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Topiramate 25 mg Capsule, Extended Release, 100-count — NDC 43598-0939-01 package photo

Topiramate 25 mg Capsule, Extended Release, 100-count

by Dr. Reddys Laboratories Inc. · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-939-01)
NDC 43598-0939-01
🏷️ FDA NDC (as labeled) 43598-939-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $15.02/unit — full pricing hub ↓
Also comes in: 30 capsules 43598-0939-30
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

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) 43598-939-01
Product NDC 43598-939
11-digit billing NDC 43598093901
RxCUI 1436239, 1437278, 1437283, 1437288
UNII 0H73WJJ391
Application # ANDA217231
SPL Set ID f07d81bc-5090-fbc5-2945-557cf002849c
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 2026-02-01
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance TOPIRAMATE
GPI-14 72600075007020
GCN Seq No 071343
GCN 35103
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 ER 25 MG CAPSULE
FDB brand name Topiramate Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 43598-939-01 — 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 → 43598-0939-01. 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

LabelerDr. Reddys Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA217231 (ANDA)
Labeler code43598
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio34 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 TOPIRAMATE ER 25 MG CAPSULE 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 →
1
Nutrient depletion considerations

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

🧪 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 Pink / Yellow / Green / Brown
ShapeCapsule
ImprintDRL;942
Size23 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 656HXR6YXN
    A combination of two additives: docusate sodium softens the medicine's texture to help it break apart, while sodium benzoate acts as a preservative to prevent spoilage and maintain shelf life.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • 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 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 2UMI9U37CP
    Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • 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 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 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

15 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $15.02 $1,502.35 / 100 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Topiramate 25 mg 72603-0120-01 NorthStar 30 capsules $2.334 AB2 Availability likely —
Topiramate 25 mg 69680-0177-30 Vitruvias 30 capsules $2.334 AB2 Availability likely —
Topiramate 25 mg 70710-1039-03 Zydus 30 capsules $2.334 AB2 Availability likely —
Topiramate 25 mg 00480-2356-01 Teva 100 capsules $4.208 — Availability likely —
Topiramate 25 mg 10370-0365-01 Par 100 capsules $4.208 AB1 Availability likely —
Topiramate 25 mg 70748-0275-06 Lupin 30 capsules $4.208 AB1 Availability likely —
Trokendi XR 25 mg 17772-0101-01 Supernus 100 capsules $11.794 AB1 FDA listed —
Topiramate 25 mg 27241-0227-01 Ajanta 100 capsules — AB1 FDA listed —
Topiramate 25 mg 31722-0547-30 Camber 30 capsules — AB1 FDA listed —
Topiramate 25 mg 42291-0955-30 AvKARE 30 capsules — AB1 FDA listed —
Topiramate 25 mgthis 43598-0939-01 Dr. 100 capsules — AB1 FDA listed —
Topiramate 25 mg 68382-0863-01 Zydus 100 capsules — AB1 FDA listed —
Topiramate 25 mg 70771-1315-01 Zydus 100 capsules — AB1 FDA listed —
Topiramate 25 mg 70771-1656-03 Zydus 30 capsules — AB2 FDA listed —
Topiramate 25 mg 27241-0296-30 Ajanta 30 capsules — AB2 FDA listed —
Topiramate 25 mg 00832-1071-15 Upsher-Smith 500 capsules — AB2 FDA listed —
Qudexy Xr 25 mg 00245-1071-30 Upsher-Smith 30 capsules — AB2 FDA listed —
Topiramate 25 mg 68462-0372-05 Glenmark 500 capsules — AB2 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 NDCDescription Per unit Per pack Marketing startStatus
43598-0939-01 You're viewing this 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-939-01) — — 2026-02-01 Active
43598-0939-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-939-30) $4.21 / ea $126.23 2026-02-01 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 43598-0939-01?
NDC 43598-0939-01 is a 100-count package — 100 capsule, extended release in 1 bottle.
What is the difference between NDC 43598-0939-01 and NDC 43598-0939-30?
Both are Topiramate 25 mg Capsule, Extended Release — the drug itself is identical. NDC 43598-0939-01 is the 100-count package, while NDC 43598-0939-30 is the 30 capsules package.
What NDC number is used to bill for this package of Topiramate 25 mg Capsule, Extended Release?
Bill NDC 43598-0939-01 — the 11-digit billing format is 43598093901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 43598-939-01, 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: 43598-0939-01, written without dashes as 43598093901. 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 43598-0939-01, the first segment (43598) is the labeler code FDA assigned to Dr. Reddys Laboratories Inc.; the middle segment (0939) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Dr. Reddys Laboratories 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 30 capsules (43598-0939-30). 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?
Dr. Reddys Laboratories 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 ⏱️ 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 176 words ▾

