Carbamazepine-XR

Swallow Tegretol-XR tablets whole. Do not bite them or break them. Before taking a tablet, look at it to make sure that it is not cracked or broken. Do not use a damaged Tegretol-XR tablet. After the tablets are swallowed, fluid is absorbed through the shell. The contents expand and are slowly pushed out through the small opening on one side. If the shell is broken, the contents will be released too quickly. If this happens, it is like taking a tablet of regular Tegretol.

The shell does not dissolve, so you may see it in the toilet when you have a bowel movement. This is normal.

As the doctor increases the amount of Tegretol-XR that you take, you may be given a different kind of tablet than the ones you've been taking. For example, you may start out using 100-mg tablets and then switch to 200-mg tablets. If this happens, be careful to use the correct number. Don't automatically continue to use the same number of tablets as before.

Don't drink grapefruit juice, because it can interfere with the body's use of the medication.

Store Tegretol-XR at room temperature (below 86°F, 30°C). Protect the tablets from moisture. Don't keep them in the bathroom, where it's damp.

A forgotten dose should be taken right away, unless it is almost time for the next one. In that case, just use one dose, not a double dose, and call the doctor's office for more advice.

Do your best to follow the doctor's directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!

Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. The medicine in Carbatrol, carbamazepine, helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning.

After medicine is swallowed, it must be absorbed into the blood so it can move throughout the body. The process of absorbing, digesting, and excreting a medicine or food is called metabolism. The way the body metabolizes a particular medicine affects how often it must be taken. It also determines whether it will interact with other medicines or be affected by conditions such as liver disease.

Carbatrol is a form of the seizure medicine carbamazepine. Carbamazepine and many other medicines are broken down (digested) in the liver. If the person takes both Carbatrol and another medicine that is digested in the liver, things can get complicated. How well each medicine works and how quickly it leaves the body may be changed.

This is why the doctor needs to know about everything that a person takes—not just prescription medicines but even things like vitamins, herbs, and aspirin!

Doctors have studied large numbers of patients to find out how well carbamazepine, the medicine in Carbatrol, controls seizures. They have reported that it completely controls partial seizures in about 70% of people just beginning their treatment, and that it completely controls tonic-clonic (grand mal) seizures in about 80%.

These promising results are not always matched in everyday life. Sometimes patients don't take all their medicine on time. Not everyone's seizures can be controlled at a dose that can be taken without side effects. Because of individual differences, there is no "best" amount for everyone. Adjustments are often needed to reduce seizures or side effects.

Many studies have compared carbamazepine with other seizure medicines, to see which medicine is best for people who have just begun treatment for epilepsy. On average, the results were about the same for carbamazepine as for several other seizure medicines that are often used.

Differences in side effects may be important in deciding which medicine is best for each person. Because some people do better with carbamazepine and others do better with something else, it's difficult to forecast the results in any given person. Some people have less trouble with side effects when they take Carbatrol than when they take other forms of carbamazepine, because the amount of medicine in the blood is more even throughout the day.

If seizures continue, the doctor probably will change the amount of Carbatrol prescribed. If that doesn't work, the next step may be either to prescribe a different seizure medicine by itself or to prescribe a combination of Carbatrol and another seizure medicine. Dilantin (phenytoin) is often used, but many other medicines are also available. No single combination is best for everyone.

If you notice any of these problems, call the doctor. Sometimes the doctor can help by changing the amount or type of medicine prescribed. No one should stop taking Carbatrol or change the amount they take without their doctor's guidance.

Some people who have trouble with side effects after taking other forms of carbamazepine do better with an extended-release form like Carbatrol or Tegretol-XR. With other types of carbamazepine, the level of medicine in the blood may become too high (and cause side effects) within a few hours after taking a dose. Because Carbatrol releases the medicine slowly, the amount in the blood does not become so high after a dose is taken. Instead, it stays fairly even throughout the day.

People who have just started taking Carbatrol (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.

