CARBAMAZEPINE (Systemic)

Some commonly used brand names are:

In the U.S.?

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

In Canada?

• Apo-Carbamazepine
• Novo-Carbamaz
• Nu-Carbamazepine
• Taro-Carbamazepine
• Taro-Carbamazepine CR
• Tegretol
• Tegretol Chewtabs
• Tegretol CR

Generic name product may be available in the U.S.

Category

• Anticonvulsant
• Antidiuretic
• Antimanic
• Antineuralgic,specific pain syndromes
• Antipsychotic

Description

Carbamazepine (kar-ba-MAZ-e-peen)is used to control some types of seizures in the treatment of epilepsy. Itis 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 beused in the treatment of bipolar disorder (manic-depressive illness).

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

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Oral suspension (U.S. and Canada)
• Tablets (U.S. and Canada)
• Chewable tablets (U.S. and Canada)
• Extended-release capsules (U.S.)
• Extended-release tablets (U.S. and Canada)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to carbamazepine or to any of the tricyclic antidepressants,such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine,nortriptyline, protriptyline, or trimipramine. Also tell your health careprofessional if you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Carbamazepine has not been studied in pregnant women.However, there have been reports of babies having low birth weight, smallhead size, skull and facial defects, underdeveloped fingernails, and delaysin growth when their mothers had taken carbamazepine in high doses duringpregnancy. In addition, birth defects have been reported in some babies whenthe mothers took other medicines for epilepsy during pregnancy. Also, studiesin animals have shown that carbamazepine causes birth defects when given inlarge doses. Therefore, the use of carbamazepine during pregnancy should bediscussed with your doctor.

Breast-feeding?Carbamazepine passes into the breast milk, andin some cases the baby may receive enough of it to cause unwanted effects.In animal studies, carbamazepine has affected the growth and appearance ofthe nursing babies. Be sure you have discussed the risks and benefits of themedicine with your doctor.

Children?Behavior changes are more likely to occur in children.

Older adults?Confusion; restlessness and nervousness; irregular,pounding, or unusually slow heartbeat; and chest pain may be especially likelyto occur in elderly patients, who are usually more sensitive than youngeradults to the effects of carbamazepine.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingcarbamazepine, it is especially important that your health care professionalknow if you are taking any of the following:

• Anticoagulants (blood thinners)?The effects of anticoagulantsmay be decreased; monitoring of blood clotting time may be necessary duringand after carbamazepine treatment

• Central nervous system (CNS) depressants (medicines that cause drowsiness)or
• Alcohol?May increase the risk of serious side effects

• Cimetidine (e.g., Tagamet)?Blood levels of carbamazepine maybe increased, leading to an increase in serious side effects

• Clarithromycin (e.g., Biaxin)?Blood levels of carbamazepinemay be increased, increasing the risk of unwanted effects

• Clomipramine (e.g., Anafranil)?Blood levels of clomipraminemay be increased, increasing risk of unwanted effects

• Corticosteroids (cortisone-like medicine)?The effects of corticosteroidsmay be decreased

• Delavirdine (e.g., Rescriptor)?May cause delavirdine to notwork

• Diltiazem (e.g., Cardizem) or
• Erythromycin (e.g., E-Mycin, Erythrocin, Ilosone) or
• Propoxyphene (e.g., Darvon) or
• Verapamil (e.g., Calan)?Blood levels of carbamazepine may beincreased; these medicines should not be used with carbamazepine

• Estrogens (female hormones) or
• Oral contraceptives (birth control pills) containing estrogen or
• Quinidine?The effects of these medicines may be decreased;use of a nonhormonal method of birth control or an oral contraceptive containingonly a progestin may be necessary

• Fluvoxamine (e.g., Luvox)?Blood levels of carbamazepine maybe increased, increasing the risk of unwanted effects

• Isoniazid (e.g., INH)?The risk of serious side effects maybe increased

• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral)?The effects of these medicinesmay be decreased

