Please See Important Safety Information, Including Boxed Warning Below

Equetro® (carbamazepine) Extended-Release Capsules is the only carbamazepine-containing product that has successfully completed FDA trials to establish an approved indication for the treatment of the Manic and Mixed Episodes of Bipolar I Disorder2

No other carbamazepine-containing product has gone through the FDA-process to obtain this indication2

Most Common Adverse Events Reported in Double-Blind,
Placebo-Controlled Trials

Adverse Events

*Source: Table 1 of Equetro® Full Prescribing Information
† Reported as blurred vision

Serious Adverse Events (SARs)

SAEs reported during the study occurred in 10 subjects

  • 6 on ERC-CBZ
  • 4 on placebo

The 6 SAEs occurring in ERC-CBZ group included

  • 2 instances of manic-depressive reaction
  • 2 worsening of depressive episodes
  • 1 personality disorder
  • 1 fever with rash
  • Of these, only 1 SAE was deemed possibly related to ERC-CBZ. This was a male subject who developed a fever and erythematous macular rash over the trunk and lower extremities

The 4 SAEs occurring in the placebo group included

  • 2 manic reactions
  • 1 depressive reaction
  • 1 accidental injury

Post-hoc Analysis Showed that the Most Frequently Reported Adverse Events Decrease Over Time

Adverse Events Graph

aData are from the current study pooled with Weisler RH, Kalali AH, Ketter TA, and the SPD417 Study Group. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of Extended-Release carbamazepine Capsules As Monotherapy For Bipolar Disorder Patients With Manic Or Mixed Episodes. J. Clin. Psychiatry 2004;65:478-484
bAggressive ERC-CBZ titration protocol for hospitalized patients (200 mg/day as tolerated) was used in both studies.

Equetro®'s Durable Safety and Tolerability were Established During
Extensive Study4

Adverse Events Table

*Safety population

REMINDER: Equetro® contains carbamazepine. Please ensure patient is not taking any other form of carbamazepine.

WARNING

Important Safety Information about Equetro® (carbamazepine) Extended-Release Capsules

Warning Serious Dermatologic Reactions and HLA-B*1502 Allele

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported during treatment with carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene. HLA-B*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with Equetro® (carbamazepine) Extended-Release Capsules. Patients testing positive for the allele should not be treated with Equetro® (carbamazepine) Extended-Release Capsules unless the benefit clearly outweighs the risk (see warnings and precautions, laboratory tests).

Aplastic Anemia and Agranulocytosis

Aplastic Anemia and Agranulocytosis have been reported in association with the use of carbamazepine. Data from a population based case-control study demonstrate that the risk of developing these reactions is 5–8 times greater than in the general population. However, the overall risk of these reactions in the untreated general population is low, approximately six patients per one million population per year for Agranulocytosis and two patients per one million population per year for Aplastic Anemia.

Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of carbamazepine, data are not available to estimate accurately their incidence or outcome. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of Aplastic Anemia or Agranulocytosis.

Because of the very low incidence of Agranulocytosis and Aplastic Anemia, the vast majority of minor hematologic changes observed in monitoring of patients on carbamazepine are unlikely to signal the occurrence of either abnormality. 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.

Anti-epileptic drugs (AEDs), including Equetro®, may increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence of worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Please see FULL PRESCRIBING INFORMATION including contraindications, warnings and precautions, and boxed warning for additional safety information on Equetro® (carbamazepine) Extended-Release Capsules.

Please see Medication Guide for additional information.