For the treatement of partial and generalized seizures

To date, newer AEDs have shown similar efficacy to carbamazepine.*

*Newer AEDs are AEDs approved after 1997.

Confidence is patient-friendly dosing and known tolerability profile

Carbatrol convenient BID dosing schedule may enhance patient compliance

  • Can be taken with or without food
  • Sprinkle option for easier swallowing1
  • Range of dosage strengths–100 mg, 200 mg, and 300 mg
    —Allows for ease of titration for new starts or switched patients
Range of Carbatrol dosing strengths

Capsules not shown to actual size.

Carbatrol provides well-established tolerability profile

In a 3-month, open-label study (n=453)*2

  • Carbatrol was generally well tolerated in patients converted from IR-CBZ to Carbatrol at the same total daily dose

Treatment-emergent AEs reported by >2 subjects at an incidence of >2%2

Treatment-emergent AEs reported by >=2 subjects at an incidence of >=2% (2)

*The Carbatrol SPEQT Study. A 3-month, open-label study in 453 patients converted from IR-CBZ to Carbatrol. After initial screening, subjects continued IR-CBZ for a 1-month screening period then converted to Carbatrol for 3 months at a dose equal to that of the prior IR-CBZ total daily dose. Spontaneously reported AEs were recorded at each study visit and during telephone contacts. AEs were assessed in all treated subjects (n=458).
NOS=not otherwise specified

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. McLean A, Browne S, Zhang Y, Slaughter E, Halstenson C, Couch R. The influence of food on the bioavailability of a twice-daily controlled release carbamazepine formulation. J Clin Pharmacol. 2001;41:183-186.
  2. 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