TOPAMAX Patient Support Programs

Ortho-McNeil Neurologics^® and TOPAMAX programs for patients include:

Everyday Essentials™, a free support program for TOPAMAX patients and their loved ones
TOPAMAX^® CAN program (1-877-937-9682). If your patients have questions about TOPAMAX, now there’s another way they can get answers quickly and easily from people who care. They can call 1-877-937-9682 to speak with friendly and knowledgeable healthcare professionals.
TOPAMAXepilepsy.com, a website that discusses epilepsy and its treatment

TOPAMAX [Prescribing Information]. Titusville, NJ: Ortho-McNeil Neurologics^®; 2006.
French JA, Kanner AM, Bautista J, et al. Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new onset epilepsy patients. Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2004;62:1252-1260.
Bourgeois BFD. Pharmacokinetics and pharmacodynamics of antiepileptic drugs. In: Wyllie E, ed. The Treatment of Epilepsy: Principles and Practice. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2006:655-664.
Kyllonen KC, Gupta A. Selected drug interactions between antiepileptic drugs and other types of medications. In: Wyllie E, ed. The Treatment of Epilepsy: Principles and Practice. 4th ed. Philadelphia: Lippincott Williams & Wilkins;2006:665-669.
Nallani SC, Glauser TA, Hariparsad N, et al. Dose-dependent induction of cytochrome P450 (CYP) 3A4 and activation of pregnane X receptor by topiramate. Epilepsia. 2003;44:1521-1528.
Data on file, Ortho-McNeil Neurologics^®
Baram TZ, Hartman AL, Vining EPG, et al. Seizures. In: Johnson RT, Griffin JW, McArthur JC, eds. Current Therapy in Neurologic Disease. 7th ed. Philadelphia: Mosby;2006:23-53.
Tomson T. Drug selection for the newly diagnosed patient: when is a new generation antiepileptic drug indicated? J Neurol. 2004 Sep;251:1043-1049.
Physician's Desk Reference Web site. Available at: www.pdr.net. Accessed February 5, 2007.
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.
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.
Doose DR, Wang S-S, Padmanabhan M, Schwabe S, Jacobs D, Bialer M. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia. 2003;44:540-549.
Rogawski MA, Loscher W. The neurobiology of antiepileptic drugs. Nat Rev Neurosci. 2004;5:553-5647.

Important

Avoid confusion with Toprol-XL^® (metoprolol succinate) by spelling out TOPAMAX^® (topiramate) on your prescription. Toprol-XL is a registered trademark of the AstraZeneca group of companies.

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 in 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 US Prescribing Information.

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