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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide
|authorTag=
| image =
 
| width = 130
{{VP}}
| CAS_number = 28721-07-5
 
| ATC_prefix = N03
<!--Overview-->
| ATC_suffix = AF02
 
| ATC_supplemental =  
|genericName=
| PubChem = 34312
 
| DrugBank = APRD01308
Oxcarbazepine
| C = 15 | H = 12 | N = 2 | O = 2
 
| molecular_weight = 252.268 g/mol
|aOrAn=
| bioavailability = > 95%
 
| protein_bound = ?
an
| metabolism = Hepatic <br><small>(Cytosolic Enzymes & Glucuronic Acid)</small>
 
| elimination_half-life = 1-5 hours (healthy adults)
|drugClass=
| pregnancy_US = C
 
| legal_US = Rx-only
[[antiepileptic]] drug
| routes_of_administration = Oral (Tablets or Suspension)
 
| excretion = Renal
|indication=
}}
 
'''Oxcarbazepine''' (marketed as '''Trileptal'''<sup>®</sup> by [[Novartis]]) is an [[anticonvulsant]] and [[mood stabilizer|mood stabilizing drug]], used primarily in the treatment of [[epilepsy]] and [[bipolar disorder]].
[[partial seizures]]
 
|hasBlackBoxWarning=
 
|adverseReactions=
 
[[dizziness]], [[somnolence]], [[diplopia]], [[fatigue]], [[nausea]], [[vomiting]], [[ataxia]], abnormal vision, [[abdominal pain]], [[tremor]], [[dyspepsia]], [[abnormal gait]]
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====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 (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
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====Precautions====
 
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=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
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=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
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|useInImmunocomp=
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<!--Administration and Monitoring-->
 
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* Oral
 
* Intravenous
 
|monitoring=
 
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* Description
 
<!--IV Compatibility-->
 
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<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
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===Chronic Overdose===
 
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
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There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
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<!--How Supplied-->


Oxcarbazepine is structurally a derivative of [[carbamazepine]], adding an extra [[oxygen]] atom on the dibenzazepine ring. This difference helps reduce the impact on the [[liver]] of [[drug metabolism|metabolizing]] the drug, and also prevents the serious forms of [[anemia]] occasionally associated with [[carbamazepine]]. Aside from this reduction in side effects, it is thought to have the same mechanism as carbamazepine - [[sodium channel]] inhibition - and is generally used to treat the same conditions.  Oxcarbazepine has recently been found associated with a greater enhancement in mood and reduction in anxiety symptoms than other drugs employed to treat epilepsy.<!--
|howSupplied=


--><ref name="Mazza_2007"> Mazza M, Della Marca G, Di Nicola M, Martinotti G, Pozzi G, Janiri L, Bria P, Mazza S. ''Oxcarbazepine improves mood in patients with epilepsy.'' Epilepsy Behav. 2007 May;10(3):397-401. Epub 2007 Feb 14. PMID 17300991</ref><!--
*


-->
<!--Patient Counseling Information-->


==Side effects==
|fdaPatientInfo=
Oxcarbazepine occasionally causes fatigue, nausea, vomiting, headache, dizziness, drowsiness, and blurred or double vision. It can cause [[hyponatremia]], so blood sodium levels should be tested if the patient complains of severe fatigue.  Some of these side effects (such as headache) are more pronounced shortly after a dose is taken and tend to fade with the passage of time (generally 60 to 90 minutes).
Along with these side effects, pseudo side effects have also been that of desires for salty foods (such as potato chips).


Concentration loss is also reported to be a frequent side effect. Its appearance seems correlated to whether the patients actually make use of their concentration; for example, people working in areas related to mathematical reasoning seem to have trouble in almost every case. In other words, Oxcarbazepine seems to decrease the patient's IQ,{{Fact|date=June 2007}} but this is only noticed by people whose life actually depends on their reasoning capabilities.
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==History==
<!--Precautions with Alcohol-->
First synthesized in 1966,{{Fact|date=April 2007}} it was approved for use as an anticonvulsant in Denmark in 1990. It was approved in Spain in 1993, in Portugal in 1997, and eventually for all other EU countries in 1999. It was approved in the US in 2000.


