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Topiramate 100 mg Tablet, Film Coated, 30-count

by Proficient Rx LP · 30 TABLET, FILM COATED in 1 BOTTLE (63187-801-30)

NDC 63187-0801-30

🏷️ FDA NDC (as labeled) 63187-801-30 billing pads the product segment with a zero

This package

Contains30-count Pack sizes3 compare ↓

Also priced by: Part D plans $0.0808/unit — full pricing hub ↓

Also comes in: 60 tablets 63187-0801-60 90 tablets 63187-0801-90

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 →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Topiramate (different manufacturers) — 2 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class III · Aug 31, 2026 — Failed dissolution specifications. (Supernus Pharmaceuticals, Inc.) · FDA recall D-0833-2026

Class III · Jul 6, 2026 — Failed Dissolution Specifications (Supernus Pharmaceuticals, Inc.) · FDA recall D-0758-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63187-801-30

Product NDC 63187-801

11-digit billing NDC 63187080130

RxCUI 199889

UNII 0H73WJJ391

Application # ANDA090278

SPL Set ID 7d6752ce-7a56-4b04-ab15-cbd40aa5cc94

Mechanism of action Cytochrome P450 3A4 Inducers; Cytochrome P450 2C19 Inhibitors

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 2014-12-15

Route ORAL

Dosage form TABLET, FILM COATED

Substance TOPIRAMATE

GPI-14 72600075000330

GPI class Topiramate

GCN Seq No 026170

GCN 36551

HICL code 011060

Ingredient (HICL) Topiramate

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 28:12.92.00

AHFS class Anticonvulsants, Miscellaneous

FDB label name TOPIRAMATE 100 MG TABLET

FDB brand name Topiramate

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 63187-801-30 — 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 → 63187-0801-30. 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 Centrally acting antiobesity products class.

Drug family (ATC) Centrally acting antiobesity products, Other antiepileptics

How it works Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 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

LabelerProficient Rx LP

Application holderSUN PHARMACEUTICAL INDUSTRIES LTD

FDA applicationANDA090278 (ANDA)

Labeler code63187

First marketedDec 2014

Product typeHuman Prescription Drug

Portfolio1,723 products on file

🔎 All NDCs from Proficient Rx LP

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 TOPIRAMATE 100 MG TABLET Ingredient Topiramate

📖 What it is MedlinePlus · NLM

Topiramate is used to treat certain types of seizures. Topiramate is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

📖 Read our full Topiramate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Topiramate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Topiramate (125 interactions) — ranked by severity →

Nutrient depletion considerations

Topiramate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

VITAMIN K Insignificant Depletion

🧪 Full Topiramate nutrient depletion report →

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 Yellow

ShapeRound

ImprintS;711

Size1 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 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 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 DailyMed — ingredient 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 system	Per each	Per 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	$0.0808	$2.42 / 30 tablets

