DOFETILIDE capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Greenstone LLC

INN (International Name):

DOFETILIDE

구성:

DOFETILIDE 0.125 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 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 patients wi

제품 요약:

Dofetilide Capsules 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with a light orange cap and white body, printed with TKN 125 PFIZER, and are available in: Dofetilide Capsules 250 mcg (0.25 mg) capsules are supplied as No. 4 capsules, peach cap and body, printed with TKN 250 PFIZER, and are available in: Dofetilide Capsules 500 mcg (0.5 mg) capsules are supplied as No. 2 capsules, peach cap and white body, printed with TKN 500 PFIZER, and are available in: Store at controlled room temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP).

승인 상태:

New Drug Application

환자 정보 전단

DOFETILIDE- DOFETILIDE CAPSULE
Greenstone LLC
----------
MEDICATION GUIDE
Dofetilide Capsules
Read the Medication Guide before you start taking dofetilide 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?
Dofetilide 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 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 that your doctor
prescribed for you.
While you take dofetilide, 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?
Dofetilide is a prescription medicine that is used to treat an
irregular heartbeat (atrial fibrillation or atrial
flutter).
It is not known if dofetilide is safe and effective in children under
18 years of age.
Who should not take dofetilide?
Do not take dofetilide 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-PAR, MICROZIDE, or ORETIC)*
Ask your doctor if you are not sure if any of your medicines are the

제품 특성 요약

DOFETILIDE- DOFETILIDE CAPSULE
GREENSTONE LLC
----------
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. 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.
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
, I
). At clinically relevant
concentrations, dofetilide has no effect on sodium channels
(associated with Class I effect), adrenergic
alpha-receptors, or adrenergic beta-receptors.
ELECTROPHYS IOLOGY
Dofetilide increases the monophasic action potential duration in a
predictabl