For Healthcare Professionals
This portion of the Web site for TOPAMAX contains clinical information and data that are intended for U.S. healthcare professionals only.
Attention TOPAMAX Patients and Medical Professionals
Dispensing errors have been reported between TOPAMAX ® (topiramate) tablets and TOPROL-XL ® (metroprolol succinate) extended-release tablets.
Please visit www.RxforSafety.com for complete information,
and be sure to check your tablets to ensure you are taking the right medicine.
Click here if you would like to be contacted by an Ortho-McNeil Neurologics Sales Representative.
TOPAMAX Overview
TOPAMAX has been available in the United States since 1997, when it was approved for use as adjunctive therapy in epilepsy. It has also been available in parts of Europe since 1995, regardless of condition.
Studies show that TOPAMAX offers significant benefit in patients with primary generalized tonic-clonic seizures and partial-onset seizures previously resistant to antiepileptic drug therapy.
Click here for Broad-Spectrum Coverage of Seizure Types.
About TOPAMAX®
TOPAMAX® is indicated 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 indicated as adjunctive 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
TOPAMAX® has been associated with serious adverse events including:
-
acute myopia and secondary angle-closure glaucoma-patients should
seek medical attention if they experience blurred vision or ocular
pain
-
oligohidrosis and hyperthermia-occurs most often in hot weather and
in children
-
hyperchloremic, non-anion gap metabolic acidosis (lowering of serum
bicarbonate levels)-measurement of baseline and periodic serum
bicarbonate levels is recommended
-
cognitive/psychiatric side effects including somnolence, fatigue,
cognitive dysfunction, and psychiatric/behavioral disturbances
including suicidal thoughts or behavior
-
hyperammonemia with or without encephalopathy-associated with the
concomitant use of valproic acid; and kidney stones-patients should
maintain an adequate fluid intake to minimize the risk of renal stone
formation.
Antiepileptic drugs (AEDs); including TOPAMAX® increase the risk of
suicidal thoughts or behavior in patients taking these drugs for any
indication. Patients treated with any AED for any indication should be
monitored for the emergence or worsening of depression, suicidal
thoughts or behavior, and/or any unusual changes in mood or behavior.
There are no adequate and well-controlled studies using TOPAMAX® in
pregnant women. Pregnancy registry data suggest that there may be an
association between the use of TOPAMAX® during pregnancy and
congenital malformations (e.g., craniofacial defects, such as cleft
lip/palate, hypospadias, and anomalies involving various body
systems). This has been reported with topiramate monotherapy and
topiramate as part of a polytherapy regimen.
Physicians are advised to recommend that pregnant patients taking
TOPAMAX® enroll in the NAAED Pregnancy Registry by calling
1-888-233-2334.
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: paresthesia, weight decrease, somnolence, anorexia,* dizziness,
and difficulty with memory; and in children: weight decrease, upper
respiratory tract infection, paresthesia, anorexia, diarrhea, and mood
problems.
In combination with other antiepileptic drugs (AEDs), the most common
side effects of TOPAMAX® in adults (dosed at 200 to 400 mg/day) were:
somnolence, dizziness, nervousness, ataxia, fatigue, speech disorders
and related problems, psychomotor slowing, abnormal vision, difficulty
with memory, paresthesia, and diplopia; and in children (dosed at 5 to
9 mg/kg/day): fatigue, somnolence, anorexia, nervousness, difficulty
with concentration/attention, difficulty with memory, aggressive
reaction, and weight decrease.
In women taking combination oral contraceptives with TOPAMAX®, a
significant decrease in estrogen exposure has been shown at TOPAMAX®
doses >200 mg/day. The possibility of decreased contraceptive efficacy
and increased breakthrough bleeding should be considered.
*Anorexia is defined as loss of appetite.
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: Jul 26 2007 at 13:45:29 EDT