Please See Important Safety Information, Including Boxed Warning Below

Product Information

How Equetro® (carbamazepine) Extended-Release Capsules Can Help: Equetro® effectively relieves the acute manic and mixed symptoms of Bipolar I Disorder.2

In the clinical studies designed for it's FDA approval application, Equetro® effectively reduced the acute manic and mixed episodes of Bipolar I Disorder. As a result, Equetro® is the first and only carbamazepine treatment FDA approved for Bipolar I Disorder.1

You can take Equetro® with or without food because only Equetro® utilizes the patented Equetro® system drug delivery system to assure that a steady level of medication is maintained with every dose1.

How Equetro® (carbamazepine) Extended-Release Capsules's Patented Technology Works for You1

Inside the unique Equetro® patented delivery system capsule is an effective drug called carbamazepine, which has been studied extensively for many years. In studies that were submitted to gain FDA approval, we put carbamazepine into the unique, patented Equetro® delivery system formulation because it assured that steady blood concentrations of the medication would be maintained. Without the patented Equetro® delivery system chemistry, carbamazepine levels would fluctuate and produce a less than optimal treatment for Bipolar I symptoms.

Only the Equetro® patented delivery system automatically releases a steady amount of carbamazepine into your bloodstream over a period of 12-hours without being affected by meals or digestion.1

  • The patented Equetro® delivery system uses 3-kinds of tiny, specially coated time-release beads of carbamazepine to steadily control your symptoms of Bipolar I Disorder.1

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.