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Important Warning : Serious skin rashes requiring medical hospitalization and discontinuation of treatment have been associated with Lamictal. Although rare, this rash (also known as Stevens– Johnson Syndrome) can be life threatening. Any patient who develops a rash while taking Lamictal (or any other medication) should report this to their doctor quickly. People who may be at a higher risk for this rash are those who are also taking Depakene or Depakote, those who have their Lamictal doses increased rapidly, and those patients who are younger than 16 years.

FDA ALERT [1/31/2008] - The FDA has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. These drugs are commonly referred to as antiepileptic drugs. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

FDA Alert (9/2006) New information suggests that babies exposed to Lamictal during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. Babies born with cleft lip or cleft palate have a gap in the upper lip or roof of the mouth. If you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor. Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy. Do not start or stop using Lamictal without talking to your doctor. More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal.

Note: It is very important to check your medication each time it is filled. There have been errors reported in consumers receiving Lamisil instead of Lamictal.

Brand and Generic Names

What is Lamictal® and what does it treat?

Lamotrigine is an anticonvulsant drug approved for the treatment of seizures (epilepsy) in adults and children. It can be used alone, or in combination with other anticonvulsants. It has also been approved for the maintenance treatment of bipolar disorder (manic-depressive disorder). That means lamotrigine will help to delay the time to occurrence of mood episodes. Some patients with rapid-cycling bipolar disorder (four or more mood episodes in one year) have been treated with lamotrigine by itself.

Bipolar disorder is a brain disorder (mental illness) that exposes people to these mood changes over the course of time. Bipolar disorder affects more than two million American each year, but patients with this disorder can lead fulfilling lives when they receive proper treatment. Unfortunately, many people with this illness do not receive treatment.

Bipolar disorder involves episodes of depression and/or mania. A depressive episode, or depression, is when a person experiences several of the following symptoms at the same time: “low” or depressed mood (for example, sad, empty, tearful), decreased interest in most or all activities, changes in appetite (usually decreased), changes in sleep (usually poor sleep), loss of energy, feeling worthless/guilty/ hopeless/ helpless, difficulty concentrating, thoughts of death (suicidal thinking). Lamotrigine has been studied for the treatment of bipolar depression.

A manic episode, or mania, is when a person experiences several of the following symptoms at the same time: “high” or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees). Lamotrigine by itself has not been useful for severe or recurrent mania.

What is the most important information I should know about Lamictal®?

Since bipolar disorder is a long–term illness, duration of treatment with mood stabilizers like lamotrigine may also be long–term. It is very important to take Lamictal regularly and exactly as prescribed by your doctor. Missing doses of lamotrigine increases your risk for a relapse in your mood symptoms. It may also increase the possibilities of troublesome side effects such as seizures.

Do not stop taking lamotrigine or change your dose without talking to with your healthcare provider first.

In order for lamotrigine to work properly, it should be taken every day as ordered by your health care provider.

Are There specific concerns about Lamictal® and pregnancy?

Lamotrigine can interfere with folic acid. Therefore, female patients should be aware that lamotrigine may increase the chances of birth defects in babies. New information suggests that babies exposed to lamotrigine during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. Babies born with cleft lip or cleft palate have a gap in the upper lip or roof of the mouth. More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who takelamotrigine.

If you are planning on becoming pregnant or have become pregnant, you should talk with your healthcare provider so that he/she can best manage your medications. People living with bipolar disorder who wish to become pregnant face important decisions about the risks and benefits of the medications as they relate to the illness, and to the fetus. This is a complex decision as untreated bipolar disorder has risks to the fetus as well as the mother. There are many dimensions to these choices, so be sure to confer with your doctor and caregivers. Do not start or stop taking lamotrigine without talking to your doctor.

Due to a lack of data to ensure safety, breast feeding while takinglamotrigineis not recommended.

What should I discuss with my healthcare provider before taking Lamictal®?

How should I take Lamictal®?

The amount of lamotrigine you take, and how quickly your dose will increase depends on whether or not you are taking other medications that may interact with lamotrigine. The table that follows provides important information about dosing. The maximum lamotrigine dose in the treatment of Bipolar disorder is different depending on other medications you are taking. Your healthcare provider will determine the dose that is right for you based upon your response

What happens if I miss a dose of Lamictal®?

If you miss a dose of lamotrigine, take it as soon as you remember to, but only if it is not too close to when your next dose is due - discuss this with your healthcare provider. If it is close to your next dose, wait until then to take the medication and skip the missed dose. Do not double your next dose or take more than what you have been told to take.

What should I avoid while taking lamictal®?

What happens if I overdose?

If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).

There have been reports of people who have overdosed with lamotrigine. Some of the overdoses resulted in death. Overdose has resulted in dizziness, abnormal eye movements, seizures, sleepiness or loss of consciousness, and abnormal heart rhythms.

What are the possible side effects of Lamictal®?

Patients being treated with lamotrigine for bipolar disorder should report to their doctor if suicidal thinking starts or worsens. They should also report to their doctor if their mood symptoms begin to “switch” from symptoms of depression tosymptoms of mania.

Common side effects reported by people who have taken lamotrigine alone for the treatment of bipolar disorder include: nausea, insomnia, daytime sleepiness, feeling physically tired (fatigue), runny nose, and non–serious rash.

Common side effects reported by people who were taking lamotrigine in combination with another treatment or treatments for bipolar disorder include: headache, rash, dizziness, diarrhea, abnormal dreams, and itchy skin.

A serious, life threatening rash (also known as Stevens–Johnson Syndrome) may occur with the use of lamotrigine. Although this rash is believed to be rare, any patient who develops a rash while taking lamotrigine (or any other medication) should report this to their doctor quickly. Extra caution is needed in patients who are younger than the age of 16 and receiving lamotrigine - these patients may be at an increased risk of developing this life threatening rash. Other rare, but serious, side effects may occur with lamotrigine. Talk with your healthcare provider if you experience side effects that are bothersome.

Are there any risks for taking Lamictal®for long periods of time?

None are known, however, lamotrigine is meant to be taken for a long time. In fact, you should not suddenly stop taking lamotrigine l without talking to your doctor first .

What other drugs interact with lamictal®?

How long does it take for Lamictal®to work?

It is very important to tell your doctor how you feel things are going during the first two months after you start taking lamotrigine, or after your dose has been changed. It will probably take several weeks for you and your doctor to see enough changes in your symptoms to decide if lamotrigine is the right drug for you.

Mood stabilizer treatment is generally needed lifelong for persons with bipolar illness. Your doctor can best discuss the duration of treatment you need based on your symptoms and course of illness

For further information. Please contact the pharmaceutical company listed below.

Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.

Lamictal® (lamotrigine)