1 INDICATIONS AND USAGE Topiramate extended-release capsule is indicated for: Epilepsy: initial monotherapy for the treatment of partial- onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1) ; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2) Preventive treatment of migraine in patients 12 years of age and older (1.3)

1.1Monotherapy Epilepsy Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see Clinical Studies (14.2) ].

1.2Adjunctive Therapy Epilepsy Topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older [see Clinical Studies (14.3) ] .

1.3Migraine Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Topiramate extended-release capsules initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Swallow capsule whole and intact. Do not sprinkle on food, chew, or crush (2.7)

2.1Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures The recommended dose for topiramate extended-release capsules monotherapy in adults and in pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate topiramate extended-release capsules according to the following schedule: Week 1: 50 mg once daily Week 2: 100 mg once daily Week 3: 150 mg once daily Week 4: 200 mg once daily Week 5: 300 mg once daily Week 6: 400 mg once daily Pediatric Patients Ages 6 to 9 Years of Age Dosing in patients 6 to 9 years of age is based on weight.

During the titration period, the initial dose of topiramate extended-release capsules is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day in the second week. Dosage can be increased by 25 mg 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 mg to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (see Table 1).

Table 1: Monotherapy Target Total Daily Maintenance Dosing for Patients 6 to 9 Years of Age Weight (kg) Total Daily Dose (mg/day) Minimum Maintenance Dose Total Daily Dose (mg/day) Maximum Maintenance Dose Up to 11 150 250 12 to 22 200 300 23 to 31 200 350 32 to 38 250 350 Greater than 38 250 400

2.2Dosing in Adjunctive Therapy Epilepsy Adults (17 Years of Age and Older) The recommended total daily dose of topiramate extended-release capsules as adjunctive therapy in adults with partial-onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily and with primary generalized tonic-clonic seizures is 400 mg orally once daily. Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50 mg every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose.

Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. Pediatric Patients 6 to 16 Years of Age The recommended total daily dose of topiramate extended-release capsules as adjunctive therapy for patients 6 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (or less, based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week.

Subsequently, increase the dosage at 1- or 2-week intervals by increments of 1 mg/kg/day to 3 mg/kg/day to achieve optimal clinical response. Dose titration should be guided by clinical outcome. The total daily dose should not exceed 400 mg/day.

2.3Dosing for the Preventive Treatment of Migrain The recommended total daily dose of topiramate extended-release capsules as treatment for the preventive treatment of migraine in patients 12 years of age and older is 100 mg once daily. Titrate topiramate extended-release capsules for the preventive treatment of migraine according to the following schedule: Week 1: 25mg once daily Week 2: 50mg once daily Week 3: 75mg once daily Week 4: 100 mg once daily Dose and titration rate s…

💊 Dosage Forms and Strengths 161 words ▾

3 DOSAGE FORMS AND STRENGTHS Topiramate extended-release capsules are available in the following strengths and colors: 25 mg: Size 4 hard gelatin capsule with pink opaque colored cap and orange opaque colored body imprinted ‘DRL’ on the cap and ‘939’ on body with black ink. Free from physical defects. 50 mg: Size 3 hard gelatin capsule with yellow opaque colored cap and pink opaque colored body imprinted ‘DRL’ on the cap and ‘940’ on body with black ink.

