Topiramate 25 mg Tablet, Film Coated, 1,000-count
Other active recalls for Topiramate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Centrally acting antiobesity products class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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 ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Topiramate — tap one for details:
Topiramate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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.
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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.
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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.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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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.
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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.
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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.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.026 | $25.60 / 1000 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1397 | $139.70 / 1000 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0808 | $80.80 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| topiramate 25 mg 00904-6928-61 | Major | 1 tablet | $0.026 | AB | Availability likely | — |
| Topiramate 25 mg 68084-0342-01 | American | 1 tablet | $0.026 | AB | Availability likely | — |
| Topiramate 25 mgthis 68462-0108-10 | Glenmark | 1000 tablets | $0.026 | AB | Availability likely | — |
| Topiramate 25 mg 69097-0122-03 | Cipla | 60 tablets | $0.026 | AB | Availability likely | — |
| Topiramate 25 mg 76282-0278-10 | EXELAN | 1000 tablets | $0.026 | AB | Availability likely | — |
| topiramate 25 mg 82009-0135-05 | Quallent | 500 tablets | $0.026 | AB | Availability likely | — |
| Topiramate 25 mg 69097-0816-03 | Cipla | 60 tablets | $0.035 | AB | FDA listed | +37% |
| Topamax 25 mg 50458-0639-65 | Janssen | 60 tablets | $6.576 | AB | Availability likely | +25558% |
| Topiramate 25 mg 00615-8138-39 | NCS | 30 tablets | — | AB | Discontinued | — |
| Topiramate 25 mg 00615-8593-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 29300-0115-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 31722-0181-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 43063-0735-15 | PD-Rx | 15 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 43063-0998-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 47335-0707-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 50090-2102-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 50090-4614-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 50090-5853-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 50090-6827-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 50090-7067-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 50268-0806-15 | AvPAK | 1 tablet | — | AB | FDA listed | — |
| topiramate 25 mg 51655-0429-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 55154-7146-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| topiramate 25 mg 60760-0075-30 | St. | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 60760-0752-60 | St. | 60 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 62756-0707-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 63187-0077-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 63187-0118-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 63187-0773-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 65841-0647-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 65862-0171-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 67046-0375-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 67046-1180-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 68071-1971-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 68071-3660-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 68382-0138-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 68788-7460-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 68788-8817-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 70518-0233-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 70518-0625-01 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 70518-1718-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| topiramate 25 mg 70518-4515-00 | REMEDYREPACK | 120 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 71205-0202-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 71205-0214-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 71205-0233-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 71335-0548-00 | Bryant | 28 tablets | — | AB | Discontinued | — |
| topiramate 25 mg 71335-1684-00 | Bryant | 28 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 71335-9727-00 | Bryant | 28 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 71610-0485-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 72162-2480-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 72789-0471-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 72865-0313-10 | XLCare | 1000 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 76420-0278-30 | Asclemed | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 80425-0208-02 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 80425-0288-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| topiramate 25 mg 80425-0576-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 87441-0079-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Topiramate 25 mg 70518-2517-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68462-0108-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-108-05) | $0.0256 / ea | $12.82 | 2020-07-30 | Active |
| 68462-0108-10 You're viewing this | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-108-10) | $0.0256 / ea | $25.63 | 2009-03-27 | Active |
| 68462-0108-60 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-108-60) | $0.0256 / ea | $1.54 | 2009-03-27 | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0256 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 40% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68462-0108-10?
What is the difference between NDC 68462-0108-10 and NDC 68462-0108-60?
What NDC number is used to bill for this package of Topiramate 25 mg Tablet, Film Coated?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Topiramate tablets are indicated for: • Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 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 tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic‑clonic seizures in patients 2 years of age and older.
1.2Adjunctive Therapy Epilepsy Topiramate tablets 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 2 years of age and older.
1.3Migraine Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Topiramate tablets 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 )
2.1Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age 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. 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 Pediatric Patients 2 to 9 Years of Age Dosing in patients 2 to 9 years of age is based on weight.
