HomeNDC LookupIngredientsEthosuximide › 00071-2418-19
Zarontin Ethosuximide 250 mg/5mL Solution — NDC 00071-2418-19 package photo

Zarontin Ethosuximide 250 mg/5mL Solution

by Parke-Davis Div of Pfizer Inc · 1 BOTTLE, PLASTIC in 1 CARTON (0071-2418-19) / 474 mL in 1 BOTTLE, PLASTIC
NDC 00071-2418-19
🏷️ FDA NDC (as labeled) 0071-2418-19 billing pads the labeler segment with a zero
This package
Contains474 mL in 1 bottle, plastic Medicaid pays$0.2778 / unit · 12 mo Per package$131.68 / 474 ml · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $0.3166/unit — full pricing hub ↓
Also comes in: 474 mL 00071-2418-35
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) 0071-2418-19
Product NDC 0071-2418
11-digit billing NDC 00071241819
NCPDP billing unit ML — per mL (volume)
RxCUI 251322, 755357
UNII 5SEH9X1D1D
Application # ANDA080258
SPL Set ID 7bf3e616-45e8-4469-a75d-4d824ce951ea
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 2020-03-10
Route ORAL
Dosage form SOLUTION
Substance ETHOSUXIMIDE
GPI-14 72400010002005
GPI class Zarontin
GCN Seq No 004555
GCN 17430
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 ZARONTIN 250 MG/5 ML SOLUTION
FDB brand name Zarontin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 0071-2418-19 — a 4-4-2 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 labeler segment → 00071-2418-19. 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

LabelerParke-Davis Div of Pfizer Inc
Application holderPARKE-DAVIS DIVISION OF PFIZER INC
FDA applicationANDA080258 (ANDA)
Labeler code00071
First marketedMar 2020
Product typeHuman Prescription Drug
Portfolio14 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 ZARONTIN 250 MG/5 ML SOLUTION 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

FlavorRaspberry
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

9 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.2778 $131.68 / 474 ml
Medicare drug plans payPart D · Q2 2026 $0.3166 $150.07 / 474 ml
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/5mL 59762-2350-06 Mylan 1 bottle $0.081 AA FDA listed
Ethosuximide 250 mg/5mL 00121-0670-16 PAI 473 ml $0.094 AA Availability likely
Zarontin 250 mg/5mLthis 00071-2418-19 Parke-Davis 1 bottle AA FDA listed
Ethosuximide 250 mg/5mL 62135-0064-47 Chartwell 473 ml AA FDA listed
Ethosuximide 250 mg/5mL 68999-0064-24 Chartwell 10 cups AA 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

🏛️
2020
On the market since
Mar 2020
📍
2026
Currently FDA-listed
6 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 00071-2418-19, 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
120
Units reimbursed last 4 qtrs
45.5K
Gross reimbursed last 4 qtrs
$12.6K
Avg / prescription
$105.26
Avg / unit
$0.2778
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care
100% MCO
Fee-for-service · 0 Rx Managed care · 120 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 45,466 units · 149 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
149149
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 Texas 149 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle00071-2418-35 No Medicaid data
Drug total (last 4 qtrs): 120 Rx · 45,466 units · $12,631 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Zarontin — 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 Zarontin. 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
$11.8K
Claims incl. refills
67
Beneficiaries
37
Spend / beneficiary
$319.38
Spend / claim
$176.38
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00071-2418-19 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (0071-2418-19) / 474 mL in 1 BOTTLE, PLASTIC 2022-06-01 Active
00071-2418-35 1 BOTTLE, PLASTIC in 1 CARTON (0071-2418-35) / 474 mL in 1 BOTTLE, PLASTIC 2020-03-10 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00071-2418-19?
NDC 00071-2418-19 is listed by the FDA — 1 bottle, plastic in 1 carton / 474 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Zarontin Ethosuximide 250 mg/5mL Solution?
Bill NDC 00071-2418-19 — the 11-digit billing format is 00071241819. 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 ✓ Available
Inactive ingredients (structured) ✓ 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) ✓ Available
“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 0071-2418-19, 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: 00071-2418-19, written without dashes as 00071241819. 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 00071-2418-19, the first segment (00071) is the labeler code FDA assigned to Parke-Davis Div of Pfizer Inc; the middle segment (2418) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (19) 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 Parke-Davis Div of Pfizer Inc. 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 1 other package presentation of this same product, including 1 bottle (00071-2418-35). 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?
Parke-Davis Div of Pfizer Inc 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 14 words

INDICATIONS AND USAGE Zarontin is indicated for the control of absence (petit mal) epilepsy.

