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| IUPAC_name = 3-ethyl-5-phenyl-imidazolidine-2,4-dione
|authorTag=<!--Overview-->
| image = Ethotoin.png
|aOrAn=a
| width = 201
|indicationType=treatment
| CAS_number = 86-35-1
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'''Ethotoin''' (marketed as '''Peganone'''® by [[Ovation Pharma|Ovation]]) is an [[anticonvulsant]] drug used in the treatment of [[epilepsy]]. It is a [[hydantoin]], similar to [[phenytoin]]. Ethotoin lacks phenytoin's side effects of [[gingiva|gingival]] [[hyperplasia]] and [[hirsutism]], however it is less effective. This, combined with the need for frequent dosing has limited its usefulness. Ethotoin is no longer widely used.
<!--Pill Image-->


==Mechanism of action==
Similar to phenytoin.


==Approval history==
*'''1957''' Peganone was granted [[Food and Drug Administration]] (FDA) approval to [[Abbott Laboratories]] for treatment of grand mal (tonic clonic) and partial complex (psychomotor) seizures.
*'''2003''' Peganone was acquired from Abbott Laboratories by Ovation Pharmaceuticals (specialty pharmaceutical company who acquire underpromoted branded pharmaceutical products).


==Indications and usage==
<!--Label Display Image-->
Ethotoin is indicated for tonic-clonic and partial complex seizures.


==Dosing==
Ethotoin is available in 250mg tablets. It is taken orally in 4 to 6 divided doses per day, preferably after food.


==Side effects==
[[Ataxia]], visual disturbances, rash and [[Gastrointestinal tract|gastrointestinal]] problems.


==References==
*[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=13317788&query_hl=10 Peganone, a new antiepileptic drug.]
: Dis Nerv Syst. 1956 May;17(5):155-8.
: Schwade ED, Richards RK, Everett GM. PMID 13317788
*''The Treatment of Epilepsy'' edited by S. D. Shorvon, David R. Fish, Emilio Perucca, W. Edwin Dodson. Blackwell Publishing. 2004. ISBN 0-632-06046-8
*[http://www.drugs.com/pdr/ETHOTOIN.html Drugs.com: Ethotoin]
*[http://ovationpharmaceuticals.com/images/products/pdf/peganone_pi.pdf PEGANONE® 250 mg Ethotoin Tablets, USP] (PDF)


==External links==
*[http://www.ovationpharma.com/ Ovation Pharmaceuticals]


{{Anticonvulsants}}
<!--Category-->


[[Category:Anticonvulsants]]
[[Category:Drug]]

Revision as of 16:21, 20 February 2015

Ethotoin
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

Ethotoin is a {{{drugClass}}} that is FDA approved for the treatment 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 Ethotoin in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Ethotoin01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Ethotoin 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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