PROPAFENONE- propafenone hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPAFENONE (UNII: 68IQX3T69U) (PROPAFENONE - UNII:68IQX3T69U)

Available from:

Rebel Distributors Corp

INN (International Name):

PROPAFENONE

Composition:

PROPAFENONE 325 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propafenone Extended Release Capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease. The use of propafenone ER capsules in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. Propafenone ER capsules should not be used to control ventricular rate during atrial fibrillation. The effect of propafenone ER capsules on mortality has not been determined (see black box WARNINGS ). Propafenone ER capsules are contraindicated in the presence of congestive heart failure, cardiogenic shock, sinoatrial, atrioventricular and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, atrioventricular block) in the absence of an artificial pacemaker, bradycardia, marked hypotension, bronchospastic disorders, electrolyte imbalance, or hypersensitivity to the drug.

Product summary:

Propafenone Extended Release Capsules, 325 mg are available as hard gelatin capsules containing 325 mg of propafenone HCl. The capsule is an orange opaque cap printed “par/210” in black ink and white opaque body printed “par/210” in black ink. NDC 49884-210-02 Bottles of 60 capsules NDC 49884-210-01 Bottles of 100 capsules NDC 49884-210-05 Bottles of 500 capsules NDC 49884-210-10 Bottles of 1000 capsules Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 I03/10 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPAFENONE- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
REBEL DISTRIBUTORS CORP
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PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES
DESCRIPTION
Propafenone hydrochloride is an antiarrhythmic drug supplied in
extended-release capsules of 225 mg,
325 mg and 425 mg for oral administration.
The structural formula of propafenone HCl is given below:
Propafenone HCl has some structural similarities to beta-blocking
agents. Propafenone HCl occurs as
colorless crystals or white crystalline powder with a very bitter
taste. It is slightly soluble in water
(20ºC), chloroform and ethanol. Propafenone extended release are
capsules filled with granules
containing the following inactive ingredients: ethylcellulose, lactose
anhydrous, magnesium stearate and
povidone. The capsules consist of D&C Red #28, FD&C Blue #1, FD&C Red
#40, FD&C Yellow #5,
FD&C Yellow #6, gelatin and titanium dioxide. In addition the ink
consists of D&C Yellow #10
aluminum lake, iron oxide black, n-butyl alcohol, propylene glycol,
FD&C Blue #2 aluminum lake,
FD&C Red #40 aluminum lake, FD&C Blue #1 aluminum lake and shellac
glaze~45% (20% esterfied)
in ethanol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Propafenone is a Class 1C antiarrhythmic drug with local anesthetic
effects, and a direct stabilizing
action on myocardial membranes. The electrophysiological effect of
propafenone manifests itself in a
reduction of upstroke velocity (Phase 0) of the monophasic action
potential. In Purkinje fibers, and to a
lesser extent myocardial fibers, propafenone reduces the fast inward
current carried by sodium ions.
Diastolic excitability threshold is increased and effective refractory
period prolonged. Propafenone
reduces spontaneous automaticity and depresses triggered activity.
Studies in anesthetized dogs and isolated organ preparations show that
propafenone has beta-
sympatholytic activity at about 1/50 the potency of propranolol.
Clinical studies employing
isoproterenol challenge and exercise testing after single doses of
propafenone indicat