Benznidazole: Difference between revisions

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{{Drugbox
{{DrugProjectFormSinglePage
| verifiedrevid = 414638558
|genericName=generic name
| IUPAC_name = ''N''-benzyl-2-(2-nitro-1''H''-imidazol-1-yl)acetamide
|aOrAn=a
| image = Benznidazole Wiki Str.png
|drugClass=Acetylcholine release inhibitor, Adrenergic receptor agonist
|indicationType=(type of indication of drug)
|indication=a list of indications, separated by commas.
|hasBlackBoxWarning=Yes
|adverseReactions=a list of adverse reactions, separated by commas.
|blackBoxWarningTitle=Warning Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult======Condition 1=====


* Dosing Information
:* (Dosage)
=====Condition 2=====
* Dosing Information
:* (Dosage)
|offLabelAdultGuideSupport======Condition 1=====
* Developed by: (Organisation)
* Class of Recommendation: (Class) (Link)
* Strength of Evidence: (Category A/B/C) (Link)
* Dosing Information/Recommendation
:* (Dosage)
=====Condition 2=====
* Developed by: (Organisation)
* Class of Recommendation: (Class) (Link)
* Strength of Evidence: (Category A/B/C) (Link)
* Dosing Information/Recommendation
:* (Dosage)
|offLabelAdultNoGuideSupport======Condition 1=====
* Dosing Information
:* (Dosage)
=====Condition 2=====
* Dosing Information
:* (Dosage)
=====Condition 3=====
* Dosing Information
:* (Dosage)
|fdaLIADPed======Condition 1=====
* Dosing Information
:* (Dosage)
=====Condition 2=====
* Dosing Information
:* (Dosage)
|offLabelPedGuideSupport======Condition 1=====
* Developed by: (Organisation)
* Class of Recommendation: (Class) (Link)
* Strength of Evidence: (Category A/B/C) (Link)
* Dosing Information/Recommendation
:* (Dosage)
=====Condition 2=====
* Developed by: (Organisation)
* Class of Recommendation: (Class) (Link)
* Strength of Evidence: (Category A/B/C) (Link)
* Dosing Information/Recommendation
:* (Dosage)
|offLabelPedNoGuideSupport======Condition 1=====
* Dosing Information
:* (Dosage)
=====Condition 2=====
* Dosing Information
:* (Dosage)
=====Condition 3=====
* Dosing Information
:* (Dosage)
|contraindications=CONTRAINDICATIONS
|warnings======Conidition 1=====
(Description)
=====Conidition 2=====
(Description)
=====Conidition 3=====
(Description)
|clinicalTrials=======Central Nervous System======
: (list/description of adverse reactions)
======Cardiovascular======
: (list/description of adverse reactions)
======Respiratory======
: (list/description of adverse reactions)
======Gastrointestinal======
: (list/description of adverse reactions)
======Hypersensitive Reactions======
: (list/description of adverse reactions)
======Miscellaneous======
: (list/description of adverse reactions)
=====Condition 2=====
======Central Nervous System======
: (list/description of adverse reactions)
======Cardiovascular======
: (list/description of adverse reactions)
======Respiratory======
: (list/description of adverse reactions)
======Gastrointestinal======
: (list/description of adverse reactions)
======Hypersensitive Reactions======
: (list/description of adverse reactions)
======Miscellaneous======
: (list/description of adverse reactions)
|postmarketing=(Description)
|drugInteractions=* Drug 1
* Drug 2
* Drug 3
* Drug 4
* Drug 5
=====Drug 1=====
(Description)
=====Drug 2=====
(Description)
=====Drug 3=====
(Description)
=====Drug 4=====
(Description)
=====Drug 5=====
(Description)
|useInPregnancyFDA=(Description)
|useInPregnancyAUS=(Description)
|useInLaborDelivery=(Description)
|useInNursing=(Description)
|useInPed=(Description)
|useInGeri=(Description)
|useInGender=(Description)
|useInRace=(Description)
|useInRenalImpair=(Description)
|useInHepaticImpair=(Description)
|useInReproPotential=(Description)
|useInImmunocomp=(Description)
|othersTitle=Others
|useInOthers=(Description)
|administration=(Oral/Intravenous/etc)
|monitoring======Condition 1=====
(Description regarding monitoring, from ''Warnings'' section)
=====Condition 2=====
(Description regarding monitoring, from ''Warnings'' section)
=====Condition 3=====
(Description regarding monitoring, from ''Warnings'' section)
|overdose====Acute Overdose===
====Signs and Symptoms====
(Description)
====Management====
(Description)
===Chronic Overdose===
====Signs and Symptoms====
(Description)
====Management====
(Description)
|drugBox={{Drugbox2
| verifiedrevid =
| IUPAC_name =
| image =
| drug_name =


