HomeNDC LookupIngredientsPhenytoin Sodium › 61919-0815-72
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PHENYTOIN SODIUM 100 mg Capsule, 120-count

by DIRECT RX · 120 CAPSULE in 1 BOTTLE (61919-815-72)
NDC 61919-0815-72
🏷️ FDA NDC (as labeled) 61919-815-72 billing pads the product segment with a zero
This package
Contains120-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2087/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 61919-815-72
Product NDC 61919-815
11-digit billing NDC 61919081572
NCPDP billing unit EA — each (per item)
RxCUI 855671
UNII 4182431BJH
Application # ANDA040765
SPL Set ID df0bf42b-ce9a-42c3-8c24-46f1ea3bd214
Established class (EPC) Anti-epileptic Agent; Cytochrome
Mechanism of action Cytochrome P450 1A2 Inducers; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C19 Inducers; Cytochrome P450 2C8 Inducers; Cytochrome P450 2C9 Inducers; Cytochrome P450 2D6 Inducers
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-01
Route ORAL
Dosage form CAPSULE
Substance PHENYTOIN SODIUM
GPI-14 72200030200110
GPI class Phenytoin Sodium Extended
GCN Seq No 004521
GCN 17700
HICL code 001877
Ingredient (HICL) Phenytoin Sodium Extended
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 24:04.04.08
AHFS class Class Ib Antiarrhythmics
FDB label name PHENYTOIN SOD EXT 100 MG CAP
FDB brand name Phenytoin Sodium Extended
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-815-72 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61919-0815-72. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anti-epileptic Agent class.

Pharmacologic class Anti-epileptic Agent
Drug family (ATC) Hydantoin derivatives
How it works Cytochrome P450 2C9 Inducers, Cytochrome P450 2C19 Inducers, Cytochrome P450 2C8 Inducers, Cytochrome P450 2B6 Inducers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerDIRECT RX
Application holderAMNEAL PHARMACEUTICALS NY LLC
FDA applicationANDA040765 (ANDA)
Labeler code61919
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHENYTOIN SOD EXT 100 MG CAP Ingredient Phenytoin Sodium Extended
📖 What it is MedlinePlus · NLM

Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Phenytoin is an antiseizure medication — it's used to treat and prevent different types of seizures, including tonic-clonic (grand mal) seizures, complex partial seizures, and seiz...
  • The most important thing is to take it exactly as prescribed and not skip doses. If you're on chewable tablets or the liquid suspension, those are not once-a-day medications — they...
  • How do I take phenytoin correctly — are there any tricks I should know?
  • The most common side effects involve your nervous system — things like dizziness, unsteady walking, slurred speech, drowsiness, and rapid eye movements. These are often dose-relate...
📖 Read our full Phenytoin guide →
13
Nutrient depletion considerations

Phenytoin may be associated with lower levels of 13 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeCapsule
ImprintIP;212
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2087 $25.04 / 120 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenytoin Sodium 100 mg 00904-7416-61 Major 1 capsule $0.147 AB Availability likely
Phenytoin Sodium 100 mg 50268-0719-13 AvPAK 1 capsule $0.147 AB Availability likely
Extended Phenytoin Sodium 100 mg 60687-0841-01 American 100 capsules $0.147 AB Availability likely
Phenytoin Sodium 100 mg 65862-0692-01 Aurobindo 100 capsules $0.147 Availability likely
Dilantin 100 mg 58151-0110-01 Viatris 100 capsules $1.739 Availability likely
Extended Phenytoin Sodium 100 mg 00615-8556-39 NCS 30 capsules AB FDA listed
Phenytoin Sodium 100 mg 29300-0379-01 Unichem 100 capsules FDA listed
Phenytoin Sodium 100 mg 50090-3539-00 A-S 100 capsules AB FDA listed
Phenytoin Sodium 100 mg 50090-5700-00 A-S 100 capsules AB FDA listed
Phenytoin Sodium 100 mg 51407-0982-01 Golden 100 capsules AB FDA listed
Phenytoin Sodium 100 mg 51672-4111-00 Sun 10 capsules AB Discontinued
Phenytoin Sodium 100 mgthis 61919-0815-72 DIRECT 120 capsules AB FDA listed
Extended Phenytoin Sodium 100 mg 65162-0212-03 Amneal 30 capsules AB FDA listed
Phenytoin Sodium 100 mg 67046-0585-03 Coupler 30 capsules AB FDA listed
Phenytoin Sodium 100 mg 70518-0107-00 REMEDYREPACK 30 capsules AB FDA listed
Extended Phenytoin Sodium 100 mg 70518-2227-00 REMEDYREPACK 30 capsules AB Discontinued
Phenytoin Sodium 100 mg 70518-2293-01 REMEDYREPACK 1 capsule AB FDA listed
Phenytoin Sodium 100 mg 71610-0869-92 Aphena 270 capsules AB FDA listed
Phenytoin Sodium 100 mg 71610-0934-92 Aphena 270 capsules AB FDA listed
Phenytoin Sodium 100 mg 72162-1646-00 Bryant 1000 capsules AB Discontinued
Extended Phenytoin Sodium 100 mg 72162-2514-00 Bryant 1000 capsules AB FDA listed
Phenytoin Sodium 100 mg 82804-0269-72 Proficient 120 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Phenytoin Sodium — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Phenytoin Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$511.44
Claims incl. refills
18
Beneficiaries
Spend / beneficiary
Spend / claim
$28.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phenytoin Sodium — the ingredient across all brands.