During the titration period, the initial dose of topiramate tablets is 25 mg/day 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 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 *Administered in two equally divided doses
2.2Dosing in Adjunctive Therapy Epilepsy Adults (17 Years of Age and Older) The recommended total daily dose of topiramate tablets as adjunctive therapy in adults with partial-onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. Topiramate tablets should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day 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 2 to 16 Years of Age The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses.
Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), 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 Migraine The recommended total daily dose of topiramate tablets as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). The recommended titration rate for topiramate tablets for the preventive treatment of migraine is as follows: Table 3: Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older Morning Dose Evening D…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Topiramate Tablets, USP are available as circular, biconvex, film-coated tablets in the following strengths and colors: 25 mg white tablets with ‘G’ engraved on one side and ‘25’ on the other side. 50 mg yellow tablets with ‘G’ engraved on one side and ‘50’ on the other side. 100 mg yellow tablets with ‘G’ engraved on one side and ‘100’ on the other side.
200 mg pink tablets with ‘G’ engraved on one side and ‘200’ on the other side. • Tablets: 25 mg, 50 mg, 100 mg, and 200 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Topiramate is contraindicated in patients with a history of hypersensitivity reaction to topiramate, Topiramate tablets, or any of the inactive ingredients of Topiramate tablet. Anaphylaxis and angioedema have occurred [see Warnings and Precautions (5.13)] . History of hypersensitivity reaction to topiramate, topiramate tablets, or any of the inactive ingredients of topiramate tablet. ( 4 , 5.13 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate tablets as soon as possible ( 5.1 ) • Visual field defects: consider discontinuation of topiramate tablets ( 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 tablets if clinically appropriate ( 5.4 ) • Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation ( 5.5 ) • Cognitive/neuropsychiatric adverse reactions: use caution when operating machinery including cars; depression and mood problems may occur ( 5.6 ) • 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 ( 5.7 ) • Withdrawal of AEDs: withdraw topiramate tablets gradually ( 5.8 ) • Decrease in Bone Mineral Density: has been shown to decrease bone mineral density and bone mineral content in pediatric patients ( 5.9 ) • Negative effects on growth (height and weight): may slow height increase and weight gain; carefully monitor children receiving prolonged therapy ( 5.10 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multiorgan Hypersensitivity, serious skin reactions (SJS or TEN), anaphylaxis, and angioedema: Discontinue topiramate tablets if an alternative etiology cannot be established ( 5.11 , 5.12 , 5.13 ) • Hyperammonemia/encephalopathy: measure ammonia if encephalopathic symptoms occur ( 5.14 ) • Kidney stones: avoid use with other carbonic anhydrase inhibitors, drugs causing metabolic acidosis, or in patients on a ketogenic diet ( 5.15 ) • Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use ( 5.16 )
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 tablets. 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 tablets therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate tablets 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 tablets, 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 tablets use. Decreased sweating and an elevat…
🤒 Adverse Reactions ▾
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 )] • 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 )] • Decrease of Bone Mineral Density [see Warnings and Precautions ( 5.9 )] • Negative Effects on Growth (Height and Weight) [see Warnings and Precautions ( 5.10 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions ( 5.11 )] • Serious Skin Reactions [see Warnings and Precautions ( 5.12 )] • Anaphylaxis and Angioedema [see Warnings and Precautions (5.13)] • Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see Warnings and Precautions ( 5.14 )] • Kidney Stones [see Warnings and Precautions ( 5.15 )] • Hypothermia with Concomitant Valproic Acid (VPA) Use [see Warnings and Precautions ( 5.16 )] The data described in the following sections were obtained using topiramate tablets.
Epilepsy : Most common (≥10% more frequent than placebo or low-dose topiramate tablets) 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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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. Monotherapy Epilepsy Adults 16 Years of Age and Older The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in adults in the 400 mg/day topiramate tablets group and at an incidence higher (≥10 %) than in the 50 mg/day group were: paresthesia, weight loss and anorexia (see Table 5).