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone],isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g.,Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])?Takingcarbamazepine while you are taking or within 2 weeks of taking monoamine oxidase(MAO) inhibitors may cause sudden high body temperature, extremely high bloodpressure, and severe convulsions; at least 14 days should be allowed betweenstopping treatment with one medicine and starting treatment with the other

• Other anticonvulsants (seizure medicine)?The effects of thesemedicines may be decreased; in addition, if these medicines and carbamazepineare used together during pregnancy, the risk of birth defects may be increased

• Risperidone [e.g., Risperdal]?The effects of risperidone maybe decreased

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])?Centralnervous system depressant effects of carbamazepine may be increased whilethe anticonvulsant effects of carbamazepine may be decreased; seizures mayoccur more frequently

Other medical problems?The presence of other medicalproblems may affect the use of carbamazepine. Make sure you tell your doctorif you have any other medical problems, especially:

• Alcohol abuse (or history of)?Drinking alcohol may decreasethe effectiveness of carbamazepine

• Anemia or other blood problems or
• Behavioral problems or
• Glaucoma or
• Heart or blood vessel disease or
• Problems with urination?Carbamazepine may make the conditionworse

• Diabetes mellitus (sugar diabetes)?Carbamazepine may causeincreased 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 tolessen the chance of stomach upset (nausea and vomiting). Carbamazepine extended-releasecapsules 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 teaspoonfulof applesauce or other similar food; the capsule or its contents should notbe crushed or chewed.

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

It is very important that you take this medicine exactlyas directed by your doctor to obtain the best results and lessen thechance of serious side effects. Do not take more of it, do not take it moreoften, 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 painreliever. It should be used only when a doctor prescribes it for certain kindsof pain. Do not take carbamazepine for any other achesor pains.

If you are taking this medicine for epilepsy:

• Do not suddenly stop taking this medicine withoutfirst checking with your doctor. To keep your seizures under control,it is usually best to gradually reduce the amount of carbamazepine you aretaking before stopping completely.

Dosing?The dose of carbamazepine will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of carbamazepine. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of suspension that you take dependson the strength of the medicine. Also, the number ofdoses you take each day, the time allowed between doses, and the length oftime you take the medicine depend on the medical problem for which you aretaking carbamazepine.

• For oral dosage form (suspension):
  • For epilepsy:
    • Adults and teenagers?At first, 100 milligrams (mg) taken upto 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 timesa day. Your doctor may increase your dose if needed. However, the dose isusually not more than 1000 mg a day.
    • Children up to 6 years of age?Dose is based on body weightand will be determined by your doctor.
  • For trigeminal neuralgia:
    • Adults and teenagers?At first, 50 mg four times a day. Yourdoctor may increase your dose if needed. However, the dose is usually notmore than 1200 mg a day.
    • Children?Use and dose must be determined by your doctor.
• For oral dosage form (tablets and chewabletablets):
  • 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 usuallynot more than 1200 mg a day.
    • Children 6 to 12 years of age?At first, 100 mg taken two timesa day. Your doctor may increase your dose if needed. However, the dose isusually not more than 1000 mg a day.
    • Children up to 6 years of age?Dose is based on body weightand 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 usuallynot more than 1200 mg a day.
    • Children?Use and dose must be determined by your doctor.
• For oral extended-release capsule dosageform:
  • For bipolar disorder:
    • Adults?At first, 200 mg taken two times a day. Your doctormay increase your dose if needed. However, the dose is usually not more than1600 mg a day.
    • Children and teenagers?Use and dose must be determined by yourdoctor.
  • For epilepsy:
    • Adults and teenagers?At first, 200 mg taken one or two timesa day. Your doctor may increase your dose if needed. However, the dose isusually not more than 1200 mg a day.
    • Children up to 12 years of age?Dose is based on body weightand will be determined by your doctor. However, the dose is usually not morethan 1000 mg a day.
  • For trigeminal neuralgia:
    • Adults and teenagers?At first, 200 mg a day. Your doctor mayincrease your dose if needed. However, the dose is usually not more than 1200mg a day.
    • Children?Use and dose must be determined by your doctor.
• For oral extended-release tablet dosageform:
  • For epilepsy:
    • Adults and teenagers?At first, 100 to 200 mg taken one or twotimes 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 takenin 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 determinedby 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 usuallynot 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 assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.However, if you miss more than one dose a day, check with your doctor.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet forms of carbamazepinein the bathroom, near the kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down and become less effective.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

Do not take other medicines (prescription, over-the-counter [OTC] or herbalproducts) unless they have been discussed with your doctor.