Top reported reactions

Convulsion2,381
Seizure1,751
Fall1,027
Dizziness979
Drug Hypersensitivity946
Headache930
Fatigue883

Age at onset

Neonate12
Infant22
Child26
Adolescent13
Adult550
Elderly305

Reporter sex

20,229 reports
Male · 44%
Female · 55%
Unknown · 1%

Serious outcomes

Hospitalization6,565
Death1,487
Life-threatening812
Disabling618
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,261 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0815-30 30 CAPSULE in 1 BOTTLE (61919-815-30) 2014-01-01 Active
61919-0815-71 100 CAPSULE in 1 BOTTLE (61919-815-71) 2014-01-01 Active
61919-0815-72 You're viewing this 120 CAPSULE in 1 BOTTLE (61919-815-72) 2014-01-01 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61919-0815-72?
NDC 61919-0815-72 is a 120-count package — 120 capsule in 1 bottle.
What is the difference between NDC 61919-0815-72 and NDC 61919-0815-30?
Both are PHENYTOIN SODIUM 100 mg Capsule — the drug itself is identical. NDC 61919-0815-72 is the 120-count package, while NDC 61919-0815-30 is the 30 capsules package.
What NDC number is used to bill for this package of PHENYTOIN SODIUM 100 mg Capsule?
Bill NDC 61919-0815-72 — the 11-digit billing format is 61919081572. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61919-815-72, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61919-0815-72, written without dashes as 61919081572. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61919-0815-72, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0815) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (72) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DIRECT RX. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 capsules (61919-0815-30), 100 capsules (61919-0815-71). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
DIRECT RX is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 56 words

INDICATIONS & USAGE SECTION Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).

⏱️ Dosage and Administration ~3 min read

DOSAGE & ADMINISTRATION SECTION Serum concentrations should be monitored in changing from extended phenytoin sodium capsules, USP to Prompt Phenytoin Sodium Capsules, USP, and from the sodium salt to the free acid form. Extended phenytoin sodium capsules, USP are formulated with the sodium salt of phenytoin. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.

General: Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum level is usually 10 to 20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.

Adult Dosage: Divided daily dosage: Patients who have received no previous treatment may be started on one 100-mg extended phenytoin sodium capsule, USP three times daily and the dosage then adjusted to suit individual requirements. For most adults, the satisfactory maintenance dosage will be one capsule three to four times a day. An increase up to two capsules three times a day may be made, if necessary.

Once-a-day dosage: In adults, if seizure control is established with divided doses of three 100-mg extended phenytoin sodium capsules, USP daily, once-a-day dosage with 300 mg of extended phenytoin sodium capsules, USP may be considered. Studies comparing divided doses of 300 mg with a single daily dose of this quantity indicated absorption, peak plasma levels, biologic half-life, difference between peak and minimum values, and urinary recovery were equivalent. Once-a-day dosage offers a convenience to the individual patient or to nursing personnel for institutionalized patients and is intended to be used only for patients requiring this amount of drug daily.

A major problem in motivating noncompliant patients may also be lessened when the patient can take this drug once a day. However, patients should be cautioned not to miss a dose, inadvertently. Only extended phenytoin sodium capsules, USP are recommended for once-a-day dosing.

Inherent differences in dissolution characteristics and resultant absorption rates of phenytoin due to different manufacturing procedures and/or dosage forms preclude such recommendation for other phenytoin products. When a change in the dosage form or brand is prescribed, careful monitoring of phenytoin serum levels should be carried out. Loading dose: Some authorities have advocated use of an oral loading dose of phenytoin in adults who require rapid steady-state serum levels and where intravenous administration is not desirable.

This dosing regimen should be reserved for patients in a clinic or hospital setting where phenytoin serum levels can be closely monitored. Patients with a history of renal or liver disease should not receive the oral loading regimen. Initially, one gram of extended phenytoin sodium capsules, USP is divided into three doses (400 mg, 300 mg, 300 mg) and administered at two-hour intervals.

