DOFETILIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

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 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 is contraindicated in patients with congenital or acquired long QT syndromes. Dofetilide should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities). Dofetilide is 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 is 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. The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with dofetilide is contraindicated (see PRECAUTIONS, Drug-Drug Interactions ) because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation. Dofetilide is also contraindicated in patients with a known hypersensitivity to the drug.

Product summary:

Dofetilide Capsules, 125 mcg (0.125 mg) are supplied as No. 4 capsules with an opaque orange cap and opaque orange body, printed with “∑ 44” on both cap and body, and are available in bottles of 60 capsules (NDC 42291-411-60). Dofetilide Capsules, 250 mcg (0.25 mg) are supplied as No. 4 capsules, opaque peach cap and opaque white body, printed with “∑ 45” on both cap and body, and are available in bottles of 60 capsules (NDC 42291-412-60). Dofetilide Capsules, 500 mcg (0.5 mg) are supplied as No. 2 capsules, opaque peach cap and opaque peach body, printed with “∑ 46” on both cap and body, and are available in bottles of 60 capsules (NDC 42291-413-60). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in a tight container as defined in the USP, with a child resistant closure. Rx only Manufactured by: Sigmapharm Laboratories, LLC Bensalem, PA 19020 Manufactured for: AvKARE Pulaski, TN 38478 OS046A-00 REV.0121

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOFETILIDE- DOFETILIDE CAPSULE
AvKARE
----------
MEDICATION GUIDE
DOFETILIDE (doe-FEH-till-ide) 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 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 ESIDRIX, EZIDE,
HYDRO

Summary of Product characteristics

DOFETILIDE- DOFETILIDE CAPSULE
AVKARE
----------
DOFETILIDE CAPSULES
RX ONLY
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 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-
19
27
3
5
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,
pregelatinized starch, silicon dioxide, magnesium stearate, anhydrous
citric acid and
copovidone. Dofetilide Capsules are supplied for oral administration
in three dosage
strengths: 125 mcg (0.125 mg) opaque orange capsules, 250 mcg (0.25
mg) opaque
peach and white capsules, and 500 mcg (0.5 mg) opaque peach capsules.
The capsule
shell contains FD&C Red# 40, D&C Yellow# 10, titanium dioxide, sodium
lauryl sulfate,
gelatin and edible imprinting ink. The 0.125 mg strength capsule shell
also contains D&C
Red# 28. The ingredients in the imprinting ink include ammonia, black
iron oxide, butyl
alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide,
propylene glycol
and shellac.
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,