Label: TOPAMAX- topiramate 50mg tablet, film coated

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

Drug Label Information

Updated November 16, 2020

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

  • Medication Guide Section

    MEDICATION GUIDE

    MEDICATION GUIDE

    Topiramate (toe pir' a mate) Tablets, USP

    Topiramate (toe pir' a mate) Capsules, USP

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

    Topiramate 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 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 can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:

    feel tired
    not feel hungry (loss of appetite)
    feel changes in heartbeat
    have trouble thinking clearly

    Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with topiramate. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

    Like other antiepileptic drugs, topiramate 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 without first talking to a healthcare provider.

    Stopping topiramate 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 can harm your unborn baby.

    If you take topiramate during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
    Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
    There may be other medicines to treat your condition that have a lower chance of birth defects.
    All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of topiramate. If the decision is made to use topiramate, 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.
    Tell your healthcare provider right away if you become pregnant while taking topiramate. You and your healthcare provider should decide if you will continue to take topiramate while you are pregnant.
    If you take topiramate 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 baby. Talk to your healthcare provider if topiramate has caused metabolic acidosis during your pregnancy.
    Pregnancy Registry: If you become pregnant while taking topiramate, 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 topiramate and other antiepileptic drugs during pregnancy.

    What is topiramate?

    Topiramate is a prescription medicine used:

    to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 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,
    to prevent migraine headaches in adults and adolescents 12 years and older.

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

    have or have had depression, mood problems, or suicidal thoughts or behavior.
    have kidney problems, have kidney stones, or are getting kidney dialysis.
    have a history of metabolic acidosis (too much acid in the blood).
    have liver problems.
    have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, 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.
    are breastfeeding or plan to breastfeed. Topiramate passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the topiramate that passes into breast milk can cause other serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take topiramate.

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

    Especially tell your healthcare provider if you take:

    Valproic acid (such as DEPAKENE®or DEPAKOTE®).
    any medicines that impair or decrease your thinking, concentration, or muscle coordination.
    birth control pills. Topiramate 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.

    Ask your 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?

    Take topiramate exactly as prescribed.
    Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
    Take topiramate tablets whole. Do not chew the tablets. They may leave a bitter taste.
    Topiramate capsules may be swallowed whole or may be opened and sprinkled on a teaspoon of soft food. Drink fluids right after eating the food and medicine mixture to make sure it is all swallowed. Do not chew the food and medicine mixture.
    Do not store any medicine and food mixture for later use.
    Topiramate 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.
    If you take too much topiramate, call your healthcare provider right away or go to the nearest emergency room.
    If you miss a single dose of topiramate, 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, and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare provider for advice.
    Do not stop taking topiramate without talking to your healthcare provider. Stopping topiramate suddenly may cause serious problems. If you have epilepsy and you stop taking topiramate suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking topiramate slowly.
    Your healthcare provider may do blood tests while you take topiramate.

    What should I avoid while taking topiramate?

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

    What are the possible side effects of topiramate?

    Topiramate may cause serious side effects including:

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

    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 is taken with a medicine called valproic acid (DEPAKENE®and DEPAKOTE®).
    Effects on thinking and alertness. Topiramate may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. Topiramate may cause depression or mood problems, tiredness, and sleepiness.
    Dizziness or loss of muscle coordination.
    Serious skin reactions. Topiramate may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Topiramate may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
    Kidney stones. Drink plenty of fluids when taking topiramate to decrease your chances of getting kidney stones.
    Low body temperature. Taking topiramate when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, or can cause tiredness, confusion, or coma.

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

    The most common side effects of topiramate 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
    speech problems
    tiredness
    dizziness
    sleepiness/drowsiness
    slow reactions
    difficulty with memory
    pain in the abdomen
    fever
    abnormal vision
    decreased feeling or sensitivity, especially in the skin

    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.

    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?

    Store topiramate at 20oto 25oC (68oto 77oF) [See USP Controlled Room Temperature].
    Keep topiramate in a tightly closed container.
    Keep topiramate dry and away from moisture.

    Keep topiramate and all medicines out of the reach of children.

    General information about the safe and effective use of topiramate.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use topiramate for a condition for which it was not prescribed. Do not give topiramate to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about topiramate that is written for health professionals.

    Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

    What are the ingredients in topiramate?

    Topiramate Tablets, USP

    Active ingredient: topiramate, USP

    Inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.

    Topiramate Capsules, USP

    Active ingredient: topiramate, USP

    Inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc and titanium dioxide.

    DEPAKENE® and DEPAKOTE® are registered trademarks of Abbott Laboratories.

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

  • Dosage and Administration Section

    2 DOSAGE AND ADMINISTRATION

    2.1 Dosing in Monotherapy Epilepsy

    Adults and Pediatric Patients 10 Years of Age and Older

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

    * Administered in two equally divided doses



    Weight (kg)
    Total Daily Dose (mg/day)*
    Minimum Maintenance Dose
    Total Daily Dose (mg/day)*
    Maximum Maintenance Dose
    Up to 11
    150
    250
    12 to 22
    200
    300
    23 to 31
    200
    350
    32 to 38
    250
    350
    Greater than 38
    250
    400

    2.2 Dosing in Adjunctive Therapy Epilepsy

    Adults (17 Years of Age and Older)

    The recommended total daily dose of topiramate as adjunctive therapy in adults with partial-onset seizures or Lennox-Gastaut Syndrome is 200 mg/day 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 should be initiated at 25 mg/day to 50 mg/day followed by titration to an effective dose in increments of 25 mg/day 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 as adjunctive therapy for pediatric patients 2 years to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg/day to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 mg/kg/day 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 mg/kg/day 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.

    2.3 Dosing for the Preventive Treatment of Migraine

    The recommended total daily dose of Topiramate 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 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.

    2.4 Administration Information

    Topiramate can be taken without regard to meals.

    Topiramate Tablets

    Because of the bitter taste, tablets should not be broken.

    Topiramate Capsules

    Topiramate capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed. It should not be stored for future use.

    2.5 Dosing in Patients with Renal Impairment

    In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of topiramate is recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].

    2.6 Dosing in Patients Undergoing Hemodialysis

    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 [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

    1.1 Monotherapy Epilepsy

    Topiramate tablets and topiramate capsules 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.

    1.2 Adjunctive Therapy Epilepsy

    Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.

    1.3 Migraine

    Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.

  • Principal Display Panel

    Topiramate 50mg

  • INGREDIENTS AND APPEARANCE
    TOPAMAX 
    topiramate 50mg tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0092(NDC:68382-139)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE50 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code ZD;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0092-260 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07823503/27/2009
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0092)