Pronunciation:

kar-ba-MAZ-e-peen

Brand Names:

• Carbatrol
• Epitol
• Equetro
• Tegretol
• Tegretol-XR

Dosage Forms:

• Suspension
• Tablet, Extended Release
• Tablet, Chewable
• Capsule, Extended Release
• Tablet

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 carbamazepine. 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 carbamazepine. Patients testing positive for the allele should not be treated with carbamazepine unless the benefit clearly outweighs the risk.

• Aplastic Anemia and Agranulocytosis
  • Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine. 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 carbamazepine, 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 carbamazepine 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 .

Serious and sometimes fatal dermatologic reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported, especially in patients with the inherited allelic variant HLA-B*1502. Genetically at-risk patients should be screened prior to receiving carbamazepine. Carbamazepine should not be started in patients who test positive for the allele. Aplastic anemia and agranulocytosis have also been reported. 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 .

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Dibenzazepine Carboxamide

Uses of This Medicine:

Carbamazepine is used to control some types of seizures in the treatment of epilepsy. It is also used to relieve pain due to trigeminal neuralgia (tic douloureux). It should not be used for other more common aches or pains. It can also be used in the treatment of bipolar disorder (manic-depressive illness).

Carbamazepine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, carbamazepine is used in certain patients with the following medical conditions:

• Alcohol withdrawal
• Bipolar disorder (manic-depressive illness) prevention
• Central partial diabetes insipidus (water diabetes)
• Neurogenic pain (a type of continuing pain)
• Psychotic disorders (severe mental illness)

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of carbamazepine in children .

Older adults—

Although appropriate studies on the relationship of age to the effects of carbamazepine have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of carbamazepine in the elderly. However, elderly patients are more likely to have confusion or agitation, which may require caution in patients receiving carbamazepine .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nefazodone
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Selegiline
• Toloxatone
• Tranylcypromine
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of)—Drinking alcohol may decrease the effectiveness of carbamazepine.

• Anemia or other blood problems or
• Behavioral or mental problems or
• Blood vessel disease or
• Glaucoma or
• Heart disease or heart rhythm problems or
• Problems with urination or
• Skin diseases (e.g., Lyell's syndrome or Stevens-Johnson syndrome)—Carbamazepine may make these conditions worse .

• Asian ancestry—Carbamazepine may increase the risk for dangerous skin reactions. Before prescribing carbamazepine for you, your doctor may test for a risk factor (called HLA-B*1502) for these skin reactions .

• Diabetes mellitus (sugar diabetes)—Carbamazepine may cause increased urine glucose levels.

• Kidney disease or
• Liver disease—Higher blood levels of carbamazepine may result, increasing the chance of side effects.

Proper Use of This Medicine:

Carbamazepine suspension and tablets should be taken with meals to lessen the chance of stomach upset (nausea and vomiting). Carbamazepine extended-release capsules do not need to be taken with meals unless they upset your stomach. The contents of these extended-release capsules may be sprinkled over a teaspoonful of applesauce or other similar food; the capsule or its contents should not be crushed or chewed. The extended-release tablets must be swallowed whole and should not be crushed or chewed. Do not take extended-release tablets that are damaged or have chips or cracks .

Grapefruit and grapefruit juice may increase the effects of carbamazepine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

It is very important that you take this medicine exactly as directed by your doctor to obtain the best results and lessen the chance of serious side effects. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you are taking this medicine for pain relief:

• Carbamazepine is not an ordinary pain reliever. It should be used only when a doctor prescribes it for certain kinds of pain. Do not take carbamazepine for any other aches or pains.

If you are taking this medicine for epilepsy:

• Do not suddenly stop taking this medicine without first checking with your doctor. To keep your seizures under control, it is usually best to gradually reduce the amount of carbamazepine you are taking before stopping completely.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension):
  • For epilepsy:
    • Adults and teenagers—At first, 100 milligrams (mg) taken up to four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children 6 to 12 years of age—At first, 50 mg taken four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg a day.
    • Children up to 6 years of age—Dose is based on body weight and will be determined by your doctor.
  • For trigeminal neuralgia:
    • Adults and teenagers—At first, 50 mg four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets and chewable tablets):
  • For epilepsy:
    • Adults and teenagers—At first, 200 mg taken two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children 6 to 12 years of age—At first, 100 mg taken two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg a day.
    • Children up to 6 years of age—Dose is based on body weight and will be determined by your doctor.
  • For trigeminal neuralgia:
    • Adults and teenagers—At first, 100 mg taken two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release capsules):
  • For bipolar disorder:
    • Adults—At first, 200 mg taken two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1600 mg a day.
    • Children and teenagers—Use and dose must be determined by your doctor.
  • For epilepsy:
    • Adults and teenagers—At first, 200 mg taken one or two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children up to 12 years of age—Dose is based on body weight and will be determined by your doctor. However, the dose is usually not more than 1000 mg a day.
  • For trigeminal neuralgia:
    • Adults and teenagers—At first, 200 mg a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
  • For epilepsy:
    • Adults and teenagers—At first, 100 to 200 mg taken one or two times a day with meals. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children 6 to 12 years of age—At first, 100 to 200 mg taken in smaller doses during the day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg a day.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
  • For trigeminal neuralgia:
    • Adults and teenagers—At first, 100 mg taken two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Your doctor may want to have certain tests done to see if you are receiving the right amount of medicine or if certain side effects may be occurring without your knowing it. Also, the amount of medicine you are taking may have to be changed often.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away .