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
topiramate 100 mg 00904-6929-61	Major	1 tablet	$0.055	AB	Availability likely	—
Topiramate 100 mg 68084-0344-01	American	1 tablet	$0.055	AB	Availability likely	—
Topiramate 100 mg 68462-0109-05	Glenmark	500 tablets	$0.055	AB	Availability likely	—
Topiramate 100 mg 69097-0124-03	Cipla	60 tablets	$0.055	AB	Availability likely	—
Topiramate 100 mg 76282-0280-10	EXELAN	1000 tablets	$0.055	AB	Availability likely	—
topiramate 100 mg 82009-0137-05	Quallent	500 tablets	$0.055	AB	Availability likely	—
Topiramate 100 mg 69097-0818-03	Cipla	60 tablets	$0.065	AB	FDA listed	—
Topamax 100 mg 50458-0641-65	Janssen	60 tablets	$17.918	AB	Availability likely	—
Topiramate 100 mg 00615-8140-39	NCS	30 tablets	—	AB	Discontinued	—
Topiramate 100 mg 00615-8595-39	NCS	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 29300-0117-01	Unichem	100 tablets	—	AB	FDA listed	—
Topiramate 100 mg 31722-0183-05	Camber	500 tablets	—	AB	FDA listed	—
Topiramate 100 mg 43063-0729-07	PD-Rx	7 tablets	—	AB	FDA listed	—
Topiramate 100 mg 47335-0711-08	Sun	100 tablets	—	AB	FDA listed	—
Topiramate 100 mg 50090-3389-00	A-S	60 tablets	—	AB	FDA listed	—
topiramate 100 mg 50090-5309-00	A-S	60 tablets	—	AB	FDA listed	—
Topiramate 100 mg 50090-6895-00	A-S	90 tablets	—	AB	FDA listed	—
topiramate 100 mg 50268-0808-15	AvPAK	1 tablet	—	AB	FDA listed	—
Topiramate 100 mg 51655-0608-26	Northwind	90 tablets	—	AB	FDA listed	—
topiramate 100 mg 51655-0848-26	Northwind	90 tablets	—	AB	FDA listed	—
topiramate 100 mg 55154-7142-00	Cardinal	1 tablet	—	AB	FDA listed	—
Topiramate 100 mg 61919-0213-30	C	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 62756-0711-08	Sun	100 tablets	—	AB	FDA listed	—
Topiramate 100 mg 63187-0060-30	Proficient	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 63187-0283-30	Proficient	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 63187-0696-30	Proficient	30 tablets	—	AB	FDA listed	—
Topiramate 100 mgthis 63187-0801-30	Proficient	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 65841-0649-01	Zydus	100 tablets	—	AB	FDA listed	—
Topiramate 100 mg 65862-0173-05	Aurobindo	500 tablets	—	—	FDA listed	—
Topiramate 100 mg 68071-3088-03	NuCare	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 68071-4877-03	NuCare	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 68382-0140-01	Zydus	100 tablets	—	AB	FDA listed	—
topiramate 100 mg 68788-7468-03	Preferred	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 68788-8835-03	Preferred	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 70518-1196-01	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 70518-1953-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 70518-2104-01	REMEDYREPACK	1 tablet	—	AB	Discontinued	—
Topiramate 100 mg 70518-2955-00	REMEDYREPACK	1 tablet	—	AB	Discontinued	—
topiramate 100 mg 71205-0195-30	Proficient	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 71335-0325-01	Bryant	60 tablets	—	AB	FDA listed	—
Topiramate 100 mg 71335-0337-01	Bryant	60 tablets	—	AB	Discontinued	—
topiramate 100 mg 71335-1143-01	Bryant	60 tablets	—	AB	Discontinued	—
topiramate 100 mg 71335-2318-01	Bryant	60 tablets	—	AB	FDA listed	—
Topiramate 100 mg 71610-0492-30	Aphena	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 72162-2482-00	Bryant	1000 tablets	—	AB	FDA listed	—
Topiramate 100 mg 72789-0004-21	PD-Rx	21 tablets	—	AB	FDA listed	—
Topiramate 100 mg 72865-0315-10	XLCare	1000 tablets	—	AB	FDA listed	—
Topiramate 100 mg 76420-0279-30	Asclemed	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 80425-0373-01	Advanced	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 80425-0398-01	Advanced	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 80425-0488-01	Advanced	30 tablets	—	AB	FDA listed	—
Topiramate 100 mg 67046-1688-03	Coupler	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 67046-1691-03	Coupler	30 tablets	—	AB	FDA listed	—
topiramate 100 mg 67046-0357-03	Coupler	30 tablets	—	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

Dec 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 Topiramate — the program that covers self-administered drugs. 17 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 Topiramate. 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

$11.47M

Claims incl. refills

835.2K

Beneficiaries

482K

Spend / beneficiary

$23.80

Spend / claim

$13.73

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 NDC	Description	Marketing start	Status
63187-0801-30 You're viewing this	30 TABLET, FILM COATED in 1 BOTTLE (63187-801-30)	2017-01-02	Active
63187-0801-60	60 TABLET, FILM COATED in 1 BOTTLE (63187-801-60)	2017-01-02	Active
63187-0801-90	90 TABLET, FILM COATED in 1 BOTTLE (63187-801-90)	2017-01-02	Active

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

Pack size FAQ

What quantity is in NDC 63187-0801-30?

