Drug Catalog - Product Detail
PROPAFENONE HCL ER CP 225MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0113-09 | PAR PHARMACEUTICAL | 90 | 225MG | CAPSULE |
PACKAGE FILES
Generic Name
PROPAFENONE HYDROCHLORIDE
Substance Name
PROPAFENONE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078540
Description
11 DESCRIPTION Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended-release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C 21 H 27 NO 3 •HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below: 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 ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Propafenone Hydrochloride Extended Release Capsules, USP, 225 mg are available as hard gelatin capsules containing 225 mg of propafenone HCl. The capsule is a white opaque cap printed “par/209” in black ink and white opaque body printed “par/209” in black ink. NDC 49884-113-02 Bottles of 60 capsules NDC 49884-113-09 Bottles of 90 capsules NDC 49884-113-01 Bottles of 100 capsules NDC 49884-113-05 Bottles of 500 capsules NDC 49884-113-10 Bottles of 1000 capsules Propafenone Hydrochloride Extended Release Capsules, USP, 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 49884-210-09 Bottles of 90 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 Propafenone Hydrochloride Extended Release Capsules, USP, 425 mg are available as hard gelatin capsules containing 425 mg of propafenone HCl. The capsule is a red opaque cap printed “par/211” in black ink and white opaque body printed “par/211” in black ink. NDC 49884-211-02 Bottles of 60 capsules NDC 49884-211-09 Bottles of 90 capsules NDC 49884-211-01 Bottles of 100 capsules NDC 49884-211-05 Bottles of 500 capsules NDC 49884-211-10 Bottles of 1000 capsules Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Indications & Usage
1 INDICATIONS AND USAGE Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended. The effect of propafenone on mortality has not been determined [see BOXED WARNING ]. Propafenone HCl Extended Release Capsules, USP is an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. ( 1 ) Usage Considerations: • Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. ( 1 ) • In patients with atrial fibrillation and atrial flutter, use propafenone ER capsules with drugs that increase the atrioventricular nodal refractory period. ( 1 ) • The effect of propafenone on mortality has not been determined. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Propafenone HCl Extended Release Capsules, USP can be taken with or without food. Do not crush or further divide the contents of the capsule. The dose of propafenone ER capsules must be individually titrated on the basis of response and tolerance. Initiate therapy with propafenone ER capsules 225 mg given every 12 hours. Dosage may be increased at a minimum of 5-day intervals to 325 mg given every 12 hours. If additional therapeutic effect is needed, the dose of propafenone ER capsules may be increased to 425 mg given every 12 hours. In patients with hepatic impairment or those with significant widening of the QRS complex or second- or third-degree AV block, consider reducing the dose. The combination of cytochrome P450 3A4 (CYP3A4) inhibition and either cytochrome P450 2D6 (CYP2D6) deficiency or CYP2D6 inhibition with the simultaneous administration of propafenone may significantly increase the concentration of propafenone and thereby increase the risk of proarrhythmia and other adverse events. Therefore, avoid simultaneous use of propafenone ER capsules with both a CYP2D6 inhibitor and a CYP3A4 inhibitor. [SEE WARNINGS AND PRECAUTIONS ( 5.4 ), DRUG INTERACTIONS ( 7.1 )]. • Initiate therapy with 225 mg given every 12 hours. ( 2 ) • Dosage may be increased at a minimum of 5-day intervals to 325 mg every 12 hours and, if necessary, to 425 mg every 12 hours. ( 2 ) • Consider reducing the dose in patients with hepatic impairment, significant widening of the QRS complex, or second- or third-degree AV block. ( 2 )