For the treatement of partial and generalized seizures

Carbatrol is the first carbmazepine to offer a 3-bead extended-release delivery system, providing treatment to your patients with only two doses per day.

Confidence is improvements in QOL and reduction in CNS side effects*

In a 3-month, open-label study (n=453)†1
Carbatrol patients experienced overall improvements in QOL after converting from IR-CBZ

Carbatrol patients experienced overall improvements in QOL after converting from IR-CBZ(||)
  • P<.01 significance against all measures

*Selection of AED should be based on full evaluation of patient needs.
†SPEQT (Safety, Preference, Effectiveness, Quality of Life, and Tolerability): a 3-month, open-label study with 453 ITT patients converted from IR-CBZ to Carbatrol at the same daily dose. Quality of life was assessed in 415 evaluable adult subjects using the Quality of Life in Epilepsy-31 (QOLIE-31). QOLIE-31 is a validated, epilepsy-specific assessment tool for adult patients that contains 7 multi-item scales measuring: emotional well-being, social functioning, energy/fatigue levels, cognitive functioning, seizure worry, medication effects, and overall quality of life of an adult with epilepsy. Increase in QOLIE-31 scores represents improvements in quality of life.
‡Statistical significance is the same for all baseline vs endpoint comparisons. P value from 1-sample t test.

Carbatrol patients experienced significant decrease in CNS adverse events after converting from IR-CBZ§

Carbatrol patients experienced significant decrease in CNS adverse events after converting from IR-CBZ (||)
  • Side effects measured showed significant improvement in the mean adult subject group at endpoint

§The occurrence of the most common AED-associated adverse events was assessed in 419 evaluable subjects at baseline (visit 2) and end of study (visit 6) using the Adverse Events Profile Scale (AEP). The AEP is a 19-item questionnaire that measures many adverse events associated with the use of AEDs that occurred in the month prior to the study visit. The primary tolerability outcome measure was a CNS side effect-specific subset of the AEP. Secondary tolerability measures were the total of all item scores from the complete AEP scale.1
||Statistical significance is the same for all baseline vs endpoint comparisons. P value from 1-sample t test.

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. Data on file [Safety, Preference, Effectiveness, Quality of Life, and Tolerability], Shire US Inc.

See Important Safety Information for Health Care Professionals

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C510 01/04/2008