NDC 63187-0801-30 is a 30-count package — 30 tablet, film coated in 1 bottle.

What is the difference between NDC 63187-0801-30 and NDC 63187-0801-60?

Both are Topiramate 100 mg Tablet, Film Coated — the drug itself is identical. NDC 63187-0801-30 is the 30-count package, while NDC 63187-0801-60 is the 60 tablets package.

What NDC number is used to bill for this package of Topiramate 100 mg Tablet, Film Coated?

Bill NDC 63187-0801-30 — the 11-digit billing format is 63187080130. 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)	— 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 63187-801-30, 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: 63187-0801-30, written without dashes as 63187080130. 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 63187-0801-30, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0801) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Proficient Rx LP. 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 60 tablets (63187-0801-60), 90 tablets (63187-0801-90). 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?

Proficient Rx LP 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Topiramate is indicated for: • Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ) • Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2 )

1.1Monotherapy Epilepsy Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies ( 14.1 )] .

1.2Adjunctive Therapy Epilepsy Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies ( 14.2 )] . Additional pediatric use information for patients ages 12 to 17 years is approved for Janssen Pharmaceuticals, Inc.’s TOPAMAX (topiramate) Tablets and Sprinkle Capsules. However, due to Janssen Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and Adjunctive Therapy Use for additional details ( 2.1 ) Initial Dose Titration Recommended Dose Epilepsy monotherapy: children 2 to <10 years ( 2.1 ) 25 mg/day administered nightly for the first week The dosage should be titrated over 5 to 7 weeks Daily doses in two divided doses based on weight (Table 2) Epilepsy monotherapy: adults and pediatric patients ≥10 years ( 2.1 ) 50 mg/day in two divided doses The dosage should be increased weekly by increments of 50 mg for the first 4 weeks then 100 mg for weeks 5 to 6.

400 mg/day in two divided doses Epilepsy adjunctive therapy: adults with partial onset seizures or LGS ( 2.1 ) 25 to 50 mg/day The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. 200 to 400 mg/day in two divided doses Epilepsy adjunctive therapy: adults with primary generalized tonic clonic seizures ( 2.1 ) 25 to 50 mg/day The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. 400 mg/day in two divided doses Epilepsy adjunctive therapy: pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures or LGS ( 2.1 ) 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week The dosage should be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses).

Dose titration should be guided by clinical outcome. 5 to 9 mg/kg/day in two divided doses

2.1Epilepsy It is not necessary to monitor topiramate plasma concentrations to optimize topiramate therapy. On occasion, the addition of topiramate tablets to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate tablets may require adjustment of the dose of topiramate tablets.

Because of the bitter taste, tablets should not be broken. Topiramate tablets can be taken without regard to meals. Monotherapy Use Adults and Pediatric Patients 10 Years and Older The recommended dose for topiramate tablets monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses.

Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titration according to the following schedule (Table 1): Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older Morning Dose Evening Dose Week 1 25 mg 25 mg Week 2 50 mg 50 mg Week 3 75 mg 75 mg Week 4 100 mg 100 mg Week 5 150 mg 150 mg Week 6 200 mg 200 mg Children Ages 2 to <10 Years Dosing of topiramate as initial monotherapy in children 2 to < 10 years of age with partial onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach [see Clinical Studies ( 14.1 )] .

Dosing in patients 2 to <10 years is based on weight. During the titration period, the initial dose of topiramate tablets should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week.

Dosage can be increased by 25 to 50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 to 50 mg/day weekly increments.

