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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = 3-ethyl-3-methyl-pyrrolidine-2,5-dione
|authorTag=<!--Overview-->
| image = Ethosuximide.png
|aOrAn=a
| width = 120px
|hasBlackBoxWarning=Yes
| CAS_number = 77-67-8
|adverseReactions=<!--Black Box Warning-->
| ATC_prefix = N03
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| ATC_suffix = AD01
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| PubChem = 3291
 
| DrugBank = APRD00318
* Content
| C = 7 |H = 11 |N = 1 |O = 2
 
| molecular_weight = 141.168 [[Gram|g]]/[[Mole (unit)|mol]]
<!--Adult Indications and Dosage-->
| bioavailability = 93%{{ref|bioavailability}}
 
| metabolism = [[Liver|Hepatic]] ([[CYP3A4]], [[CYP2E1]])
<!--FDA-Labeled Indications and Dosage (Adult)-->
| elimination_half-life = 53 [[hour]]s
|fdaLIADAdult======Condition1=====
| excretion = [[Kidney|Renal]] (20%)
 
| pregnancy_category = D <small>([[Australia|Au]], [[United States|U.S.]])</small>
* Dosing Information
| legal_status = [[Prescription drug|℞-only]] <small>(U.S.)</small>
 
| routes_of_administration = Oral
:* Dosage
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* Developed by:
 
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=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
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* Dosing Information
 
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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=====
 
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There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
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|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


'''Ethosuximide''' is a [[succinimide]] [[anticonvulsant]], used mainly in [[absence seizure]]s. It is sold by [[Pfizer]] under the name '''Zarontin®''' and was once also sold under the name '''Emeside'''®, both of which were discontinued from the United Kingdom market in capsule form in November of 2005.{{ref|no_more_capsules_UK}}
<!--Nonclinical Toxicology-->
==Uses==
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
===Approved===
It is approved for absence seizures.{{ref|approved_use}} Ethosuximide is considered the first choice drug for treating absence seizures in part because it lacks the idiosyncratic hepatotoxicity of the alternative anti-absence drug, [[valproic acid]].{{ref|approved_use}}


===Unapproved===
<!--Clinical Studies-->
It was reported to have been used for [[intermittent explosive disorder]] in 1980 by Drs Andrulonis, Donnelly, Glueck, Stroebel, and Szabek.{{ref|Andrulonis_et_al_1980}}
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


===Dosage===
<!--How Supplied-->
Therapeutic drug concentrations are individualized according to response and tolerance. Common Serum Therapeutic Range: 40-100 ug/mL.  Potentially Toxic Serum Concentration: >100 ug/mL.
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==Mechanism of Action==
<!--Precautions with Alcohol-->
There is some controversy over the exact mechanism by which ethosuximide prevents absence seizures. While the view that ethosuximide is a T-type calcium channel blocker gained widespread support following its proposal, attempts to replicate the initial finding were inconsistent.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


In March of 1989, Coulter, Huguenard and Prince showed that ethosuximide and [[dimethadione]], both effective anti-absence agents, reduced low-threshold [[calcium|Ca<sup>2+</sup>]] [[current (electric)|current]]s in [[Voltage-dependent calcium channel|T-type Ca<sup>2+</sup> channel]]s in freshly removed [[thalamus|thalamic]] [[neuron]]s.{{ref|Coulter1989-1}} In June of that same year, they also found the mechanism of this reduction to be [[voltage]]-dependent, using acutely neurons of rats and guinea pigs; it was also noted that [[valproic acid]], which is also used in absence seizures, did not do that.{{ref|Coulter1989-2}} The next year, they showed that anticonvulsant succinimides did this and that the [[proconvulsant]] ones did not.{{ref|Coulter1990}} The first part was supported by Kostyuk et al in 1992, who reported a substantial reduction in current in [[dorsal root]] [[ganglion|ganglia]] at concentrations ranging from 7 [[mu (letter)|μ]][[concentration|M]] to 1 mM.{{ref|Kostyuk}}
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>


That same year, however, Herrington and Lingle found no such effect at concentrations of up to 2.5 mM.{{ref|Herrington-Lingle}} The year after, a study conducted on human [[neocortex|neocortical]] cells removed during surgery for intractable epilepsy, the first to use human tissue, found that ethosuximide had no effect on Ca<sup>2+</sup> currents at the concentrations typically needed for a therapeutic effect.{{ref|sayer1993}}
<!--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>


