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Tegretol

Generic Name: Carbamazepine
Drug Category: Anticonvulsant
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 1 year old and under the age of 65 years old for a maximum duration of 24 weeks.

Approved Uses

Indicated for:

Epilepsy:

Patients with the following seizure types:

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

Trigeminal Neuralgia:

• 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. 

Tegretol should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients Tegretol has been associated with increased frequency of generalized convulsions.

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (ten) and stevens-johnson syndrome (sjs), have been reported during treatment with Tegretol. 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.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with Tegretol. Some of these events have been fatal or life-threatening.

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.

Aplastic anemia and agranulocytosis have been reported in association with the use of Tegretol.

Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in patients after taking the first or subsequent doses of Tegretol.

Antiepileptic drugs (AEDs), including Tegretol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

Tegretol has shown mild anticholinergic activity that may be associated with increased intraocular pressure; therefore, patients with increased intraocular pressure should be closely observed during therapy.

Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be borne in mind.

The use of Tegretol should be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).

Hyponatremia can occur as a result of treatment with Tegretol. In many cases, the hyponatremia appears to be caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

AV heart block, including second- and third-degree block, have been reported following Tegretol treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances.

Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure have been reported.

Tegretol should not be used in patients with a history of previous bone marrow depression, sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended.

Before administration of Tegretol, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.

Co-administration of carbamazepine with nefazodone is contraindicated.

The use of carbamazepine with lapatinib should generally be avoided.

There is a potential for increased cyclophosphamide toxicity when co-administered with carbamazepine.

Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.

Concomitant use of carbamazepine and isoniazid has been reported to increase isoniazid-induced hepatotoxicity.

Alterations of thyroid function have been reported in combination therapy with other anticonvulsant medications.

Concomitant use of Tegretol with hormonal contraceptive products (e.g., oral, and levonorgestrel subdermal implant contraceptives) may render the contraceptives less effective because the plasma concentrations of the hormones may be decreased. Breakthrough bleeding and unintended pregnancies have been reported. Alternative or back-up methods of contraception should be considered.

CYP3A4 inhibitors inhibit Tegretol metabolism and can thus increase plasma carbamazepine levels. Drugs that have been shown, or would be expected, to increase plasma carbamazepine levels include aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, trazodone, olanzapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles (e.g., ketoconazole, itraconazole, fluconazole, voriconazole), acetazolamide, verapamil, ticlopidine, grapefruit juice, and protease inhibitors.

Drugs that have been shown, or that would be expected, to decrease plasma carbamazepine levels include cisplatin, doxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.

When carbamazepine is added to aripiprazole, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. If carbamazepine is later withdrawn, the aripiprazole dose should be reduced.

Carbamazepine can cause fetal harm when administered to a pregnant woman.

Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

Off-label Uses

• Bipolar disorder. GoToSource

• Absence seizures. GoToSource

• Agitation and aggression in dementia. GoToSource 

• Alcohol withdrawal syndrome. GoToSource

• Restless legs syndrome. GoToSource

• Peripheral neuropathy. GoToSource

• Cocaine dependence. GoToSource

• Migraines. GoToSource

• Post-traumatic stress disorder. GoToSource

• Neuromyotonia. GoToSource

• Schizophrenia and schizoaffective psychoses. GoToSource

• Attention-deficit hyperactivity disorder. GoToSource 

• Vestibular paroxysmia. GoToSource 

• Tourette syndrome. GoToSource

Adverse Events

Toxic epidermal necrolysis and stevens-johnson syndrome (severe drug reaction). GoToSource

Aplastic anemia. GoToSource

Suicidal ideation or behavior. GoToSource

Decreased bone mass with osteoporotic fractures. GoToSource

Vitamin B deficiency. GoToSource

Lichen planus (skin disorder). GoToSource 

Double vision, blurred vision and nystagmus (involuntary eye movements). GoToSource

Birth defects. GoToSource 

Aggravation of childhood occipital epilepsy. GoToSource 

Drug-induced lupus erythematosus causing cardiac tamponade. GoToSource 

Growth suppression. GoToSource 

Tic disorder. GoToSource 

Hypothyroidism. GoToSource 

Drug rash with eosinophilia and systemic symptoms. GoToSource 

Neutrophilic eccrine hidradenitis (skin disorder). GoToSource 

Vanishing bile duct syndrome (drug-induced liver injury). GoToSource

Hyponatremia (low sodium level). GoToSource

Litigation

Lawsuits filed for toxic epidermal necrolysis, stevens-johnson syndrome, suicidal behavior and birth defects.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024