Eslicarbazepine acetate: Difference between revisions

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(Created page with "__NOTOC__ {{Drugbox | IUPAC_name = (''S'')-10-Acetoxy- 10,11-dihydro- 5''H''-dibenz[b,f]azepine- 5-carboxamide | image = Eslicarbazepine acetate structure.svg <!--Clinical da...")
 
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__NOTOC__
{{DrugProjectFormSinglePage
{{Drugbox
|aOrAn=a
| IUPAC_name = (''S'')-10-Acetoxy- 10,11-dihydro- 5''H''-dibenz[b,f]azepine- 5-carboxamide
|indicationType=treatment
| image = Eslicarbazepine acetate structure.svg
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* Content
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| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_status = 
| routes_of_administration = Oral


<!--Pharmacokinetic data-->
<!--Adult Indications and Dosage-->
| bioavailability = 
| protein_bound = 
| metabolism = 
| elimination_half-life = 
| excretion = ~90% renal


<!--Identifiers-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
| CAS_number = 236395-14-5
|fdaLIADAdult======Condition1=====
| CAS_supplemental =
| ATC_prefix = N03
| ATC_suffix = AF04
| ATC_supplemental =
| PubChem = 179344
| DrugBank =
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 1067


<!--Chemical data-->
* Dosing Information
| chemical_formula =
 
| C=17 | H=16 | N=2 | O=3
:* Dosage
| molecular_weight = 296.320 g/mol
 
| smiles = CC(=O)OC2Cc1ccccc1N(C(N)=O)c3c2cccc3
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
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=====Condition4=====
 
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<!--Off-Label Use and Dosage (Adult)-->
 
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* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
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* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
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* Dosing Information
 
:* Dosage
 
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<!--Warnings-->
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=====Endocrine=====
 
 
 
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|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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* Intravenous
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====Signs and Symptoms====
 
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<!--Pharmacokinetics-->
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==Overview==
'''Eslicarbazepine acetate''' ('''BIA 2-093''') is an [[antiepileptic]] drug. It is a [[prodrug]] which is activated to '''eslicarbazepine''' (''S''-[[licarbazepine]]), an active metabolite of [[oxcarbazepine]].<ref name="Dulsat" />


It is being developed by [[Bial]]<ref>[http://ec.europa.eu/enterprise/pharmaceuticals/register/h520.htm Community register of medicinal products for human use: Exalief]</ref> and will be marketed as '''Zebinix''' or '''Exalief''' by [[Eisai Co.]] in Europe and as '''Stedesa''' by [[Sepracor]]<ref name="medicalnewstoday" /> in America.


The [[European Medicines Agency]] (EMA) has recommended granting marketing authorization in 2009 for [[combination therapy|adjunctive therapy]] for [[Partial seizure|partial-onset seizures]], with or without secondary generalisation, in adults with [[epilepsy]].<ref name="Dulsat">{{cite journal
| author = Dulsat, C., Mealy, N., Castaner, R., Bolos, J.
| title = Eslicarbazepine acetate
| journal = Drugs of the Future
| year = 2009
| volume = 34
| issue = 3
| pages = 189
| doi = 10.1358/dof.2009.034.03.1352675
}}</ref>
The [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) announced on 2 June 2009 that the drug has been accepted for filing.<ref name="medicalnewstoday">[http://www.medicalnewstoday.com/articles/152305.php Medical News Today: Sepracor's STEDESA (Eslicarbazepine Acetate) New Drug Application Formally Accepted For Review By The FDA]</ref>


== Mechanism of action and indications ==
<!--Label Display Image-->
Eslicarbazepine acetate is a prodrug for S(+)-licarbazepine, the major active metabolite of oxcarbazepine.<ref>{{Cite journal
| first = MA
| last = Rogawski
| authorlink =
| coauthors =
| year = 2006
| month = Jun
| date =
| title = Diverse Mechanisms of Antiepileptic Drugs in the Development Pipeline
| quote =
| journal = Epilepsy Res
| volume = 69
| issue = 3
| pages = 273–294
| pmid = 16621450
| id =
| url =
| format =
| accessdate =
| doi=10.1016/j.eplepsyres.2006.02.004
| pmc=1562526
}}</ref> Its mechanism of action is therefore identical to that of oxcarbazepine.
<ref>{{cite journal | pmid = 15208697 | doi=10.1038/nrn1430 | volume=5 | issue=7 | title=The neurobiology of antiepileptic drugs | year=2004 | month=July | pages=553–64 | author=Rogawski MA, Löscher W | journal = Nature Reviews Neuroscience}}</ref> There may, however, be pharmacokinetic differences. Eslicarbazepine acetate may not produce as high peak levels of (''S'')-(+)-licarbazepine immediately after dosing as does oxcarbazepine which could theoretically improve tolerability.


Like oxcarbazepine, eslicarbazepine may be used to treat [[bipolar disorder]] and [[trigeminal neuralgia]].


==Patents==
The first European [[patent]] to protect this drug is {{patent|EP|0751129}}. The priority of this European patent is the Portuguese patent application {{patent|PT|101732}}.


== References ==
{{Reflist|2}}


{{Anticonvulsants}}
{{Mood stabilizers}}
{{Tricyclics}}


{{DEFAULTSORT:Eslicarbazepine Acetate}}
<!--Category-->
[[Category:Anticonvulsants]]
[[Category:Enantiopure drugs]]
[[Category:Dibenzazepines]]
[[Category:Ureas]]
[[Category:Acetate esters]]
[[Category:Portuguese inventions]]
{{anticonvulsant-stub}}


[[de:Eslicarbazepinacetat]]
[[Category:Drug]]
[[hu:Eslikarbazepin-acetát]]
[[pt:Acetato de eslicarbazepina]]

Revision as of 14:21, 11 March 2015

Eslicarbazepine acetate
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

Eslicarbazepine acetate 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 Eslicarbazepine acetate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Eslicarbazepine acetate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Eslicarbazepine acetate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Eslicarbazepine acetate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Eslicarbazepine acetate 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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