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__NOTOC__
{{DrugProjectFormSinglePage
{{Propafenone}}
|authorTag=
{{CMG}}; {{AE}} {{SS}}


'''''For patient information about Propafenone, click [[Propafenone (patient information)|here]].'''''
Gerald Chi


{{SB}} RYTHMOL<sup>®</sup>;RYTHMOL SR<sup>®</sup>;generic
<!--Overview-->


==Overview==
|genericName=


==Category==


[[Category:Antiarrhythmic agents]];[[Ketones]];[[Phenol ethers]];[[Alcohols]];[[Amines]];[[Sodium channel blockers]];[[Cardiovascular Drugs]]


==FDA Package Insert==
|aOrAn=


====RYTHMOL (propafenone hydrochloride) tablet, film coated ====
a


'''  [[RYTHMOL indications and usage|Indications and Usage]]'''
|drugClass=
'''| [[RYTHMOL dosage and administration|Dosage and Administration]]'''
'''| [[RYTHMOL dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[RYTHMOL contraindications|Contraindications]]'''
'''| [[RYTHMOL warnings and precautions|Warnings and Precautions]]'''
'''| [[RYTHMOL adverse reactions|Adverse Reactions]]'''
'''| [[RYTHMOL drug interactions|Drug Interactions]]'''
'''| [[RYTHMOL use in specific populations|Use in Specific Populations]]'''
'''| [[RYTHMOL overdosage|Overdosage]]'''
'''| [[RYTHMOL description|Description]]'''
'''| [[RYTHMOL clinical pharmacology|Clinical Pharmacology]]'''
'''| [[RYTHMOL nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[RYTHMOL clinical studies|Clinical Studies]]'''
'''| [[RYTHMOL how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[RYTHMOL patient counseling information|Patient Counseling Information]]'''
'''| [[RYTHMOL labels and packages|Labels and Packages]]'''


<font color="#F8F8FF">
{| style="border: 3px solid #696969;" align="center"
| style="background: #000000; border: 0px; padding: 0 5px; width: 800px;" |




<center>
|indication=
'''BOXED WARNING'''
</center>


<center>
''See full prescribing information for complete boxed warning.''
</center>




<b>
|hasBlackBoxWarning=


WARNING: MORTALITY
Yes


See full prescribing information for complete boxed warning.
|adverseReactions=
*
An increased rate of death or reversed cardiac arrest rate was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo. At present it is prudent to consider any IC antiarrhythmic to have a significant risk of provoking proarrhythmic events in patients with structural heart disease.
*
Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.


</b>




|}
<!--Black Box Warning-->
</font>


====RYTHMOL SR (propafenone hydrochloride) capsule, extended release====
|blackBoxWarningTitle=
Title


'''  [[RYTHMOL SR indications and usage|Indications and Usage]]'''
|blackBoxWarningBody=
'''| [[RYTHMOL SR dosage and administration|Dosage and Administration]]'''
<i><span style="color:#FF0000;">ConditionName: </span></i>
'''| [[RYTHMOL SR dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[RYTHMOL SR contraindications|Contraindications]]'''
'''| [[RYTHMOL SR warnings and precautions|Warnings and Precautions]]'''
'''| [[RYTHMOL SR adverse reactions|Adverse Reactions]]'''
'''| [[RYTHMOL SR drug interactions|Drug Interactions]]'''
'''| [[RYTHMOL SR use in specific populations|Use in Specific Populations]]'''
'''| [[RYTHMOL SR overdosage|Overdosage]]'''
'''| [[RYTHMOL SR description|Description]]'''
'''| [[RYTHMOL SR clinical pharmacology|Clinical Pharmacology]]'''
'''| [[RYTHMOL SR nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[RYTHMOL SR clinical studies|Clinical Studies]]'''
'''| [[RYTHMOL SR how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[RYTHMOL SR patient counseling information|Patient Counseling Information]]'''
'''| [[RYTHMOL SR labels and packages|Labels and Packages]]'''


<font color="#F8F8FF">
* Content
{| style="border: 3px solid #696969;" align="center"
| style="background: #000000; border: 0px; padding: 0 5px; width: 800px;" |


<!--Adult Indications and Dosage-->


<center>
<!--FDA-Labeled Indications and Dosage (Adult)-->
'''BOXED WARNING'''
</center>


<center>
|fdaLIADAdult=
''See full prescribing information for complete boxed warning.''
</center>


=====Condition1=====


<b>
* Dosing Information


WARNING: MORTALITY
:* Dosage


See full prescribing information for complete boxed warning.
=====Condition2=====


* Dosing Information


*An increased rate of death or reversed cardiac arrest rate was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo. At present it is prudent to consider any IC antiarrhythmic to have a significant risk of provoking proarrhythmic events in patients with structural heart disease.
:* Dosage


=====Condition3=====


*Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
* Dosing Information


</b>
:* Dosage


=====Condition4=====


|}
* Dosing Information
</font>


==Taking Alcohol with Propafenone==
:* Dosage


Alcohol-Propafenone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Off-Label Use and Dosage (Adult)-->


==References==
<!--Guideline-Supported Use (Adult)-->


{{Reflist|2}}
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
=====Condition1=====
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*
 
<!--Structure-->
 
|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
 
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
 
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
 
|nonClinToxic=
 
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
 
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
=====Condition1=====
 
* Description
 
<!--How Supplied-->
 
|howSupplied=
 
*
 
<!--Patient Counseling Information-->
 
|fdaPatientInfo=
 
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
 
|brandNames=
 
* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
<!--Look-Alike Drug Names-->
 
|lookAlike=
 
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
 
<!--Drug Shortage Status-->
 
|drugShortage=
}}
 
<!--Pill Image-->
 
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}
 
<!--Label Display Image-->
 
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
 
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
 
<!--Category-->


[[Category:Antiarrhythmic agents]]
[[Category:Ketones]]
[[Category:Phenol ethers]]
[[Category:Alcohols]]
[[Category:Amines]]
[[Category:Sodium channel blockers]]
[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drug]]

Revision as of 16:02, 13 July 2014

Propafenone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Propafenone is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Propafenone in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Propafenone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Propafenone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Propafenone in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Propafenone in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Propafenone in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Propafenone in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Propafenone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Propafenone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Propafenone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Propafenone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Propafenone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Propafenone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Propafenone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Propafenone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Propafenone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Propafenone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Propafenone in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Propafenone in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Propafenone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Propafenone in the drug label.

Pharmacology

There is limited information regarding Propafenone Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Propafenone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Propafenone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Propafenone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Propafenone in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Propafenone Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Propafenone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Propafenone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Propafenone in the drug label.

Precautions with Alcohol

  • Alcohol-Propafenone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


{{#subobject: 

 |Page Name=Propafenone
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 |Pill Scoring=
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}}


{{#subobject: 

 |Label Page=Propafenone
 |Label Name=Propafenone11.png

}}


{{#subobject: 

 |Label Page=Propafenone
 |Label Name=Propafenone11.png

}}

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