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Tegretol (Carbamazepine) - Summary

 
 



WARNINGS

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 TEGRETOL. 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 TEGRETOL. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL 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 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.

 

TEGRETOL 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).

Epilepsy

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:

  1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
  2. Generalized tonic-clonic seizures (grand mal).
  3. 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).
Trigeminal Neuralgia

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.


See all Tegretol indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Tegretol (Carbamazepine)

Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy. A randomized, double-blind trial. [2014]
venlafaxine in patients with painful diabetic neuropathy (PDN)... CONCLUSION: This study showed the efficacy of venlafaxine, pregabalin, and

Population pharmacokinetics of carbamazepine in elderly patients. [2012]
these parameters... CONCLUSIONS: Carbamazepine clearance was not associated with body weight or any

The effect of levetiracetam monotherapy on subjective sleep quality and objective sleep parameters in patients with epilepsy: compared with the effect of carbamazepine-CR monotherapy. [2011.05]
PURPOSE: There is relatively little known about the effects of new antiepileptic drugs (AEDs) on sleep. This study was done to evaluate the effect of levetiracetam (LEV) on subjective sleep quality and sleep architecture in patients with epilepsy, and the results were compared with the effects of carbamazepine-CR (CBZ-CR)... CONCLUSION: LEV may increase sleep efficiency without major effects on sleep structure with an overall effect on sleep parameters comparable to CBZ-CR. Copyright (c) 2011 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Pregabalin effect on steady-state pharmacokinetics of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproate, and tiagabine. [2011.02]
By reducing neuronal excitability through selective binding to the alpha(2)delta subunit of voltage-dependent calcium channels, pregabalin effectively treats epilepsy, chronic pain, and anxiety disorders. To evaluate if pregabalin coadministration affects pharmacokinetics of other antiepileptic drugs, population pharmacokinetic analyses using NONMEM software were performed on data from three epilepsy trials involving seven antiepileptic drugs with pregabalin as add-on therapy...

Carbamazepine coadministration with an oral contraceptive: effects on steroid pharmacokinetics, ovulation, and bleeding. [2011.02]
PURPOSE: Antiepileptic drugs (AEDs) are widely used in reproductive-age women...

more studies >>

Clinical Trials Related to Tegretol (Carbamazepine)

Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency [Recruiting]
The primary objective is to determine if the medication Carbamazepine, can be used as a therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .

Fed Bioequivalence Study of CBZ Formulations [Completed]
Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction. The primary objective of this study is to estimate the bioequivalence of the new brand generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective will be evaluation of safety issues. The study design will be randomized two sequences, two periods and crossover. For a power of not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be administered with food (high calories/high fat breakfast) after an overnight fast. Time vs. concentration curves will be built for each subject and formulation and Area Under Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual curves. This parameters will be statistically processed with the WinNonlin 6. 3 Pharmacokinetics/Statistic software in order to prove bioequivalence between the study products.

Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia [Completed]
The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).

Carbamazepine Extended-Release for the Treatment of Bipolar Depression [Completed]
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.

A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir [Completed]
The purpose of this study is to investigate the potential pharmacokinetic (what the body does to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state (constant concentration of medication in the blood) in healthy participants.

more trials >>

Reports of Suspected Tegretol (Carbamazepine) Side Effects

Convulsion (150)Pyrexia (108)Rash (96)Drug Rash With Eosinophilia and Systemic Symptoms (56)Somnolence (54)Malaise (54)Fall (50)Dizziness (50)Vomiting (48)Pruritus (46)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Tegretol has an overall score of 2.33. The effectiveness score is 7.33 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
 

Tegretol review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   epilepsy
Dosage & duration:   600 mg taken once a day for the period of 5 years
Other conditions:   hypothyroid
Other drugs taken:   nature throid
  
Reported Results
Benefits:   i no longer had seizures. i was having a seizure everytime i ate food. my sizure responce was food.
Side effects:   my appetite increases. i gained weight i was tired all the time. i also had balance problems i also had periods of nasuea
Comments:   I was givin an eeg. from that point my doctor decided i needed a fairly high dose It took 30 days before enough tegretol had built up in my system before the seizures were under control.

 

Tegretol review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   neuropathic pain
Dosage & duration:   200 mg taken twice a day for the period of 4 months
Other conditions:   migraine
Other drugs taken:   Imitrex
  
Reported Results
Benefits:   There was no benefit for either my neuropathic pain or migraine headaches.
Side effects:   I had massive weight gain. Ten pounds the first month, ten pounds the second month, five pounds the third month and five pounds the fourth month. The weight gain totaled forty pounds. Almost fifteen years later, despite the same healthy diet & exercise that kept me at a healthy weight before, the extra forty pounds of weight is still there. It also made me very tired.
Comments:   I had blood tests for blood levels & blood count every month.

 

Tegretol review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   neuropathic pain
Dosage & duration:   200 mg taken twice a day for the period of 4 months
Other conditions:   migraine
Other drugs taken:   Imitrex
  
Reported Results
Benefits:   There was no benefit for either my neuropathic pain or migraine headaches.
Side effects:   I had massive weight gain. Ten pounds the first month, ten pounds the second month, five pounds the third month and five pounds the fourth month. The weight gain totaled forty pounds. Almost fifteen years later, despite the same healthy diet & exercise that kept me at a healthy weight before, the extra forty pounds of weight is still there. It also made me very tired.
Comments:   I had blood tests for blood levels & blood count every month.

See all Tegretol reviews / ratings >>

Page last updated: 2014-11-30

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