
BOXED WARNING
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 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 in 1.0 N
sodium hydroxide, acetone, 0.1N
hydrochloric acid, very slightly soluble in isopropyl alcohol and
insoluble in water.
Dofetilide capsules contain the following inactive ingredients:
magnesium stearate, pregelatinized
starch, silicified microcrystalline cellulose.The capsule shell
contains titanium dioxide, FD&C yellow
6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow
10 and FD&C red 40. The
printing ink contains shellac, iron oxide black, propylene glycol and
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 ACTIONDofetilide 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
19
27
3
5
2
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