Topiramate 50 mg Tablet, Film Coated, 30-count
Other active recalls for Topiramate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Centrally acting antiobesity products class.
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🏭 Manufacturer & labeler
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🩺 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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💊 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.0808 | $2.42 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Topiramate 50 mg 68084-0343-01 | American | 1 tablet | $0.035 | AB | Availability likely | — |
| Topiramate 50 mg 68462-0153-05 | Glenmark | 500 tablets | $0.035 | AB | Availability likely | — |
| Topiramate 50 mg 69097-0123-03 | Cipla | 60 tablets | $0.035 | AB | Availability likely | — |
| Topiramate 50 mg 76282-0279-10 | EXELAN | 1000 tablets | $0.035 | AB | Availability likely | — |
| topiramate 50 mg 82009-0136-05 | Quallent | 500 tablets | $0.035 | AB | Availability likely | — |
| Topiramate 50 mg 69097-0817-03 | Cipla | 60 tablets | $0.044 | AB | FDA listed | — |
| Topamax 50 mg 50458-0640-65 | Janssen | 60 tablets | $13.136 | AB | Availability likely | — |
| Topiramate 50 mg 00615-8139-39 | NCS | 30 tablets | — | AB | Discontinued | — |
| Topiramate 50 mg 00615-8594-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 29300-0116-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 31722-0182-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 43063-0734-07 | PD-Rx | 7 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 43063-0997-21 | PD-Rx | 21 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 47335-0710-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 50090-2203-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 50090-3461-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 50090-6828-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 50090-7757-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 50268-0807-15 | AvPAK | 1 tablet | — | AB | FDA listed | — |
| Topiramate 50 mg 51655-0606-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 51655-0746-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 60760-0577-60 | St. | 60 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 62756-0710-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 63187-0059-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 63187-0228-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 63187-0479-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 63187-0758-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 65841-0648-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 65862-0172-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 67046-1202-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 68071-4760-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 68071-5165-06 | NuCare | 60 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 68382-0139-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 68788-7351-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 68788-8828-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 70518-1180-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| topiramate 50 mg 70518-1937-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 70518-4340-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| topiramate 50 mg 71205-0187-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 71205-0819-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 71335-0487-00 | Bryant | 20 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 71335-1064-00 | Bryant | 20 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 71335-1147-00 | Bryant | 20 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 71610-0486-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 72162-2481-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 72789-0443-60 | PD-Rx | 60 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 72865-0314-10 | XLCare | 1000 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 76420-0276-30 | Asclemed | 30 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 80425-0092-02 | Advanced | 60 tablets | — | AB | FDA listed | — |
| Topiramate 50 mg 80425-0195-02 | Advanced | 60 tablets | — | AB | FDA listed | — |
| Topiramate 50 mgthis 80425-0214-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 80425-0495-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| topiramate 50 mg 83008-0011-30 | Quality | 30 tablets | — | AB | Discontinued | — |
| Topiramate 50 mg 70518-2419-00 | 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 80425-0214-02 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0214-2) | 2023-01-03 | Active |
| 80425-0214-01 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0214-1) | 2023-01-03 | Active |
| 80425-0214-03 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0214-3) | 2023-01-03 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 80425-0214-01?
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🧭 About this NDC listing & data coverage
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. Indications and Usage
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
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 Dose Week 1 None 25 mg Week 2 25 mg 25 mg Week 3 25 mg 50 mg Week 4 50 mg 50 mg Dose and titration rate should be guided by clinical outcome.
If required, longer intervals between dose adjustments can be used.
2.4Administration Information Topiramate tablets can be taken without regard to meals. Topiramate Tablets Because of…
💊 Dosage Forms and Strengths ▾
3. Dosage Forms and Strengths Topiramate tablets, USP are available as round, biconvex, film-coated tablets in the following strengths and colors: 25 mg: Light yellow with 'U' debossed on one side and '115' debossed on other side. 50 mg: White to off-white, bevel edged with 'U' debossed on one side and '116' debossed on other side.
100 mg: Salmon, bevel edged with 'U' debossed on one side and '117' debossed on other side. 200 mg: Yellow, bevel edged with 'U' debossed on one side and "118' debossed on other side.
⛔ Contraindications ▾
4. Contraindications None.
⚠️ Warnings and Cautions ▾
5. Warnings and Precautions
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 as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate, may be helpful. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.
5.2Visual Field Defects Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.
5.3Oligohidrosis and Hyperthermia Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures.
The majority of the reports have been in pediatric patients. Patients (especially pediatric patients) treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when topiramate is given with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.
5.4Metabolic Acidosis Topiramate can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by topiramate. Topiramate-induced metabolic acidosis can occur at any time during treatment.
Bicarbonate decrements are usually mild-moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet, or specific drugs) may be additive to the bicarbonate lowering effects of topiramate. Metabolic acidosis was commonly observed in adult and pediatric patients treated with topiramate in clinical trials.