The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years Weight (kg) Total Daily Dose (mg/day) Administered in two equally divided doses Minimum Maintenance Dose Total Daily…

💊 Dosage Forms and Strengths 83 words ▾

3 DOSAGE FORMS AND STRENGTHS Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded "S" on one side; "707" on the other) 50 mg yellow (coded "S" on one side; "710" on the other) 100 mg yellow (coded "S" on one side; "711" on the other) 200 mg brown (coded "S" on one side; "712" on the other) • Tablets: 25 mg, 50 mg, 100 mg, and 200 mg ( 3 )

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible ( 5.1 ) • Visual field defects: These have been reported independent of elevated intraocular pressure. Consider discontinuation of topiramate ( 5.2 ) • Oligohidrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients ( 5.3 ) • Metabolic acidosis: Baseline and periodic measurement of serum bicarbonate is recommended.

Consider dose reduction or discontinuation of topiramate if clinically appropriate ( 5.4 ) • Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation ( 5.5 ) • Cognitive/neuropsychiatric: Topiramate may cause cognitive dysfunction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur in epilepsy populations ( 5.6 ) • Fetal Toxicity: Topiramate use during pregnancy can cause cleft lip and/or palate ( 5.7 ) • Withdrawal of AEDs: Withdrawal of topiramate should be done gradually ( 5.8 ) • Hyperammonemia and encephalopathy associated with or without concomitant valproic acid use: Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia.

Measure ammonia if encephalopathic symptoms occur ( 5.10 ) • Kidney stones: Use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet should be avoided ( 5.11 ) • Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use ( 5.12 )

5.1Acute Myopia and Secondary Angle Closure Glaucoma A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness), and increased intraocular pressure.

Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy.

In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate, may be helpful.

Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

5.2Visual Field Defects Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.

5.3Oligohidrosis and Hyperthermia Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures.

The majority of the reports have been in pediatric patients. Patients, especially pediatric patients, treated with topiramate should be monitored closely for evidence of decreased sweating and incre…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Acute Myopia and Secondary Angle Closure [see Warnings and Precautions ( 5.1 )] • Visual Field Defects [see Warnings and Precautions ( 5.2 )] • Oligohidrosis and Hyperthermia [see Warnings and Precautions ( 5.3 )] • Metabolic Acidosis [see Warnings and Precautions ( 5.4 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 )] • Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Fetal Toxicity [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] • Sudden Unexplained Death in Epilepsy (SUDEP) [see Warnings and Precautions ( 5.9 )] • Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see Warnings and Precautions ( 5.10 )] • Kidney Stones [see Warnings and Precautions ( 5.11 )] • Hypothermia with Concomitant Valproic Acid (VPA) Use [see Warnings and Precautions ( 5.12 )] • Paresthesia [see Warnings and Precautions ( 5.13 )] The data described in the following sections were obtained using topiramate tablets.

The most common (≥ 10% more frequent than placebo or low-dose topiramate in monotherapy) adverse reactions at recommended dosing in adult and pediatric controlled, epilepsy clinical trials were paresthesia, anorexia, weight decrease, speech disorder related speech problem, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever. (6)To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug, and may not reflect the incidence of adverse reactions observed in practice. Increased Risk for Bleeding Topiramate treatment is associated with an increased risk for bleeding. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse event for topiramate than for placebo (4.5% versus 3% in adult patients, and 4.4% versus 2.3% in pediatric patients).

In this analysis, the incidence of serious bleeding events for topiramate and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients. Adverse bleeding reactions reported with topiramate ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants).

Monotherapy Epilepsy Adults ≥16 Years The adverse reactions in the controlled trial that occurred most commonly in adults in the 400 mg/day topiramate group and at an incidence higher (≥5 %) than in the 50 mg/day group were: paresthesia, weight decrease, anorexia, somnolence, and difficulty with memory (see Table 5). Approximately 21% of the 159 adult patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. The most common (≥2% more frequent than low-dose 50 mg/day topiramate) adverse reactions causing discontinuation in this trial were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia.

Pediatric Patients 6 to <16 Years of Age The adverse reactions in the controlled trial that occurred most commonly in pediatric patients in the 400 mg/day topiramate group and…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS In vitro studies indicate that topiramate does not inhibit enzyme activity for CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4/5 isozymes. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. Drug interactions with some antiepileptic drugs, CNS depressants and oral contraceptives are described here.

