Label: TOPIRAMATE- topiramate tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    DESCRIPTION

    Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration.

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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY
    Mechanism of Action:

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

    Pharmacodynamics:

    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.


    Pharmacokinetics:

    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) is approximately 20 to 30 mL/min in humans following oral administration.

    Pharmacokinetic Interactions

    (see also Drug Interactions):

    Antiepileptic Drugs

    Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. The effect of these interactions on mean plasma AUCs are summarized under PRECAUTIONS (Table 4).


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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE Monotherapy Epilepsy

    Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.

    Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

    Adjunctive Therapy Epilepsy

    Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS

    Topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product.

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  • WARNINGS

    WARNINGS Acute Myopia and Secondary Angle Closure Glaucoma

    A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate, may be helpful.

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

    Oligohidrosis 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 children. 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 prescribed 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.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDs), including topiramate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

    Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

    The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

    The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed

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  • PRECAUTIONS

    PRECAUTIONS
    Hyperammonemia and Encephalopathy Associated with Concomitant Valproic Acid Use

    Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting. In most cases, symptoms and signs abated with discontinuation of either drug. This adverse event is not due to a pharmacokinetic interaction.

    It is not known if topiramate monotherapy is associated with hyperammonemia.

    Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, an interaction of topiramate and valproic acid may exacerbate existing defects or unmask deficiencies in susceptible persons.

    In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.

    Kidney Stones

    A total of 32/2,086 (1.5%) of adults exposed to topiramate during its adjunctive epilepsy therapy development reported the occurrence of kidney stones, an incidence about 2 to 4 times greater than expected in a similar, untreated population. In the double-blind monotherapy epilepsy study, a total of 4/319 (1.3%) of adults exposed to topiramate reported the occurrence of kidney stones. As in the general population, the incidence of stone formation among topiramate treated patients was higher in men. Kidney stones have also been reported in pediatric patients.


    An explanation for the association of topiramate and kidney stones may lie in the fact that topiramate is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors, e.g., acetazolamide or dichlorphenamide, promote stone formation by reducing urinary citrate excretion and by increasing urinary pH. The concomitant use of topiramate with other carbonic anhydrase inhibitors or potentially in patients on a ketogenic diet may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.

    Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Hydration is recommended to reduce new stone formation.

    Paresthesia

    Paresthesia (usually tingling of the extremities), an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of topiramate. Paresthesia was more frequently reported in the monotherapy epilepsy trials versus the adjunctive therapy epilepsy trials. In the majority of instances, paresthesia did not lead to treatment discontinuation.

    Adjustment of Dose in Renal Failure

    The major route of elimination of unchanged topiramate and its metabolites is via the kidney. Dosage adjustment may be required in patients with reduced renal function (see DOSAGE AND ADMINISTRATION).

    Decreased Hepatic Function

    In hepatically impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased.



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  • ADVERSE REACTIONS

    ADVERSE REACTIONS

    The data described in the following section were obtained using topiramate tablets.

    Monotherapy Epilepsy

    The adverse events in the controlled trial that occurred most commonly in adults in the 400 mg/day group and at a rate higher than the 50 mg/day group were: paresthesia, weight decrease, somnolence, anorexia, dizziness, and difficulty with memory NOS [see Table 5].

    The adverse events in the controlled trial that occurred most commonly in children (10 years up to 16 years of age) in the 400 mg/day group and at a rate higher than the 50 mg/day group were: weight decrease, upper respiratory tract infection, paresthesia, anorexia, diarrhea, and mood problems [see Table 6].

    Approximately 21% of the 159 adult patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse events. Adverse events associated with discontinuing therapy (≥2%) included depression, insomnia, difficulty with memory (NOS), somnolence, paresthesia, psychomotor slowing, dizziness, and nausea.

    Approximately 12% of the 57 pediatric patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse events. Adverse events associated with discontinuing therapy (≥5%) included difficulty with concentration/attention.

    The prescriber should be aware that these data cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during the clinical study. Similarly, the cited frequencies cannot be directly compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. Inspection of these frequencies, however, does provide the prescribing physician with a basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied

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  • OVERDOSAGE

    OVERDOSAGE

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

    Topiramate overdose has resulted in severe metabolic acidosis (see WARNINGS).

    A patient who ingested a dose between 96 and 110 g topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.

    In acute topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb topiramate in vitro. Treatment should be appropriately supportive. Hemodialysis is an effective means of removing topiramate from the body.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION
    Epilepsy

    In the controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and clinical efficacy. No evidence of tolerance has been demonstrated in humans. Doses above 400 mg/day (600, 800, or 1000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures.

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


    Topiramate tablets can be taken without regard to meals.

    Monotherapy Use

    The recommended dose for topiramate monotherapy in adults and children 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titrating according to the following schedule:


    Adjunctive Therapy Use
    Adults (17 Years of Age and Over) - Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

    The recommended total daily dose of topiramate as adjunctive therapy in adults with partial seizures 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. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/week. Titrating in increments of 25 mg/week may delay the time to reach an effective dose. Daily doses above 1,600 mg have not been studied.


    In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks (see CLINICAL STUDIES, Adjunctive Therapy Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).

