For the treatement of partial and generalized seizures

Carbatrol has a range of dosage strengths. This allows for ease of titration when starting Carbatrol or converting from another medication.

Confidence is well-established evidence of CBZ efficacy
and demonstrated safety profile

Confirming a record of effective seizure control

Efficacy confirmed...

  • The VA Cooperative Group studies established the benefits of carbamazepine1-3
    • —Demonstrated efficacy and safety as first-line monotherapy in patients beginning pharmacotherapy*

Efficacy reconfirmed...

  • Head-to-head and noninferiority trials continue to demonstrate the efficacy of carbamazepine as first-line monotherapy4-11
    • —To date, newer AEDs have shown similar efficacy to carbamazepine, an established standard of treatment for partial seizures†
Carbamazepine vs newer AEDs

"No drug has shown superior efficacy to CBZ in a randomized, head-to-head comparison in newly diagnosed epilepsy patients with partial or generalized tonic-clonic seizures." 5

–Brodie et al. Neurology, 2007

Based on head-to-head comparison and noninferiority trials vs phenobarbital, phenytoin, primidone, oxcarbazepine, valproate, lamotrigine, topiramate, and gabapentin.

*Results from Treatment of epilepsy in adults expert opinion, 2005. Top US epileptologists (n=48) were surveyed on epilepsy treatments. Physicians rated treatment opinions on a modified RAND 9-point scale (with "9" most appropriate and "1" least appropriate). Results were compared against a similar survey conducted in 2000.

†Newer AEDs are AEDs approved after 1997.
AED=antiepileptic drug
CBZ-CR=carbamazepine controlled-release
VA=Veterans Affairs

Taking a new look at CBZ tolerability

In a multicenter, randomized, double-blind, parallel-group, positive-controlled, noninferiority, monotherapy trial comparing levetiracetam (LEV) and CBZ-CR‡5

  • There were no significant differences in discontinuations due to AEs between LEV and CBZ-CR (14.4% and 19.2%, respectively)

The most common AEs reported by patients receiving either LEV or CBZ-CR§5

The most common AEs reported by patients receiving either LEV or CBZ (§,5)

‡Objective was to determine if LEV (n=288) was noninferior to CBZ-CR (n=291) in adults (>16 years)

§Intent-to-Treat (ITT) population.

AE=adverse event

Anticonvulsants should be taken in the manner and at the times prescribed by the physician.

Important Safety Information for Health Care Professionals

  • Carbatrol® contains carbamazepine. Please ensure patient is not taking any other form of carbamazepine.
  • The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. Initiating therapy at the lowest possible effective dose can minimize adverse reactions.
  • Toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported with use of carbamazepine. These skin disorders are rare, but appear to be more common in patients of Asian ancestry. A strong association between Asian ancestry and the presence of HLA-B*1502 allele in the development of toxic epidermal necrolysis and Stevens-Johnson syndrome has been reported. Patients of ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating Carbatrol. Patients testing positive for the allele should not be treated with Carbatrol unless the benefit clearly outweighs the risk.
  • Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine. Reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of carbamazepine. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis. Nonetheless, complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.
  • Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds.
  • Carbamazepine is Pregnancy Category D.
  • Absence seizures (petit mal) do not appear to be controlled by carbamazepine.

References

  1. Mattson RH, Cramer JA, Collins JF, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985;313:145-151.
  2. Mattson RH, Cramer JA, Collins JF and the Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. N Engl J Med. 1992;327:765-771.
  3. Karceski S, Morrell MJ, Carpenter D. Treatment of epilepsy in adults: expert opinion, 2005. Epilepsy Behav. 2005;7(suppl 1):S1-S64.
  4. Kwan P, Brodie MJ. Clinical trials of antiepileptic medications in newly diagnosed patients with epilepsy. Neurology. 2003;60(suppl 4):S2-S12.
  5. Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; for the Levetiracetam Monotherapy Study Group. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007;68:402-408.
  6. Brodie MJ, Richens A, Yuen AWC. Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. Lancet. 1995;345:476-479.
  7. Reunanen M, Dam M, Yuen AW. A randomised open multicentre comparative trial of lamotrigine and carbamazepine as monotherapy in patients with newly diagnosed or recurrent epilepsy. Epilepsy Res. 1996;23:149-155.
  8. Brodie MJ, Overstall PW, Giorgi L, and the UK Lamotrigine Elderly Study Group. Multicentre, double-blind, randomised comparison between lamotrigine and carbamazepine in elderly patients with newly diagnosed epilepsy. Epilepsy Res. 1999;37:81-87.
  9. Nieto-Barrera M, Brozmanova M, Capovilla G, et al, on behalf of the Lamictal vs Carbamazepine Study Group. A comparison of monotherapy with lamotrigine or carbamazepine in patients with newly diagnosed partial epilepsy. Epilepsy Res. 2001;46:145-155.
  10. Privitera MD, Brodie MJ, Mattson RH, Chadwick DW, Neto W, Wang S, for the EPMN 105 Study Group. Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy. Acta Neurol Scand. 2003;107:165-175.
  11. Dam M, Ekberg R, Loyning Y, Waltimo O, Jakobsen K. A double-blind study comparing oxcarbazepine and carbamazepine in patients with newly diagnosed, previously untreated epilepsy. Epilepsy Res. 1989;3:70-76.
  12. Marson AG, Al-Kharusi AM, Alwaidh M, et al, on behalf of the SANAD Study Group. The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial. Lancet. 2007;369:1000-1015.
  13. Saetre E, Perucca E, Isojärvi J, Gjerstad L, on behalf of the LAM 40089 Study Group. An international multicenter randomized double-blind controlled trial of lamotrigine and sustained-release carbamazepine in the treatment of newly diagnosed epilepsy in the elderly. Epilepsia. 2007;48:1292-1302.

See Important Safety Information for Health Care Professionals

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C510 01/04/2008