Propafenone hydrochloride is the generic equivalent of the brand-name drug Propafenone Hydrochloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Propafenone hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Propafenone hydrochloride extended-release capsules 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 hydrochloride extended-release 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 hydrochloride extended-release capsules to control ventricular rate during AF. • Some patients with atrial flutter treated with propafenone have developed 1:1 conduc…
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse events with propafenone (greater than 5% and greater than placebo) excluding those not reasonably associated with the use of the drug included the following: dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.…
Drug Interactions
7 DRUG INTERACTIONS • Inhibitors of CYP2D6, 1A2, and 3A4 may increase propafenone levels which may lead to cardiac arrhythmias. Simultaneous use with both a CYP3A4 and CYP2D6 inhibitor (or in patients with CYP2D6 deficiency) should be avoided. ( 7.1 ) • Propafenone may increase digoxin or warfarin levels. ( 7.2 , 7.3 ) • Orlistat may reduce propafenone concentrations. Abrupt cessation of orlistat in patients stable on propafenone hydrochloride extended-release capsules has resulted in convulsion…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Propafenone hydrochloride extended-release capsules can be taken with or without food. Do not crush or further divide the contents of the capsule. The dose of propafenone hydrochloride extended-release capsules must be individually titrated on the basis of response and tolerance. Initiate therapy with propafenone hydrochloride extended-release 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.…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). • Instruct patients to notify their healthcare providers of any change in over-the-counter, prescription, and supplement use. • Instruct patients to report symptoms that may be associated with altered electrolyte balance, such as excessive or prolonged diarrhea, sweating, vomiting, or loss of appetite or thirst. • Instruct patients not to double the next dose if a dose is missed. The next dose should be taken at the usual time. Manufactured for: Northstar Rx LLC Memphis, TN 381…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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