Allergic reactions
About 5% to 10% of people who take Carbatrol or other forms of carbamazepine have a red rash within in the first month of taking it. If this happens, tell the doctor or nurse right away, to be sure that it's not the beginning of a serious problem.

Serious side effects of carbamazepine are rare. It is important to be aware of possible reactions and what to do if they happen. Only a very small number of people have died from them.

• Read the package insert for a complete list of all reactions to carbamazepine. 
• Call your provider's office right away if any of these problems occur. 

Allergic reactions: About 5 to 10% of people who take carbamazepine have a red rash within in the first month of taking it. If this happens, tell your health care provider to be sure that it's not the beginning of a serious problem.

• Tell your provider if you have had a rash to oxcarbazepine or eslicarbazepine or any similar medications in the past. You could have a similar reaction to carbamazepine.

Severe skin reactions: Carbamazepine can cause rare but serious skin reactions, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). These conditions may start with a fever and flu-like symptoms. Then a rash develops. Ulcers or lesions of the mucous membranes may be seen and develop into painful blisters. 

• Report any fever or rash to a health care provider as this can be a life-threatening condition. 
• These types of skin reactions happen most commonly in the second or third week after starting the medicine. Though it can happen at other times too. 
• Serious skin rashes are more common in people with a particular gene called “HLA-B*1502.” (An allele is a form of a gene that is found on a chromosome. Alleles are involved in deciding whether certain traits passed on from a parent to a child will occur. The tendency to severe drug reactions can be one of these traits.) 
  • This gene is found in ancestry or family lines from broad areas of Asia including South Asian Indians. People who are Chinese, Thai, Filipino, Malaysian, and Korean may have an increased risk for these skin reactions with carbamazepine.
  • People at risk should be tested for the HLA-B*1502 allele before starting carbamazepine. If you test positive, you should avoid using this medicine unless your provider and you decide the benefits are worth the risks. 

Blood disorders: Certain changes in blood cells may happen and lead to serious problems. Only 1 in 30,000 people who take carbamazepine will develop one of these blood disorders. This risk is higher than the risk for people who do not take carbamazepine. Some symptoms of a blood disorder may include:

• Bruising easily
• Fever
• Nosebleeds or other unusual bleeding
• Sore throat
• Sores in the mouth
• Tiny red spots on the skin

Blood tests are usually done before starting carbamazepine and again while taking it. These tests look for any changes that happen while on this medicine. Some people may have some small changes in their blood that go away on their own. 

If you notice any of these symptoms, call your health care provider right away. Do not stop taking carbamazepine without your doctor's advice. 

Liver problems: Liver problems are another serious disorder that occurs in a few people who take carbamazepine. Some symptoms may include: 

• Black or pale color of bowel movements
• Loss of appetite
• Nausea, upset stomach, vomiting
• Stomach pain
• Yellow eyes or skin

Tell your health care provider right away if you notice any of these problems. Do not stop taking carbamazepine without your doctor's advice. 

Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo.

• Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
•  Do not make any changes to the medicines without first talking to your prescribing health care provider.
•  Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions
• Contact your health care provider before stopping any seizure meicine. This could possibly lead to worsening of seizure and mood.

Carbamazepine use has been associated with osteoporosis and or osteopenia in both men and women taking this drug.  It is essential that if you taking this medication, that one take supplemental calcium of 1000 milligrams per day.  Talk to your doctor about bone health.  He/She may decide to check Vitamin D levels and other tests to check for the impact of this drug on your bones.

Often doctors find that medicines are useful for more than one purpose. Various forms of carbamazepine (the medicine in Carbatrol) have been used successfully for many years to treat a type of facial pain called trigeminal neuralgia. Studies have shown that this treatment is effective, so Carbatrol is approved by the Food and Drug Administration (FDA) for this purpose.

