HomeNDC LookupIngredientsEthosuximide › 69452-0152-20
Ethosuximide 250 mg Capsule, Liquid Filled, 100-count — NDC 69452-0152-20 package photo

Ethosuximide 250 mg Capsule, Liquid Filled, 100-count

by Bionpharma Inc. · 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-152-20)
NDC 69452-0152-20
🏷️ FDA NDC (as labeled) 69452-152-20 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 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) 69452-152-20
Product NDC 69452-152
11-digit billing NDC 69452015220
NCPDP billing unit EA — each (per item)
RxCUI 197682
UNII 5SEH9X1D1D
UPC 0369452152201
Application # ANDA040430
SPL Set ID efb047e8-0020-4504-97fa-6aa1af3af05e
Established class (EPC) Anti-epileptic Agent
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-10-21
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ETHOSUXIMIDE
GPI-14 72400010000105
GPI class Ethosuximide
GCN Seq No 004554
GCN 17420
HICL code 001891
Ingredient (HICL) Ethosuximide
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 28:12.20.00
AHFS class Succinimides
FDB label name ETHOSUXIMIDE 250 MG CAPSULE
FDB brand name Ethosuximide
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 69452-152-20 — 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 → 69452-0152-20. 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) Succinimide derivatives
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

LabelerBionpharma Inc.
Application holderBIONPHARMA INC
FDA applicationANDA040430 (ANDA)
Labeler code69452
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio163 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 ETHOSUXIMIDE 250 MG CAPSULE Ingredient Ethosuximide
📖 What it is MedlinePlus · NLM

Ethosuximide is used to control absence seizures (petit mal) (a type of seizure in which there is a very short loss of awareness during which the person may stare straight ahead or blink his eyes and does not respond to others). Ethosuximide is in a class of medications called anticonvulsants. It works by reducing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • An absence seizure is a brief episode — usually just a few seconds — where you or your child suddenly stares blankly and loses awareness, then snaps back as if nothing happened. Th...
  • What exactly is an absence seizure, and will ethosuximide stop them?
  • Ethosuximide comes as a capsule or a liquid solution, and you take it by mouth. Your doctor will start you on a lower dose and gradually increase it until your seizures are well co...
  • How do I take it, and does it matter if I take it with food?
📖 Read our full Ethosuximide guide →
1
Nutrient depletion considerations

