Isoniazid (oral): Difference between revisions

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__NOTOC__
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{{Isoniazid}}
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==Overview==
* Content


Isoniazid also known as isonicotinylhydrazine (INH), is an [[organic compound]] that is the first-line medication in prevention and treatment of [[tuberculosis]]. The compound was first synthesized in the early 20th century,<ref>{{Cite journal|author=Meyer H, Mally J|title=On hydrazine derivatives of pyridine carbonic acids|journal=Monatshefte Chemie verwandte Teile anderer Wissenschaften|volume=33|pages=393&ndash;414|doi = 10.1007/BF01517946|language=German|year=1912}}[http://springerlink.metapress.com/content/p7145p063227623j/fulltext.pdf PDF fulltext]</ref> but its activity against tuberculosis was first reported in the early 1950s, and three pharmaceutical companies attempted unsuccessfully to simultaneously patent the drug<ref>{{Cite journal|journal=Lancet|volume=373|issue=9670|pages=1148&ndash;1149|year=2009
<!--Adult Indications and Dosage-->
|doi=10.1016/S0140-6736(09)60559-6|title=Fourth-generation fluoroquinolones in tuberculosis|author=Hans L Riede|pmid=19345815}}</ref> (the most prominent one being Roche, which launched its version, [http://www.rocheusa.com/about/history.html Rimifon], in 1952). The drug was first tested at [[Many Farms, Arizona|Many Farms]], a [[Navajo Nation|Navajo]] community, due to the Navajo reservation's dire tuberculosis problem and the fact that the population was [[Naïveté|naïve]] with respect to [[streptomycin]], the main tuberculosis treatment at the time.<ref>{{cite journal|last=Jones|first=David|title=The Health Care Experiments at Many Farms: The Navajo, Tuberculosis, and the Limits of Modern Medicine, 1952-1962|journal=Bulletin of the History of Medicine|year=2002|volume=76|issue=4|pages=749–790}}</ref> With the introduction of isoniazid, a cure for tuberculosis was first considered reasonable.


==Category==
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====


Antimycobacterial
* Dosing Information


==US Brand Names==
:* Dosage


ISONIAZID<sup>®</sup>, LANIAZID<sup>®</sup> (''DISCONTINUED''), NYDRAZID<sup>®</sup> (''DISCONTINUED'')
=====Condition2=====


==FDA Package Insert==
* Dosing Information


'''  [[Isoniazid description|Description]]'''
:* Dosage
'''| [[Isoniazid clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Isoniazid microbiology|Microbiology]]'''
'''| [[Isoniazid indications and usage|Indications and Usage]]'''
'''| [[Isoniazid contraindications|Contraindications]]'''
'''| [[Isoniazid warnings and precautions|Warnings and Precautions]]'''
'''| [[Isoniazid adverse reactions|Adverse Reactions]]'''
'''| [[Isoniazid overdosage|Overdosage]]'''
'''| [[Isoniazid dosage and administration|Dosage and Administration]]'''
'''| [[Isoniazid how supplied|How Supplied]]'''


==Mechanism of Action==
=====Condition3=====


Isoniazid is a [[prodrug]] and must be activated by a bacterial catalase-peroxidase enzyme that in ''M. tuberculosis'' is called KatG.<ref>{{Cite journal|author=Suarez J, Ranguelova K, Jarzecki AA, ''et al.'' |title=An oxyferrous heme/protein-based radical intermediate is catalytically competent in the catalase reaction of Mycobacterium tuberculosis catalase-peroxidase (KatG) |journal=The Journal of Biological Chemistry |volume=284 |issue=11 |pages=7017–29 |year=2009 |month=March |pmid=19139099 |doi=10.1074/jbc.M808106200 |pmc=2652337}}</ref>  KatG couples the isonicotinic acyl with [[NADH]] to form isonicotinic acyl-NADH complex. This complex binds tightly to the [[enoyl-acyl carrier protein reductase]] known as InhA, thereby blocking the natural enoyl-AcpM substrate and the action of [[fatty acid synthase]]. This process inhibits the synthesis of [[mycolic acid]], required for the [[mycobacterium|mycobacterial]] cell wall. A range of radicals are produced by KatG activation of isoniazid, including [[nitric oxide]],<ref>{{Cite journal|author=Timmins GS, Master S, Rusnak F, Deretic V |title=Nitric oxide generated from isoniazid activation by KatG: source of nitric oxide and activity against Mycobacterium tuberculosis |journal=Antimicrobial Agents and Chemotherapy |volume=48 |issue=8 |pages=3006–9 |year=2004 |month=August |pmid=15273113 |pmc=478481 |doi=10.1128/AAC.48.8.3006-3009.2004}}</ref> which has also been shown to be important in the action of another antimycobacterial prodrug [[PA-824]].<ref>{{Cite journal|author=Singh R, Manjunatha U, Boshoff HI, ''et al.'' |title=PA-824 kills nonreplicating Mycobacterium tuberculosis by intracellular NO release |journal=Science |volume=322 |issue=5906 |pages=1392–5 |year=2008 |month=November |pmid=19039139 |doi=10.1126/science.1164571 |pmc=2723733}}</ref>
* Dosing Information


Isoniazid is [[bactericidal]] to rapidly dividing [[mycobacterium|mycobacteria]], but is [[bacteriostatic]] if the mycobacteria are slow-growing.<ref>{{cite pmid|19686043}}</ref>
:* Dosage


Isoniazid inhibits the [[CYP450]] system.<ref>{{Cite book|title=Pharmacology, Harvey 4th edition|date=November 2009}}</ref>
=====Condition4=====


==References==
* Dosing Information


{{Reflist|2}}
:* Dosage


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[[Category:Drug]]

Revision as of 14:46, 18 December 2014

Isoniazid (oral)
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

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

Overview

Isoniazid (oral) is a that is FDA approved for the 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 Isoniazid (oral) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isoniazid (oral) 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 Isoniazid (oral) 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 Isoniazid (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isoniazid (oral) in pediatric patients.

Contraindications

  • Condition1

Warnings

ConditionName:
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 Isoniazid (oral) 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 Isoniazid (oral) 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 Isoniazid (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Isoniazid (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Isoniazid (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Isoniazid (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Isoniazid (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Isoniazid (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Isoniazid (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Isoniazid (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Isoniazid (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Isoniazid (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Isoniazid (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Isoniazid (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Isoniazid (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Isoniazid (oral) in the drug label.

Pharmacology

There is limited information regarding Isoniazid (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Isoniazid (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Isoniazid (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Isoniazid (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Isoniazid (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Isoniazid (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Isoniazid (oral) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Isoniazid (oral) |?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::Isoniazid (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Isoniazid (oral) in the drug label.

Precautions with Alcohol

  • Alcohol-Isoniazid (oral) 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)

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