Carbamazepine may cause some people to be agitated, irritable or displayother abnormal behaviors. It may also cause some people to have suicidal thoughtsand tendencies or to become more depressed. If you or your caregiver noticeany of these unwanted effects, tell your doctor right away.

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

This medicine will add to the effects of alcohol and other CNS depressants(medicines that cause drowsiness). Some examples of CNS depressants are antihistaminesor 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 dentalanesthetics. Check with your doctor before taking anyof 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 treatmentor increasing the dose. It may also cause blurred or double vision, weakness,or loss of muscle control in some people. Make sure youknow how you react to this medicine before you drive, use machines, or doanything else that could be dangerous if you are not alert and well-coordinatedor able to see well.

Some people who take carbamazepine may become more sensitive to sunlightthan 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 10:00a.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 aboutthis, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
• Do not use a sunlamp or tanning bed or booth.

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

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

For diabetic patients:

• Carbamazepine may affect urine sugar levels. While you are usingthis 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 anyquestions 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 youtake your dose of Tegretol without first checking with your doctor.

Before having any medical tests, tell the medical doctor in charge thatyou are taking this medicine. The results of some pregnancy tests and themetyrapone 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 thatyou are taking this medicine. Taking carbamazepine together with medicinesthat are used during surgery or dental or emergency treatments may increasethe CNS depressant effects and cause other unwanted effects.

Your doctor may want you to carry a medical identification card or braceletstating 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 sideeffects may occur, if they do occur they may need medical attention.

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

Rare

Black, tarry stools; blood in urineor stools; bone or joint pain; cough or hoarseness; darkening of urine; lower back or side pain; nosebleedsor other unusual bleeding or bruising; painful ordifficult urination; pain, tenderness, swelling,or bluish color in leg or foot; pale stools; pinpoint red spots on skin; shortnessof breath or cough; sores, ulcers, or white spotson lips or in the mouth; sore throat, chills, andfever; swollen or painful glands; unusual tiredness or weakness; wheezing, tightnessin chest, or troubled breathing; yellow eyes or skin

Symptoms of overdose

Body spasm in which head and heels are bent backward and bodyis 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 orstepping); sudden decrease in amount of urine; trembling, twitching, or abnormal body movements

In addition,check with your doctor as soon as possible if any of the following side effectsoccur:

More common

Blurred vision or double vision; continuousback-and-forth eye movements

Less common

Actions that are out of control; behavioralchanges (especially in children); confusion, agitation,or hostility (especially in the elderly); diarrhea(severe); discouragement; drooling; fear; feelingof unreality; feeling sad or empty; headache (continuing); increase in seizures; irritability; lack ofappetite; loss of balance control; loss of interest or pleasure; muscle trembling, jerkingor 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; skin rash, hives, or itching; stiffnessof limb; sudden, wide mood swings; talking, feeling, and acting with excitement; thoughtsor 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 orslurred speech; fainting; frequent urination; irregular, pounding, or unusuallyslow heartbeat; mental depression with restlessnessand 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 decreasein amount of urine; swelling of face, hands, feet,or lower legs; trembling; uncontrolled body movements; visual hallucinations(seeing things that are not there)

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Clumsiness or unsteadiness; dizziness(mild); drowsiness (mild); lightheadedness; nausea or vomiting (mild)

Less common or rare

Accidental injury; aching joints ormuscles; acid sour or 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; itchingskin; 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 abovemay also occur in some patients. If you notice any other effects, check withyour doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, carbamazepine is used in certain patients with the following medicalconditions:

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

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.