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Indications Overview
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| Frequently Asked Questions About LAMICTAL Both you and your patients may have questions about LAMICTAL. The first set of questions below is designed to assist you in answering these questions. To obtain a patient-friendly pamphlet about LAMICTAL, please contact your GlaxoSmithKline representative or call the GlaxoSmithKline Response Center at 1-888-825-5249. Jump to questions you or your staff may have about LAMICTAL> Questions your patients may ask Print to obtain a copy of the questions and answers below that you can give to your patients.
A. LAMICTAL is the brand name of an antiseizure medicine called lamotrigine. Like many antiseizure medicines, it helps regulate the electrical activity in the brain. LAMICTAL can be used to treat:
Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. [ return to top ] Q. Who should not take LAMICTAL? A. Anyone who has had an allergic reaction to this medication in the past should not take LAMICTAL. [ return to top ] Q.Can a pregnant woman take LAMICTAL? A. All women of childbearing potential should discuss with their doctor their antiseizure medicine regimen and what to do in the event of pregnancy. The effects of LAMICTAL during pregnancy are not known at this time. Any woman who becomes pregnant while taking LAMICTAL should talk to her doctor as soon as possible. [ return to top ] Q. Can a woman breast-feed while taking LAMICTAL? A. Some LAMICTAL passes into breast milk and the effect of this on infants is unknown. So, if you (or your loved one) is considering breast-feeding, notify your epilepsy doctor so he or she can determine if LAMICTAL should be continued or stopped. [ return to top ] Q. How long does it take to reach the maintenance dose of LAMICTAL? A. It may take several weeks or even months to arrive at the best maintenance dose of LAMICTAL. Never take more or less LAMICTAL than prescribed. [ return to top ] Q. Why does it take several weeks to determine the right dose of LAMICTAL? A. There are 2 reasons. First, you need to start treatment with a low dose of LAMICTAL and slowly increase the dose over a number of weeks to decrease the risk of rash, including serious rash. Second, the right dosage of medication varies from person to person. Slowly increasing the dose until seizures are controlled will assure that you are taking the lowest amount of LAMICTAL that's effective. Do not increase the dose or take more frequent doses, unless instructed to by your doctor. It's important to follow instructions exactly regarding how much LAMICTAL to take and when to take it. Contact your doctor if you stop taking LAMICTAL for any reason. Do not restart without consulting your doctor. [ return to top ] Q. What should I do if I miss a dose of LAMICTAL? A. If a dose of LAMICTAL is missed for any reason, do not double the next dose. Simply take the next scheduled dose on time. If you (or your loved one) find that you are missing doses, ask your doctor about ways to help you stay on track. Remember: do not stop taking LAMICTAL or any other antiseizure medicines unless your doctor tells you to. Contact your doctor if you stop taking LAMICTAL for any reason. Do not restart without consulting your doctor. [ return to top ] Q. Will LAMICTAL affect my ability to drive? A. Use caution before driving a car or operating complex, hazardous machinery until you (or your loved one) know if LAMICTAL affects the ability to perform such tasks. It is important to learn about issues related to driving and seizure control in your state; regulations vary. Be sure to ask your doctor if LAMICTAL will affect your (or your loved one's) ability to perform such tasks. [ return to top ] Q. What if my seizures get worse? A. If seizures get worse, or if you (or your loved one) experience a new type of seizure, tell your epilepsy doctor right away. [ return to top ] Q. Can I take other medications while I'm taking LAMICTAL? A. Both prescription and nonprescription medicines can interact with LAMICTAL. So, it's important to check with the doctor and pharmacist before taking any other medicines or herbal remedies such as those sold in drug stores and health food stores. Do not start or stop using birth control pills or other female hormonal products until you have consulted your doctor. Stopping or starting these products may cause side effects (such as dizziness, lack of coordination, or double vision) or decrease the effectiveness of LAMICTAL. Also, tell your doctor as soon as possible if you experience side effects or changes in your menstrual pattern (eg, break-through bleeding) while taking LAMICTAL and these medications. [ return to top ] Q. What are the most common side effects of LAMICTAL? A. Most people who take LAMICTAL can tolerate it well. However, as with all medications, some people experience side effects. The most common side effects with LAMICTAL include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, and rash. LAMICTAL may cause other side effects not listed here. If you (or your loved one) develop any side effects or symptoms you are concerned about, or if you need more information, call your doctor. [ return to top ] Q. Are any side effects of LAMICTAL serious? A. In a small number of people, LAMICTAL causes a serious skin rash. In these cases, the person must be treated at a hospital; rarely, deaths have been reported. Serious skin rashes are most likely to occur within the first 8 weeks of treatment with LAMICTAL, although people taking LAMICTAL for several months have also been affected. Serious skin rashes are also more likely to occur in children than in adults. [ return to top ] Q. How