    Pediatric Patients (Ages 2 to 16 Years)– Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

    The recommended total daily dose of topiramate as adjunctive therapy for patients with partial 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 (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.


    In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks (see CLINICAL STUDIES, Adjunctive Therapy Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).

    Patients with Renal Impairment:

    In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.

    Geriatric Patients (Ages 65 Years and Over):

    Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate ≤70 mL/min/1.73 m2) is evident (see DOSAGE AND ADMINISTRATION: Patients with Renal Impairment and CLINICAL PHARMACOLOGY: Special Populations: Age, Gender, and Race).

    Patients Undergoing Hemodialysis:

    Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.

    Patients with Hepatic Disease:

    In hepatically impaired patients topiramate plasma concentrations may be increased. The mechanism is not well understood.



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  • HOW SUPPLIED

    HOW SUPPLIED

    Topiramate tablets are available as debossed, film-coated, circular tablets in the following strengths and colors:


    25 mg white (coded "S" on one side; "707" on the other)
    50 mg yellow (coded "S" on one side; "710" on the other)
    100 mg yellow (coded "S" on one side; "711" on the other)
    200 mg brown (coded "S" on one side; "712" on the other)

    They are supplied as follows:
    25 mg tablets    Bottles of 30's with Child Resistant Cap… …………NDC 62756-707-83
                                Bottles of 60's with Child Resistant Cap… …………NDC 62756-707-86
                                Bottles of 100's with Child Resistant Cap… … … …NDC 62756-707-88
                                Bottles of 100's with Non Child Resistant Cap………NDC 62756-707-08
                                Bottles of 500's with Non Child Resistant Cap………NDC 62756-707-13
                                Bottles of 1000's with Non Child Resistant Cap… …NDC 62756-707-18

    50 mg tablets    Bottles of 30's with Child Resistant Cap… …………NDC 62756-710-83
                                Bottles of 60's with Child Resistant Cap… …………NDC 62756-710-86
                                Bottles of 100's with Child Resistant Cap… … … …NDC 62756-710-88
                                Bottles of 100's with Non Child Resistant Cap………NDC 62756-710-08
                                Bottles of 500's with Non Child Resistant Cap………NDC 62756-710-13
                                Bottles of 1000's with Non Child Resistant Cap… …NDC 62756-710-18

    100 mg tablets  Bottles of 30's with Child Resistant Cap… …………NDC 62756-711-83
                                Bottles of 60's with Child Resistant Cap… …………NDC 62756-711-86
                                Bottles of 100's with Child Resistant Cap… … … …NDC 62756-711-88
                                Bottles of 100's with Non Child Resistant Cap………NDC 62756-711-08
                                Bottles of 500's with Non Child Resistant Cap………NDC 62756-711-13
                                Bottles of 1000's with Non Child Resistant Cap… …NDC 62756-711-18


    200 mg tablets  Bottles of 30's with Child Resistant Cap… …………NDC 62756-712-83
                                Bottles of 60's with Child Resistant Cap… …………NDC 62756-712-86
                                Bottles of 100's with Child Resistant Cap… … … …NDC 62756-712-88
                                Bottles of 100's with Non Child Resistant Cap………NDC 62756-712-08
                                Bottles of 500's with Non Child Resistant Cap………NDC 62756-712-13
                                Bottles of 1000's with Non Child Resistant Cap… …NDC 62756-712-18

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  • INFORMATION FOR PATIENTS

    Information for Patients

    Patients and their caregivers should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking topiramate tablets. Patients should be instructed to take topiramate tablets only as prescribed.

    Patients taking topiramate should be told to seek immediate medical attention if they experience blurred vision or periorbital pain.

    Patients, especially pediatric patients, treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather.

    Patients, their caregivers, and families should be counseled that AEDs, including topiramate, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, behavior or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

    Patients, particularly those with predisposing factors, should be instructed to maintain an adequate fluid intake in order to minimize the risk of renal stone formation (see PRECAUTIONS: Kidney Stones, for support regarding hydration as a preventative measure).

    Patients should be warned about the potential for somnolence, dizziness, confusion, and difficulty concentrating, and advised not to drive or operate machinery until they have gained sufficient experience on topiramate to gauge whether it adversely affects their mental performance and/or motor performance.

    Additional food intake may be considered if the patient is losing weight while on this medication.

    Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number, 1-888-233-2334 (see PRECAUTIONS: Pregnancy: Pregnancy Category C).

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  • MEDICATION GUIDE

    TOPIRAMATE  - topiramate tablet, film coated 
    Sun Pharmaceutical Industries Limited

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    MEDICATION GUIDE


    Topiramate Tablets

    Read this Medication Guide before you start taking topiramate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about topiramate tablets, talk to your healthcare provider or pharmacist.

    What is the most important information I should know about topiramate tablets?

    • Topiramate tablets may cause eye problems. Serious eye problems include:
      • any sudden decrease in vision with or without eye pain and redness
      • a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).
      • These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms.
    • 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.
    • Like other antiepileptic drugs, topiramate tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

    Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in behavior or mood

    Do not stop topiramate tablets without first talking to a healthcare provider.

