Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
PROPAFENONE (UNII: 68IQX3T69U) (PROPAFENONE - UNII:68IQX3T69U)
Rebel Distributors Corp
PROPAFENONE
PROPAFENONE 325 mg
ORAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
PROPAFENONE- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE REBEL DISTRIBUTORS CORP ---------- 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 read_full_document