Topiramate

What is Topiramate?

• Topiramate (TOPAMAX) is a sulfamate-substituted monosaccharide used to treat epilepsy and prevent migraines.

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What are the uses of this medicine?

This medicine is 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.

How does this medicine work?

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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Concomitant administration of phenytoin or carbamazepine with TOPAMAX® resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to TOPAMAX® given alone. A dosage adjustment may be needed.
• 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.
• TOPAMAX® should be used with extreme caution if used in combination with alcohol and other CNS depressants.
• The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX®.
• The addition of Hydrochlorothiazide (HCTZ) to TOPAMAX® may require a decrease in the TOPAMAX® dose.
• When TOPAMAX® is added to pioglitazone therapy or pioglitazone is added to TOPAMAX® therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
• An increase in systemic exposure of lithium following TOPAMAX® doses of up to 600 mg/day can occur. Lithium levels should be monitored when co-administered with high-dose TOPAMAX®

Is this medicine FDA approved?

• Initial U.S. Approval: 1996
• It was approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17.

How should this medicine be used?

Recommended Dosage:

Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Olderː

• The recommended dose for TOPAMAX® 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 scheduleː

	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 Ageː

• Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of TOPAMAX® 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 25–50 mg/day each subsequent week as tolerated.
• Titration to the minimum maintenance dose should be attempted over 5–7 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 25–50 mg/day weekly increments.
• The total daily dose should not exceed the maximum maintenance dose for each range of body weight

Dosing in Adjunctive Therapy Epilepsy

Adults (17 Years of Age and Older)ː

• The recommended total daily dose of TOPAMAX® 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. TOPAMAX® 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 Ageː

• The recommended total daily dose of TOPAMAX® 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.

Dosing for the Preventive Treatment of Migraineː

• The recommended total daily dose of TOPAMAX® 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.

	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

Administration

• Take TOPAMAX exactly as prescribed.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Take TOPAMAX Tablets whole. Do not chew the tablets. They may leave a bitter taste.
• TOPAMAX Sprinkle 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.
• TOPAMAX can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking TOPAMAX.
• If you take too much TOPAMAX, call your healthcare provider right away or go to the nearest emergency room.
• If you miss a single dose of TOPAMAX, 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 TOPAMAX, 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 TOPAMAX without talking to your healthcare provider. Stopping TOPAMAX suddenly may cause serious problems. If you have epilepsy and you stop taking TOPAMAX suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking TOPAMAX slowly.
• Your healthcare provider may do blood tests while you take TOPAMAX.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 25 mg, 50 mg, 100 mg, and 200 mg
• Sprinkle Capsules: 15 mg and 25 mg

This medicine is available in fallowing brand namesː

• TOPAMAX

What side effects can this medication cause?

The most common side effects of this medicine 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

TOPAMAX may cause serious side effects including:

• eye problems
• decreased sweating and increased body temperature (fever)
• metabolic acidosis
• High blood ammonia levels
• Effects on thinking and alertness
• Dizziness or loss of muscle coordination
• Serious skin reactions
• Kidney stones
• Low body temperature

What special precautions should I follow?

• A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. Discontinue TOPAMAX® as soon as possible.
• Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. consider discontinuation of TOPAMAX.
• Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX® use. monitor decreased sweating and increased body temperature, especially in pediatric patients.
• TOPAMAX® 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). Baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of TOPAMAX® if clinically appropriate.
• Antiepileptic drugs (AEDs), including TOPAMAX®, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
• TOPAMAX® can cause cognitive/neuropsychiatric adverse reactions. use caution when operating machinery including cars; depression and mood problems may occur.
• TOPAMAX® can cause fetal harm when administered to a pregnant woman. use during pregnancy can cause cleft lip and/or palate and being small for gestational age.
• In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TOPAMAX®, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
• Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. TOPAMAX should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related.
• Topiramate treatment can cause hyperammonemia with or without encephalopathy. Measure ammonia if encephalopathic symptoms occur.
• Avoid use with other carbonic anhydrase inhibitors, drugs causing metabolic acidosis, or in patients on a ketogenic diet.
• Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use.

What to do in case of emergency/overdose?

Signs and symptoms of overdosage may include:

• convulsions
• drowsiness
• speech disturbance
• blurred vision
• diplopia
• impaired mentation
• lethargy
• abnormal coordination
• stupor
• hypotension
• abdominal pain
• agitation
• dizziness
• depression
• deaths have been reported after overdoses involving TOPAMAX®.
• metabolic acidosis

Management of overdosage:

• In the event of overdose, TOPAMAX® should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. Hemodialysisis an effective means of removing topiramate from the body.

Can this medicine be used in pregnancy?

• TOPAMAX® can cause fetal harm when administered to a pregnant woman.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TOPAMAX® during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.
• Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy.
• Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine.

What are the active and inactive ingredients in this medicine?

• Active ingredient: topiramate
• Inactive ingredients:
• Tablets - carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide.
• Sprinkle Capsules - black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide.

Who manufactures and distributes this medicine?

• Manufactured by: Janssen Ortho LLC, Guarabo, Puerto Rico
• Manufactured for: Janssen Pharmaceuticals, Inc., Titusville

What should I know about storage and disposal of this medication?

• Store TOPAMAX Tablets at room temperature between 59°F to 86°F (15°C to 30°C).
• Store TOPAMAX Sprinkle Capsules at or below 77°F (25°C).
• Keep TOPAMAX in a tightly closed container.
• Keep TOPAMAX dry and away from moisture.
• Keep TOPAMAX and all medicines out of the reach of children.

• Dailymed label info on Topiramate
• FDA Topiramate

Topiramate Resources
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