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.
2. Pediatric Population:
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.
3. Geriatric Population:
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.
4. Pregnancy
All Trimesters: Category 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.
5. Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
6. Drug Interactions
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.
Grapefruit Juice
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.
• Black Tea
8. 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:
Toxic epidermal necrolysis (severe skin disease)—Use with caution. May make these conditions worse.
Asian ancestry (eg, Filipino, Chinese, Japanese, Korean, Taiwanese)—May increase the risk for serious skin reactions. Your doctor may order a special test before prescribing this medicine.
Bone marrow depression—Should not be used in patients with this condition.
Fructose intolerance (rare inherited problem)—Tegretol® suspension contains sorbitol and should not be given to patients with this condition.
3 Proper Usage
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:
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 Tegretol® oral suspension:
Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Do not take any other liquid medicines at the same time that you take your dose of Tegretol® without first checking with your doctor.
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®.
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 (extended-release capsules):
Adults—At first, 200 milligrams (mg) two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
Children—Use and dose must be determined by your doctor.
Adults and teenagers—At first, 200 milligrams (mg) one or two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1200 mg per day.
Children younger than 12 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually not more than 1000 mg per day.
Adults and teenagers—At first, 200 milligrams (mg) a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1200 mg per day.
Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
o For epilepsy:
Adults and teenagers—At first, 200 mg two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
Children 6 to 12 years of age—At first, 100 mg two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1000 mg per day.
Children younger than 6 years of age—Use and dose must be determined by your doctor.
o For trigeminal neuralgia:
Adults and teenagers—At first, 100 milligrams (mg) two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1200 mg per day.
 Children—Use and dose must be determined by your doctor.
• For oral dosage form (suspension):
o For epilepsy:
Adults and teenagers—100 milligrams (mg) or 1 teaspoon four times a day (400 mg per day). Your doctor may adjust your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
Children 6 to 12 years of age—At first, 50 milligrams (mg) or one-half teaspoon four times a day (200 mg per day). Your doctor may adjust your dose if needed. However, the dose is usually not more than 1000 mg per day.
Children younger than 6 years of age—Dose is based on body weight and will be determined by your doctor. The dose is 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, taken four times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 35 mg per kg of body weight per day.
o For trigeminal neuralgia:
Adults and teenagers—At first, 50 milligrams (mg) or one-half teaspoon four times a day (200 mg per day). Your doctor may adjust your dose if needed. However, the dose is usually not more than 1200 mg per day.
Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets, chewable tablets):
o For epilepsy:
Adults and teenagers—At first, 200 milligrams (mg) two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
Children 6 to 12 years of age—At first, 100 mg two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1000 mg per day.
Children younger than 6 years of age—Dose is based on body weight and will be determined by your doctor. The dose is 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, taken two or three times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 35 mg per kg of body weight per day.
o For trigeminal neuralgia:
Adults and teenagers—At first, 100 milligrams (mg) two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1200 mg per 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.
4 Precautions To Take
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.
Pregnancy:
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.
Other Medicines:
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®).
Behavioural changes:
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.
Blood Problems:
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.
Skin Reactions:
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.
Allergic Reactions:
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.
Alcohol and CNS depressants:
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.
Sunlight:
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 AM and 3:00 PM, if possible.
Wear protective clothing, including a hat. Also, wear sunglasses.
Apply a sun block product that has a sun 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 doctor.
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.
Medical Tests:
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:
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:
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)
Sores, Ulcers, or White spots on the lips or in the mouth
Swelling of the face, hands, feet, or lower legs
Swollen or Painful glands
Sudden decrease in the amount of urine
Tightness in the chest
Trembling
Troubled breathing
Uncontrolled body movements
Unusual tiredness or weakness
Visual hallucinations (seeing things that are not there)
Yellow eyes or skin
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:
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