    • Stopping topiramate tablets suddenly can cause serious problems.
    • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

    How can I watch for early symptoms of suicidal thoughts and actions?

    • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled.
    • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    What is topiramate tablet?

    Topiramate tablet is a prescription medicine used:

    • to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in people 10 years and older
    • with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older

    What should I tell my healthcare provider before taking topiramate tablets?

    Before taking topiramate tablets, tell your healthcare provider about all your medical conditions, including if you:

    • have or have had depression, mood problems or suicidal thoughts or behavior
    • have kidney problems, kidney stones, or are getting kidney dialysis
    • have a history of metabolic acidosis (too much acid in the blood)
    • have liver problems
    • have osteoporosis, soft bones, or decreased bone density
    • have lung or breathing problems
    • have eye problems, especially glaucoma
    • have diarrhea
    • have a growth problem
    • are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet
    • are having surgery
    • are pregnant or plan to become pregnant. It is not known if topiramate tablets will harm your unborn baby. If you become pregnant while taking topiramate tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
    • are breastfeeding. It is not known if topiramate passes into breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take topiramate tablets.

    Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Topiramate tablets and other medicines may affect each other causing side effects.

    Especially, tell your healthcare provider if you take:

    • Valproic acid
    • any medicines that impair or decrease your thinking, concentration, or muscle coordination.
    • birth control pills. Topiramate tablets may make your birth control pills less effective. Tell your healthcare provider if your menstrual bleeding changes while you are taking birth control pills and topiramate tablets.

    Ask you healthcare provider if you are not sure if your medicine is listed above.

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

    How should I take topiramate tablets?

    • Take topiramate tablets exactly as prescribed.
    • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
    • Topiramate tablets should be swallowed whole. Do not chew the tablets. They may leave a bitter taste.
    • Do not store any medicine and food mixture for later use.
    • Topiramate tablets can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking topiramate tablets.
    • If you take too many topiramate tablets, call your healthcare provider or poison control center right away or go to the nearest emergency room.
    • If you miss a single dose of topiramate tablets, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of topiramate tablets, and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare professional for advice.
    • Do not stop taking topiramate tablets without talking to your healthcare provider. Stopping topiramate tablets suddenly may cause serious problems. If you have epilepsy and you stop taking topiramate tablets suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking topiramate tablets slowly.
    • Your healthcare provider may do blood tests while you take topiramate tablets.

    What should I avoid while taking topiramate tablets?

    • Do not drink alcohol while taking topiramate tablets. Topiramate tablets and alcohol can affect each other causing side effects such as sleepiness and dizziness.
    • Do not drive a car or operate heavy machinery until you know how topiramate tablets affect you. Topiramate tablets can slow your thinking and motor skills.

    What are the possible side effects of topiramate tablets?

    Topiramate tablets may cause serious side effects including:

    See “What is the most important information I should know about topiramate tablets?”

    • Metabolic Acidosis. Metabolic acidosis can cause:
      • tiredness
      • loss of appetite
      • irregular heartbeat
      • impaired consciousness
    • High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when topiramate tablets are taken with a medicine called valproic acid.
    • Kidney stones. Drink plenty of fluids when taking topiramate tablets to decrease your chances of getting kidney stones.
    • Effects on Thinking and Alertness. Topiramate tablets may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech. Topiramate tablets may cause depression or mood problems, tiredness, and sleepiness.
    • Dizziness or Loss of Muscle Coordination.

    Call your healthcare provider right away if you have any of the symptoms above.

    The most common side effects of topiramate tablets include:

    • tingling of the arms and legs (paresthesia)
    • not feeling hungry
    • nausea
    • a change in the way foods taste
    • diarrhea
    • weight loss
    • nervousness
    • upper respiratory tract infection

    Tell your healthcare provider about any side effect that bothers you or that does not go away.

    These are not all the possible side effects of topiramate tablets. For more information, ask your healthcare provider or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store topiramate tablets?

    • Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
    • Keep topiramate tablets in a tightly closed container
    • Keep topiramate tablets dry and away from moisture
    • Keep topiramate tablets and all medicines out of the reach of children.

    General information about topiramate tablets.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use topiramate tablet for a condition for which it was not prescribed. Do not give topiramate tablets to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about topiramate tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about topiramate tablets that is written for health professionals.

    For more information, call 1-800-818-4555

    What are the ingredients in topiramate tablets?

    Active ingredient: topiramate



    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Revised: 11/2009 Sun Pharmaceutical Industries Limited Close
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    TOPIRAMATE 
    topiramate tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:35356-471(NDC:62756-711)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    MAGNESIUM STEARATE  
    WATER  
    POLYVINYL ALCOHOL  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOL 400  
    TALC  
    FERRIC OXIDE YELLOW  
    D&C YELLOW NO. 10  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND (circular) Size 10mm
    Flavor Imprint Code S;711
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35356-471-60 60 in 1 BOTTLE, PLASTIC
    2 NDC:35356-471-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090278 10/28/2010
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    Name Address ID/FEI Business Operations
    Lake Erie Medical DBA Quality Care Products LLC 831276758 relabel(35356-471)
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