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__NOTOC__
{{DrugProjectFormSinglePage
{{Carbamazepine}}
|authorTag=
{{CMG}}; {{AE}} {{PB}}


'''''For patient information about Carbamazepine, click [[Carbamazepine (patient information)|here]].'''''


{{SB}} Tegretol<sup>®</sup>, Biston<sup>®</sup>, Calepsin<sup>®</sup>, Carbatrol<sup>®</sup>, Epitol<sup>®</sup>, Equetro<sup>®</sup>, Finlepsin<sup>®</sup>, Sirtal<sup>®</sup>, Stazepine<sup>®</sup>, Telesmin<sup>®</sup>, Timonil<sup>®</sup>, Trimonil<sup>®</sup>, Epimaz<sup>®</sup>, Degranol<sup>®</sup>.
<!--Overview-->


==Overview==
|genericName=
{{drugbox
 
| IUPAC_name = 5''H''-dibenz[b,f]azepine-5-carboxamide
 
| image = Carbamazepine.png
 
| image2 = Carbamazepine 3D.png
|aOrAn=
| width=127
 
| CAS_number = 298-46-4
a
| CAS_supplemental = {{CAS|85756-57-6}} (dihydrate)
 
| ATC_prefix = N03
|drugClass=
| ATC_suffix = AF01
 
| ATC_supplemental =  
 
| PubChem = 2554
 
| DrugBank = APRD00337
|indication=
| C=15 | H=12 | N=2 | O=1
 
| molecular_weight = 236.269 g/mol
 
| bioavailability = 80%
 
| protein_bound = 76%
|hasBlackBoxWarning=
| metabolism = [[Liver|Hepatic]]—by [[CYP3A4]], to active [[epoxide]] form (carbamazepine-10,11 epoxide)
 
| elimination_half-life = 25–65 hours
Yes
| excretion = 2–3% excreted unchanged in urine
 
| pregnancy_US = C
|adverseReactions=
| legal_AU =  
 
| legal_UK = POM
 
| legal_US =  
 
| legal_status =  
<!--Black Box Warning-->
| routes_of_administration = Oral
 
}}
|blackBoxWarningTitle=
'''Carbamazepine ("CBZ")''' is an [[anticonvulsant]] and [[mood stabilizer|mood stabilizing]] drug, used primarily in the treatment of [[epilepsy]] and [[bipolar disorder]]. It is also used to treat [[Attention-deficit hyperactivity disorder|ADD]], [[ADHD]], [[schizophrenia]] and [[trigeminal neuralgia]].
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=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*
 
<!--Structure-->
 
|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
 
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
 
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->


== History ==
|nonClinToxic=
Carbamazepine was discovered by chemist Walter Schindler at J.R. Geigy AG (now part of [[Novartis]]) in [[Basel]], [[Switzerland]], in 1953.<ref>Schindler W, Häfliger F (1954). "Über Derivate des Iminodibenzyls". ''[[Helvetica Chimica Acta]]'' '''37''' (2): 472–483. {{doi|10.1002/hlca.19540370211}}.</ref> Schindler then synthesized the drug in 1960, before its anti-epileptic properties had been discovered.


Carbamazepine was first marketed as a drug to treat [[trigeminal neuralgia]] in 1962. It has been used as an anticonvulsant in the [[United Kingdom|UK]] since 1965, but only approved in the [[United States|U.S.]] since 1974.
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


== Adverse effects ==
<!--Clinical Studies-->
Carbamazepine renders certain methods of [[hormonal contraception]] ineffective because it is an enzyme inducer of the cytochrome P450 system which metabolises the oral contraceptive, leaving less active contraceptive in the plasma.


Common [[adverse drug reaction|side effect]]s include drowsiness, [[motor coordination]] impairment and/or upset stomach. Carbamazepine preparations can greatly decrease alcohol tolerance.
|clinicalStudies=


Less common side effects include cardiac arrhythmias, blurry or double [[Visual perception|vision]] and/or the temporary or mild loss of [[blood cell]]s or [[platelet]]s. In rare cases the latter can be life-threatening if unnoticed, so frequent blood tests are required during the first few months' use, followed by three or four tests per year. In the UK testing would be less frequent in long-term use, typically once every year or two. Underactivity of the thyroid gland may be provoked, so thyroid function tests are advisable every year or two.
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


Small reductions in white cell count and serum sodium are common.
<!--How Supplied-->


There are also reports of an auditory side effect, whereby patients perceive musical notes about a [[semitone]] lower than their actual pitch (so [[middle C]] would be heard as the note B3 just below it, etc).
|howSupplied=


[[Oxcarbazepine]], a derivative of carbamazepine, has fewer and less serious side effects.
*


Carbamazepine may cause [[Syndrome of inappropriate antidiuretic hormone|SIADH]] (syndrome of inappropriate antidiuretic hormone), since it both increases the release and potentiates the action of ADH ([[vasopressin]]).
<!--Patient Counseling Information-->


Carbamazepine may aggravate [[juvenile myoclonic epilepsy]], so it is important to mention any history of jerking, especially in the morning, before starting to take this drug.
|fdaPatientInfo=


Pregnant women taking carbamazepine for seizures are putting their fetuses at increased risk for teratogenic effects and should be given [[folic acid]] supplementation and undergo prenatal ultrasonography for diagnosis.
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


In addition, carbamazepine has been linked to serious adverse cognitive effects, including EEG slowing<ref>http://www.blackwell-synergy.com/doi/abs/10.1046/j.1528-1157.2002.22501.x</ref> and cell apoptosis<ref>http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=8719616&dopt=AbstractPlus</ref>.
<!--Precautions with Alcohol-->
==Category==