⏱️ Dosage and Administration 172 words

DOSAGE AND ADMINISTRATION Zarontin is administered by the oral route. The initial dose for patients 3 to 6 years of age is one teaspoonful (250 mg) per day; for patients 6 years of age and older, 2 teaspoonfuls (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 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Zarontin 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

CONTRAINDICATIONS 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. Drug-Induced Immune Thrombocytopenia: Drug-induced immune thrombocytopenia (DITP) has been reported with ethosuximide.

In the reported cases, the onset of symptoms occurred 1 to 3 weeks after initiation of ethosuximide; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug. In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm 3 . When DITP is suspected, discontinue Zarontin, monitor serial platelet counts, and treat as appropriate.

If possible, assess the presence of drug-dependent antiplatelet antibodies. Avoid future use of Zarontin in patients with history of ethosuximide-induced DITP. 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 Zarontin, 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 (5–100 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 Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 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…

🤒 Adverse Reactions 187 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, eosinophilia, and thrombocytopenia (see WARNINGS ). 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 42 words

Drug Interactions: Since Zarontin (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 63 words

Pregnancy: To provide information regarding the effects of in utero exposure to Zarontin, physicians are advised to recommend that pregnant patients taking Zarontin 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 53 words

HOW SUPPLIED Zarontin is supplied as: NDC 0071-2418-19: 1 pint amber polyethylene terephthalate (PET) bottles (polyethylene cap liner). Each 5 mL of oral solution contains 250 mg ethosuximide in a raspberry flavored base. Store at 20°–25°C (68° – 77°F); [see USP Controlled Room Temperature] Preserve in tight containers. Protect from freezing and light.

📦 Storage and Handling 20 words

Store at 20°–25°C (68° – 77°F); [see USP Controlled Room Temperature] Preserve in tight containers. Protect from freezing and light.

📋 Description 61 words

DESCRIPTION Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula: Each teaspoonful (5 mL), for oral administration, contains 250 mg ethosuximide, USP. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No.

6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; sodium citrate, USP; sucrose, NF. 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 Zarontin. Instruct patients to take Zarontin 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 when they develop signs and/or symptoms suggesting an infection (e.g., sore throat, fever). Patients, their caregivers, and families should be counseled that AEDs, including Zarontin, 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 Zarontin, 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 ZARONTIN, (Ză rŏn' tĭn) (ethosuximide) Capsules, Oral Solution Read this Medication Guide before you start taking ZARONTIN 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 ZARONTIN, ask your healthcare provider or pharmacist. What is the most important information I should know about ZARONTIN? Do not stop taking ZARONTIN without first talking to your healthcare provider.

Stopping ZARONTIN suddenly can cause serious problems. ZARONTIN 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, ZARONTIN 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 ZARONTIN without first talking to a healthcare provider. • Stopping ZARONTIN 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 is ZARONTIN? ZARONTIN is a prescription medicine used to treat absence (petit mal) seizures.

Who should not take ZARONTIN? Do not take ZARONTIN if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in ZARONTIN. See the end of this Medication Guide for a complete list of ingredients in ZARONTIN.

What should I tell my healthcare provider before taking ZARONTIN? Before you take ZARONTIN, 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 ZARONTIN can harm your unborn baby.

Tell your healthcare provider right away if you become pregnant while taking ZARONTIN. You and your healthcare provider should decide if you should take ZARONTIN while you are pregnant. o If you become pregnant while taking ZARONTIN, talk to your healthcare provider about registering with…

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.