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What is Tegretol?

Tegretol (carbamazepine)

Tegretol is an anticonvulsant medication that is most commonly used to treat seizures in patients with epilepsy. Although epilepsy is the only FDA approved indication, Tegretol is also used to treat bipolar disorder and several pain syndromes. Tegretol evens out the "highs"(mania) and "lows"(depression) in mood associated with bipolar disorder. Tegretol is recommended to treat acute mania when lithium and/or valproate are ineffective or poorly tolerated. Sometimes Tegretol is used in combination with other mood stabilizers like lithium or valproate.  Another brand name product of carbamazepine, Equetro, has a FDA indication to treat acute manic and mixed episodes associated with bipolar I disorder.

A manic episode, or mania, is when a person experiences several of the following symptoms at the same time: "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).

A depressive episode or depression occurs when a person experiences several of the following symptoms at the same time: "low" or depressed mood (for example, sad, empty, tearful); decreased interest in most or all activities; changes in appetite (usually decreased); changes in sleep (usually poor sleep); loss of energy; feeling worthless/guilty/ hopeless/ helpless; psychomotor agitation or retardation (i.e. thoughts/movements speeding up or slowing down); difficulty concentrating, and thoughts of death (suicidal thinking).

A mixed episode is one that has characteristics of both mania and depression present and occurs nearly everyday during at least one week. Symptoms may include inability to sleep, agitation, irritability, anxiety, impulsiveness, and pressured speech.

Bipolar disorder is a brain disorder (mental illness) that exposes people to these mood changes over the course of time. Bipolar disorder affects more than two million American each year, but patients with this disorder can lead fulfilling lives when they receive proper treatment. Unfortunately, many people with this illness do not receive treatment.

What is the most important information I should know about Tegretol?

Bipolar disorder requires long-term treatment. Do not stop taking the Tegretol, even when you feel better. Only your healthcare provider can determine the length of Tegretol treatment that is right for you. Missing doses of Tegretol may increase your risk for a relapse in your mood symptoms. It may also increase the possibilities of troublesome side effects such as seizures.

In order for Tegretol to work properly, it should be taken every day as ordered by your healthcare provider. 

Are there specific concerns about Tegretol and pregnancy?

If you are planning on becoming pregnant, notify your healthcare provider so that he/she can best manage your medications. People living with bipolar disorder who wish to become pregnant face important decisions, about the risks and benefits of the medications as they relate to the illness, and to the fetus. This is a complex decision as untreated bipolar disorder has risks to the fetus as well as the mother. There are many dimensions to these choices, so be sure to confer with your doctor and caregivers.

For example, exposure to Tegretol during the first three months of pregnancy is associated with defects of the head and face (11%), fingernails (26%), and developmental delay (20%). The risk of birth defects is increased when Tegretol is combined with other medications (in particular valproate) because the level of toxic metabolites is increased. In order to decrease this risk, exposure to Tegretol during the first three months should be avoided if possible. Tegretol can also cause vitamin K deficiency in the baby, which will increase the risk of bleeding. If Tegretol is used during pregnancy, close monitoring of fetal serum levels is recommended and a vitamin K supplement may be necessary.

Regarding breast-feeding, caution is advised since Tegretol does pass into breast milk. The American Academy of Pediatrics committee on medications in breast-feeding lists Tegretol as “compatible” with breast-feeding.

What should I discuss with my healthcare provider before taking Tegretol?

How should I take Tegretol?

What happens if I miss a dose?

If you miss a dose of Tegretol , take it as soon as you remember unless it is close to when your next dose is due. If it is close to your next dose, wait until then to take the medication and skip the missed dose. Do not double your next dose or take more than your prescribed dose.

What should I avoid while taking Tegretol?

What happens if I overdose?

If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).

Symptoms that may occur in an overdose include: dizziness, poor coordination, drowsiness, nausea, vomiting, tremor, twitching, irregular heart beat, and muscle weakness. In severe cases people can develop seizures, respiratory difficulty, coma, and death.

What are the possible side effects of Tegretol?

Common side effects of Tegretol include: dizziness, sedation, rash, upset stomach, dry mouth and constipation.

Less common, but potentially serious, side effects include: difficulty walking, fatigue, tremor, abnormal vision, vomiting, stomach pain, indigestion, concentration or memory difficulties and weight gain.

Tegretol can cause a decrease in the body’s sodium level, especially at higher doses. Although low sodium levels may not cause observable symptoms, some signs of low sodium include nausea, drowsiness, impaired consciousness, or confusion.

Mild rash occurs in about 10-15% in those who take Tegretol . In rare cases (<1%) a severe, spreading rash with blistering of the skin in patches over the entire body along with fever, headache and cough can occur (Stevens-Johnson Syndrome). Although this is rare with Tegretol , discontinuation of this medication is necessary.

Talk with your healthcare provider if you experience side effects that are bothersome to you. Contact your healthcare provider immediately if you develop a skin reaction, fever, swelling, or shortness of breath.

Are there any risks for taking Tegretol for long periods of time?

Thyroid dysfunction has occurred with Tegretol use.
 

What other drugs may interact with Tegretol?

Tegretol may decrease the effectiveness of several other medications by increasing their breakdown and elimination from the body. For example, individuals taking antipsychotic medications like haloperidol, quetiapine or others may require higher doses of these medications to get the same therapeutic effect. Similarly, the effectiveness of Tegretol may be reduced by other anticonvulsants. People who are taking Tegretol should consult their doctor before taking or discontinuing the following:

How long does it take for Tegretol to work?

Several weeks are often required for Tegretol to reach its maximum effectiveness; however, improvement in some symptoms may occur sooner.

It is very important to tell your doctor how you feel things are going during the first few weeksafter you start taking oxcarbazepine. It will probably take several weeks to see enough changes in your symptoms to decide if oxcarbazepineis helpful for you.

Mood stabilizer treatment is generally needed lifelong in persons with bipolar illness.  Your doctor can best discuss the duration of treatment you need based on your symptoms and course of illness.

Brand and Generic Names

Available forms…

Tegretol

Tablet: 200mg

Chewable tablet: 100mg

Liquid suspension 100mg/5mL (citrus vanilla flavor)

Tegretol-XR

Extended release tablet: 100mg, 200mg, 400mg

Carbatrol

Extended release capsule: 100mg, 200mg, 300mg

Equetro

Extended release capsule: 100mg, 200mg, 300mg

Epitol

Tablet: 200mg

Generic name: carbamazepine

Liquid suspension: 100mg/5mL

Updated by Ching-Yi Liu Pharm.D.
(June 2007)

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 6 patients per one million population per year for agranulocytosis and two patients per one million population 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.