<!--Clinical data-->
<!--Clinical data-->
| tradename = Rochagan, Radanil
| tradename =  
| Drugs.com = {{drugs.com|CONS|benznidazole}}
| MedlinePlus =  
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| licence_US =
| pregnancy_US = <!-- A / B            / C / D / X -->
| pregnancy_AU =  
| pregnancy_category = 
| pregnancy_US =  
| legal_AU = <!-- Unscheduled / S2 / S3 / S4  / S8 -->
| legal_status =  
| legal_CA = <!--                            / Schedule I, II, III, IV, V, VI, VII, VIII -->
| routes_of_administration =
| legal_UK = <!-- GSL        / P      / POM / CD / Class A, B, C -->
| legal_US = <!-- OTC                  / Rx-only  / Schedule I, II, III, IV, V -->
| legal_status =
| routes_of_administration = Oral


<!--Pharmacokinetic data-->
<!--Pharmacokinetic data-->
| bioavailability = High
| bioavailability =  
| protein_bound = 
| metabolism =  
| metabolism = [[Liver|Hepatic]]
| elimination_half-life =  
| elimination_half-life = 12 hours
| excretion =  
| excretion = [[Kidney|Renal]] and fecal


<!--Identifiers-->
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|??}}
| CAS_number_Ref =  
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number =  
| CAS_number = 22994-85-0
| ATC_prefix =  
| ATC_prefix = P01
| ATC_suffix =  
| ATC_suffix = CA02
| PubChem =  
| PubChem = 31593
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank_Ref =  
| DrugBank =
| DrugBank =  
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID_Ref =  
| ChemSpiderID = 29299
| ChemSpiderID =  
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII_Ref =  
| UNII = YC42NRJ1ZD
| UNII =  
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG_Ref =  
| KEGG = D02489
| KEGG =
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEBI_Ref =
| ChEMBL = 110
| ChEBI =  
| ChEMBL_Ref =  
| ChEMBL =  


<!--Chemical data-->
<!--Chemical data-->
| C=12 | H=12 | N=4 | O=3
| C= | H= | N= | O=  
| molecular_weight = 260.249 g/mol
| molecular_weight =  
| smiles = O=[N+]([O-])c1nccn1CC(=O)NCc2ccccc2
| smiles =  
| InChI = 1/C12H12N4O3/c17-11(14-8-10-4-2-1-3-5-10)9-15-7-6-13-12(15)16(18)19/h1-7H,8-9H2,(H,14,17)
| InChI =  
| InChIKey = CULUWZNBISUWAS-UHFFFAOYAD
| InChIKey =  
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI_Ref =  
| StdInChI = 1S/C12H12N4O3/c17-11(14-8-10-4-2-1-3-5-10)9-15-7-6-13-12(15)16(18)19/h1-7H,8-9H2,(H,14,17)
| StdInChI =  
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey_Ref =  
| StdInChIKey = CULUWZNBISUWAS-UHFFFAOYSA-N
| StdInChIKey =
| melting_point =  
}}
}}
__NOTOC__
|mechAction=(Description)
{{SI}}
|structure=(Description with picture)
{{CMG}}
|PD=(Description)
== Overview ==
|PK=(Description)
'''Benznidazole''' ([[International Nonproprietary Name|INN]], formerly marketed by [[Hoffman-La Roche]] under the trade names Rochagan and Radanil) is an [[antiparasitic]] [[medication]] used in the treatment of [[Chagas disease]]. Its mechanism of action is the production of [[Radical_(chemistry)|free radicals]], to which the ''[[Trypanosoma cruzi]]'' is particularly sensitive given its reduced detoxification capabilities.<ref name=urbina>{{cite web | url=http://www.fac.org.ar/fec/chagas2/llave/md5/md508/urbina.htm | title=Nuevas drogas para el tratamiento etiológico  de la Enfermedad de Chagas | accessdate=March 24, 2012 | author=Urbina, Julio A. | language=Spanish}}</ref> Roche donated the technology and rights to produce benznidazole to the Brazilian government.<ref>http://www.itg.be/evde/04_Chagas_diseasep12.htm</ref>
|nonClinToxic=(Description)
|clinicalStudies======Condition 1=====