Normal maintenance dosage is then instituted 24 hours after the loading dose, with frequent serum level determinations. Dosing in Special Populations Patients with Renal or Hepatic Disease: Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution. Unbound phenytoin concentrations may be more useful in these patient populations.

Elderly Patients: Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required. Pediatric: Initiall…

Contraindications 54 words

CONTRAINDICATIONS SECTION Phenytoin, USP is contraindicated in those patients with a history of hypersensitivity to phenytoin, USP, its inactive ingredients, or other hydantoins. Coadministration of extended phenytoin sodium is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

⚠️ Warnings ~3 min read

WARNINGS SECTION Effects of Abrupt Withdrawal Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic medication arises, this should be done gradually. In the event of an allergic or hypersensitivity reaction, more rapid substitution of alternative therapy may be necessary.

In this case, alternative therapy should be an antiepileptic drug not belonging to the hydantoin chemical class. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including extended phenytoin sodium, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.

There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs. Table 1 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients RelativeRisk: Incidence of Events inDrug Patients/Incidence in Placebo Patients Risk Difference:Additional DrugPatients with Events Per1000 Patients Epilepsy 1 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing extended phenytoin sodium or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.

Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of…

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS SECTION Body as a Whole: Allergic reactions in the form of rash and rarely more serious forms (see Skin and Appendages paragraph below) and DRESS (see WARNINGS ) have been observed. Anaphylaxis has also been reported. There have also been reports of coarsening of facial features, systemic lupus erythematosus, periarteritis nodosa and immunoglobulin abnormalities.

Nervous System: The most common manifestations adverse reactions encountered with phenytoin therapy are referable to this nervous system reactions and are usually dose-related. These Reactions include nystagmus, ataxia, slurred speech, decreased coordination, somnolence and mental confusion. Dizziness, vertigo, insomnia, transient nervousness, motor twitchings, paresthesias and headaches have also been observed.

There have also been rare reports of phenytoin induced dyskinesias, including chorea, dystonia, tremor and asterixis, similar to those induced by phenothiazine and other neuroleptic drugs. A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy. Digestive System: Acute hepatic failure, toxic hepatitis, liver damage, Nnausea, vomiting, constipation, enlargement of the lips,and gingival hyperplasia, toxic hepatitis and liver damage.

Skin and Appendages: Dermatological manifestations sometimes accompanied by fever have included scarlatiniform or morbilliform rashes. A morbilliform rash (measles-like) is the most common; other types of dermatitis are seen more rarely. Other more serious forms which may be fatal have included bullous, exfoliative or purpuric dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see WARNINGS section).

There have also been reports of hypertrichosis. Hematologic and Lymphatic System: Hematopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis and pancytopenia with or without bone marrow suppression.

While macrocytosis and megaloblastic anemia have occurred, these conditions usually respond to folic acid therapy. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma and Hodgkin’s disease have been reported (see WARNINGS section). Special Senses: Altered taste sensation including metallic taste.

Urogenital: Peyronie’s disease.

🆘 Overdosage 207 words

OVERDOSAGE SECTION The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 to 5 grams. The initial symptoms are nystagmus, ataxia and dysarthria.

Other signs are tremor, hyperreflexia, lethargy, slurred speech, nausea, vomiting. The patient may become comatose and hypotensive. Death is due to respiratory and circulatory depression.

There are marked variations among individuals with respect to phenytoin plasma levels where toxicity may occur. Nystagmus, on lateral gaze, usually appears at 20 mcg/mL, ataxia at 30 mcg/mL; dysarthria and lethargy appear when the plasma concentration is over 40 mcg/mL, but as high a concentration as 50 mcg/mL has been reported without evidence of toxicity. As much as 25 times the therapeutic dose has been taken to result in a serum concentration over 100 mcg/mL with complete recovery.

Treatment: Treatment is nonspecific since there is no known antidote. The adequacy of the respiratory and circulatory systems should be carefully observed and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin is not completely bound to plasma proteins.

Total exchange transfusion has been used in the treatment of severe intoxication in pediatric patients. In acute overdosage, the possibility of other CNS depressants, including alcohol, should be borne in mind.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY SECTION Mechanism of Action Phenytoin is an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, phenytoin tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes capable of reducing membrane sodium gradient.

This includes the reduction of post tetanic potentiation at synapses. Loss of post tetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures.