Approximately 21% of the 159 adult patients in the 400 mg/day group who received topiramate tablets as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common (≥ 2% more frequent than low-dose 50 mg/day topiramate tablets) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia. Pediatric Patients 6 to 15 Years of Age The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in pediatric patients in the 400 mg/day topiramate tablets group and at an incidence higher (≥10%) than in the 50 mg/day group were fever and weight loss (see Table 5).
Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received topiramate tablets 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 tablets) adverse reactions resulting in discontinuation were difficulty with concentration/attention, fever, flushing, and confusion. Table 5 presents the incidence of adverse reactions occurring in at least 3% of adult and pediatric patient…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day ( 7.4 ) • Monitor lithium levels if lithium is used with high-dose topiramate tablets ( 7.7 )
7.1Antiepileptic Drugs Concomitant administration of phenytoin or carbamazepine with topiramate tablets resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate tablets 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 tablets 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 ( 5.14 , 5.16 ), Clinical Pharmacology ( 12.3 )].
7.2Other 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. Therefore, patients given topiramate tablets concomitantly with another carbonic anhydrase inhibitor should be monitored particularly closely for the appearance or worsening of metabolic acidosis [see Clinical Pharmacology ( 12.3 )] .
7.3CNS Depressants Concomitant administration of topiramate tablets 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 tablets should be used with extreme caution if used in combination with alcohol and other CNS depressants.
7.4Contraceptives The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking contraceptive products with topiramate tablets. 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 )].
7.5Hydrochlorothiazide (HCTZ) Topiramate C max and AUC increased when HCTZ was added to topiramate tablets. The clinical significance of this change is unknown. The addition of HCTZ to topiramate tablets may require a decrease in the topiramate tablets dose [see Clinical Pharmacology ( 12.3 )] .
7.6Pioglitazone A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and topiramate tablets in a clinical trial. The clinical relevance of these observations is unknown; however, when topiramate tablets is added to pioglitazone therapy or pioglitazone is added to topiramate tablets 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 )] .
7.7Lithium An increase in systemic exposure of lithium following topiramate tablets doses of up to 600 mg/day can occur. Lithium levels should be monitored when co-administered with high-dose topiramate tablets [see Clinical Pharmacology ( 12.3 )] .
7.8Amitriptyline Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate tablets and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate tablets 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 tablets 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 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 produced 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, 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 tablets 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 tablets 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 tablets 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 malformations, including but not limited to oral clefts in infants exposed to topiramate during the first trimest…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate tablets 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 tablets 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 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 produced 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, 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 tablets 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 tablets 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 tablets 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 malformations, including but not limited to oral clefts in infants exposed to topiramate during the first trimester of pregnancy.
Other than or…
🧒 Pediatric Use ▾
8.4Pediatric Use Adjunctive Treatment for Epilepsy Pediatric Patients 2 Years of Age and Older The safety and effectiveness of topiramate tablets as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome have been established in pediatric patients 2 years of age and older [see Adverse Reactions (6.1) and Clinical Studies (14.2)] . Pediatric Patients Below the Age of 2 Years 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 pediatric patients 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 for topiramate tablets 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 pediatric patients 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 pediatric patients [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.
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.
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 hyperammonemia [see Warnings and Precautions ( 5.14 )] .
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 ), 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…
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials, 3% of patients were over age 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 age-related renal impairment (creatinine clearance rate <70 mL/min/1.73 m 2 ) resulting in reduced clearance [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Overdoses of topiramate tablets 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 tablets.