Free from physical defects. 100 mg: Size 1 hard gelatin capsule with light green opaque colored cap and blue opaque colored body imprinted ‘DRL’ on the cap and ‘941’ on body with black ink. Free from physical defects.

200 mg: Size 00 hard gelatin capsule with brown opaque colored cap and green opaque colored body imprinted ‘DRL’ on the cap and ‘942’ on body with black ink. Free from physical defects. Extended-release capsules: 25 mg, 50 mg, 100 mg, and 200 mg (3)

⛔ Contraindications 56 words ▾

4 CONTRAINDICATIONS Topiramate extended-release capsules are contraindicated in patients with recent alcohol use (i.e., within 6 hours prior to and 6 hours after topiramate extended-release capsules use) [see Warnings and Precautions (5.5) ] With recent alcohol use, ie, within 6 hours prior to and 6 hours after topiramate extended-release capsules use ( 4 , 5.5 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate extended-release capsules as soon as possible (5.1) Visual field defects: consider discontinuation of topiramate extended-release capsules (5.2) Oligohydrosis 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 extended-release capsules if clinically appropriate (5.4) Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (5.6) Cognitive/neuropsychiatric adverse reactions: use caution when operating machinery including cars; depression and mood problems may occur (5.7) Fetal toxicity: use during pregnancy can cause major congenital malformations, including but not limited to cleft lip and/or palate, and being small for gestational age (5.8) Withdrawal of AEDs: withdraw topiramate extended-release capsules gradually (5.9) Decrease in Bone Mineral Density: has been shown to decrease bone mineral density and bone mineral content in pediatric patients ( 5.10 ) Negative effects on growth (height and weight): may slow height increase and weight gain; carefully monitor children receiving prolonged therapy ( 5.11 ) Serious skin reactions: If SJS or TEN is suspected, discontinue topiramate extended-release capsules (5.12) Hyperammonemia/encephalopathy: measure ammonia if encephalopathic symptoms occur (5.13) Kidney stones: avoid use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet (5.14) Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use (5.15)

5.1Acute Myopia and Secondary Angle Closure Glaucoma Syndrome 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 some or all of the following: myopia , mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure.

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 extended-release capsules as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate extended-release capsules, 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 treatment with topiramate extended-release capsules, consideration should be given to discontinuing the drug.

5.3Oligohydrosis and Hyperthermia Oligohydrosis (decreased sweating), resulting in hospitalization in some cases, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cas…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma [see Warnings and Precautions (5.1) ] Visual Field Defects [see Warnings and Precautions (5.2) ] Oligohydrosis and Hyperthermia [see Warnings and Precautions (5.3) ] Metabolic Acidosis [see Warnings and Precautions (5.4) ] Interaction With Alcohol [see Warnings and Precautions ( 5.5 )] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.7) ] Fetal Toxicity [see Warnings and Precautions ( 5.8 )] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.9) ] Decrease of Bone Mineral Density [see Warnings and Precautions ( 5.10 )] Negative Effects on Growth (Height and Weight) [see Warnings and Precautions ( 5.11 )] Serious Skin Reactions [see Warnings and Precautions (5.12) ] Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use) [see Warnings and Precautions (5.13) ] Kidney Stones [see Warnings and Precautions (5.14) ] Hypothermia With Concomitant Valproic Acid Use [see Warnings and Precautions (5.15) ] The data described in the following sections were obtained using immediate-release topiramate tablets.

Topiramate extended-release capsules have not been studied in a randomized, placebo-controlled Phase III clinical study; however, it is expected that topiramate extended-release capsules would produce a similar adverse reaction profile as immediate-release topiramate. Epilepsy : Most common (≥ 10% more frequent than placebo or low-dose topiramate) adverse reactions in adult and pediatric patients were paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever (6.1).