For other drug interactions, please refer to Clinical Pharmacology ( 12.3 ) . Summary of AED interactions with topiramate ( 7.1 ) AED Coadministered AED Concentration Topiramate Concentration Phenytoin NC or 25% increase Plasma concentration increased 25% in some patients, generally those on a twice a day dosing regimen of phenytoin. 48% decrease Carbamazepine (CBZ) NC 40% decrease CBZ epoxide Is not administered but is an active metabolite of carbamazepine.

NC NE Valproic acid 11% decrease 14% decrease Phenobarbital NC NE Primidone NC NE Lamotrigine NC at TPM doses up to 400 mg/day 13% decrease NC = Less than 10% change in plasma concentration. NE = Not Evaluated • Oral contraceptives: Decreased contraceptive efficacy and increased breakthrough bleeding should be considered, especially at doses greater than 200 mg/day ( 7.3 ) • Metformin is contraindicated with metabolic acidosis, an effect of topiramate ( 7.4 ) • Lithium levels should be monitored when coadministered with high-dose topiramate ( 7.5 ) • Other carbonic anhydrase inhibitors: Monitor the patient for the appearance or worsening of metabolic acidosis ( 7.6 )

7.1Antiepileptic Drugs Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. Concomitant administration of phenytoin or carbamazepine with topiramate decreased plasma concentrations of topiramate by 48% and 40%, respectively when compared to topiramate given alone [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy.

Concomitant administration of topiramate with valproic acid has also been associated with hypothermia (with and without hyperammonemia) in patients who have tolerated either drug alone. It may be prudent to examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions ( 5.10 ), ( 5.12 ) and Clinical Pharmacology ( 12.3 )] .

7.2CNS Depressants Concomitant administration of topiramate and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, topiramate should be used with extreme caution if used in combination with alcohol and other CNS depressants.

7.3Oral Contraceptives Exposure to ethinyl estradiol was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18%, 21%, and 30%, respectively) when topiramate was given as adjunctive therapy in patients taking valproic acid. However, norethindrone exposure was not significantly affected. In another pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 mcg ethinyl estradiol (EE), topiramate, given in the absence of other medications at doses of 50 to 200 mg/day, was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive.

The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with topiramate. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [ see Clinical Pharmacology ( 12.3 )].

7.4 Metfo…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Renal impairment: In renally impaired patients (creatinine clearance less than 70 mL/min/1.73 m 2 ), one-half of the adult dose is recommended ( 2.4 ) • Patients undergoing hemodialysis: Topiramate is cleared by hemodialysis. Dosage adjustment is necessary to avoid rapid drops in topiramate plasma concentration during hemodialysis ( 2.6 ) • Pregnancy: Increased risk of cleft lip and/or palate. ( 8.1 ) • Nursing mothers: Caution should be exercised when administered to a nursing mother ( 8.3 ) • Geriatric use: Dosage adjustment may be necessary for elderly with impaired renal function ( 8.5 ) Additional pediatric use information for patients ages 12 to 17 years is approved for Janssen Pharmaceuticals, Inc.’s TOPAMAX (topiramate) Tablets and Sprinkle Capsules.

However, due to Janssen Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

8.1Pregnancy Pregnancy Category D. [see Warnings and Precautions ( 5.7 )] Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.

Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations ( 8.9 )] . Pregnancy Registry 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. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/ .

Human Data Data from the NAAED Pregnancy Registry (425 prospective topiramate monotherapy-exposed pregnancies) indicate an increased risk of oral clefts in infants exposed during the first trimester of pregnancy. The prevalence of oral clefts among topiramate-exposed infants was 1.2% compared to a prevalence of 0.39% for infants exposed to a reference AED. In infants of mothers without epilepsy or treatment with other AEDs, the prevalence was 0.12%.

For comparison, the Centers for Disease Control and Prevention (CDC) reviewed available data on oral clefts in the United States and found a similar background rate of 0.17%. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% Confidence Interval [CI] 4 to 23) as compared to the risk in a background population of untreated women. The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts of 3.2% among infants exposed to topiramate monotherapy.