can I know if a mild rash will develop into something more serious? A. It is not always possible to tell if a mild rash will develop into a more serious reaction. For this reason, if you (or your loved one) develop any kind of skin rash, hives, fever, swollen glands in the neck, painful sores in the mouth and around the eyes, or swelling of the lips or tongue, tell a doctor right away, since these symptoms may be the first signs of a serious reaction. A doctor will evaluate the condition and decide whether LAMICTAL should be stopped. [ return to top ] Q. Are some people more likely than others to develop a serious rash? A. Serious skin rashes may be more likely to occur if LAMICTAL is taken in combination with another medication called valproate (brand names are Depakene®* and Depakote®*). Serious skin rashes are also more likely to occur if you (or a loved one) take a higher starting dose of LAMICTAL than instructed by the doctor, or if the dosage is increased faster than instructed. *Depakene (valproic acid) and Depakote (divalproex sodium) are registered trademarks of Abbott Laboratories. [ return to top ] Q. How is LAMICTAL taken? A. You (or your loved one) and your epilepsy doctor can choose the right type of LAMICTAL tablets for you. There are 2 kinds of LAMICTAL tablets: regular tablets that you swallow whole, and chewable dispersible tablets that can be swallowed whole, chewed, or dissolved in liquid. To dissolve the chewable dispersible tablets, add them to a small amount of water or diluted fruit juice, just enough to cover the medicine. Wait about 1 minute, until the tablets are dissolved. Then swirl the solution around so that it is evenly dispersed, and drink the entire quantity immediately. To make sure that you (or your loved one) are taking the correct medication, compare your tablet with the images shown below. [ return to top ] Q. Should I keep LAMICTAL in the refrigerator? A. No. Store LAMICTAL at room temperature and away from heat and light. Always keep LAMICTAL out of the reach of children. If for any reason your doctor stops treatment with LAMICTAL, do not keep any leftover medicine unless your doctor tells you to. Medication should be thrown away as instructed. [ return to top ] Questions you or your staff may have about LAMICTAL Print to obtain a copy of the questions and answers below.
A. LAMICTAL is available as scored tablets and chewable dispersible tablets for maximum dosing flexibility.  
Berry-flavored, chewable dispersible tablets can be chewed, dissolved in juice or water, or swallowed whole. 2-mg dosage available to healthcare professionals only from your representative or through the GlaxoSmithKline Response Center (1-888-825-5249). 5-mg and 25-mg tablets available from your GlaxoSmithKline representative and through retail pharmacies. FREE 5-week Sample Kits help simplify titration for patients >12 years. Easy-to-follow Starter Kits are available by prescription. [ return to top ] Q. How is LAMICTAL dosed? A. Dosing guidelines are available in the Prescribing Information for LAMICTAL, or see the dosing section of this Web site. [ return to top ] Q. What should I tell my patients before initiating LAMICTAL? A. Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. In addition, the patient should notify his or her physician if worsening of seizure control occurs. Patients should be advised that LAMICTAL may cause dizziness, somnolence, and other symptoms and signs of central nervous system depression. Accordingly, they should be advised neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on LAMICTAL to gauge whether or not it adversely affects their mental and/or motor performance. Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy. Patients should be advised to notify their physicians if they intend to breast-feed or are breast-feeding an infant. Women should be advised to notify their physician if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Stopping or starting these products may cause side effects (such as dizziness, lack of coordination, or double vision) or decrease the effectiveness of LAMICTAL. They should also be advised to promptly notify their physician if they experience changes in menstrual pattern (eg, break-through bleeding) while receiving LAMICTAL in combination with these medications. Patients should be advised to notify their physician if they stop taking LAMICTAL for any reason and not to resume LAMICTAL without consulting their physician. [ return to top ] Q. Do any medications interact with LAMICTAL? A. You should be aware of the following: Valproate (VPA) reduces the clearance of LAMICTAL. The dosage of LAMICTAL required in the presence of VPA is less than half of that required in its absence. See Prescribing Information for LAMICTAL. The interaction of LAMICTAL and several medications has been studied. A table that summarizes these interactions is included below. Please see complete Prescribing Information for full description of drug interactions. Summary of Drug Interactions With LAMICTAL
* From adjunctive clinical trials and volunteer studies. † Net effects were estimated by comparing the mean clearance values obtained in adjunctive clinical trials and volunteers studies. ‡ The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated in clinical trials and the effect may not be similar to that seen with the ethinylestradiol/levonorgestrel combinations. §Modest decrease in levonorgestrel. ║Not administered, but an active metabolite of carbamazepine. ¶Slight decrease, not expected to be clinically relevant. #Not administered, but an active metabolite of oxcarbazepine. ** Slight increase not expected to be clinically relevant. <—> = No significant effect. ? = Conflicting data.