Topiramate tablets overdose has resulted in severe metabolic acidosis [see Warnings and Precautions ( 5.4 )] . A patient who ingested a dose of topiramate tablets between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. In the event of overdose, topiramate tablets 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 ▾
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 The sprinkle formulation is bioequivalent to the immediate-release tablet formulation and, therefore, may be substituted as a therapeutic equivalent. 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)…
🧬 Mechanism of Action ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Topiramate Tablets, USP are available as circular, biconvex, film-coated tablets in the following strengths and colors: 25 mg white tablets with ‘G’ engraved on one side and ‘25’ on the other side. Bottles of 60 count with desiccant (NDC 68462-108-60) Bottles of 500 count with desiccant (NDC 68462-108-05) Bottles of 1,000 count with desiccant (NDC 68462-108-10) 50 mg yellow tablets with ‘G’ engraved on one side and ‘50’ on the other side. Bottles of 60 count with desiccant (NDC 68462-153-60) Bottles of 500 count with desiccant (NDC 68462-153-05) Bottles of 1,000 count with desiccant (NDC 68462-153-10) 100 mg yellow tablets with ‘G’ engraved on one side and ‘100’ on the other side.
Bottles of 60 count with desiccant (NDC 68462-109-60) Bottles of 500 count with desiccant (NDC 68462-109-05) Bottles of 1,000 count with desiccant (NDC 68462-109-10) 200 mg pink tablets with ‘G’ engraved on one side and ‘200’ on the other side. Bottles of 60 count with desiccant (NDC 68462-110-60) Bottles of 500 count with desiccant (NDC 68462-110-05) Bottles of 1,000 count with desiccant (NDC 68462-110-10)
16.2Storage and Handling Topiramate tablets should be stored in tightly-closed containers at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
16.1How Supplied Topiramate Tablets, USP are available as circular, biconvex, film-coated tablets in the following strengths and colors: 25 mg white tablets with ‘G’ engraved on one side and ‘25’ on the other side. Bottles of 60 count with desiccant (NDC 68462-108-60) Bottles of 500 count with desiccant (NDC 68462-108-05) Bottles of 1,000 count with desiccant (NDC 68462-108-10) 50 mg yellow tablets with ‘G’ engraved on one side and ‘50’ on the other side. Bottles of 60 count with desiccant (NDC 68462-153-60) Bottles of 500 count with desiccant (NDC 68462-153-05) Bottles of 1,000 count with desiccant (NDC 68462-153-10) 100 mg yellow tablets with ‘G’ engraved on one side and ‘100’ on the other side.
Bottles of 60 count with desiccant (NDC 68462-109-60) Bottles of 500 count with desiccant (NDC 68462-109-05) Bottles of 1,000 count with desiccant (NDC 68462-109-10) 200 mg pink tablets with ‘G’ engraved on one side and ‘200’ on the other side. Bottles of 60 count with desiccant (NDC 68462-110-60) Bottles of 500 count with desiccant (NDC 68462-110-05) Bottles of 1,000 count with desiccant (NDC 68462-110-10)
📦 Storage and Handling ▾
16.2Storage and Handling Topiramate tablets should be stored in tightly-closed containers at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
📋 Description ▾
11 DESCRIPTION Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder.
It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate, USP 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: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color. structure
💬 Information for Patients ▾
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 tablets-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 ), 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. Topiramate tablets increase 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 tablets during pregnancy [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.1 )] . When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. 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 or progestin-only contraceptives with topiramate [see Drug Interactions ( 7.4 )] .
Encourage pregnant women using topiramate tablets, to enroll in the North American Antiepileptic Drug (NAAED)…
💬 Medication Guide ▾
MEDICATION GUIDE MEDICATION GUIDE Topiramate (TOE-pee-rah-mate) Tablets 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.
If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. 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: 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: 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 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 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 providers about using other possible treatments instead of topiramate tablets. If the decision is made to use topiramate tablets, you should use effective birth control (contraception) unless you are planning to become pregnant.
You should talk to your doctor about the best kind of birth control to use while you are taking topiramate tablets. • Tell your healthcare provider right away if you become pregnant while taking topiramate tablets. You and your healthcare provider should decide if you will continue to take topiramate tablets while you are pregnant. • If you take topiramate tablets during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known.
Talk to your healthcare provider if you have questions about this risk during pregnancy. • Metabolic acidosis may have harmful effects on your ba…