The observed rate of oral clefts was 16 times higher than the background rate in the UK, which is approximately 0.2%. Topiramate treatment can cause metabolic acidosis [see Warnings and Precautions ( 5.4 )] . The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus’ ability to tolerate labor.

🤰 Pregnancy ~3 min read ▾

Pregnant patients should be monitored for metabolic acidosis and treated as in the nonpregnant state [see Warnings and Precautions ( 5.4 )] . Newborns of mothers treated with topiramate should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Animal Data Topiramate has demonstrated selective developmental toxicity, including teratogenicity, in multiple animal species at clinically relevant doses.

When oral doses of 20, 100, or 500 mg/kg were administered to pregnant mice during the period of organogenesis, the incidence of fetal malformations (primarily craniofacial defects) was increased at all doses. The low dose is approximately 0.2 times the recommended human dose (RHD) 400 mg/day on a mg/m 2 basis. Fetal body weights and skeletal ossification were reduced at 500 mg/kg in conjunction with decreased maternal body weight gain.

In rat studies (oral doses of 20, 100, and 500 mg/kg or 0.2, 2.5, 30, and 400 mg/kg), the frequency of limb malformations (ectrodactyly, micromelia, and amelia) was increased among the offspring of dams treated with 400 mg/kg (10 times the RHD on a mg/m 2 basis) or greater during the organogenesis period of pregnancy. Em…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers (1 to 24 months) Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. In a single randomized, double-blind, placebo-controlled investigational trial, the efficacy, safety, and tolerability of topiramate oral liquid and sprinkle formulations as an adjunct to concurrent antiepileptic drug therapy in infants 1 to 24 months of age with refractory partial onset seizures were assessed.

After 20 days of double-blind treatment, topiramate (at fixed doses of 5, 15, and 25 mg/kg/day) did not demonstrate efficacy compared with placebo in controlling seizures. In general, the adverse reaction profile in this population was similar to that of older pediatric patients, although results from the above controlled study and an open-label, long-term extension study in these infants/toddlers (1 to 24 months old) suggested some adverse reactions/toxicities (not previously observed in older pediatric patients and adults; i.e., growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications.

These very young pediatric patients appeared to experience an increased risk for infections (any topiramate dose 12%, placebo 0%) and of respiratory disorders (any topiramate dose 40%, placebo 16%). The following adverse reactions were observed in at least 3% of patients on topiramate and were 3% to 7% more frequent than in patients on placebo: viral infection, bronchitis, pharyngitis, rhinitis, otitis media, upper respiratory infection, cough, and bronchospasm. A generally similar profile was observed in older children [see Adverse Reactions ( 6 )] .

Topiramate resulted in an increased incidence of patients with increased creatinine (any topiramate dose 5%, placebo 0%), BUN (any topiramate dose 3%, placebo 0%), and protein (any topiramate dose 34%, placebo 6%), and an increased incidence of decreased potassium (any topiramate dose 7%, placebo 0%). This increased frequency of abnormal values was not dose-related. Creatinine was the only analyte showing a noteworthy increased incidence (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase [see Warnings and Precautions ( 5.16 )] .

The significance of these findings is uncertain. Topiramate treatment also produced a dose-related increase in the percentage of patients who had a shift from normal at baseline to high/increased (above the normal reference range) in total eosinophil count at the end of treatment. The incidence of these abnormal shifts was 6 % for placebo, 10% for 5 mg/kg/day, 9% for 15 mg/kg/day, 14% for 25 mg/kg/day, and 11% for any topiramate dose [see Warnings and Precautions ( 5.16 )] .

There was a mean dose-related increase in alkaline phosphatase. The significance of these findings is uncertain. Topiramate produced a dose-related increased incidence of treatment-emergent hyperammonemia [see Warnings and Precautions ( 5.10 )] .

