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, found almost exclusively in patients of Asian descent. Screen genetically at-risk patients prior to receiving carbamazepine. Do not start carbamazepine in patients who test positive for the allele. Aplastic anemia and agranulocytosis have also been reported. Obtain pretreatment hematological testing and periodically monitor CBC. Consider drug discontinuation if significant bone marrow depression develops .
Carbamazepine is used to treat certain types of seizures (epilepsy). It is also used to relieve pain due to trigeminal neuralgia (tic douloureux) and in the treatment of bipolar disorder (manic-depressive illness). Carbamazepine works in the brain and nervous system to control seizures, pain, and bipolar disorder. This medicine is an anticonvulsant.
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:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of carbamazepine extended-release capsules to treat bipolar disease in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of carbamazepine to treat epilepsy in children.
Although appropriate studies on the relationship of age to the effects of carbamazepine have not been performed in the geriatric population, geriatric-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.
|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.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of 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:
Take this medicine exactly as directed by your doctor. 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. To do so may increase the chance of side effects.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand before taking this medicine.
Carbamazepine 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 the extended-release capsules may be sprinkled over a teaspoon 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 this medicine by increasing the amount in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.
If you are taking this medicine for pain relief:
If you are taking Tegretol® oral suspension:
Tegretol® tablets works differently than Tegretol® oral suspension, even at the same dose (number of milligrams). Do not switch from the tablets to the oral suspension unless your doctor tells you to.
Tegretol® may be used alone or together with other seizure medicines. Ask your doctor first before taking any other seizure medicine together with Tegretol®.
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.
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.
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.
It is very important that your doctor check the progress of you or your child 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 or your child 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.
Do not take carbamazepine together with a monoamine oxidase inhibitor (MAOI) or during the first 14 days after you stop taking a MAOI. MAOIs are used for depression and some examples are isocarboxazid (Marplan®), phenelzine (Nardil®), procarbazine (Matulane®), selegiline (Eldepryl®), or tranylcypromine (Parnate®). Do not use this medicine together with nefazodone (Serzone®) and certain medicines for HIV/AIDS (such as delavirdine, efavirenz, Atripla®, Sustiva®, Rescriptor®).
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, your child, 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, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, a fever, or chills while you are using this medicine.
Carbamazepine may cause serious allergic reactions affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you or your child have the following symptoms: a fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.
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, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child 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:
If you have a severe reaction from the sun, check with your doctor.
Before having any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some pregnancy tests may be affected by this medicine.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of seizures and reduce the possibility of withdrawal symptoms.
Birth control pills containing estrogen may not work properly if you take them while you are taking carbamazepine. Unplanned pregnancies may occur. Use a different or additional means of birth control while you are taking carbamazepine. If you have any questions about this, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.