Pharmacokinetics and Drug Metabolism The plasma half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours. Steady-state therapeutic levels are achieved at least 7 to 10 days (5 to 7 half-lives) after initiation of therapy with recommended doses of 300 mg/day. When serum level determinations are necessary, they should be obtained at least 5 to 7 half-lives after treatment initiation, dosage change, or addition or subtraction of another drug to the regimen so that equilibrium or steady-state will have been achieved.

Trough levels provide information about clinically effective serum level range and confirm patient compliance and are obtained just prior to the patient’s next scheduled dose. Peak levels indicate an individual’s threshold for emergence of dose-related side effects and are obtained at the time of expected peak concentration. For extended phenytoin sodium capsules, peak serum levels occur 4 to 12 hours after administration.

Optimum control without clinical signs of toxicity occurs more often with serum levels between 10 and 20 mcg/mL, although some mild cases of tonic-clonic (grand mal) epilepsy may be controlled with lower serum levels of phenytoin. In most patients maintained at a steady dosage, stable phenytoin serum levels are achieved. There may be wide interpatient variability in phenytoin serum levels with equivalent dosages.

Patients with unusually low levels may be noncompliant or hypermetabolizers of phenytoin. Unusually high levels result from liver disease, variant CYP2C9 and CYP2C19 alleles, or drug interactions which result in metabolic interference. The patient with large variations in phenytoin plasma levels, despite standard doses, presents a difficult clinical problem.

Serum level determinations in such patients may be particularly helpful. As phenytoin is highly protein bound, free phenytoin levels may be altered in patients whose protein binding characteristics differ from normal. Most of the drug is excreted in the bile as inactive metabolites which are then reabsorbed from the intestinal tract and excreted in the urine.

Urinary excretion of phenytoin and its metabolites occurs partly with glomerular filtration but more importantly by tubular secretion. Because phenytoin is hydroxylated in the liver by an enzyme system which is saturable at high plasma levels, small incremental doses may increase the half-life and produce very substantial increases in serum levels, when these are in the upper range. The steady-state level may be disproportionately increased, with resultant intoxication, from an increase in dosage of 10% or more.

Special Populations Patients with Renal or Hepatic Disease: Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution (see DOSAGE AND ADMINISTRATION). Unbound phenytoin concentrations may be more useful in these patient populations. Age: Phenytoin clearance tends to decrease with increasing age (20% less in patients over 70 years of age relative to that in patients 20 to 30 years of age).

Phenytoin dosing requirements…

📦 How Supplied / Storage and Handling 79 words

HOW SUPPLIED SECTION Extended Phenytoin Sodium Capsules, USP 100 mg are supplied as white opaque / light lavender opaque, hard gelatin capsules imprinted with "IP 212" on both cap and body. They are available as follows: Bottles of 30: NDC 65162-212-03 Bottles of 100: NDC 65162-212-10 Bottles of 500: NDC 65162-212-50 Bottles of 1000: NDC 65162-212-11 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.

Protect from moisture. Rx only

📋 Description 117 words

DESCRIPTION SECTION Phenytoin sodium, USP is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula: [6184a1b4-figure-01] Each extended phenytoin sodium capsule, USP contains 100 mg phenytoin sodium, USP. Each capsule also contains the following inactive ingredients: D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide.

Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.

💬 Medication Guide ~3 min read

SPL MEDGUIDE SECTION Extended Phenytoin (FEN-i-toyn) Sodium Capsules Read this Medication Guide before you start taking extended phenytoin sodium capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

If you have any questions about extended phenytoin sodium capsules, ask your healthcare provider or pharmacist. What is the most important information I should know about extendedphenytoin sodium capsules? Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider.

Stopping extended phenytoin sodium capsules suddenly can cause serious problems. Extended phenytoin sodium capsules can cause serious side effects including: 1. Like other antiepileptic drugs, extended phenytoin sodium capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking extended phenytoin sodium capsules without first talking to a healthcare provider. Stopping extended phenytoin sodium capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2.

Extended phenytoin sodium capsules may harm your unborn baby. If you take extended phenytoin sodium capsules during pregnancy, your baby is at risk for serious birth defects. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.

If you take extended phenytoin sodium capsules during pregnancy, your baby is also at risk for bleeding problems right after birth. Your healthcare provider may give you and your baby medicine to prevent this. All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of extended phenytoin sodium capsules.

If the decision is made to use extended phenytoin sodium capsules, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking extended phenytoin sodium capsules. You and your healthcare provider should decide if you will take extended phenytoin sodium capsules while you are pregnant.

Pregnancy Registry: If you become pregnant while taking extended phenytoin sodium capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

3. Swollen glands (lymph nodes) 4. Allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells.

You may or may not have a rash with these types of reactions. Symptoms can include any of the following: swelling o…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.