TOPIRAMATE (Page 10 of 11)

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.

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

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

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

Inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc.

In addition, individual tablets contain:

50 mg tablets: iron oxide yellow
100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake
200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black

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

Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive, Detroit, MI 48202

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri-Kurla Road,
Andheri (East), Mumbai — 400 059, India.

ISS. 07/2009
PGPI0101A

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