Migraine: Most common (≥5% more frequent than placebo) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain, and upper respiratory tract infection (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. Monotherapy Epilepsy Adults 16 Years of Age and Older The most common adverse reactions in the controlled trial (Study 1) that occurred in adults in the 400 mg/day topiramate group and at an incidence higher (≥ 10%) than in the 50 mg per day group were: paresthesia, weight loss, and anorexia (see Table 3).

Approximately 21% of the 159 adult patients in the 400 mg/day group who received topiramate as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common (≥ 2% more frequent than low-dose 50 mg/day topiramate) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia. Pediatric Patients 6 Years to 15 Years of Age The most common adverse reactions in the controlled trial (Study 1) that occurred in pediatric patients in the 400 mg/day topiramate group and at an incidence higher (≥ 10%) than in the 50 mg/day group were fever and weight loss (see Table 3).

Approximately 14% of the 77 pediatric 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 in the 50 mg/day group) adverse reactions resulting in discontinuation in this trial were difficulty with concentration/attention, fever, flushing, and confusion. Table…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Contraceptives: Decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg per day (7.5) Monitor lithium levels if lithium is used with high-dose topiramate extended-release capsules (7.8)

7.1Alcohol Alcohol use is contraindicated within 6 hours prior to and 6 hours after topiramate extended-release capsules administration [see Contraindications (4) and Warnings and Precautions (5.5) ].

7.2Antiepileptic Drugs Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. A dosage adjustment may be needed [see Dosage and Administration (2.1) , Clinical Pharmacology (12.3) ] . Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy.

Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions ( 5.13 , 5.15 ) and Clinical Pharmacology (12.3) ].

7.3Other Carbonic Anhydrase Inhibitors Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Patients should be monitored for the appearance or worsening of metabolic acidosis when topiramate extended-release capsules is given concomitantly with another carbonic anhydrase inhibitor [see Clinical Pharmacology (12.3) ] .

7.4CNS Depressants Concomitant administration of topiramate with other CNS depressant drugs or alcohol 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 extended-release capsules should be used with extreme caution if used in combination with alcohol and other CNS depressants [see Contraindications (4) and Warnings and Precautions (5.7) ] .

7.5Contraceptives The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking contraceptive products with topiramate extended-release capsules. Patients taking estrogen-containing or progestin-only 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) ].

7.6Hydrochlorothiazide (HCTZ) Topiramate C max and AUC increased when HCTZ was added to immediate-release topiramate. The clinical significance of this change is unknown. The addition of HCTZ to topiramate extended-release capsules may require a decrease in the topiramate extended-release capsules dose [see Clinical Pharmacology (12.3) ].

7.7Pioglitazone A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and immediate-release topiramate in a clinical trial. The clinical relevance of these observations is unknown; however, when topiramate extended-release capsules is added to pioglitazone therapy or pioglitazone is added to topiramate extended-release capsules therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state [see Clinical Pharmacology (12.3) ].

7.8Lithium An increase in systemic exposure of lithium following topiramate doses of up to 600 mg/day can occur. Lithium levels should be monitored when co-administered with high-dose topiramate extended-release capsules [see Clinical Pharmacology (12.3) ].

7.9Amitriptyline Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate extended-release capsules and any adjustments in amitriptyline dose should be made according to the patients’ clinical response and no…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as topiramate extended-release capsules, during pregnancy. 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.aedpregnancyregistry.org/. Risk Summary Topiramate extended-release capsules can cause fetal harm when administered to a pregnant woman.

Data from pregnancy registries indicate that infants exposed to topiramate in utero have increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA) [see Human Data]. SGA has been observed at all doses and appears to be dose-dependent. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy.

In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. In multiple animal species, topiramate demonstrated developmental toxicity, including increased incidences of fetal malformations, in the absence of maternal toxicity at clinically relevant doses [see Animal Data]. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse reactions Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death.

Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy before many women know they are pregnant, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. Labor or Delivery Although the effect of topiramate on labor and delivery in humans has not been established, the development of topiramate-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus’ ability to tolerate labor.

Topiramate extended-release capsules 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. 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 extended-release capsules should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth.

Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. Data Human Data Data from pregnancy registries indicate an increase…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as topiramate extended-release capsules, during pregnancy. 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.aedpregnancyregistry.org/. Risk Summary Topiramate extended-release capsules can cause fetal harm when administered to a pregnant woman.

Data from pregnancy registries indicate that infants exposed to topiramate in utero have increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA) [see Human Data]. SGA has been observed at all doses and appears to be dose-dependent. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy.

In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. In multiple animal species, topiramate demonstrated developmental toxicity, including increased incidences of fetal malformations, in the absence of maternal toxicity at clinically relevant doses [see Animal Data]. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse reactions Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death.

Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy before many women know they are pregnant, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. Labor or Delivery Although the effect of topiramate on labor and delivery in humans has not been established, the development of topiramate-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus’ ability to tolerate labor.

Topiramate extended-release capsules 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. 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 extended-release capsules should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth.

Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. Data Human Data Data from pregnancy registries indicate an increased risk of major congenital mal…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Seizures in Pediatric Patients 6 Years of Age and Older The safety and effectiveness of topiramate extended-release capsules for treatment of partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndromes in pediatric patients at least 6 years of age is based on controlled trials with immediate-release topiramate [ see Adverse Reactions ( 6.1 ), Clinical Studies (14.2, 14.3)]. The adverse reactions in pediatric patients treated for partial onset seizure, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome are similar to those seen in adults [see Warnings and Precautions (5) and Adverse Reactions (6) ] .

These include, but are not limited to: oligohydrosis and hyperthermia [see Warnings and Precautions (5.3) ] dose-related increased incidence of metabolic acidosis [see Warnings and Precautions (5.4) ] dose-related increased incidence of hyperammonemia [see Warnings and Precautions (5.13) ] Not Recommended for Pediatric Patients Younger than 6 Years of Age The safety and effectiveness of topiramate extended-release capsules for treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndromes in pediatric patients younger than 6 years of age has not been established.

Because the capsule must be swallowed whole, and may not be sprinkled on food, crushed or chewed, topiramate extended-release capsules is recommended only for children age 6 or older. The following pediatric use information for adjunctive treatment for partial onset epilepsy in infants and toddlers (1 to 24 months) is based on studies conducted with immediate-release topiramate, which failed to demonstrate efficacy. Safety and effectiveness of immediate-release topiramate in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial onset seizures, primary generalized tonic­clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

In a single randomized, double-blind, placebo-controlled investigational trial, the efficacy, safety, and tolerability of immediate-release topiramate oral liquid and sprinkle formulations as an adjunct to concurrent antiepileptic drug therapy in pediatric patients 1 to 24 months of age with refractory partial-onset seizures were assessed. After 20 days of double-blind treatment, immediate-release topiramate (at fixed doses of 5, 15, and 25 mg/kg per day) did not demonstrate efficacy compared with placebo in controlling seizures.

In general, the adverse reaction profile for immediate-release topiramate in this population was similar to that of older pediatric patients, although results from the above controlled study, and an open-label, long­term extension study in these pediatric patients 1 to 24 months old suggested some adverse reactions not previously observed in older pediatric patients and adults; i.e., growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions 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 immediate-release 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 pediatric patients [see Adverse Reactions (6.1) ].

Immediate-release 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%, plac…

🧓 Geriatric Use 63 words ▾

8.5Geriatric Use Clinical studies of immediate-release topiramate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Dosage adjustment may be necessary for elderly with creatinine clearance less than 70 mL/min/1.73 m 2 . Estimate GFR should be measured prior to dosing [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]

🆘 Overdosage 152 words ▾

10 OVERDOSAGE Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, 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 overdoses involving topiramate.