Ethosuximide may be associated with lower levels of 1 nutrient — 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 orange
ShapeCapsule
ImprintPA1000
Size9 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.248 $24.83 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3900 $39.00 / 100 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Aug 2022 Jan 2026 Aug 2026 $0.610 $0.240
▼ Down 14% over the last 22 months.
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
Ethosuximide 250 mg 42806-0708-01 Epic 100 capsules $0.248 AB Availability likely
Ethosuximide 250 mg 42806-0711-01 Epic 100 capsules $0.248 AB Availability likely
Ethosuximide 250 mg 62135-0790-12 Chartwell 120 capsules $0.248 Availability likely
Ethosuximide 250 mg 64380-0878-06 Strides 100 capsules $0.248 AB Availability likely
Ethosuximide 250 mgthis 69452-0152-20 Bionpharma 100 capsules $0.248 AB Availability likely
Zarontin 250 mg 00071-0237-24 Parke-Davis 100 capsules $1.309 AB Availability likely +427%
Ethosuximide 250 mg 63629-8005-01 Bryant 90 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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69452-0152-20, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
19.2K
Units reimbursed last 4 qtrs
2.5M
Gross reimbursed last 4 qtrs
$982.5K
Avg / prescription
$51.17
Avg / unit
$0.3900
Latest quarter Q4 2025
4.4KRx
Medicaid pays / ea
$0.3900
gross reimbursed
vs
NADAC / ea
$0.2483
acquisition cost
=
Spread
+$0.1417
+57% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
34% FFS 66% MCO
Fee-for-service · 6,542 Rx Managed care · 12,659 Rx
State Medicaid map
Alaska: 6,634 units · 905 per 100k residents AK Maine: no data reported ME Washington: 102,929 units · 1,318 per 100k residents WA Idaho: 9,900 units · 504 per 100k residents ID Montana: 10,254 units · 906 per 100k residents MT North Dakota: 7,770 units · 992 per 100k residents ND Minnesota: 46,615 units · 813 per 100k residents MN Wisconsin: 50,156 units · 849 per 100k residents WI Michigan: 65,561 units · 653 per 100k residents MI New York: 144,101 units · 736 per 100k residents NY Vermont: 14,400 units · 2,226 per 100k residents VT New Hampshire: 19,132 units · 1,365 per 100k residents NH Oregon: 22,652 units · 535 per 100k residents OR Nevada: 9,564 units · 299 per 100k residents NV Wyoming: no data reported WY South Dakota: 5,826 units · 634 per 100k residents SD Iowa: 20,814 units · 649 per 100k residents IA Illinois: 72,319 units · 576 per 100k residents IL Indiana: 121,095 units · 1,765 per 100k residents IN Ohio: 156,462 units · 1,328 per 100k residents OH Pennsylvania: 195,750 units · 1,510 per 100k residents PA New Jersey: 39,111 units · 421 per 100k residents NJ Massachusetts: 80,748 units · 1,153 per 100k residents MA California: 132,785 units · 341 per 100k residents CA Utah: 9,340 units · 273 per 100k residents UT Colorado: 18,268 units · 311 per 100k residents CO Nebraska: 10,070 units · 509 per 100k residents NE Missouri: 81,725 units · 1,319 per 100k residents MO Kentucky: 65,141 units · 1,439 per 100k residents KY West Virginia: 23,430 units · 1,324 per 100k residents WV Virginia: 72,350 units · 830 per 100k residents VA Maryland: 52,204 units · 845 per 100k residents MD Connecticut: 28,385 units · 785 per 100k residents CT Rhode Island: 9,930 units · 907 per 100k residents RI Arizona: 33,000 units · 444 per 100k residents AZ New Mexico: 17,053 units · 807 per 100k residents NM Kansas: 10,830 units · 368 per 100k residents KS Arkansas: 44,006 units · 1,435 per 100k residents AR Tennessee: 48,755 units · 684 per 100k residents TN North Carolina: 107,725 units · 994 per 100k residents NC South Carolina: 72,317 units · 1,346 per 100k residents SC Delaware: 2,142 units · 208 per 100k residents DE Oklahoma: 48,503 units · 1,197 per 100k residents OK Louisiana: 39,728 units · 869 per 100k residents LA Mississippi: 15,376 units · 523 per 100k residents MS Alabama: 38,163 units · 747 per 100k residents AL Georgia: 132,966 units · 1,206 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 140,634 units · 461 per 100k residents TX Florida: 56,295 units · 249 per 100k residents FL
Units reimbursed · per 100k residents
2082,226
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Vermont 2,226 /100k
2 Indiana 1,765 /100k
3 Pennsylvania 1,510 /100k
4 Kentucky 1,439 /100k
5 Arkansas 1,435 /100k
6 New Hampshire 1,365 /100k
7 South Carolina 1,346 /100k
8 Ohio 1,328 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Ethosuximide — the program that covers self-administered drugs. 6 manufacturers.
⚠️ 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 Ethosuximide. 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
$408.9K
Claims incl. refills
3.9K
Beneficiaries
1.9K
Spend / beneficiary
$215.88
Spend / claim
$105.30
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 Ethosuximide — the ingredient across all brands.

Top reported reactions

Seizure367
Somnolence157
Generalised Tonic-clonic Seizure149
Petit Mal Epilepsy118
Drug Interaction116
Treatment Failure116
Fatigue112

Reporter sex

2,490 reports

Serious outcomes

Death63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 251 74
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
69452-0152-20 You're viewing this 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-152-20) 2016-10-21 Active

📄 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 15 words

INDICATIONS AND USAGE Ethosuximide capsules are indicated for the control of absence (petit mal) epilepsy.

⏱️ Dosage and Administration 176 words

DOSAGE AND ADMINISTRATION Ethosuximide capsules are administered by the oral route. The initial dose for patients 3 years to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response.

Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician.

The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 mcg/mL to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Ethosuximide capsules may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.

Contraindications 15 words

CONTRAINDICATION Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

⚠️ Warnings ~3 min read

WARNINGS Blood dyscrasias Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point. Effects on Liver and Kidneys Ethosuximide is capable of producing morphological and functional changes in the animal liver.

