WARNING
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.
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EQUETRO SUMMARY
EQUETROTM
(carbamazepine) Extended-Release Capsules
Rx only
EQUETRO™ is available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone.
EQUETRO™ is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.
A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).
The efficacy of EQUETRO™ in acute mania was established in 2 placebo-controlled, double-blind, 3-week studies in patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode (see CLINICAL PHARMACOLOGY).
The effectiveness of EQUETRO™ for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use EQUETRO™ for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
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EQUETRO NEWS HIGHLIGHTS
Published Studies Related to Equetro (Carbamazepine)
Bipolar I and II disorder residual symptoms: Oxcarbazepine and carbamazepine as add-on treatment to lithium in a double-blind, randomized trial. [2009.02.01]
Bipolar affective disorders often require adjunctive therapy to treat persistent symptoms. In order to evaluate bipolar symptoms inadequately responsive to lithium, we have compared the effects of two structurally related compounds carbamazepine [generic for Equetro] (CBZ) and oxcarbazepine (OXC).However, further adequately placebo-controlled trials are needed to expand these findings.
Comparison of carbamazepine and lithium in treatment of bipolar disorder: a systematic review of randomized controlled trials. [2009.01]
OBJECTIVES: To review data from randomized controlled trials (RCTs) assessing the comparative efficacy of carbamazepine [generic for Equetro] and lithium in treatment of acute manic and maintenance phase of bipolar disorder (BD)... CONCLUSION: This review suggests that carbamazepine might be comparable to lithium in terms of efficacy and safety, and therefore a valuable option in the treatment of both manic and maintenance phases.
The effectiveness of carbamazepine in unipolar depression: a double-blind, randomized, placebo-controlled study. [2008.07]
Our previous studies have shown the effectiveness of carbamazepine [generic for Equetro] (CBZ) in the treatment of bipolar depression. This double-blind, randomized, placebo-controlled study was designed to further evaluate the efficacy of CBZ in unipolar depressed subjects who never received antidepressant and other psychotherapeutic treatment... Based on the results of our present and previous studies, we suggest that CBZ might be considered an alternative in the management of certain conditions in major depressive disorder.
Erythrocyte and plasma fatty acid profiles in patients with epilepsy: does carbamazepine affect omega-3 fatty acid concentrations? [2008.02]
Fatty acids (FAs) determine membrane properties and may affect cardiac and neuronal function. In this study, FA profiles were determined in 56 patients with epilepsy who participated in a 12-week double-blind randomized trial of omega-3 FA supplementation (1 g eicosapentaenoic acid and 0.7 g docosahexaenoic acid daily)...
Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets. [2008.01]
AIMS: To assess whether, using the current regulatory criteria, therapeutically important differences can exist between bioequivalent carbamazepine [generic for Equetro] (CBZ) tablets. A secondary goal was to demonstrate quantitatively the relationship between the risk of neurological adverse effects to orally ingested CBZ and the rate of absorption... CONCLUSIONS: In clinical and regulatory considerations, the development of acute tolerance for adverse effects of CBZ must be taken into account. Partial AUC reflects more sensitively the risk of adverse events than C(max). Instead of the current trend of tightening of the bioequivalence criteria for narrow therapeutic index drugs, the use of alternative, more sensitive PK metrics is proposed.
Clinical Trials Related to Equetro (Carbamazepine)
Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder [Completed]
This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the
treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum
Disorder. The main goal of this study is to begin to address the void of information on
safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar
Disorder.
Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania [Completed]
This trial will assess any efficacious benefit and any safety issues associated with the
concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I
disorder, manic or mixed episodes
Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder [Active, not recruiting]
This is an open label design using Lithium plus extended release carbamazepine (Equetro) in
combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory
and associated with repeated hospitalizations and complications. The results of this study
will offer a promising approach to treat this complex disorder. The primary efficacy measure
will be the time to relapse. Relapse will determined by the investigator based on the
following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for
an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.
Carbamazepine Extended-Release for the Treatment of Bipolar Depression [Recruiting]
To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the
treatment of patients with Bipolar Disorder with a Major Depressive Episode.
Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine. [Active, not recruiting]
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that
metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of
these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical
observations suggest that oxcarbazepine does not induce these enzymes to the same degree.
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4
enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme
activity.
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than
carbamazepine.
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Page last updated: 2009-02-07
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