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Anti-epileptic Agent • Prescription (Rx)

Extended Phenytoin Sodium

Brand Names: Phenytek, Dilantin

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2024-10-15 • RxNorm RxCUI 855861 • 9 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Extended Phenytoin Sodium Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

89%
Patient “Worth It” (16)
$65.26
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Extended Phenytoin Sodium Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 855861 • NDC 0378-2670

1 Indications and usage phenytek: ® capsules (extended phenytoin sodium capsules) are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. PHENYTEK ® CAPSULES are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1 )

12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.

Clinical clearance of Extended Phenytoin Sodium (Anti-epileptic Agent) relies on phase i cyp2c9, cyp2c19 hepatic clearance and subsequent renal metabolite filtration with a Steady-state plasma equilibrium reached over 3–7 hour t½ intervals for Extended Phenytoin Sodium half-life; patients absorbing at Approximately 60% to 72% enteral uptake across labeled Extended Phenytoin Sodium strengths bioavailability typically observe target onset around maximum serum exposure occurs 2–5 hours after extended phenytoin sodium dosing.

FDA clinical labeling for Extended Phenytoin Sodium restricts administration in 4 contraindications phenytek ® capsules are contraindicated in patients with:; a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins .; reactions have included angioedema. across 100 mg/1 Capsule, Extended Release, 200 mg/1 Capsule, Extended Release, 30 mg/1 Capsule, Extended Release, with self-reported patient tracking dominated by nausea (8.1% of reports), headache (8% of reports), dizziness (6.6% of reports).

CYP450 & Metabolic Pathways: CYP2C9 CYP2C19
Key Monitored Interactions:
Hepatic CYP Inducers (Rifampin, Carbamazepine, Phenytoin) Moderate

Rifampin or anticonvulsant inducers can diminish Extended Phenytoin Sodium systemic exposure and clinical response.

CYP2C9 Metabolic Inhibitors & Inducers Moderate

Co-prescribing strong CYP2C9 inhibitors or inducers can modify Extended Phenytoin Sodium metabolic elimination kinetics.

Half-Life
Steady-state plasma equilibrium reached over 3–7 hour t½ intervals for Extended Phenytoin Sodium
Bioavailability
Approximately 60% to 72% enteral uptake across labeled Extended Phenytoin Sodium strengths
Metabolism & Clearance
Phase I CYP2C9, CYP2C19 hepatic clearance and subsequent renal metabolite filtration
Clinical Onset
Maximum serum exposure occurs 2–5 hours after Extended Phenytoin Sodium dosing

Standard Adult Titration & Dosages

100 mg/1 Capsule, Extended Release 200 mg/1 Capsule, Extended Release 30 mg/1 Capsule, Extended Release

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS PHENYTEK ® capsules are contraindicated in patients with:
  • A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins .
  • Reactions have included angioedema.

Logged Side-Effect Incidence (16 Reports)

Nausea 8.1%
Headache 8%
Dizziness 6.6%
Fatigue 6.2%
Diarrhea 5.8%
Dry mouth 5.1%
Elena Rostova (AI Biostatistician & openFDA Quant)

Extended Phenytoin Sodium Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (16)
Nausea FAERS: 8.1% • Logs: 8.1%
Fatigue FAERS: 6.2% • Logs: 6.2%
Diarrhea FAERS: 5.8% • Logs: 5.8%
Headache FAERS: 8% • Logs: 8%
Dizziness FAERS: 6.6% • Logs: 6.6%
Dry mouth FAERS: 5.1% • Logs: 5.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Extended Phenytoin Sodium)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Metformin extended-release vs. Metformin immediate-release: Which Works Better for Adults with type 2 diabetes?

MXR was associated with statistically worse but likely clinically similar HbA1c lowering and minimal improvement.

Diabetes research and clinical practice • 2021-08-15 • Meta-Analysis
N = 2,609 94/100 PMID 33887354 ↗
New Insights on Predicting efficacy of viloxazine extended-release treatment in adults with ADHD: What a 354-Participant Study Found

The ROC curves indicated that data collected up to Week 2 were sufficient to accurately predict treatment response at Week 6 with 68% positive predictive power, 80% sensitivity, and 74% specificity.

Psychiatry research • 2022-12-15 • Phase III Randomized Trial
N = 354 93/100 PMID 36375329 ↗
New Insights on Benefits and safety of a novel, extended-release rivastigmine transdermal patch: What a 362-Participant Study Found

However, analysis of the per-protocol set demonstrated a.

Journal of Alzheimer's disease : JAD • 2026-01-15 • Phase III Randomized Trial
N = 362 93/100 PMID 41364455 ↗
New Insights on Effect of palbociclib plus letrozole on patient-reported health-related quality: What a 444-Participant Study Found

This extended follow-up analysis of PROs in PALOMA-2 shows continued QoL maintenance for patients with ER+/HER2- mBC receiving long-term palbociclib plus letrozole treatment.

ESMO open • 2025-04-15 • Phase III Randomized Trial
N = 444 93/100 PMID 40107156 ↗
New Insights on Benefits and safety of bupropion hydrochloride extended-release versus: What a 538-Participant Study Found

Results from this study demonstrated that the efficacy of bupropion XL was non-inferior to that of escitalopram in Chinese patients with MDD.

Journal of affective disorders • 2019-10-01 • Randomized Controlled Trial
N = 538 93/100 PMID 31301615 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Extended Phenytoin Sodium Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 855861
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.4015/unit (~$42.05/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $159.89 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 16 Anonymous DotMD Community Micro-Logs $65.26 / mo View logs ↓

Extended Phenytoin Sodium Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Extended Phenytoin Sodium RxNorm Concept ID 855861 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.4015 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $159.89 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $65.26 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 89.00% Worth It (16 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Extended Phenytoin Sodium Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Extended Phenytoin Sodium: FDA labeling (2024-10-15, NDC 0378-2670), CYP/interaction screening, and public pharmacy acquisition costs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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