It is also legal to prescribe medicines for "off-label uses" even though the FDA has not formally approved such use. Carbatrol is sometimes used "off-label" to treat certain other types of pain and some kinds of mental illness.

A very similar product called "Equetro" is approved for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. For more information please go to www.equetro.com

People who have certain genes: People with the genes called “HLA-B*1502” or HLA-A*3101 should not use carbamazepine. Rashes that may be very serious are more likely to occur in people with these genes.

• The HLA-B*1502 gene ioccurs almost exclusively in people with ancestry or family lines across broad areas of Asia, including South Asian Indians.
• The HLA-A*3101 gene is reported in people of European descent.

People with a history of severe skin rashes: People who have had severe skin rashes with carbamazepine should not take it again. People have had had severe skin reactions to other seizure medicines should be careful about taking carbamazepine.

People with absence seizures or myoclonic seizures: Carbamazepine may worsen absence and myoclonic seizures. 

People with liver disease and who take certain medicines: People with liver disease or who take certain types of medicine should be careful taking carbamazepine. Work closely with your health care provider about how much carbamazepine to take and what to look for. Tell your doctor about any liver problems and about all medicines you take.  

Sometimes one kind of medicine cha0nges the way another kind of medicine works in the body. This is true not only for prescription medicines, but also for medicines you just pick up off the shelf at the store. It’s also true for herbal products, vitamins, a few kinds of food, and even cigarettes!

Any time a doctor suggests a new prescription, be sure to talk about what other medicines are already in use. If two kinds of medicine affect each other, the doctor may want to prescribe something else or change the amount to be taken.

How does Carbatrol affect other medicines?

Carbatrol makes birth control pills less effective, so the chances of becoming pregnant are greater. Women who use pills for birth control should talk to the doctor who prescribed them right away if they start taking Carbatrol. The same is true for some other forms of birth control such as Depo-Provera and implants. Birth control methods like condoms, IUDs, and diaphragms are not affected by Carbatrol.

Carbatrol also affects the way the body handles many other seizure medicines. Some of these are:

• Depakote (valproic acid)
• Dilantin or Phenytek (phenytoin)
• Klonopin (clonazepam)
• Topamax (topiramate)

How do other medicines affect Carbatrol?

Some medicines can cause carbamazepine (the medicine in Carbatrol) to build up in the blood. Having too much carbamazepine in the blood makes people feel dizzy, unsteady, or sleepy. Some of the medicines and other things that may do this include:

• Depakote and seizure medicines closely related to it
• some medicines for high blood pressure, including Cardizem (diltiazem) and verapamil
• Prozac (fluoxetine)
• certain antibiotics, including erythromycin
• cimetidine (Tagamet, also available without a prescription)
• painkillers Darvon and Darvocet
• several medicines used to treat fungus infections
• grapefruit juice

On the other hand, some medicines reduce the amount of carbamazepine in the blood. More seizures may occur unless more Carbatrol is taken. Medicines that may have this effect include:

• Dilantin or Phenytek (phenytoin)
• Felbatol (felbamate)
• Trileptal (oxcarbazepine)
• phenobarbital
• Mysoline (primidone)

Children’s bodies digest carbamazepine, the medicine in Carbatrol, faster than adults’ bodies do. Because they absorb it so quickly, side effects like sleepiness, double vision, or dizziness can be a problem for children when they take forms that are quickly absorbed. This kind of effect should be reduced if they take Carbatrol, because the level of medicine in their blood will be more even.

Because their bodies break down the medicine faster, children need to take more, pound for pound, than adults do. Even so, the smallest Carbatrol capsule, 100 milligrams, may be too large a dose for a very small child, especially when treatment is just beginning.

By the time children reach their early teens, their bodies absorb, digest, and excrete medicines more like adults do, so they may need to take less medicine than they took when they were a little younger.

Carbatrol is useful in treating many kinds of seizures that occur in children. But other types that are also common can be made worse, so a correct diagnosis is very important.