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking carbamazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking carbamazepine. If you have any questions about this, check with your health care professional .

Do not take carbamazepine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Also, do not take nefazodone (Serzone®) and other medicines (prescription, over-the-counter [OTC] or herbal products) unless they have been discussed with your doctor .

Carbamazepine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, easy bruising, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.

Contact your doctor immediately, if you experience any sign of a skin rash. This could be a symptom of a serious skin condition

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally, especially when they are starting treatment or increasing the dose. It may also cause blurred or double vision, weakness, or loss of muscle control in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well-coordinated or able to see well.

Some people who take carbamazepine may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

For diabetic patients:

• Carbamazepine may affect urine sugar levels. While you are using this medicine, be especially careful when testing for sugar in your urine. If you notice a change in the results of your urine sugar tests or have any questions about this, check with your doctor.

For patients taking the oral suspension form of Tegretol:

• Do not take any other liquid medicines at the same time that you take your dose of Tegretol without first checking with your doctor.

Before having any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some pregnancy tests and the metyrapone test may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking carbamazepine together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects and cause other unwanted effects.

Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Black, tarry stools

blood in urine or stools

bone or joint pain

cough or hoarseness

darkening of urine

lower back or side pain

nosebleeds or other unusual bleeding or bruising

pain, tenderness, swelling, or bluish color in leg or foot

painful or difficult urination

pale stools

pinpoint red spots on skin

shortness of breath or cough

skin rash, hives, or itching

sore throat, chills, and fever

sores, ulcers, or white spots on lips or in the mouth

swollen or painful glands

unusual tiredness or weakness

wheezing, tightness in chest, or troubled breathing

yellow eyes or skin

Symptoms of overdose

Body spasm in which head and heels are bent backward and body is bowed forward

clumsiness or unsteadiness

convulsions (seizures)—especially in small children

dizziness (severe) or fainting

drowsiness (severe)

fast or irregular heartbeat

high or low blood pressure (hypertension or hypotension)

irregular, slow, or shallow breathing

large pupils

nausea or vomiting (severe)

overactive reflexes followed by underactive reflexes

poor control in body movements (for example, when reaching or stepping)

sudden decrease in amount of urine

trembling, twitching, or abnormal body movements

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Blurred vision or double vision

continuous back-and-forth eye movements

Less common

Actions that are out of control

behavioral changes (especially in children)

confusion, agitation, or hostility (especially in the elderly)

diarrhea (severe)

discouragement

drooling

fear

feeling of unreality

feeling sad or empty

headache (continuing)

increase in seizures

irritability

lack of appetite

loss of balance control

loss of interest or pleasure

muscle trembling, jerking, or stiffness

nausea and vomiting (severe)

other problems with muscle control or coordination

sense of detachment from self or body

shakiness and unsteady walk

shuffling walk

stiffness of limb

sudden, wide mood swings

talking, feeling, and acting with excitement

thoughts or attempts of killing oneself

tiredness

trouble concentrating

trouble sleeping

twisting movements of the body

uncontrolled movements, especially of face, neck, and back

unusual drowsiness

Rare

Chest pain

difficulty in speaking or slurred speech

fainting

frequent urination

irregular, pounding, or unusually slow heartbeat

mental depression with restlessness and nervousness or other mood or mental changes

muscle or stomach cramps

numbness, tingling, pain, or weakness in hands and feet

rapid weight gain

rigidity

ringing, buzzing, or other unexplained sounds in the ears

sudden decrease in amount of urine

swelling of face, hands, feet, or lower legs

trembling

uncontrolled body movements

visual hallucinations (seeing things that are not there)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Clumsiness or unsteadiness

dizziness (mild)

drowsiness (mild)

lightheadedness

nausea or vomiting (mild)

Less common or rare

Accidental injury

aching joints or muscles

acid or sour stomach

back pain

belching

constipation

diarrhea

dryness of mouth

headache

heartburn

increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn)

increased sweating

indigestion

irritation or soreness of tongue or mouth

itching skin

lack or loss of strength

loss of appetite

loss of hair

loss of memory

problems with memory

sexual problems in males

sleepiness

stomach pain, upset, or discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.