Procainamide: Difference between revisions

Jump to navigation Jump to search
No edit summary
No edit summary
Line 1: Line 1:
__NOTOC__
{{DrugProjectFormSinglePage
{{Procainamide}}
|authorTag=
{{CMG}}; {{AE}} {{SS}}


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


{{SB}} PROCAINAMIDE HYDROCHLORIDE<sup>®</sup>
<!--Overview-->


==Overview==
|genericName=


'''Procainamide''' (proe-KANE-a-mide) ([[International Nonproprietary Name|INN]], trade names '''Pronestyl®''', '''Procan®''', '''Procanbid®''') is a [[pharmaceutical]] [[antiarrhythmic agent]] used for the [[medicine|medical]] [[Pharmacotherapy|treatment]] of [[cardiac arrhythmia]]s, classified by the [[Vaughan Williams classification]] system as class Ia.  Procanbid® will no longer be manufactured.<sup>1</sup>


It blocks open [[sodium]] (Na<sup>+</sup>) channels and prolongs the [[heart|cardiac]] [[action potential]] (outward [[potassium]] (K<sup>+</sup>) currents may be blocked).
This results in slowed conduction, and ultimately the decreased rate of rise of the action potential, which may result in widening of [[QRS complex|QRS]] on [[electrocardiogram]] (ECG).
This [[medication|drug]] is used for both supraventricular and ventricular arrhythmias.
For example, it can be used to convert new-onset [[atrial fibrillation]], though it is suboptimal for this purpose.


Procainamide is administered [[intravenous]]ly or [[Wiktionary:oral|oral]]ly.When administered intravenously, a [[loading dose]] should first be given, though care should be taken not to cause [[hypotension]].Procainamide's active metabolite is [[N-acetyl procainamide]], which is excreted by the [[kidneys]] and the [[renal system]].
|aOrAn=


Adverse effects include [[rash]], [[myalgia]], [[hypersensitivity|hypersensitivity reaction]]s ([[fever]], [[agranulocytosis]]), [[Drug-Induced Lupus Erythematosus]] (particularly in slow-acetylators), and proarrhythmic effects (''e.g.'', [[torsades de pointes]]). Treatment with procainamide can cause antibody production against cellular components, accounting for the systemic lupus erythematosus-like adverse reactions.
a


==Category==
|drugClass=


[[Benzamides]];[[Anilines]];[[Sodium channel blockers]];[[Antiarrhythmic agents]];[[Cardiovascular Drugs]]


==FDA Package Insert==


====PROCAINAMIDE HYDROCHLORIDE injection, solution ====
|indication=


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




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


Yes


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


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




<b>
<!--Black Box Warning-->
WARNING: The prolonged administration of procainamide often leads to the development of a positive anti-nuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefit versus risks of continued procainamide therapy should be assessed.
</b>


|blackBoxWarningTitle=
Title


|}
|blackBoxWarningBody=
</font>
<i><span style="color:#FF0000;">ConditionName: </span></i>


==Taking Alcohol with Procainamide==
* Content


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


==References==
<!--FDA-Labeled Indications and Dosage (Adult)-->


{{Reflist|2}}
|fdaLIADAdult=


=====Condition1=====


{{Antiarrhythmic agents}}
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|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:Benzamides]]
[[Category:Anilines]]
[[Category:Sodium channel blockers]]
[[Category:Antiarrhythmic agents]]
[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drug]]

Revision as of 02:52, 13 July 2014

Procainamide
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

Procainamide 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 Procainamide in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Procainamide 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 Procainamide 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 Procainamide 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 Procainamide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

Condition1
  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Procainamide 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 Procainamide in the drug label.

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

Condition1
  • Description

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Procainamide 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=Procainamide
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage=
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}


{{#subobject:

 |Label Page=Procainamide
 |Label Name=Procainamide11.png

}}


{{#subobject:

 |Label Page=Procainamide
 |Label Name=Procainamide11.png

}}