Full U.S. Prescribing Information
TOPAMAX Product Information
The following information provided by Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. does not take
the place of a discussion with your doctor, pharmacist, or other healthcare professional about the
risks and benefits of TOPAMAX. It is important to speak with one of these healthcare professionals
about any prescribed medication.
Click here for the full U.S. Prescribing Information for TOPAMAX (topiramate) Tablets
or Sprinkle Capsules.
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About TOPAMAX
TOPAMAX is approved 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.
TOPAMAX is approved as add-on therapy for patients 2 years of age and older with primary generalized
tonic-clonic seizures, partial-onset seizures, or seizures associated with Lennox-Gastaut syndrome.
Important Safety Information
Serious risks associated with TOPAMAX include lowered bicarbonate levels in the blood resulting in an
increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation
(rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat or changes in the level of alertness.
Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic,
untreated metabolic acidosis may increase the risk for kidney stones or bone disease.
Other serious risks include decreased sweating, increased body temperature, kidney stones, sleepiness,
dizziness, confusion, difficulty concentrating, and increased eye pressure (glaucoma). Call your doctor
immediately if you have any decrease in vision or eye pain. These problems can lead to blindness if not
treated right away.
More common side effects in adults are nervousness, coordination problems, fatigue, speech problems, slowed
thinking, memory difficulty, tingling in arms and legs, and double vision; and in children, fatigue, loss of appetite,
nervousness, memory difficulty, aggressive behavior, and weight loss.
As monotherapy, the most common side effects of TOPAMAX (in the 400 mg/day group and at a rate higher than the 50
mg/day group) in adults were tingling in arms and legs, weight decrease, sleepiness, loss of appetite, dizziness, and
difficulty with memory; and in children, weight decrease, upper respiratory tract infection, tingling in arms and legs,
loss of appetite, diarrhea, and mood problems.
In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX in adults (200 to 400 mg/day)
were sleepiness, dizziness, nervousness, loss of muscle coordination, fatigue, speech disorders and related problems, psychomotor
slowing, abnormal vision, difficulty with memory, tingling in arms and legs, and double vision; and in children (5 to 9 mg/kg/day), fatigue,
sleepiness, loss of appetite, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease.
Tell your doctor about other medications you take.
Please see full U.S. Prescribing Information.
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This site was last modified on: Apr 29 2008 at 16:11:49 EDT