==FDA Package Insert==
|alcohol=
==TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release  Normal  0          false  false  false    EN-US  X-NONE  X-NONE==
'''  [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release indications and usage|Indications and Usage]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release dosage and administration|Dosage and Administration]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release contraindications|Contraindications]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release warnings and precautions|Warnings and Precautions]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release adverse reactions|Adverse Reactions]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release drug interactions|Drug Interactions]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release use in specific populations|Use in Specific Populations]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release overdosage|Overdosage]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release description|Description]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release clinical pharmacology|Clinical Pharmacology]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release clinical studies|Clinical Studies]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release patient counseling information|Patient Counseling Information]]'''
'''| [[TEGRETOL (carbamazepine) tablet,chewable, TEGRETOL (carbamazepine) suspension, TEGRETOL (carbamazepine) tablet, TEGRETOL XR (carbamazepine) tablet, extended release labels and packages|Labels and Packages]]'''


== Mechanisms ==
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
The mechanism of action of carbamazepine and its derivatives is relatively well understood. Voltage-gated [[sodium channel]]s are the molecular pores that allow brain cells ([[neuron]]s) to generate [[action potential]]s, the electrical events that allow [[neuron]]s to communicate over long distances. After the sodium channels open, to start the action potential, they inactivate, essentially closing the channel. Carbamazepine stabilizes the inactivated state of sodium channels, meaning that fewer of these channels are available to open, making brain cells less excitable.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | publisher =  | date =  | accessdate = }}</ref>  Normal  0          false  false  false    EN-US  X-NONE  X-NONE                                                                                                                                                                                         
== Interactions ==


[[Valproic acid]] and [[valnoctamide]] both interact with carbamazepine, as they inhibit [[epoxide hydrolase|microsomal epoxide hydrolase]] (mEH), the [[enzyme]] responsible for the breakdown of carbamazepine-10,11 epoxide into inactive metabolites.<ref>{{cite book |last=Gonzalez |first=Frank J. |coauthors=Robert H. Tukey |editor=Laurence Brunton, John Lazo, Keith Parker (eds.) |title=[[Goodman & Gilman's The Pharmacological Basis of Therapeutics]] |edition=11<sup>th</sup> ed. |year=2006 |publisher=[[McGraw-Hill]] |location=New York |isbn=978-0071422802|pages=p. 79 |chapter=Drug Metabolism }}</ref> By inhibiting mEH, valproic acid and valnoctamide cause a buildup of the active metabolite, prolonging the effects of carbamazepine and delaying its excretion.
<!--Brand Names-->


Carbamazepine,as CYP 450 inducer, may increase clearance of many drugs, decreasing their blood levels.
|brandNames=
                                                                                                                                                                                         
==References==


{{Reflist|2}}
* ®<ref>{{Cite web | title =  | url =  }}</ref>


{{Antimigraine preparations}}
<!--Look-Alike Drug Names-->
[[Category:Drugs]]


|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>


<!--Drug Shortage Status-->


== See also ==
|drugShortage=
* [[Oxcarbazepine]]
}}


== Notes ==
<!--Pill Image-->
{{Reflist}}


== External links ==
{{PillImage
* [http://www.carbatrol.com Carbatrol website]
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
* [http://www.equetro.com Equetro website]
|drugName=
* [http://www.rxlist.com/cgi/generic/carbam.htm TA warning]
|NDC=
* [http://www.psycheducation.org/depression/meds/carbamazepine.htm Carbamazepine overview] from PsychEducation.org
|drugAuthor=
* [http://patimg1.uspto.gov/.piw?Docid=02948718&homeurl=http%3A%2F%2Fpatft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO1%2526Sect2%3DHITOFF%2526d%3DPALL%2526p%3D1%2526u%3D%2Fnetahtml%2Fsrchnum.htm%2526r%3D1%2526f%3DG%2526l%3D50%2526s1%3D2,948,718.WKU.%2526OS%3DPN%2F2,948,718%2526RS%3DPN%2F2,948,718&PageNum=&Rtype=&SectionNum=&idkey=2A0649DBED16 U.S. Patent 2,948,718, August 1960]
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


{{Anticonvulsants}}
<!--Label Display Image-->


<!--Categories-->
{{LabelImage
[[Category:Carboxamides]]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
[[Category:Anticonvulsants]]
}}
[[Category:Mood stabilizers]]
 
[[Category:Prodrugs]]
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


<!--Other languages-->
<!--Category-->


[[de:Carbamazepin]]
[[Category:Drug]]
[[es:Carbamazepina]]
[[fa:کاربامازپین]]
[[fr:Carbamazépine]]
[[hr:Karbamazepin]]
[[it:Carbamazepina]]
[[hu:Karbamazepin]]
[[nl:Carbamazepine]]
[[pl:Karbamazepina]]
[[pt:Carbamazepina]]
[[ru:Карбамазепин]]
[[sv:Karbamazepin]]
[[zh:卡马西平]]
{{WikiDoc Help Menu}}

Revision as of 14:10, 30 September 2014

Carbamazepine
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

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

Overview

Carbamazepine is a that is FDA approved for the {{{indicationType}}} 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 Carbamazepine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

Title
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 Carbamazepine 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 Carbamazepine 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 Carbamazepine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Carbamazepine01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Carbamazepine 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 Carbamazepine in the drug label.

Precautions with Alcohol

  • Alcohol-Carbamazepine 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.

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