WARNING
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF TEGRETOL. 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 TEGRETOL, 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 TEGRETOL 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.
Before prescribing Tegretol, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.
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TEGRETOL-XR SUMMARY
Tegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg, tablets of 200 mg, XR tablets of 100, 200, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon).
Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
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Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
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Generalized tonic-clonic seizures (grand mal).
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Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol
(see PRECAUTIONS, General).
Tegretol is indicated in the treatment of the pain associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
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TEGRETOL-XR NEWS HIGHLIGHTS
Published Studies Related to Tegretol-XR (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 Tegretol-XR] (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 Tegretol-XR] 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 Tegretol-XR] (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 Tegretol-XR] (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 Tegretol-XR (Carbamazepine)
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.
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.
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.
Drug Interaction Study of Tegretol (Carbamazepine) and St. John's Wort in Normal Volunteers [Completed]
St. John's Wort is a popular dietary supplement that many patients-including those with
epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve
stress. Preliminary research indicates that this supplement can speed the metabolism of the
anti-seizure drug Tegretol, causing reduced blood levels of the drug. Patients who take
Tegretol to control their seizures may have more frequent seizures if the blood level of the
drug drops too low. A recent study shows that this effect is not seen when Tegretol is taken
for at least 3 weeks. The present study will examine whether there is a medically important
drug interaction between St. John's wort and Tegretol when Tegretol is taken for 1 day.
Normal healthy volunteers between 21 and 65 years old who are not taking medicines that can
affect the metabolism of drugs in the liver and have not used St. John's wort for at least 30
days may be eligible for this 25-day study.
Participants will take a 400-mg dose of Tegretol after fasting overnight. Blood samples will
be drawn the next day during a 12-hour clinic stay at the following intervals: just before
the Tegretol dose and at 1, 2, 4, 6, 8, 10, 24, 34, 48 and 72 hours after the dose. A
catheter will be placed in the vein to prevent the need for multiple needle sticks until
after the 10-hour sample. After completing the blood sampling, participants will take 300 mg
of St. John's wort 3 times a day with meals for 2 weeks. After 2 weeks, another fasting dose
of Tegretol will be given and the 72-hour blood study will be repeated.
This study may provide information important for the care of patients with epilepsy who take
both Tegretol and St. John's Wort.
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Page last updated: 2009-02-07
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