In 1998, Slobodan M. Todorovic and Christopher J. Lingle of Washington University reported a 100% block of T-type current in dorsal root ganglia at 23.7 ± 0.5 mM, far higher than Kostyuk reported.{{ref|Todorovic_Lingle}} That same year, Leresche et al reported that ethosuximide had no effect on T-type currents, but did decrease noninactivating [[sodium|Na<sup>+</sup>]] current by 60% and the Ca<sup>2+</sup>-activated K<sup>+</sup> currents by 39.1 ± 6.4% in rat and cat thalamocortical cells. It was concluded that the decrease in Na<sup>+</sup> current is responsible for the anti-absence properties.{{ref|Leresche_et_al_1998}}
<!--Drug Shortage Status-->
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->


In the introduction of a paper published in 2001, Dr. Juan Carlos Gomora and colleagues at the [[University of Virginia]] in [[Charlottesville, Virginia|Charlottesville]] pointed out that past studies were often done in isolated neurons that had lost most of their T-type channels.{{ref|Gomora_et_al_2001}} Using cloned α1G, α1H, and α1I T-type calcium channels, Gomora's team found that ethosuximide blocked the channels with an IC<sub>50</sub> of 12 ± 2 mM and that of ''N''-desmethylmethsuximide (the active metabolite of [[mesuximide]]) is 1.95 ± 0.19 mM for α1G, 1.82 ± 0.16 mM for α1I, and 3.0 ± 0.3 mM for α1H. It was suggested that the blockade of open channels is facilitated by ethosuximide's physically plugging the channels when current flows inward.
<!--==Metabolism==
Ethosuximide is primarily metabolized by [[CYP3A4]] into, and by [[CYP2E1]] into.-->


==Adverse Effects==
===Central Nervous System===
====Common====
* drowsiness
* mental confusion
* [[insomnia]]
* nervousness
* [[headache]]
* [[Euphoria (emotion)|euphoria]]
* [[ataxia]]
* hiccups
* impaired concentration
* irritability
* [[hyperactivity]]
* loss of taste
* [[night terror]]s
====Rare====
* [[paranoia|paranoid]] [[psychosis]]
* increased libido
* exacerbation of [[clinical depression|depression]]
===Gastrointestinal===
* [[dyspepsia]]
* [[vomiting]]
* [[nausea]]
* cramps
* [[constipation]]
* [[diarrhea]]
* stomach pain
* loss of appetite
* weight loss
* [[hyperplasia|gingival hyperplasia]]
* swelling of tongue
===Genitourinary===
* microscopic [[hematuria]]
* vaginal bleeding
===Hematopoietic===
''The following can occur with or without bone marrow loss:''
* [[pancytopenia]]
* [[agranulocytosis]]
* [[leukopenia]]
* [[eosinophilia]]
===Integumentary===
* [[urticaria]]
* [[systemic lupus erythematosus]]
* [[Stevens-Johnson syndrome]]
* [[hirsutism]]
* [[itch|pruritic]] [[lupus erythematosus|erythematous rash]]es


===Ocular===
<!--Label Display Image-->
* [[myopia]]
==Complications==
* abnormal [[liver|liver function]]
==Drug Interactions==
[[valproic acid|Valproate]]s can either decrease or increase the levels of ethosuximide; However, combinations of [[valproic acid|valproate]]s and ethosuximide had a greater [[Protective Index]] than either drug alone.{{ref|combo}}


It may elevate serum [[phenytoin]] levels.


==References==
* [http://www.mentalhealth.com/drug/p30-z01.html#Head_1 Ethosuximide] Internet Mental Health.
* [http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682327.html MedlinePlus Drug Information: Ethosuximide Oral]
* [http://www.pfizer.com/pfizer/download/uspi_zarontin_capsules.pdf Zarontin®] ''Pfizer.''
* [http://www.druglib.com/druginfo/zarontin/ Zarontin®] Drug information, published studies and current trials


