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-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
<!--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>
<!--Drug Shortage Status-->
|drugShortage=
}}
}}
'''Fosphenytoin''' ('''Cerebyx®''', [[Parke-Davis]]; '''Prodilantin®''', [[Pfizer|Pfizer Holding France]]<ref name=French_trade_name>{{cite web | url=http://www.vidal.fr/Medicament/prodilantin-13783.htm | title=PRODILANTIN 75 mg/ml sol inj IM et p perf IV | work=VIDAL, l'information de référence sur les produits de santé | accessdate=23 October | accessyear=2005}}</ref>) is a water-soluble [[phenytoin]] [[prodrug]] used only in hospitals for the treatment of epileptic [[seizure]]s.
{{PillImage
|fileName=No image.jpg
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{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->
On 18 November 2004, Sicor (a subsidiary of [[Teva Pharmaceutical Industries|Teva]]) received a tentative approval letter from the [[United States Food and Drug Administration]] for a generic version of fosphenytoin.<ref name=generic>{{cite web | url=http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist | title=Fosphenytoin Sodium Approval History | accessdate=20 October | accessyear=2005 }}</ref>
== Uses ==
=== Approved ===
Fosphenytoin is approved in the United States for the short term (five days or less) treatment of epilepsy when more widely used means of phenytoin administration are not possible or are ill-advised,<ref name=approved_use>{{cite web | author=Parke-Davis | year=2001 | title=Cerebyx®: Fosphenytoin Sodium Injection - Labeling Revision | work=Cerebyx Approval History | publisher=Warner-Lambert Company | url=http://www.fda.gov/cder/foi/label/2001/20450s4s5lbl.pdf | accessdate=20 October | accessyear=2005 | format=PDF }}</ref> such as [[endotracheal intubation]], [[status epilepticus]] or some other type of repeated seizures; vomiting, and/or the patient is unalert or not awake or both.<ref name=when_to_use_fosphenytoin>{{cite journal | author=Johnson J, Wrenn K | title=Inappropriate fosphenytoin use in the ED | journal=American Journal of Emergency Medicine | volume=19 | issue=4 | year=2001 | pages=293-4 | id=PMID 11447516}} [http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=11447516&dopt=ExternalLink Fulltext options] [http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=11447516&dopt=ExternalLink&ExternalLink=libs List of Library Holdings Worldwide]</ref>
=== Unapproved/off-label/investigational ===
In April of 2003, Applebaum and colleagues at the [[Ben-Gurion University of the Negev]] in [[Beersheba]] reported that even though [[anticonvulsant]]s are often very effective in [[mania]], and acute mania requires rapid treatment, fosphenytoin had no antimanic effect even 60 minutes after administration of doses used in status epilepticus.<ref name=not_an_antimanic>{{cite journal | author=Applebaum J, Levine J, Belmaker RH | title=Intravenous fosphenytoin in acute mania | journal=Journal Clinical Psychiatry | volume=64 | issue=4 | year=2003 | pages=408-9 | id=PMID 12716241 | url=http://www.psychiatrist.com/privatepdf/2003/v64n04/v64n0408.pdf | format=PDF}}</ref>
Fosphenytoin was more successfully used to relieve pain refractory to [[opiate]]s in a 37-year-old woman with [[neuroma]], according to Dr. Gary J. McCleane of the Rampark Pain Center in [[Lurgan]], [[Northern Ireland]].<ref name=neuropathic_pain>{{cite journal | author=McCleane GJ | title=Intravenous infusion of fosphenytoin produces prolonged pain relief: a case report | journal=The Journal of Pain | volume=3 | issue=2 | year=2002 | pages=156-8 | id=PMID 14622802 | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=14622802&dopt=ExternalLink}} [http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=14622802&dopt=ExternalLink&ExternalLink=libs List of Library Holdings Worldwide]</ref> She was given 1,500 phenytoin equivalent units of fosphenytoin over a 24 hour period, producing pain relief that last three to fourteen weeks after each infusion, allowing her to use less opiates.<ref name=neuropathic_pain />
<!--Label Display Image-->
== Metabolism ==
One mmol ([[milli]][[mole (unit)|mole]]) of phenytoin is produced for every mmol of fosphenytoin administered; the [[hydrolysis]] of fosphenytoin also yields [[phosphate]] and [[formaldehyde]], the latter of which is subsequently metabolized to [[formate]], which is in turn metabolized by a folate dependent mechanism.<ref name=approved_use />
== Side effects ==
Side effects are similar to phenytoin, except that fosphenytoin causes less [[hypotension]] and more [[paresthesia]].<ref name=less_and_more>{{cite journal | author=Browne TR. | title=Fosphenytoin (Cerebyx) | journal=Clinical Neuropharmacology | volume=20 | issue=1 | year=1997 | pages=1-12 | id=PMID 9037568}} [http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=9037568&dopt=ExternalLink&ExternalLink=libs List of Library Holdings Worldwide]</ref> Fosphenytoin can cause [[hyperphosphatemia]] in end-stage [[renal failure]] patients.<ref name=not_in_kidney_failure>{{cite journal | author=McBryde KD, Wilcox J, Kher KK | title=Hyperphosphatemia due to fosphenytoin in a pediatric ESRD patient | journal=Pediatric Nephrology (Berlin, Germany) | volume=20 | issue=8 | year=2005 | pages=1182-5 | id=PMID 15965770 | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&list_uids=15965770&dopt=ExternalLink | format = PDF}}</ref>
==History==
Phenytoin, in both its acidic and sodium salt forms, is erratically bioavailable whether it is injected or taken orally due to its high [[melting point]], weak [[acidity]], and its being only sparingly [[solubility|soluble]] in water.<ref name=erratic>Yamaoka Y, Roberts RD, Stella VJ. "Low-melting phenytoin prodrugs as alternative oral delivery modes for phenytoin: a model for other high-melting sparingly water-soluble drugs." ''Journal of Pharmaceutical Science.'' 1983 Apr;72(4):400-5. PMID 6864479</ref> Simply putting patients on other drugs is not always an option; this was especially true before 1993, when the number of [[anticonvulsant]]s available was much more limited.<ref name=pre-1993>[http://neuroland.com/sz/anticon/before_93.htm Anticonvulsants before 1993] Neuroland</ref> One solution was to develop a prodrug that did not have these drawbacks.
Fosphenytoin was approved by the [[Food and Drug Administration]] (FDA) on August 5, 1996 for use in epilepsy.<ref name=approval>{{cite web | url=http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory | title=Cerebyx Approval History | accessdate=20 October | accessyear=2005}}</ref>
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Fosphenytoin 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 Fosphenytoin in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fosphenytoin 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 Fosphenytoin 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 Fosphenytoin in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fosphenytoin 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 Fosphenytoin 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 Fosphenytoin in the drug label.