Topiramate overdose has resulted in severe metabolic acidosis [see Warnings and Precautions (5.4) ]. A patient who ingested a dose of immediate-release topiramate between 96 grams and 110 grams was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Similar signs, symptoms, and clinical consequences are expected to occur with overdosage of topiramate extended-release capsules.

In the event of overdose, topiramate extended-release capsules should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. 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 and preventive migraine effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and the preventive treatment of migraine. 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 the preventive treatment of migraine. 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. 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 and Distribution Linear pharmacokinetics of topiramate from topiramate extended-release capsules were observed following a single oral dose over the range of 50 mg to 200 mg. At 25 mg, the pharmacokinetics of topiramate extended-release capsules is nonlinear possibly due to the binding of topiramate to carbonic anhydrase in red blood cells. The peak plasma concentrations (C max ) of topiramate occurred at approximately 24 hours following a single 200 mg oral dose of topiramate extended-release capsules.

At steady-state, the (AUC 0-24 , C max , and C min ) of topiramate from topiramate extended-release capsules administered once-daily and the immediate-release tablet administered twice-daily were shown to be bioequivalent. Fluctuation of topiramate plasma concentrations at steady-state for topiramate extended-release capsules administered once-daily was approximately 26% and 42% in healthy subjects and in epileptic patients, respectively, compared to approximately 40% and 51%, respectively, for immediate-release topiramate [see Clinical Pharmacology (12.6) ].

Compared to the fasted state, high-fat meal increased the C max of topiramate by 37% and shortened the Tmax to approximately 8 hours following a single dose of topiramate extended-release capsules, while having no effect on the AUC. Modeling of the observed single dose fed data with simulation to steady state showed that the effect on C max is significantly reduced following repeat administrations. Topiramate extended-release capsules can be taken withoutregard to meals.

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

Sodium valproate, at 500 mcg/mL (a concentration 5 to 10 times higher th…

🧬 Mechanism of Action 88 words ▾

12.1Mechanism of Action The precise mechanisms by which topiramate exerts its anticonvulsant and preventive migraine effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and the preventive treatment of migraine. 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.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Topiramate extended-release capsules are available in the following strengths and colors: 25 mg : Size 4 hard gelatin capsule with pink opaque colored cap and orange opaque colored body imprinted ‘DRL’ on the cap and ‘939’ on body with black ink. Free from physical defects. Bottles of 30 count NDC 43598-939-30 Bottles of 100 count NDC 43598-939-01 50 mg: Size 3 hard gelatin capsule with yellow opaque colored cap and pink opaque colored body imprinted ‘DRL’ on the cap and ‘940’ on body with black ink.

Free from physical defects. Bottles of 30 count NDC 43598-940-30 Bottles of 100 count NDC 43598-940-01 100 mg: Size 1 hard gelatin capsule with light green opaque colored cap and blue opaque colored body imprinted ‘DRL’ on the cap and ‘941’ on body with black ink. Free from physical defects.

Bottles of 30 count NDC 43598-941-30 Bottles of 100 count NDC 43598-941-01 200 mg: Size 00 hard gelatin capsule with brown opaque colored cap and green opaque colored body imprinted ‘DRL’ on the cap and ‘942’ on body with black ink. Free from physical defects. Bottles of 30 count NDC 43598-942-30 Bottles of 100 count NDC 43598-942-01

16.2Storage and Handling Topiramate extended-release capsules should be stored in well closed containers at controlled room temperature [20°C to 25°C (68°F to 77°F); excursions 15°C to 30°C (59°F to 86°F)] . Protect from moisture and light.

📋 Description ~1 min read ▾

11 DESCRIPTION Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate, USP is a white to off-white powder.

Topiramate is freely soluble in dichloromethane.Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate extended-release capsules contains 25 mg, 50 mg, 100 mg and 200 mg of topiramate. Topiramate extended-release capsules contains the following inactive ingredients: Docusate sodium and sodium benzoate, ethylcellulose, hydroxy propyl methyl cellulose, iron oxide yellow, lecithin, mannitol, medium chain triglycerides, oleic acid, polyethylene glycol, polyvinyl alcohol, sugar spheres, talc, titanium dioxide, and xanthan gum.

