Propafenone Hydrochloride Sr
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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Propafenone Hydrochloride Extended-Release (SR) 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:
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- The use of Propafenone Hydrochloride Extended-Release (SR) 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 (SR) Capsules to control ventricular rate during AF.
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- 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.
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- The effect of propafenone on mortality has not been determined [see Boxed Warning].
History
There is currently no drug history available for this drug.
Other Information
Propafenone Hydrochloride Extended-Release (SR) Capsules are an antiarrhythmic drug supplied in extended-release capsules of 225, 325 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 C21H27NO3•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 (20°C), chloroform and ethanol. Propafenone Hydrochloride Extended-Release (SR) Capsules are filled with cylindrical-shaped 2 x 2 mm microtablets containing propafenone and the following inactive ingredients: antifoam, gelatin, hypromellose, magnesium stearate, red iron oxide, shellac, sodium dodecyl sulfate, sodium lauryl sulfate, soy lecithin, and titanium dioxide.
Sources
Propafenone Hydrochloride Sr Manufacturers
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Prasco Laboratories
![Propafenone Hydrochloride Sr (Propafenone Hydrochloride) Capsule, Extended Release [Prasco Laboratories]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Propafenone Hydrochloride Sr | Prasco Laboratories
Propafenone Hydrochloride Extended-Release (SR) 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 (SR) Capsules must be individually titrated on the basis of response and tolerance. Initiate therapy with Propafenone Hydrochloride Extended-Release (SR) 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 Hydrochloride Extended-Release (SR) 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 CYP3A4 inhibition and either 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 Hydrochloride Extended-Release (SR) Capsules with both a CYP2D6 inhibitor and a CYP3A4 inhibitor [see Warnings and Precautions (5.4), Drug Interactions (7.1)].
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