Treatment with topiramate for up to 1 year was associated with reductions in Z SCORES for length, weight, and head circumference [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6 )] . In open-label, uncontrolled experience, increasing impairment of adaptive behavior was documented in behavioral testing over time in this population. There was a suggestion that this effect was dose-related.

However, because of the absence of an appropriate control group, it is not known if this decrement in function was treatment-related or reflects the patient’s underlying disease (e.g., patients who received higher doses may have more severe underlying disease) [s…

🧓 Geriatric Use 86 words ▾

8.5Geriatric Use In clinical trials, 3% of patients were over 60. No age-related differences in effectiveness or adverse effects were evident. However, clinical studies of topiramate did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently than younger subjects.

Dosage adjustment may be necessary for elderly with impaired renal function (creatinine clearance rate <70 mL/min/1.73 m 2 ) due to reduced clearance of topiramate [see Clinical Pharmacology ( 12.3 ) and Dosage and Administration ( 2.5 )] .

🆘 Overdosage 151 words ▾

10 OVERDOSAGE Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after poly-drug overdoses involving topiramate.

Topiramate overdose has resulted in severe metabolic acidosis [see Warnings and Precautions ( 5.4 )] . A patient who ingested a dose between 96 g and 110 g topiramate was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. In acute topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis.

Activated charcoal has been shown to adsorb topiramate in vitro . Treatment should be appropriately supportive. Hemodialysis is an effective means of removing topiramate from the body.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanisms by which topiramate exerts its anticonvulsant effect is unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.

12.2Pharmacodynamics Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Topiramate is only weakly effective in blocking clonic seizures induced by the GABA A receptor antagonist, pentylenetetrazole. Topiramate is also effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia.

Changes (increases and decreases) from baseline in vital signs (systolic blood pressure-SBP, diastolic blood pressure-DBP, pulse) occurred more frequently in pediatric patients (6 to 17 years) treated with various daily doses of topiramate (50 mg, 100 mg, 200 mg, 2 to 3 mg/kg) than in patients treated with placebo in controlled trials for another indication . The most notable changes were SBP < 90 mm Hg, DBP < 50 mm Hg, SBP or DBP increases or decreases ≥ 20 mm Hg, and pulse increases or decreases ≥ 30 beats per minute.

These changes were often dose-related, and were most frequently associated with the greatest treatment difference at the 200 mg dose level. When a position was specified for measurement of vital signs in a trial, measurements were made in a sitting position. Systematic collection of orthostatic vital signs has not been conducted.

The clinical significance of these various changes in vital signs has not been clearly established.

12.3Pharmacokinetics Absorption of topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. The relative bioavailability of topiramate from the tablet formulation is about 80% compared to a solution. The bioavailability of topiramate is not affected by food.

The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). The mean plasma elimination half-life is 21 hours after single or multiple doses. Steady-state is thus reached in about 4 days in patients with normal renal function.

Topiramate is 15% to 41% bound to human plasma proteins over the blood concentration range of 0.5 to 250 mcg/mL. The fraction bound decreased as blood concentration increased. Carbamazepine and phenytoin do not alter the binding of topiramate.

Sodium valproate, at 500 mcg/mL (a concentration 5 to 10 times higher than considered therapeutic for valproate) decreased the protein binding of topiramate from 23% to 13%. Topiramate does not influence the binding of sodium valproate. Metabolism and Excretion Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose).

Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. There is evidence of renal tubular reabsorption of topiramate.

In rats, given probenecid to inhibit tubular reabsorption, along with topiramate, a significant increase in renal clearance of topiramate was observed. This interaction has not been evaluated in humans. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in adults following oral administration.

Specific Populations Renal Impairment…

🧬 Mechanism of Action 79 words ▾

📦 How Supplied / Storage and Handling 143 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other) 50 mg yellow (coded “S” on one side; “710” on the other) 100 mg yellow (coded “S” on one side; “711” on the other) 200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows: 100 mg tablets Bottles of 30’s with Child Resistant Cap….............. NDC 63187-801-30 Bottles of 60’s with Child Resistant Cap…………...NDC 63187-801-60 Bottles of 90’s with Child Resistant Cap ….......... ..NDC 63187-801-90

16.2Storage and Handling Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

📋 Description 184 words ▾

11 DESCRIPTION Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste.

Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL.

Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-‑Di- O -isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc.

In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black chemical-structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Eye Disorders Instruct patients taking topiramate tablets to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions ( 5.1 ), ( 5.2 )] . Oligohidrosis and Hyperthermia Closely monitor topiramate-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather.

Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Warnings and Precautions ( 5.3 )] . Metabolic Acidosis Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.1 )] .

Suicidal Behavior and Ideation Counsel patients, their caregivers, and families that AEDs, including topiramate tablets, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. Instruct patients to immediately report behaviors of concern to their healthcare providers [see Warnings and Precautions ( 5.5 )] .

Interference with Cognitive and Motor Performance Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on topiramate tablets to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions ( 5.6 )] . Even when taking topiramate tablets or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures.

Therefore, advise all patients taking topiramate tablets for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). Some patients with refractory epilepsy will need to avoid such activities altogether. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities.

Fetal Toxicity Inform pregnant women and women of childbearing potential that use of topiramate tablets during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. There may also be risks to the fetus from chronic metabolic acidosis with use of topiramate tablets during pregnancy [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 ), ( 8.9 )]. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options.

This is particularly important when topiramate tablets use is considered for a condition not usually associated with permanent injury or death. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using topiramate tablets, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate [see Drug Interactions ( 7.3 )] . Encourage pregnant women using topiramate tablets, to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

The registry is collecting information about…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Topiramate Tablets, USP (toe-PEER-uh-mate) Read this Medication Guide before you start taking topiramate tablets 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 topiramate tablets, talk to your healthcare provider or pharmacist. What is the most important information I should know about topiramate tablets? Topiramate tablets may cause eye problems.

Serious eye problems include: • any sudden decrease in vision with or without eye pain and redness, • a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). • These eye problems can lead to permanent loss of vision if not treated. • You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. Topiramate tablets may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures.

Some people may need to be hospitalized for this condition. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating. Topiramate tablets can increase the level of acid in your blood (metabolic acidosis).

If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: • feel tired • not feel hungry (loss of appetite) • feel changes in heartbeat • have trouble thinking clearly Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with topiramate tablets.

If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, topiramate tablets 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 Do not stop topiramate tablets without first talking to a healthcare provider. • Stopping topiramate tablets suddenly can cause serious problems. • 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. 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. Topiramate tablets can harm your unborn baby. • If you take topiramate tablets during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate.

These defects can begin early in pregnancy, even before you know you are pregnant. • Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors. • There may be other medicines to treat your condition that have a lower chance of birth defects. • All women of childbearing age should talk to their healthcare…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

depression: A lasting low mood with loss of interest that affects everyday life.

diplopia: Double vision, or seeing two images of a single object.

displacement: When one medicine knocks another off the blood proteins it was riding on, briefly raising the free, active amount of the second medicine.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

ecchymosis: A bruise; a flat blue or purple mark on the skin where blood has leaked underneath.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

epistaxis: A nosebleed.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

glucuronidation: The process where enzymes attach a sugar-like molecule to a drug so it dissolves in water and leaves the body.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intraocular pressure: The fluid pressure inside the eye.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

monotherapy: Treatment using a single medicine by itself.

mydriasis: Widening of the pupil, the dark center of the eye.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

osteomalacia: Softening of the bones, often from low vitamin D, that can cause bone pain and weakness.

osteopenia: Bones that are thinner and weaker than normal, but not as severe as osteoporosis.

osteoporosis: A condition where bones become thin and weak, making them more likely to break.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

pharmacokinetic interaction: When one medicine changes how the body absorbs, spreads, breaks down, or removes another, altering its level in the blood.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

refractory: Describing a disease that does not respond to, or improve with, treatment.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 63187-0800-07 · Proficient 63187-0803-20 · Proficient →

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.

Topiramate 100 mg Tablet, Film Coated, 30-count

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