Carbatrol.com: Carbatrol

For the treatement of partial and generalized seizures

Carbatrol can be taken with or without food or sprinkled over soft foods, making it easy for your patients to take.

Carbatrol capsules or their contents should not be crushed or chewed.

Health Care Professionals

Confidence is CBZ efficacy in a different kind of delivery system

Carbatrol demonstrated efficacy and a known safety profile in partial epilepsy—even when employing low-threshold seizure escape criteria^1,2

In a 12-week, randomized, double-blind study in 121 ITT patients receiving a fixed dose of Carbatrol or low-dose Depakote^®*¹

Carbatrol was proven to control seizures with BID dosing

73% of Carbatrol patients successfully completed the trial

Efficacy criteria were related to seizure frequency¹
—Patients were withdrawn from the study if they met low-threshold seizure escape criteria^†
No serious, unexpected, drug-related AEs were reported during the trial¹

In a 12-week extension study evaluating safety^‡2

81% of patients receiving Carbatrol successfully completed the study
No patients discontinued use due to AEs or laboratory test abnormalities

*A 12-week, multicenter, outpatient, randomized, double-blind, parallel-group, active-control study in 121 ITT patients with complex partial seizures to compare the efficacy and safety of Carbatrol BID vs low-dose Depakote^® (valproate sodium sustained-release) dosage form BID. Following a 4-week run-in period, patients were randomized to receive fixed doses of Carbatrol BID (800 mg, 1200 mg, or 1600 mg total daily dose) or Depakote BID (500 mg, 750 mg, or 1000 mg total daily dose). Results from treatment-eligible patients (n=107).

†Seizure escape criteria were defined as 1) a 2-fold increase in highest 2-day seizure frequency, or 2 seizures in one week for patients who had no seizures during the 4-week run-in period; 2) a 2-fold increase in weekly seizure frequency, or 2 seizures in 2 weeks for patients who had no seizures during the 4-week run-in period; 3) a single generalized tonic-clonic seizure if generalized seizures were not present during the 4-week baseline period; or 4) a prolongation of generalized seizure duration deemed by the investigator to require intervention.

‡A 12-week open-label follow-on to a 12-week, multicenter, outpatient, double-blind study in patients with complex partial seizures to evaluate the safety profile of Carbatrol (n=43).

Carbatrol offers the Microtrol^® 3-bead delivery system that dissolves throughout the dosing interval^3,4

Minimized peak-to-trough fluctuations in a simulation analysis^§5.6

In vitro dissolution and blood levels may not necessarily correlate with clinical outcomes.

§Adapted from a pharmacokinetic simulation study. Three single-dose studies of Carbatrol and 10 previously published studies of IR-CBZ were used for a pharmacokinetic comparison of Carbatrol twice daily with IR-CBZ.⁶

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

Data on file [Final Clinical Study Report: Protocol No. PI 101.104], Shire US Inc.
Data on file [Final Clinical Study Report: Protocol No. PI 101.104A], Shire US Inc.
Data on file [Miller], Shire US Inc.
Wheless JW, Venkataraman V. New formulation of drugs in epilepsy. Expert Opin Pharmacather. 1999;1:49-60.
Garnett WR, Levy B, McLean AM, et al. Pharmacokinetic evaluation of twice-daily extended-release carbamazepine (CBZ) and four-times-daily immediate-release CBZ in patients with epilepsy. Epilepsia. 1998;39:274-279.
Krauss G, Hamzeh FM, Miller A. Are FDA bioequivalence standards sufficient for "narrow therapeutic ratio" AEDS: pharmacokinetic comparisons of extended-release and immediate-release carbamazepine formulations. Poster presented at the 57th Annual Meeting of the American Epilepsy Society; December 5-10, 2003; Boston, MA.

See Important Safety Information for Health Care Professionals

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Carbatrol^® is registered in the United States Patent and Trademark Office.
Tegretol^® is a registered trademark of Novartis Pharmaceuticals Corporation.
Depakote^® is a registered trademark of Abbott Laboratories.
Microtrol^® is registered in the United States Patent and Trademark Office.