In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.

Systemic Lupus Erythematosus Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including ethosuximide, 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 years 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 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1.0 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 ethosuximide or any other AED must balance the risk of suicidal thoughts and 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 pres…

🤒 Adverse Reactions 183 words

ADVERSE REACTIONS Body As A Whole: Allergic reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.

Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, and eosinophilia. Nervous System: Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia. Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness.

These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions. Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, pruritic erythematous rashes, Stevens-Johnson syndrome, and hirsutism.

Special Senses: Myopia. Genitourinary System: Vaginal bleeding, microscopic hematuria.

🔄 Drug Interactions 41 words

Drug Interactions Since ethosuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g., ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).

🤰 Pregnancy 61 words

Pregnancy To provide information regarding the effects of in utero exposure to ethosuximide, physicians are advised to recommend that pregnant patients taking ethosuximide enroll in the NAAED Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/ See WARNINGS .

🧒 Pediatric Use 23 words

Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established (see DOSAGE AND ADMINISTRATION section).

🆘 Overdosage 96 words

OVERDOSAGE Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity.

Treatment Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are ineffective.

🧬 Clinical Pharmacology 54 words

CLINICAL PHARMACOLOGY Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.

📦 How Supplied / Storage and Handling 46 words

HOW SUPPLIED Ethosuximide capsules, USP 250 mg are supplied as: Clear, orange-colored, oval-shaped, softgel capsules in bottles of 100, Printed PA1000 NDC 69452-152-20. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Protect from moisture.

📦 Storage and Handling 23 words

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Protect from moisture.

📋 Description 48 words

DESCRIPTION Ethosuximide is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula: Each ethosuximide capsule, USP contains 250 mg ethosuximide, USP. Also contains: polyethylene glycol. The capsule contains FD&C yellow No. 6, gelatin, glycerin, hypromellose, iron oxide black, propylene glycol, and purified water. Chemical Structure

💬 Information for Patients ~1 min read

Information for Patients Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to taking ethosuximide capsules. Instruct patients to take ethosuximide capsules only as prescribed. Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.

Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen. Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms (e.g., sore throat, fever), suggesting an infection. Patients, their caregivers, and families should be counseled that AEDs, including ethosuximide, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Behaviors of concern should be reported immediately to healthcare providers. Prior to initiation of treatment with ethosuximide, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section).

💬 Medication Guide ~3 min read

MEDICATION GUIDE Ethosuximide (eth” oh sux’ i mide) Capsules, USP Read this Medication Guide before you start taking ethosuximide 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 ethosuximide capsules, ask your healthcare provider or pharmacist. What is the most important information I should know about ethosuximide capsules? Do not stop taking ethosuximide capsules without first talking to your healthcare provider.

Stopping ethosuximide capsules suddenly can cause serious problems. Ethosuximide can cause serious side effects, including: 1. Rare but serious blood problems that may be life-threatening.

Call your healthcare provider right away if you have: fever, swollen glands, or sore throat that come and go or do not go away frequent infections or an infection that does not go away easy bruising red or purple spots on your body bleeding gums or nose bleeds severe fatigue or weakness 2. Drug reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions.

These reactions can be very serious and can cause death. Call your healthcare provider right away if you have any of these symptoms: joint pain and swelling muscle pain fatigue, weakness low-grade fever pain in the chest that is worse with breathing skin rash swollen lymph glands swelling of your face yellowing of your skin or the white part of your eyes 3. Like other antiepileptic drugs, ethosuximide 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 ethosuximide capsules without first talking to a healthcare provider. Stopping ethosuximide 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. What are ethosuximide capsules?

Ethosuximide capsules are prescription medicine used to treat absence (petit mal) seizures. Who should not take ethosuximide capsules? Do not take ethosuximide capsules if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in ethosuximide capsules.

See the end of this Medication Guide for a complete list of ingredients in ethosuximide capsules. What should I tell my healthcare provider before taking ethosuximide capsules? Before you take ethosuximide capsules, tell your healthcare provider if you: have or had liver problems have or have had depression, mood problems or suicidal thoughts or behavior have any other medical conditions are pregnant or plan to become pregnant.

It is not known if ethosuximide can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ethosuximide capsules. You and your healthcare provider should decide if you should take e…

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.