Generic Name: lamotrigine (Oral route)
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) receiving the immediate-release formulation of lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive immediate-release formulation of lamotrigine, there was 1 rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
The risk of serious rash caused by treatment with lamotrigine is not expected to differ from that with the immediate-release formulation of lamotrigine. However, the relatively limited treatment experience with lamotrigine makes it difficult to characterize the frequency and risk of serious rashes caused by treatment with lamotrigine.
Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by lamotrigine. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors.
Nearly all cases of life-threatening rashes caused by the immediate-release formulation of lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (eg, 6 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.
Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring .
Serious, life-threatening rashes requiring hospitalization and discontinuation of treatment have been caused by lamotrigine. The risk of rash may also be increased by coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Nearly all cases of life-threatening rashes associated with lamotrigine have occurred within 2 to 8 weeks of treatment initiation. Lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anticonvulsant
Chemical Class: Phenyltriazine
Lamotrigine is used alone or together with other medicines to help control certain types of seizures (e.g., partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It can also be used in the treatment of bipolar disorder (manic-depressive illness) in adults older than 18 years of age.
This medicine is available only with your doctor's prescription.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lamotrigine chewable tablets, disintegrating tablets, or tablets in children with certain types of seizures older than 2 years of age. However, safety and efficacy have not been established in children less than 2 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine extended-release tablets in children with partial seizures below 13 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine chewable tablets, disintegrating tablets, or tablets in children with bipolar disorder. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of lamotrigine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of lamotrigine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving lamotrigine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
This section provides information on the proper use of a number of products that contain lamotrigine. It may not be specific to Lamictal XR. Please read with care.
Take lamotrigine only as directed by your doctor to help your condition as much as possible and to decrease the chance of unwanted effects. 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.
This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Lamotrigine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.
If you are taking the chewable dispersible tablets, they may be swallowed whole, chewed and swallowed, or dispersed in a small amount of liquid and swallowed. If the tablets are chewed, they should be followed with a small amount of water or diluted fruit juice to aid in swallowing. To break up these tablets, add the tablets in enough water or diluted fruit juice to cover the tablets (about a teaspoonful), wait until the tablets are completely dispersed (about 1 minute), then swirl the solution and swallow it immediately.
If you are taking the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet into your tongue and moved around in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.
Swallow the extended-release tablets whole. Do not break, crush, or chew it.
Use only the brand of this medicine that your doctor prescribed. Different brands and dosage forms may not work the same way.
This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.
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 important that your doctor check the progress of you or your child at regular visits, especially during the first few months of your treatment with lamotrigine. This will allow your doctor to change your dose, if necessary, and will help reduce any unwanted effects.
It is important to tell your doctor if you become pregnant while using this medicine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.
You should not start or stop using birth control pills or other female hormonal products while you are taking this medicine until you have consulted your doctor.
Tell your doctor right away if you have unusual changes in your menstrual cycle such as breakthrough bleeding while taking lamotrigine and birth control pills or other female hormonal products.
This medicine may increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; ; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
Lamotrigine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, or drowsiness. 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, well-coordinated, or able to see well. If these reactions are especially bothersome, check with your doctor.
Skin rash may be a sign of a serious unwanted effect. Check with your doctor immediately if you develop a rash, fever, flu-like symptoms, or swollen glands, or if your seizures becomes worse.
Lamotrigine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you have the following symptoms: fever, dark urine, headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellow eyes or skin.
This medicine 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 side effects, tell your doctor or your child's doctor right away.
Do not stop taking lamotrigine without first checking with your doctor. Stopping this medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.
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
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
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:More common
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.
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