The incidence of decreased serum bicarbonate in pediatric trials, for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial-onset seizures was as high as 67% for topiramate (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value < 17 mEq/L and >5 mEq/L decrease from pretreatment) in th…
🤒 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)] Serious Skin Reactions [see Warnings and Precautions (5.11)] Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see Warnings and Precautions (5.12)] Kidney Stones [see Warnings and Precautions (5.13)] Hypothermia with Concomitant Valproic Acid (VPA) Use [see Warnings and Precautions (5.14)] The data described in the following sections were obtained using topiramate tablets.
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 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 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 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 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 as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. The most common (≥2% more frequent than low-dose 50 mg/day topiramate) adverse reactions 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 patients treated with 400 mg/day topiramate and occurring with greater incidence than 50 mg/day topiramate.
Table 5: Adverse Reactions in the High Dose Group As Compared to the Low Dose Group, in Monotherapy Epilepsy Trial (Study 1) in Adult and Pediatric Patients Body System Adverse Reaction Age Group Pediatric (6 to 15 Years) Adult (Age ≥16 Years) Topiramate Daily Dosage Group (mg/day) 50 400 50 400 (N = 74) (N = 77) (N = 160) (N = 159) % % % % Body as a Whole-General Disorders Asthenia 0 3 4 6 Fever 1 12 Leg pain 2 3 Central & Peripheral Nervous System Disorders Paresthesia 3 12 21 40 Dizziness 13 14 Ataxia 3 4 Hypoesthesia 4 5 Hypertonia 0 3 Involuntary muscle contractions 0 3 Vertigo 0 3 Gastro-Intestinal System Disorders Constipation 1 4 Diarrhea 8 9 Gastritis 0 3 Dry mouth 1 3 Liver and Biliary System Disorders Increase in Gamma-GT 1 3 Metabolic and Nutritional Disorders Weight loss 7 17 6 17 Platelet, Bleeding & Clotting Disorders Epistaxis 0 4 Psychiatric Disorders Anorexia 4 14 Anxiety 4 6 Cognitive problems 1 6 1 4 Confusion 0 3 Depression…
🔄 Drug Interactions ▾
7. Drug Interactions
7.1Antiepileptic 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 (5.12, 5.14), 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 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 and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, topiramate should be used with extreme caution if used in combination with alcohol and other CNS depressants.
7.4Oral Contraceptives The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with topiramate. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see Clinical Pharmacology (12.3)].
7.5Hydrochlorothiazide (HCTZ) Topiramate Cmax and AUC increased when HCTZ was added to topiramate. The clinical significance of this change is unknown. The addition of HCTZ to topiramate may require a decrease in the topiramate 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 in a clinical trial. The clinical relevance of these observations is unknown; however, when topiramate is added to pioglitazone therapy or pioglitazone is added to topiramate 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 doses of up to 600 mg/day can occur. Lithium levels should be monitored when co-administered with high-dose topiramate [see Clinical Pharmacology (12.3)].
7.8Amitriptyline Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate 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 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 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 2-4% and 15-20%, 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 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 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 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 oral clefts, no specific…
🆘 Overdosage ▾
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 topiramate 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 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 GABAA 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 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 μg/mL. The fraction bound decreased as blood concentration increased. Carbamazepine and phenytoin do not alter the binding of topiramate.
Sodium valproate, at 500 μg/mL (a concentration 5 to 10 times higher than considered therapeutic for valproate) decreased the protein binding of topiramate from 23% to 13%. Topiramate does not influence the binding of sodium valproate. Metabolism and Excretion Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose).
Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. There is evidence of renal tubular reabsorption of topiramate.
In rats, given probenecid to inhibit tubular reabsorption, along with topiramate, a significant increase in renal clearance of topiramate was observed. This interaction has not been evaluated in humans. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in adults following oral administration.
Specific Populations Renal Impairment The clearance of topiramate was reduced…
📦 How Supplied / Storage and Handling ▾
16. How Supplied/Storage and Handling
16.1How Supplied. Topiramate Tablets, USP are available as: 50 mg Tablet: White to off-white, round, bevel edged, biconvex, film-coated tablets with 'U' debossed on one side and '116' debossed on other side. Bottles of 30 Tablets NDC: 80425-0214-01 Bottles of 60 Tablets NDC: 80425-0214-02 Bottles of 90 Tablets NDC: 80425-0214-03
16.2Storage and Handling. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
📋 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 shaped tablets for oral administration.
Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol.
The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S 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: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.
Description
💬 Medication Guide ▾
Medguide MEDICATION GUIDE Topiramate Tablets, USP (toe pir' a mate), for oral use 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: ● feel tired ● feel changes in heartbeat ● not feel hungry (loss of appetite) ● have trouble thinking clearly Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with topiramate tablets. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, topiramate tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: ● thoughts about suicide or dying ● 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 D o 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 table…