Propafenone Hydrochloride 325 mg/1
Propafenone Hydrochloride · CAPSULE, EXTENDED RELEASE · Upsher-Smith Laboratories, LLC
Propafenone Hydrochloride is a capsule, extended release containing propafenone hydrochloride at 325 mg/1, taken oral. Manufactured by Upsher-Smith Laboratories, LLC.
Key Facts
- Brand Name
- Propafenone Hydrochloride
- Generic Name
- Propafenone Hydrochloride
- NDC Code (Product)
0832-0741- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 325 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212744
- Marketing Start
- 06/25/2020
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Mckesson Packaging Services
Failed moisture limits: Out of specification for moisture content.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Propafenone hydrochloride tablets are indicated to: prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: The use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use propafenone hydrochloride tablets 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 use of propafenone hydrochloride tablets in patients with chronic atrial fibr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The dose of propafenone hydrochloride tablets must be individually titrated on the basis of response and tolerance. Initiate therapy with propafenone hydrochloride tablets 150 mg given every 8 hours (450 mg per day). Dosage may be increased at a minimum of 3- to 4- day intervals to 225 mg every 8 hours (675 mg per day). If additional therapeutic effect is needed, the dose of propafenone hydrochloride tablets may be increased to 300 mg every 8 hours (900 mg per day). The usefulness and safety of dosages exceeding 900 mg per day have not been established. 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. As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of propafenone hydrochloride tablets should be increased more gradually during the initial phase of treatment. 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 increa…
Contraindications
4 CONTRAINDICATIONS Propafenone hydrochloride tablets are contraindicated in the following circumstances: Heart failure Cardiogenic shock Sinoatrial, atrioventricular, and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, AV block) in the absence of an artificial pacemaker Known Brugada Syndrome Bradycardia Marked hypotension Bronchospastic disorders or severe obstructive pulmonary disease Marked electrolyte imbalance Heart failure (4) Cardiogenic shock (4) Sinoatrial, atrioventricular, and intraventricular disorders of impulse generation or conduction in the absence of pacemaker (4) Known Brugada Syndrome (4) Bradycardia (4) Marked hypotension (4) Bronchospastic disorders and severe obstructive pulmonary disease (4) Marked electrolyte imbalance (4)
Drug Interactions
7 DRUG INTERACTIONS Inhibitors of CYP2D6, 1A2, and 3A4 increase propafenone exposure. (7.1) Propafenone may increase digoxin or warfarin levels. (7.2 , 7.3) Orlistat may reduce propafenone exposure. Taper orlistat withdrawal. (7.4) Lidocaine may increase central nervous system side effects. (7.6) 7.1 CYP2D6 and CYP3A4 Inhibitors Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause increased plasma levels of propafenone. The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with administration of propafenone may increase the risk of adverse reactions, including proarrhythmia. Therefore, simultaneous use of propafenone hydrochloride with both a CYP2D6 inhibitor and a CYP3A4 inhibitor should be avoided [see Warnings and Precautions (5.4) , Dosage and Administration (2) ]. Amiodarone Concomitant administration of propafenone and amiodarone can affect conduction and repolarization and is not recommended. Cimetidine Concomitant administration of propafenone immediate-release tablets and cimetidine in 12 healthy su…
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse events with propafenone (greater than 5%) included: unusual taste, nausea and/or vomiting, dizziness, constipation, headache, fatigue, first-degree AV block, and intraventricular conduction delay. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with propafenone hydrochloride occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of subjects treated with propafenone hydrochloride have discontinued treatment because of adverse reactions. Adverse reactions reported for greater than 1.5% of 474 subjects with SVT who received propafenone hydrochloride in U.S. clinical trials are presented in Table 1 by incidence and percent discontinuation, reported to the nearest perc…
Frequently Asked Questions
What is Propafenone Hydrochloride used for?
Propafenone Hydrochloride contains Propafenone Hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is Propafenone Hydrochloride a controlled substance?
Propafenone Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Propafenone Hydrochloride?
The generic name for Propafenone Hydrochloride is Propafenone Hydrochloride. There are 3 other brand versions of Propafenone Hydrochloride.
What is the NDC code for Propafenone Hydrochloride 325 mg/1?
The NDC (National Drug Code) for Propafenone Hydrochloride 325 mg/1 is 0832-0741, listed by Upsher-Smith Laboratories, LLC.
Other Propafenone Hydrochloride Dosages
- Propafenone Hydrochloride225 mg/162559-231
- Propafenone Hydrochloride425 mg/170771-1527
- Propafenone Hydrochloride425 mg/10832-0742
- Propafenone Hydrochloride150 mg/151407-015
- Propafenone Hydrochloride225 mg/151407-016
- Propafenone Hydrochloride300 mg/163629-1989
- Propafenone Hydrochloride150 mg/163629-2105
- Propafenone Hydrochloride325 mg/168382-523
- Propafenone Hydrochloride425 mg/168382-524
Other Propafenone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)