MedPath

Phenytoin

Generic Name
Phenytoin
Brand Names
Dilantin, Phenytek
Drug Type
Small Molecule
Chemical Formula
C15H12N2O2
CAS Number
57-41-0
Unique Ingredient Identifier
6158TKW0C5
Background

Phenytoin is classified as a hydantoin derivative and despite its narrow therapeutic index, it is one of the most commonly used anticonvulsants. Since it's introduction about 80 years ago, phenytoin has not only been established as an effective anti-epileptic, but has also been investigated for several other indications such as bipolar disorder, retina protection, and wound healing.

Clinicians are advised to initiate therapeutic drug monitoring in patients who require phenytoin since even small deviations from the recommended therapeutic range can lead to suboptimal treatment, or adverse effects. Both parenteral and oral formulations of phenytoin are available on the market.

Indication

Phenytoin is indicated to treat grand mal seizures, complex partial seizures, and to prevent and treat seizures during or following neurosurgery. Injectable phenytoin and Fosphenytoin, which is the phosphate ester prodrug formulation of phenytoin, are indicated to treat tonic-clonic status epilepticus, and for the prevention and treatment of seizures occurring during neurosurgery.

Associated Conditions
Complex Partial Seizure Disorder, Generalized Tonic-Clonic Seizures, Grand Mal Status Epilepticus, Jacksonian epilepsy, Partial-Onset Seizures, Petit Mal Epilepsy, Seizure Disorder, Post Traumatic, Seizures, Status; Epilepticus, Tonic-clonic, Temporal Lobe Epilepsy (TLE), Convulsive disorders

Pharmacokinetics of Antiepileptics in Patients on CRRT

Completed
Conditions
Acute Kidney Injury
Renal Insufficiency
Renal Failure
Pharmacokinetics
Interventions
First Posted Date
2018-08-16
Last Posted Date
2021-10-05
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
18
Registration Number
NCT03632915
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible

Not Applicable
Completed
Conditions
Osteonecrosis Due to Drugs, Jaw
Interventions
First Posted Date
2017-08-31
Last Posted Date
2017-09-01
Lead Sponsor
Shiraz University of Medical Sciences
Target Recruit Count
20
Registration Number
NCT03269214

Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy

Not Applicable
Conditions
Anal Fistula
Interventions
Procedure: Anal fistulotomy
First Posted Date
2017-03-30
Last Posted Date
2017-03-31
Lead Sponsor
Mansoura University
Target Recruit Count
38
Registration Number
NCT03096522
Locations
🇪🇬

Mansoura university hospital, Mansoura, Dakahlia, Egypt

Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis

Phase 2
Completed
Conditions
Optic Neuritis
Interventions
Drug: placebo
First Posted Date
2016-10-20
Last Posted Date
2019-08-12
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
71
Registration Number
NCT02939937
Locations
🇮🇷

Eye Research Center Farabi Hosoital, Tehran, Iran, Islamic Republic of

Characterization of Epilepsy Patients BEEP 2b

First Posted Date
2016-03-14
Last Posted Date
2020-03-27
Lead Sponsor
Food and Drug Administration (FDA)
Target Recruit Count
21
Registration Number
NCT02707965
Locations
🇺🇸

University of Maryland, Baltimore, Baltimore, Maryland, United States

Phenytoin for Memory Impairment Secondary to Megestrol

Phase 4
Completed
Conditions
Cognitive Impairment
Interventions
Drug: Megestrol 800 mg liquid
Drug: Phenytoin-matched Placebo capsule
Drug: Megestrol-matched liquid Placebo
First Posted Date
2015-11-03
Last Posted Date
2019-09-09
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
21
Registration Number
NCT02595723
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Phenytoin in the Healing of Clean Surgical Wounds

Phase 2
Conditions
Wound
Re-Epithelialization
Interventions
Drug: Sugar solution
First Posted Date
2015-04-10
Last Posted Date
2015-04-10
Lead Sponsor
Children's Surgical Center, Cambodia
Target Recruit Count
100
Registration Number
NCT02413658
Locations
🇰🇭

Children's Surgical Centre, Phnom Penh, Cambodia

Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Phase 4
Terminated
Conditions
Seizures
Interventions
First Posted Date
2015-04-06
Last Posted Date
2016-01-07
Lead Sponsor
Lawson Health Research Institute
Target Recruit Count
3
Registration Number
NCT02409433
Locations
🇨🇦

University Hospital, London, Ontario, Canada

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations
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