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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NEWS HIGHLIGHTS
Published Studies Related to Equetro (Carbamazepine)
Cardiac function and antiepileptic drug treatment in the elderly: a comparison between lamotrigine and sustained-release carbamazepine. [2009.08]
PURPOSE: To investigate the comparative effects of carbamazepine (CBZ) and lamotrigine (LTG) on electrocardiography (ECG) parameters in elderly patients with newly diagnosed epilepsy. METHODS: The study was conducted in the Norwegian subcohort (n = 108) of an international randomized double-blind 40-week trial, which compared the efficacy and tolerability of LTG and sustained-release CBZ in patients aged 65 and older with newly diagnosed epilepsy...
Treatment of subjective tinnitus: a comparative clinical study of intratympanic steroid injection vs. oral carbamazepine. [2009.06]
CONCLUSIONS: Intratympanic steroid injection has positive effects similar to those of oral carbamazepine in subjective tinnitus. Intratympanic steroid injection may be considered an alternative treatment for subjective tinnitus.
Adverse event load in bipolar participants receiving either carbamazepine immediate-release or extended-release capsules: a blinded, randomized study. [2009.05]
In epilepsy, slow-release formulations of carbamazepine (CBZ) have fewer adverse events (AEs) compared with immediate-release (IR) formulations. As CBZ is used for mania, it is important to determine whether a similar pattern exists for bipolar patients...
Effects of ketoconazole and carbamazepine on lapatinib pharmacokinetics in healthy subjects. [2009.04]
AIMS: To characterize the impact of potent CYP3A4 inhibition and induction on lapatinib pharmacokinetics... CONCLUSIONS: Systemic exposure to lapatinib was significantly altered by potent inhibition and induction of CYP3A4. Dose adjustments may be required when lapatinib is administered with orally administered drugs that potently alter the activity of this enzyme.
Randomised controlled study-efficacy of clonidine versus carbamazepine in children with ADHD. [2009.04]
CONCLUSION: Clonidine can be a safer and cheaper alternative in treatment of children with ADHD, with a predominant effect on their hyperactivity and impulsivity symptoms.
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: 2009-10-20
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