==End Notes==
# {{note|bioavailability}} {{cite journal | first = P. N. | last = Patsalos | month = November | year = 2005 | title = Properties of Antiepileptic Drugs in the Treatment of Idiopathic Generalized Epilepsies | journal = Epilepsia | volume = 46 | issue = s9 | pages = 140-144 | id = PMID 16302888}}
# {{note|no_more_capsules_UK}} {{cite web | author = Epilepsy Research Foundation | year = 2005 | url = http://www.epilepsyresearch.org.uk/news/arch/0511ethosuximide.htm
| title = Withdrawal of Zarontin and Emeside tablets | accessdate = 2007-05-14}}
# {{note|approved_use}} {{cite web | author = Pharmaceutical Associates, Incorporated | year = 2000 | url = http://www.fda.gov/cder/foi/anda/2000/40253_Ethosuximide_Prntlbl.pdf | title = Ethosuximide Approval Label | format = PDF | work = Label and Approval History | publisher = [[Food and Drug Administration]] Center for Drug Evaluation and Research | accessdate = 2006-02-05}}
# {{note|approved_use}} "Drugs used in generalized seizures." Katzung, B. Basic and Clinical Pharmacology. 9th Ed. 2003. Lange Medical Books/McGraw-Hill.0071410929.
# {{note|Andrulonis_et_al_1980}} {{cite journal | first = P. A. | last = Andrulonis | coauthors = J. Donnelly, B. C. Glueck, C. F. Stroebel, and B. L. Szabek | month = November | year = 1980 | title = Preliminary data on ethosuximide and the episodic dyscontrol syndrome | journal = American Journal of Psychiatry | volume = 137 | issue = 11 | pages = 1455-6 | id = {{PMID|7435689}}}}
# {{note|Coulter1989-1}} Coulter DA, Huguenard JR, Prince DA. "Specific petit mal anticonvulsants reduce calcium currents in thalamic neurons." ''Neurosci Lett.'' 1989 Mar 13;98(1):74-8. PMID 2710401
# {{note|Coulter1989-2}} "Characterization of ethosuximide reduction of low-threshold calcium current in thalamic neurons." ''Annals of Neurology.'' 1989 Jun;25(6):582-93. PMID 2545161
# {{note|Coulter1990}} Coulter DA, Huguenard JR, Prince DA. "Differential effects of petit mal anticonvulsants and convulsants on thalamic neurones: calcium current reduction." ''British Journal of Pharmacology.'' 1990 Aug;100(4):800-6. PMID 2169941
# {{note|Kostyuk}} Kostyuk PG, Molokanova EA, Pronchuk NF, Savchenko AN, Verkhratsky AN. "Different action of ethosuximide on low- and high-threshold calcium currents in rat sensory neurons." ''Neuroscience.'' 1992 Dec;51(4):755-8. PMID 1336826
# {{note|Herrington-Lingle}} {{cite journal
| author = Herrington J, Lingle CJ
| title = Kinetic and pharmacological properties of low voltage-activated Ca2+ current in rat clonal (GH3) pituitary cells
| journal = Journal of Neurophysiology
| date = 1992 Jul | volume = 68 | issue = 1 | pages = 213-32
| id = PMID 1325546
| url =  http://jn.physiology.org/cgi/reprint/68/1/213
}}
# {{note|sayer1993}} Sayer RJ, Brown AM, Schwindt PC, Crill WE. "Calcium currents in acutely isolated human neocortical neurons." ''Journal of Neurophysiology.'' 1993 May;69(5):1596-606. PMID 8389832 [http://jn.physiology.org/cgi/reprint/69/5/1596 Fulltext]
# {{note|Todorovic_Lingle}} {{cite journal | author=Todorovic SM, Lingle CJ | title=Pharmacological properties of T-type Ca2+ current in adult rat sensory neurons: effects of anticonvulsant and anesthetic agents | journal=Journal of Neurophysiology | volume=79 | issue=1 | year=1998 | pages=240-52 | id=PMID 9425195
| url = http://jn.physiology.org/cgi/content/full/79/1/240
}}
# {{note|Leresche_et_al_1998}} {{cite journal | author=Leresche N, Parri HR, Erdemli G, Guyon A, Turner JP, Williams SR, Asprodini E, Crunelli V | title=On the action of the anti-absence drug ethosuximide in the rat and cat thalamus | journal=Journal of Neuroscience | volume=18 | issue=13 | year=1998 | pages=4842-53 | id=PMID 9634550
| url = http://www.jneurosci.org/cgi/content/full/18/13/4842
}}
# {{note|Gomora_et_al_2001}} {{cite journal | author=Gomora JC, Daud AN, Weiergraber M, Perez-Reyes E | title=Block of cloned human T-type calcium channels by succinimide antiepileptic drugs | journal=Molecular Pharmacology | volume=60 | issue=5 | year=2001 | pages=1121-32 | id=PMID 11641441
}}
# {{note|combo}} {{cite journal
| last = Bourgeois | first = BF
| title = Combination of valproate and ethosuximide: antiepileptic and neurotoxic interaction
| journal = The Journal of Pharmacology and Experimental Therapeutics
| date = 1988 Dec | volume = 247 | issue = 3 | pages = 1128-32
| id = PMID 3144596
}}


==External links==
* [http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist FDA-Parke Davis-Zarontin Letters]
{{Anticonvulsants}}


<!--[[he:דימיסקוסותא]]
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[[ru:Этосуксимид]]

Revision as of 17:29, 26 January 2015

Ethosuximide
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];

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Black Box Warning

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

Overview

Ethosuximide is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. 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 Ethosuximide in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Ethosuximide01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Ethosuximide 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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