The capsule shells contain gelatin, titanium dioxide and colorants. The colorants are: FD&C Blue 1 and D & C Yellow 10 (all strength capsules) FD & C Yellow 6 (50 mg, 100 mg and 200 mg capsules) FD&C Red 40 (25 mg and 50 mg capsules) D &C Red 28 (25 mg and 50 mg capsules) FD & C Red 3 (100 mg capsules) Iron oxide yellow, iron oxide red, iron oxide black (200 mg capsules) All capsule shells are imprinted with black print that contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Instructions Counsel patients to swallow topiramate extended-release capsules whole and intact. Topiramate extended-release capsules should not be sprinkled on food, chewed or crushed [see Dosage and Administration (2.7) ].

Consumption of Alcohol Advise patients to completely avoid consumption of alcohol at least 6 hours prior to and 6 hours after taking topiramate extended-release capsules [see Warnings and Precautions (5.5) ] . Eye Disorders Advise patients taking topiramate extended-release capsules to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions ( 5.1 , 5.2 )]. Oligohydrosis and Hyperthermia Counsel patients that topiramate extended-release capsules, especially pediatric patients, can cause decreased sweating and increased body temperature, especially in hot weather, and they should seek medical attention if this is noticed [see Warnings and Precautions (5.3) ] Metabolic Acidosis Inform patients about the potentially 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) ] .

Suicidal Behavior and Ideation Counsel patients, their caregivers, and families that AEDs, including topiramate extended-release capsules may increase the risk of suicidal thoughts and behavior and they should be advised 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, behavior or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.6) ] .

Interference with Cognitive and Motor Performance Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects and advise them not to drive or operate machinery until they have gained sufficient experience on topiramate extended-release capsules to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions (5.7) ]. Advise patients that even when taking topiramate extended-release capsules or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures.

Therefore, counsel all patients taking topiramate extended-release capsules 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. Physicians should discuss the appropriate level of caution with their patients, before patients with epilepsy engage in such activities Fetal Toxicity Counsel pregnant women and women of childbearing potential that use of topiramate extended-release capsules during pregnancy can cause fetal harm.

Topiramate extended-release capsules increases the risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use in Specific Populations (8.1) ]. There may also be risks to the fetus from chronic metabolic acidosis with use of topiramate extended-release capsules during pregnancy . [see Warning and Precautions ( 5.4 , 5.8 ) When appropriate, prescribers should counsel pregnant women and women of chil…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Topiramate (toe pyre' a mate) Extended-Release Capsules What is the most important information I should know about topiramate extended-release capsules? Take topiramate extended-release capsules whole. Do not sprinkle topiramate extended-release capsules on food, or break, crush, dissolve, or chew topiramate extended-release capsules before swallowing.

If you cannot swallow topiramate extended-release capsuleswhole, tell your healthcare provider. You may need a different medicine. Do not drink alcohol within 6 hours prior to and 6 hours after topiramate extended-release capsules administration.

Topiramate extended-release capsules 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 extended-release capsules 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Topiramate extended-release capsules 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 extended-release capsules.

If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, topiramate extended-release capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying trouble sleeping (insomnia) attempts to commit suicide new or worse irritability new or worse depression acting aggressive, being angry, or violent new or worse anxiety acting on dangerous impulses feeling agitated or restless an extreme increase in activity and talking (mania) panic attacks other unusual changes in behavior or mood Do not stop topiramate extended-release capsules without first talking to a healthcare provider.

Stopping topiramate extended-release capsules 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 extended-release capsules can harm your unborn baby. If you take topiramate extended-release capsules during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate.

These defects can begin early in pregnancy, even before you know you are pregnant. Birth defects may happen even in children born to women who are…

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