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
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
- First Posted Date
- 2010-05-13
- Last Posted Date
- 2021-01-27
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Target Recruit Count
- 34
- Registration Number
- NCT01122953
- Locations
- 🇲🇽
Pfizer Investigational Site, Mexico, Distrito Federal, Mexico
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
- Conditions
- NeuroblastomaImmunodeficienciesAnemiaLeukemiaLymphoma
- Interventions
- Radiation: Total Body IrradiationDrug: Horse Antithymocyte Globulin
- First Posted Date
- 2008-12-04
- Last Posted Date
- 2019-03-27
- Lead Sponsor
- Columbia University
- Target Recruit Count
- 1
- Registration Number
- NCT00801931
- Locations
- 🇺🇸
Columbia Presbyterian Medical Center, New York, New York, United States
Antiepileptic Drugs and Vascular Risk Markers
- Conditions
- Subarachnoid Hemorrhage
- Interventions
- First Posted Date
- 2008-10-17
- Last Posted Date
- 2017-12-18
- Lead Sponsor
- Thomas Jefferson University
- Target Recruit Count
- 52
- Registration Number
- NCT00774306
Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg
- Conditions
- Healthy
- Interventions
- Drug: Extended Phenytoin Sodium Capsules 100 mg
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-24
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 72
- Registration Number
- NCT00647621
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
AED/Statin Interaction Study
- First Posted Date
- 2008-03-03
- Last Posted Date
- 2017-08-04
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 119
- Registration Number
- NCT00627575
- Locations
- 🇺🇸
GSK Investigational Site, Buffalo, New York, United States
Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
- Conditions
- Traumatic Brain InjurySubarachnoid Hemorrhage
- Interventions
- First Posted Date
- 2008-02-20
- Last Posted Date
- 2014-04-07
- Lead Sponsor
- University of Cincinnati
- Target Recruit Count
- 52
- Registration Number
- NCT00618436
- Locations
- 🇺🇸
University of Cincinnati Hospital, Cincinnati, Ohio, United States
Evaluating the Transporter Protein Inhibitor Probenecid In Patients With Epilepsy
- First Posted Date
- 2008-02-08
- Last Posted Date
- 2013-05-14
- Lead Sponsor
- Jim McAuley
- Target Recruit Count
- 8
- Registration Number
- NCT00610532
- Locations
- 🇺🇸
The Ohio State University, Columbus, Ohio, United States
Preventing Epilepsy After Traumatic Brain Injury With Topiramate
- Conditions
- EpilepsyTraumatic Brain Injury
- Interventions
- First Posted Date
- 2008-01-23
- Last Posted Date
- 2017-06-27
- Lead Sponsor
- University of Pennsylvania
- Target Recruit Count
- 6
- Registration Number
- NCT00598923
Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-01-11
- Last Posted Date
- 2015-08-19
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Target Recruit Count
- 17
- Registration Number
- NCT00591006
- Locations
- 🇺🇸
UT Southwestern Medical Center of Dallas/Parkland Memorial Hospital, Dallas, Texas, United States
Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study
- Conditions
- Cognitive MeasuresDriving Simulator Performance
- Interventions
- Drug: Placebo oral capsule
- First Posted Date
- 2007-12-28
- Last Posted Date
- 2021-07-01
- Lead Sponsor
- University of Iowa
- Target Recruit Count
- 20
- Registration Number
- NCT00581893
- Locations
- 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Drug Development Updates
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