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.
Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts
or actions in a very small number of people, about 1 in 500. Pay
attention to any changes and call your doctor 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, new or worse irritability,
acting aggressive, being angry, or violent, acting on dangerous
impulses, an extreme increase in activity and talking (mania) or other
unusual changes in behavior or mood.
Do not stop taking TOPAMAX® without first talking to your doctor.
Stopping TOPAMAX® suddenly can cause serious problems.
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.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit
www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see
full U.S.
Prescribing Information.
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.
Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts
or actions in a very small number of people, about 1 in 500. Pay
attention to any changes and call your doctor 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, new or worse irritability,
acting aggressive, being angry, or violent, acting on dangerous
impulses, an extreme increase in activity and talking (mania) or other
unusual changes in behavior or mood.
Do not stop taking TOPAMAX® without first talking to your doctor.
Stopping TOPAMAX® suddenly can cause serious problems.
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.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit
www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see
full U.S. Prescribing
Information.
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This site was last modified on: Aug 10 2009 at 12:13:41 EDT