==Other information==
|alcohol=
Oxcarbazapine may cause oral hormonal contraceptives to be less effective.


Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose.  
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


When pregnant rats were given oxcarbazepine (30, 300, or 1000 mg/kg) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). Increased embryofetal death and decreased fetal body weights were seen at the high dose. Doses ≥ 300 mg/kg were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects.
<!--Brand Names-->


In a study in which pregnant rabbits were orally administered MHD (20, 100, or 200 mg/kg) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the MRHD on a mg/m2 basis). This dose produced only minimal maternal toxicity.
|brandNames=


In a study in which female rats were dosed orally with oxcarbazepine (25, 50, or 150 mg/kg) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (0.6 times the MRHD on a mg/m2 basis). Oral administration of MHD (25, 75, or 250 mg/kg) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the MRHD on a mg/m2 basis).
* ®<ref>{{Cite web | title =  | url =  }}</ref>


There are no adequate and well-controlled clinical studies of Trileptal in pregnant women; however, Trileptal is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. Given this fact, and the results of the animal studies described, it is likely that Trileptal is a human teratogen. Trileptal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
<!--Look-Alike Drug Names-->


===Labor and Delivery===
|lookAlike=


The effect of Trileptal on labor and delivery in humans has not been evaluated.  
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


===Nursing Mothers===
<!--Drug Shortage Status-->


Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. A milk-to-plasma concentration ratio of 0.5 was found for both. Because of the potential for serious adverse reactions to Trileptal in nursing infants, a decision should be made about whether to discontinue nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother.
|drugShortage=
}}


==References==
<!--Pill Image-->
<div class="references-small">
<references/>
</div>


*[http://www.chemicalland21.com/lifescience/phar/OXCARBAZEPINE.htm ChemicalLand21.com: Oxcarbazepine]
{{PillImage
*[http://www.trileptal.info/media_center/content/pages/media_center/story.htm Trileptal Story]
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
*[http://www.trileptal.com/ Trileptal.com(Novartis)]
|drugName=
*[http://www.pharma.us.novartis.com/product/pi/pdf/trileptal.pdf Prescribing Information(PDF)]
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


==External links==
<!--Label Display Image-->
*[http://www.bipolarchild.com/newsletters/0108.html Explanatory article]
*[http://www.bipolarchild.com/newsletters/metabolism_oxcarb.html Diagram illustrating the chief difference between oxcarbazepine and carbamazepine]
*[http://www.rxlist.com/cgi/generic3/oxcarbazepine.htm RxList entry]
*http://www.psycheducation.org/depression/meds/moodstabilizers.htm
*http://www.psycheducation.org/depression/meds/trileptal.htm
*[http://redpoll.pharmacy.ualberta.ca/drugbank/cgi-bin/getCard.cgi?CARD=APRD01308 DrugBank entry]
[[Image:Trileptal tablets.jpg|thumb|right|300mg Trileptal tablets]]


{{Anticonvulsants}}
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
 
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


[[Category:Anticonvulsants]]
<!--Category-->
[[Category:Carboxamides]]
[[Category:Mood stabilizers]]


[[de:Oxcarbazepin]]
[[Category:Drug]]
[[ru:Окскарбазепин]]
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Revision as of 15:24, 10 November 2014

Oxcarbazepine
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]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Overview

Oxcarbazepine is an antiepileptic drug that is FDA approved for the {{{indicationType}}} of partial seizures. Common adverse reactions include dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait.

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 Oxcarbazepine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Oxcarbazepine 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 Oxcarbazepine 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 Oxcarbazepine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Oxcarbazepine 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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