<!-- Society and culture -->
(Description)
It is on the [[World Health Organization's List of Essential Medicines]], the most important medications needed in a basic [[health system]].<ref>{{cite web|title=WHO Model List of EssentialMedicines|url=http://apps.who.int/iris/bitstream/10665/93142/1/EML_18_eng.pdf?ua=1|work=World Health Organization|accessdate=22 April 2014|date=October 2013}}</ref>


==Medical uses==  
=====Condition 2=====
Benznidazole has a significant activity during the acute phase of the disease, with a therapeutical success rate of up to 80%. Its curative capabilities during the chronic phase are, however, limited. Some studies have found parasitologic cure (a complete elimination of ''T. cruzi'' from the body) in pediatric and young patients during the early stage of the chronic phase, but overall failure rate in chronically infected individuals is typically above 80%.<ref name=urbina />


However, some studies indicate treatment with benznidazole in chronic patients, even if incapable of producing parasitologic cure, carries a significative reduction of occurrence of electrocardiographic changes and a delayed worsening of the clinical condition of the patient.<ref name=urbina />
(Description)


Benznidazole has proven to be effective in the treatment of reactivated  ''T. cruzi''  infections caused by [[immunosuppression]], such as [[AIDS]] patients or those under immunosuppressive therapy related to organ transplants.<ref name=urbina />
=====Condition 3=====


==Side effects==
(Description)
The [[adverse drug reaction|side effect]]s most commonly associated with benznidazole therapy are [[rash]] and [[Gastrointestinal tract|gastrointestinal]] symptoms such as [[nausea]]. Rarely, [[peripheral neuropathy]] may present after prolonged treatment.
|howSupplied=(Description)
 
|fdaPatientInfo=(Patient Counseling Information)
==References==
|nlmPatientInfo=(Link to patient information page)
<!--This article uses the Cite.php citation mechanism. If you would like more information on how to add references to this article, please see http://meta.wikimedia.org/wiki/Cite/Cite.php -->
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
{{Reflist|2}}
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
 
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
==External links==
|drugShortage=Drug Shortage
*{{cite web | title = Rochagan <nowiki>[Patient Information]</nowiki> | url= http://www.roche.com.br/NR/rdonlyres/26F1D9BB-FE75-4CC4-8EFD-96CB85C374BD/603/Rochagan.pdf | format = [[PDF]] | publisher = [[Hoffmann-La Roche]] | accessdate = 2006-11-27|language=pt}}
}}
 
{{Excavata antiparasitics}}
 
[[Category:Drug]]
[[Category:Antiprotozoal agents]]
[[Category:Nitroimidazoles]]
[[Category:Amides]]
[[Category:World Health Organization essential medicines]]
 
{{Antimicrobial-stub}}

Revision as of 19:28, 11 June 2018

Benznidazole
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];

Disclaimer

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Black Box Warning

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Benznidazole is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

CONTRAINDICATIONS

Warnings

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1

(Description)

Conidition 2

(Description)

Conidition 3

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

There is limited information regarding the compatibility of Benznidazole and IV administrations.

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Benznidazole
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

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

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

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

Brand Names

There is limited information regarding Benznidazole Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

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

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