Parents and doctors also need to watch for problems with thinking or behavior. These problems are uncommon, but if they occur they can interfere with the child’s development and school performance.

In the United States, the Food and Drug Administration (FDA) assigns each medication to a <link:http://my.epilepsy.com/web/info/women_pregnancy_fda>Pregnancy Category</link> according to whether it has been proven to be harmful in pregnancy. Carbamazepine, the medicine in Carbatrol, is listed in Pregnancy Category D. This means that there is a risk to the baby, but the benefits may outweigh the risk for some women.

In fact, a large majority of women who use Carbatrol during pregnancy have normal, healthy babies. Certain types of defects are increased (especially if Carbatrol is taken during the first 3 months of pregnancy) but they are still relatively uncommon. The risk of defects is higher for women who take more than one seizure medicine. Women with a family history of birth defects also have a higher risk.

All women who are capable of becoming pregnant should take 0.4 mg (400 mcg) of the vitamin called folic acid every day because it helps to prevent one type of birth defect. (The most well-known of these is spina bifida, in which the spinal cord is not completely enclosed.) These defects are more common in the babies of women who take Carbatrol during the first 4 to 6 weeks of pregnancy. If the doctor thinks a woman is at especially high risk, a much larger dose of folic acid—4 mg (4000 mcg) per day—will be recommended.

Women with epilepsy who are pregnant or thinking about becoming pregnant should talk to their doctor about their seizure medicines. Taking more than one seizure medicine may increase the risk of birth defects, so doctors sometimes gradually reduce the number or amount of seizure medicines taken by women planning for pregnancy.

This is not done routinely, however, because it increases the risk of seizures. Some kinds of seizures can injure the baby, so do not stop using seizure medicines or reduce the amount without the doctor’s OK.

Doctors have prescribed Carbatrol and other forms of carbamazepine to people over 65 for many years with good results. Seniors do have a few special problems, however.

Most seniors take more medicines than younger people, so there’s a greater risk that the medicines may affect each other. Usually seniors can continue to take all the medicines they need, including Carbatrol, without trouble if the doctor changes the amount of some of them to make up for the way they affect each other.

Seniors also tend to be more sensitive than younger adults to medicines and their side effects. For instance, many seniors have a problem with sleepiness or unsteadiness even before they start taking Carbatrol. These are common side effects of this medicine, so these problems may become worse and cause real trouble.

Seniors also face more danger from these side effects because they are more likely to be seriously hurt if they fall or have another kind of accident.

Because the level of medicine in the blood is more even throughout the day when Carbatrol is used, side effects may be less of a problem than with many other forms of carbamazepine. Seniors also may find it easier to remember to take their pills just twice a day.

To reduce side effects even more, the doctor probably will prescribe a low dose to start and then be very cautious about any increases. Because the smallest Carbatrol capsule is 100 milligrams, some seniors may have to begin by taking another form of carbamazepine and change to Carbatrol when they reach a higher daily dose.

It’s especially important for seniors keep the doctor informed about any changes that they notice.

The best amount is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors, which are different for every individual. Follow the doctor's directions. Call if you have any questions.

To avoid unwanted side effects, the doctor will prescribe a low dose to start and increase it gradually until the seizures are controlled or side effects become too troublesome. Because the smallest Carbatrol capsule is 100 milligrams, a few people may have to begin by taking another form of carbamazepine and change to Carbatrol when they reach a higher daily dose.

No one should stop taking Carbatrol or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once can cause a problem that may be life-threatening.

Don’t use more Carbatrol than the doctor prescribes. If a little extra (such as one or two extra capsules) is taken by accident, call the doctor for advice. For a larger overdose, call a poison control center or emergency room right away, unless you have special instructions from the doctor.

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called ""prescribing information"") online. The U.S. package insert for Tegretol-XR (carbamazepine-xr) is found at:

• http://www.pharma.us.novartis.com/product/pi/pdf/tegretol.pdf

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see "How to read a package insert."