For Healthcare Professionals
TOPAMAX is Efffective in Partial-Onset and Primary
Generalized Tonic-Clonic Seizures1
Kaplan-Meier Estimates of Cumulative Rates for Time to First Seizure1
Across Seizure Types in Adults and Children
In primary generalized tonic-clonic seizures, TOPAMAX demonstrated a clinically significant response
in seizure reduction. Fifty-seven percent of patients treated with TOPAMAX achieved a 50% or higher
reduction in seizure rate compared to 9% for placebo-treated patients.2
Primary Generalized Tonic-Clonic Seizures in Adults and Children2,3
Studies in adults and children with partial-onset seizures demonstrated TOPAMAX was effective in
reducing seizure rates compared to placebo.4,5
Partial-Onset Seizures in Adults4
Partial-Onset Seizures in Children 2 to 16 Years of Age5
Early Onset of Effect—Low Target Dose4
TOPAMAX 200 mg/day is an initial appropriate target dose. The therapeutic effect of TOPAMAX can
be seen as early as 2 weeks into therapy. In addition, TOPAMAX dosed at 200 mg/day in patients with
refractory partial-onset seizures was effective as adjunctive therapy when added to enzyme-inducing
AEDs. This rapid onset of effect and low target dose offer a distinct benefit to patients and professionals
alike.4
Onset of Effect During Titration4
Demonstrated Seizure Reduction Across Seizure Types in Adults and Children
In controlled clinical trials, TOPAMAX has been effective in reducing monthly seizure rates by at
least 50% in 57% of patients with primary generalized tonic-clonic seizures.2,3
An analysis of a study in adults with partial-onset seizures indicates that patients may notice
a beneficial effect on seizures early—as early as 2 weeks.
Primary Generalized Tonic-Clonic Seizures in Adults and Children2,3
After 16 weeks of TOPAMAX therapy, 44% of adults with partial-onset seizures had their monthly seizure
rate reduced by at least 50%.3,6
Partial-Onset Seizures in Adults3,6
After 16 weeks of TOPAMAX therapy, 39% of children with partial-onset seizures achieved a ≥ 50%
reduction in their monthly seizure rate.3,5
Partial-Onset Seizures in Children 2 to 16 Years of Age3,5
In their monthly rate of drop attack seizures, 28% of patients with Lennox-Gastaut syndrome achieved
a 50% or greater reduction in seizure frequency from baseline with TOPAMAX.3,7
Drop Attacks Associated With Lennox-Gastaux Syndrome3,7
References:
- Arroyo S, Dodson WE, Privitera MD, et al, for the EPMN-106/INT-28 Investigators. Randomized dose-controlled study of topiramate as first-line therapy in epilepsy. Acta Neurol Scand. 2005;112:214-222.
- Biton V, Montouris GD, Ritter F, et al, and the Topiramate YTC Study Group. A randomized, placebo-controlled
study of topiramate in primary generalized tonic-clonic seizures. Neurology. 1999;52:1330-1337.
- Data on file, Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
- Guberman A, Neto W, Gassmann-Mayer C, and the EPAJ-119 Study Group. Low-dose topiramate in adults
with treatment-resistant partial-onset seizures. Acta Neurol Scand. 2002;106:183-189.
- Elterman RD, Glauser TA, Wyllie E, et al, and the Topirmate YP Study Group. A double-blind, randomized
trial of topiramate as adjunctive therapy for partial-onset seizures in children. Neurology.
1999;52:1338-1344.
- Faught E, Wilder BJ, Ramsay RE, et al, and the Topiramate YD Study Group. Topiramate placebo-controlled
dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology.
1996;46:1684-1690.
- Sachdeo RC, Glauser TA, Ritter F, et al, and the Topiramate YL Study Group. A double-blind, randomized
trial of topiramate in Lennox-Gastaut syndrome. Neurology. 1999;52:1882-1887.
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:
hyperchloremic, non-anion gap metabolic acidosis (lowering of serum bicarbonate levels)
- measurement of baseline and periodic serum bicarbonate levels is recommended; 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; 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.
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 (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
(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.
Please see full U.S. Prescribing Information.
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This site was last modified on: Apr 29 2008 at 16:11:27 EDT