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Uses
Propafenone Hydrochloride Tablets USP 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 USP 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 USP 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 USP in patients with chronic atrial fibrillation has not been evaluated. • Because of the proarrhythmic effects of Propafenone Hydrochloride Tablets USP, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks. • 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 Tablets USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150 mg, 225 mg and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents.
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. The structural formula of propafenone hydrochloride is given below:
Propafenone hydrochloride occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: corn starch, croscarmellose sodium, hypromellose, maltodextrin, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide colloidal, titanium dioxide, and triacetin.
Sources
Propafenone Hydrochloride Manufacturers
- Ani Pharmaceuticals, Inc.
Propafenone Hydrochloride | Ani Pharmaceuticals, Inc.
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 eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day). If additional therapeutic effect is needed, the dose of Propafenone Hydrochloride Tablets may be increased to 300 mg every 8 hours (900 mg/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 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 Tablets with both a CYP2D6 inhibitor and a CYP3A4 inhibitor [see Warnings and Precautions (5.4) and Drug Interactions (7.1)].
- American Health Packaging
- Mutual Pharmaceutical Co., Inc.
Propafenone Hydrochloride | Tagi Pharma, Inc.
Selection of patients for treatment with codeine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
2.1 Individualization of DosageAs with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of codeine sulfate, attention should be given to the following:
• the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent codeine sulfate dose needed; • the patient's degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient's pain; • risk factors for abuse or addiction, including a prior history of abuse and addiction.The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving codeine sulfate is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. During chronic therapy, especially for noncancer-related pain, the continued need for the use of opioid analgesics should be re-assessed as appropriate.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the physician, other members of the healthcare team, the patient, and the caregiver/family.
2.2 Initiation of TherapyThe usual adult dosage is 15 mg to 60 mg (2.5 mL to 10 mL) repeated up to every four hours as needed for pain. The maximum 24 hour dose is 360 mg.
Titrate the dose based upon the individual patient's response to their initial dose of codeine. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the codeine by the patient.
It should be kept in mind, however, that tolerance to codeine sulfate can develop with continued use and that the incidence of untoward effects is dose-related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain and are associated with an appreciably increased incidence of undesirable side effects.
2.3 Cessation of TherapyWhen the patient no longer requires therapy with codeine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.
- Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Propafenone Hydrochloride | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
The dose of propafenone HCl must be individually titrated on the basis of response and tolerance. It is recommended that therapy be initiated with 150 mg propafenone given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and, if necessary, to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established. In those patients in whom significant widening of the QRS complex or second or third degree AV block occurs, dose reduction should be considered.
As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of propafenone HCl should be increased more gradually during the initial phase of treatment.
- Udl Laboratories, Inc.
- Par Pharmaceutical, Inc.
Propafenone Hydrochloride | Pharmacia And Upjohn Company
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Serious infections – 150 to 300 mg every 6 hours. More severe infections – 300 to 450 mg every 6 hours. Pediatric Patients: Serious infections – 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections – 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.
To avoid the possibility of esophageal irritation, CLEOCIN HCl Capsules should be taken with a full glass of water.
Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN HCl Capsules.
In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
- Qualitest Pharmaceuticals
Propafenone Hydrochloride | Qualitest Pharmaceuticals
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 eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day). If additional therapeutic effect is needed, the dose of propafenone hydrochloride tablets may be increased to 300 mg every 8 hours (900 mg/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 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 tablets with both a CYP2D6 inhibitor and a CYP3A4 inhibitor [see Warnings and Precautions (5.4) and Drug Interactions (7.1)].
- Physicians Total Care, Inc.
Propafenone Hydrochloride | Physicians Total Care, Inc.
The dose of propafenone HCl must be individually titrated on the basis of response and tolerance. It is recommended that therapy be initiated with 150 mg propafenone given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and, if necessary, to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established. In those patients in whom significant widening of the QRS complex or second or third degree AV block occurs, dose reduction should be considered.
As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of propafenone HCl should be increased more gradually during the initial phase of treatment.
- Cardinal Health
Propafenone Hydrochloride | Cardinal Health
The dose of propafenone HCl must be individually titrated on the basis of response and tolerance. It is recommended that therapy be initiated with 150 mg propafenone given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and, if necessary, to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established. In those patients in whom significant widening of the QRS complex or second or third degree AV block occurs, dose reduction should be considered.
As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of propafenone HCl should be increased more gradually during the initial phase of treatment.
- American Health Packaging
Propafenone Hydrochloride | American Health Packaging
Propafenone HCl 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 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 interval 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 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 ER capsules with both a CYP2D6 inhibitor and a CYP3A4 inhibitor. [seeWARNINGS AND PRECAUTIONS (5.2) AND DRUG INTERACTIONS (7.1)].
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