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL. The incidence of these rashes, which have included SJS, is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy and 0.3% (3/1000) in adults on adjunctive therapy. [ return to top ] Q. How can I simplify titration with LAMICTAL? A. Many AEDs require titration to effective dose—only LAMICTAL offers 5-week Sample Kits or Starter Kits available by prescription to make it simple for you and your patients older than 12 years. The green kit is for patients taking carbamazepine, phenytoin, primidone, phenobarbital, or rifampin and not taking valproate (includes valproic acid and divalproex sodium). The orange kit is for patients not taking carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate, and the blue kit is for patients taking valproate. They include clear, simple patient instructions. 
Sample Kits for LAMICTAL are available only from your GlaxoSmithKline representative. To contact your representative, please call the GlaxoSmithKline Response Center at 1-888-825-5249. Also, Starter Kits for LAMICTAL are available in pharmacies. [ return to top ] Q. Can I be confident converting my adult patients to monotherapy with LAMICTAL from carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED? A. The Expert Consensus Opinion for the Treatment of Epilepsy, published in 2005 in Epilepsy & Behavior, reported the results of a survey taken among 51 leading physicians treating epilepsy (43 of 48 responded).1 The survey was designed to address key decision points in the management of epilepsy and seizures. Participants were asked to rank the order in which they would recommend certain therapies and to rate those choices using a 9-point scale. The Expert Consensus Guideline Series: Treatment of Epilepsy was sponsored by unrestricted educational grants from Abbott Laboratories, GlaxoSmithKline, Novartis Pharmaceuticals and UCB Pharma, Inc. The opinions expressed in this survey are those of the expert panel. Dosages, indications, and methods of use referred to in the guideline may reflect the clinical experience of the editors, professional literature, or other clinical sources. When asked which monotherapy they would choose after the failure of initial monotherapy, 91% of the responding physicians recommended LAMICTAL when the first monotherapy was carbamazepine or phenytoin. This overwhelming confidence in the proven seizure control and tolerability of LAMICTAL is supported by more than 16 years of worldwide postmarketing experience and more than 5 million patient exposures worldwide—and growing.2* Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. *Based on kg of lamotrigine sold. References: 1. Karceski S, Morrell M, Carpenter D. Treatment of epilepsy in adults: expert opinion, 2005. Epilepsy & Behavior, 2005:7(S1-S64). 2. Data on file, GlaxoSmithKline. [ return to top ] |
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| • | Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs |
| Other dosing considerations | |
| For women starting estrogen-containing oral contraceptives and not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose of LAMICTAL will in most cases need to be increased, by as much as twofold over the recommended target maintenance dose, in order to maintain a consistent lamotrigine plasma level. | |
| Conversely, the maintenance dose of LAMICTAL will in most cases need to be decreased by as much as 50% if estrogen-containing oral contraceptives are stopped in these patients. | |
| Adverse events consistent with elevated levels of lamotrigine (such as dizziness, ataxia, and diplopia) may occur during the week of inactive hormone preparation (pill-free week). (See DOSAGE AND ADMINISTRATION section of the Prescribing Information for additional recommendations.) | |
| Adjustments to maintenance doses also may be necessary during pregnancy and following delivery. | |
| Dose adjustments are recommended for patients with hepatic or renal functional impairment. | |
| Important Safety Information | |
| • | Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome |
| — Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death | |
| — Mood disorders: In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adults receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy | |
| • | 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 |
| • | Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and LAMICTAL should be discontinued if an alternative etiology cannot be established |
| • | Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately |
| • | To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded |
| • | LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related |
Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets |
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