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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NEWS HIGHLIGHTS
Published Studies Related to Tegretol-XR (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 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: 2009-10-20
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